Volume I · 4.4 Health status in India_____ 21 4.5 Future of Healthcare: An industry ... the needs...

Volume I

Volume II

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The Project for defining the “Framework for Information

Technology Infrastructure for Health” has been undertaken by

The Department of Information Technology (DIT), (Ministry of Communication & Information Technology (MCIT))

with the support of the project Implementation Agency

Apollo Health Street Limited (AHSL)

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Table of Content

Volume I

1 Acknowledgement____________________________________________________ 4

2 Preamble ___________________________________________________________ 6

3 Executive Summary___________________________________________________ 7

Information Technology Infrastructure for Health: The felt need_________________ 7

3.1 Information Technology Infrastructure for Health (ITIH): An Introduction ___ 9

3.2 The ITIH Initiative ________________________________________________ 10

3.3 Collaborative effort of MCIT and AHSL ______________________________ 11

3.4 ITIH Project Methodology _________________________________________ 11

3.5 First ITIH Workshop: November 2002________________________________ 13

3.6 Second ITIH Workshop: March 2003 ________________________________ 14

3.7 The Final Recommendations: A Summary____________________________ 14

3.8 Implementation Roadmap: A Summary ______________________________ 17

4 Healthcare Scenario in India___________________________________________ 19

4.1 Introduction ____________________________________________________ 19

4.2 Healthcare Institutional Framework in India __________________________ 20

4.3 Healthcare challenges in the Indian Context – IT perspective ____________ 21

4.4 Health status in India_____________________________________________ 21

4.5 Future of Healthcare: An industry perspective ________________________ 26

5 Information Technology Infrastructure for Health (ITIH)_____________________ 27

5.1 Information Technology Infrastructure for Health: The Felt need _________ 27

5.2 ITIH and India ___________________________________________________ 29

5.3 Benefits of Standardisation through ITIH_____________________________ 30

5.4 The Telemedicine Experience and ITIH ______________________________ 31

6 Project Scope and Methodology _______________________________________ 32

6.1 Project Deliverables______________________________________________ 32

6.2 Project Assumptions and Philosophy _______________________________ 33

6.3 Methodology ___________________________________________________ 34

6.4 Project Approach ________________________________________________ 36 6.4.1 Health Information Standards______________________________________ 36 6.4.2 Legal Framework _______________________________________________ 37 6.4.3 Education_____________________________________________________ 38

7 ITIH Vision for Indian Healthcare System ________________________________ 40

8 Global Examples of ITIH ______________________________________________ 41

8.1 Benchmarked Countries __________________________________________ 41

8.2 HIPAA: USA Thrust on Standardisation ______________________________ 44

8.3 Case Example: Billing Formats in the US Context _____________________ 45

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8.3.1 Medicare: US's largest health insurance program ______________________ 45

8.4 Standards for Electronic Transactions (for Billing) under HIPAA _________ 47

8.5 Key Learning for India ____________________________________________ 51

9 Overview of Recommendations ________________________________________ 52

9.1 Billing Formats__________________________________________________ 53 Introduction _________________________________________________________ 53 Methodology ________________________________________________________ 53 Final Recommendations _______________________________________________ 55 Implementation ______________________________________________________ 77

9.2 Clinical Standards _______________________________________________ 79 Introduction _________________________________________________________ 79 Clinical Data Standards > Disease Codes __________________________________ 81 Clinical Data Standards > Procedure Codes ________________________________ 85 Clinical Data Standards > Clinical Observation Codes_________________________ 89

9.3 Data Elements __________________________________________________ 94 Introduction _________________________________________________________ 94 Methodology ________________________________________________________ 95 Recommendations____________________________________________________ 97 Implementation _____________________________________________________ 105

9.4 Minimum Data Sets _____________________________________________ 106 Introduction ________________________________________________________ 106 Methodology _______________________________________________________ 106 Recommendations___________________________________________________ 108 Implementation _____________________________________________________ 114

9.5 Health Identifiers _______________________________________________ 115 Methodology _______________________________________________________ 118 Recommendations___________________________________________________ 120 Implementation _____________________________________________________ 130

9.6 Messaging Standards ___________________________________________ 132 Methodology _______________________________________________________ 132

9.7 The Education Framework _______________________________________ 134 Introduction ________________________________________________________ 134 Methodology _______________________________________________________ 134 Recommendations___________________________________________________ 136

9.8 The Legal Framework ___________________________________________ 143 Introduction ________________________________________________________ 143 Delegated Legislation ________________________________________________ 147

9.9 Implementation Road Map for ITIH _________________________________ 148

10 Working Members & Groups of ITIH__________________________________ 161

10.1 About the Implementation Agency _________________________________ 163

10.2 Core-Project Team for ITIH _______________________________________ 164

List of Annexure - Volume II ______________________________________________ 167

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1 Acknowledgement

The implementation Agency is extremely grateful to Shri. Rajeeva Ratna Shah, the then Secretary to the Government of India - Ministry of Communications & Information Technology, for motivating the team to come out with a report that can put India onto a fast track for defining the Information Technology Infrastructure for Health (ITIH). The implementation agency is also grateful to Shri. K.K. Jaswal, the current Secretary to the Government of India - Ministry of Communications & Information Technology for having encouraged the team to carry forward the work that was initiated under the ITIH project. The team is thankful to Shri. S Lakshminarayanan, Additional Secretary to the Government of India - Ministry of Communications & Information Technology, for steering the initiative. He has been an excellent support, a rational sounding board, and has mentored the team through the duration of the ITIH project. Without his personal involvement, this project would not have seen the light of the day. The team is also grateful to Shri. B. S. Bedi, Senior Director - Ministry of Communications & Information Technology, for his involvement in the ITIH project. His experience in the Department of Electronics and in Health care programs enabled the team to explore the full potential of the ITIH project and to take the initiative forward. His active involvement in the proceedings of the ITIH project is deeply appreciated. The implementation agency would also like to take this opportunity to thank the following organizations that have contributed significantly to putting this proposal together and they include:

• AIIMS All India Institute of Medical Sciences • AMSS Amarchand Mangaldas Shroff & Sons • DGHS Directorate General of Health Services • DIT Department of Information Technology • ESIC Employee State Insurance Corporation • GIPSA General Insurers Public Sector Association • ICMR Indian Council of Medical Research • IMA Indian Medical Association • IRDA Insurance Regulatory and Development Authority • ISRO Indian Space Research Organization • MCI Medical Council of India • MCSI Medical Computer Society of India • MOHFW Ministry of Health & Family Welfare • MSH Management Sciences for Health • NIA National Insurance Academy • SGPGI Sanjay Gandhi Post Graduate Institute of Medical Sciences • TAC Tariff advisory committee (IRDA) • WHCIT Wipro Healthcare IT • WHO World Health Organization

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Additionally, the Implementation Agency thanks the following professionals who have extended their knowledge and expertise in bringing in value to the ITIH project.

• Dr. C.V.R. Prasad Cardiology, Apollo Hospitals, Hyd • Dr. Gogia CEO, Amla Mediquip • Dr. Malathi Nizams Institute of Medical Sciences • Dr. Mrs. Sachdeva MCI • Dr. P. S. Reddy MedVarsity • Dr. Padmaja Pathology Dept, Gandhi Medical College • Dr. R. S. Tyagi Deputy Director, AIIMS • Dr. Raman Clinical Trials, Shantha BioTech • Dr. Ranga Reddy President, IMA-Hyderabad Chapter • Dr. Sanjay Shrivastava CMO, DGHS • Dr. Sreenivas Chakravarthy Oncologist, Apollo Hospitals, Hyd • Dr. Sudhir Gupta CMO, DGHS • Dr. Vijay Rai CMO, UNCTD • Mr. Ajit Seth Resident Commissioner, Govt. of UP • Mr. Amit Agrawal CEO, CHIPS • Mr. Anjan Bose Chairman, CII Medical Equipment division • Mr. Atchyuth Prasad CEO, Citaldel Health Ltd • Mr. B.S. Bhalla Secretary (IT), Goa • Mr. C.K. Anil Additional Secretary, Dept of Health -Bihar • Mr. Devashish Pandaya Project Coordinator, CDAC • Mr. Deepak Bansal PSA, NIC, Haryana • Mr. Didar Singh Secretary (H&FW), Punjab Govt • Mr. H. Ansari Chair Professor, G I - National Insurance Academy • Mr. Jitendra K. Singh Director, IT, Tripura • Mr. K.K.Srinivasan Secretary, Tariff Advisory Committee, IRDA • Mr. Mukesh Khullar Secretary IT - Maharashtra • Mr. Mahapatra Secretary, GIPSA • Mr. N.D.Agrawal Joint Secretary, Health, Goa • Mr. Paul S. Lalvani Country Director SEAM, Mgmt Sciences for Health • Mr. Pradhan Ex-Secretary, GIPSA • Mr. R.K.Arora Executive Director, CDAC • Mr. Rakesh Shrivastava CEO, MP Agency for Promotion of IT • Mr. Ranjan Dwivedi Project Manager, Health - InterNetwork (WHO) • Mr. S. Suresh Kumar Joint Secretary (Health & Family welfare), WB • Mr. S.K. Dey Biswas Deputy Director General - ICMR • Mr. S.N. Raghu Kumar Health Systems Specialist, AIIMS • Mr. Sanjeev Kumar Commissioner - Health & Family Welfare, Bangalore • Mr. Satyamurthy Director Antrix Corporation, ISRO • Mr. V. C. Umakanth Partner, Amarchand Mangaldas • Mr. Vishweshwar Konda MD & Chief Mentor - Wipro Healthcare IT • Mr. Zakariah Ahmed Healthcare Desks, CII • Mrs. Alka Sirohi Principal Secretary, Govt of MP (H & FW)

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2 Preamble

Inspired by the grand vision of health for all by bringing healthcare within the reach of every individual, and to make India the healthcare destination of the world, Driven by the need to simplify administrative processes, integrate disparate systems of healthcare and to revolutionise medical practices for the benefit of the common man and the needy, Hoping that an initiative towards standardising and seamlessly integrating various sectors of healthcare on a common platform will go a long way in bridging the gaps and bringing in economies of scale, Believing that the power of information technology can leverage existing systems and evolve a health information system for the country to achieve the distant future now, Recognising the need for a standard system across the country that meets the needs of the diverse groups that record, use, transfer and disseminate health information, legal policies that govern the healthcare structure, and education system to help reinforce the strengths and values of the changing face of Indian healthcare system,

And to be able to offer value to the most important stakeholder - the patient,

The Government of India is convinced that building an Information Technology Infrastructure for Health will efficiently address all information needs of different stakeholders (patients, government, hospitals, insurance companies, vendors and others) in the healthcare industry and will streamline healthcare activities across the country and make India a viable healthcare destination. As part of this endeavour, the Department of Technology (DIT), Ministry of Communications and Information Technology (MCIT), has undertaken the initiative to prepare the ground for the Information Technology Infrastructure for Healthcare (ITIH) in India. Apollo Health Street Limited (AHSL) while coordinating with working groups from various government and private institutions supports the initiative with a mandate to evolve and submit a document on the standardisation of health information and to define the legal and educational framework for the healthcare infrastructure for India.

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3 Executive Summary Information Technology (IT) is changing the way we live, work and communicate. Technology, encompassing all forms of tools and techniques used to create, store, exchange and use information, touches every sector of the economy. In fact, it is the technology that is driving force behind what has often been called "the information revolution" towards the unexplored frontiers. Recognizing the potential of IT in empowering the way we live and function, it is imperative that the Government proactively works and exploits the power of IT for the benefit of society. "Information is a determinant of health" Healthcare, an information-intensive sector, is one of the key areas that can benefit from the use of information technology. Information Technology can play a larger role in addressing key issues that have been of concern of the health industry for many decades such as: § Simplification of administrative processes § Strengthening population-based public health systems § Delivering healthcare services to the under-privileged sections of

society in a cost-effective manner Information technology has the potential to correct inefficiencies by electronically storing and managing huge amount of information that can be used to accomplish multiple tasks and present healthcare providers with an opportunity to reduce expenses of administrative transactions & clinical procedures and enhance the processes. Information Technology Infrastructure for Health: The felt need The Indian healthcare sector, structured on three tiers (primary, secondary and tertiary), is characterized by the presence of several disparate systems of healthcare delivery such as the government, charity, missionary & corporate hospitals and numerous clinics. Currently, all players work in isolation from one another in terms of providing continuum care to patients, depriving all from the economies of scale. There are multiple entities that play an important role in defining the healthcare landscape of India. Amongst others it encompasses the following stakeholders: • Public health agencies at various levels • Health professionals and institutions • Insurance companies • Public and private healthcare organizations • Policymakers • Consumers – can be patients or the population in general, etc.

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The diversity of participants in the healthcare industry and the complexity of their relationships with each other have frustrated the voluntary adoption of information technology and industry standards. IT plays a very significant role in synergising stakeholders towards a common goal. There is a need to educate and empower different groups and players on the benefits of adopting modern technologies to get the stakeholders on a common platform, to enable easy and smooth transition of information and database and to help link them together to take effective action towards the goal ‘health for all’. The healthcare industry's reluctance to invest a percentage of its operating revenues in IT infrastructure could be attributed to various human, social, technological or economic barriers to implementation. The widespread adoption of IT by the healthcare industry is also limited by political and legal constraints. States maintain a great deal of responsibility over regulation of healthcare providers, but unfortunately, many of these states enact legislation and establish regulatory schemes that do not fully appreciate ensuing technological advances. The primary objective of building an Information Technology Infrastructure for Health (ITIH) is to address all information needs of different stakeholders (government, hospitals, insurance companies, patients, vendors and others) in the healthcare industry and to streamline healthcare activities across the country. Driven by principles of standardisation and reaching out to the population at large, the ITIH intends to make healthcare delivery system more efficient. It also aims to address issues and concerns that have hampered progress of the healthcare sector. To help achieve an optimal and efficient healthcare environment, the following issues need to be addressed: • Simplification of administrative process • Sharing of information between disparate systems • Create and maintain population-based data • Reduce data gathering and processing costs • Standardization of health data; coding, reporting & transmission of data • Standards for defining key stakeholders – Patients, doctors, etc. • Improving efficiency of clinical systems in the country • Providing greater access to healthcare in a cost-effective manner • Delivery of health-related information and services to remote locations In implementing the ITIH, it is of paramount importance to align the multiple stakeholders towards a common objective and goal. The starting point for the ITIH is to address the following constraints that are plaguing India’s healthcare industry:

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• Lack of policies and legislations to protect privacy while permitting critical analytic uses of health data,

• Lack of uniform, multipurpose data standards that meet the needs of the diverse groups that record and use health information, and

• A workforce that lacks understanding of Health Informatics.

3.1 Information Technology Infrastructure for Health (ITIH): An Introduction

Information Technology Infrastructure for Health is a set of standards, guidelines and laws that help simplify transactions between various healthcare entities. ITIH framework prescribes appropriate standards for each stakeholder across diverse healthcare settings towards building an Integrated Healthcare Information Network for India. It is an initiative to bring in value and benefits to all the healthcare players and to a billion Indians. The broad goal of the ITIH is to deliver information to individuals, providers and planners when and where they need it, so that they can use this information to make informed decisions about health and healthcare. ITIH offers a way to connect distributed health data in the framework of a secure network. It lays down the framework for collating and analysing population-based health data, collection, storage, transmission and dissemination of healthcare information across the country. The ITIH framework focuses on moving the Indian healthcare information system from information gathering to data processing to knowledge management to improved decision making and finally, prepares the ground for implementing an integrated delivery network in India. The ITIH will have a tremendous impact on the Indian healthcare scenario that will affect its key players and stake holders such as the Government and its public sector organisations, hospitals and relevant organisations of healthcare delivery, insurance, information technology, vendors, suppliers, etc.

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Regulator’s perspective

Provider’s perspective

Payor’sperspective

Consumer’s perspective

STANDARDS

LEGAL FRAMEWORK

EDUCATION

Information Technology

Infrastructure for Health

Suppliers/ Vendors

Suppliers/ Vendors

To further the initiative undertaken by MCIT, a guideline document encompassing the results of intensive study towards setting up a framework for information technology infrastructure for India was required. It is visualized that this benchmark document will go a long way in serving as a gold standard for all the initiatives of the Government and other private players for their foray into healthcare information technology and healthcare informatics. If well executed, the ITIH has the potential to place India in the league of nations that are successfully improving the face of healthcare delivery. 3.2 The ITIH Initiative Despite the significant positive impacts that information technologies have been determined to have upon the cost, quality and accessibility of healthcare services offered by providers, the healthcare sector - in comparison to other industries - has been lax in its efforts to embrace advances in IT. The Ministry of Communication and Information Technology (MCIT) of India, in response to the changing healthcare scenario, has recognised the felt need for ITIH - the imperative role of IT in the healthcare industry, and has created a special study initiative for the Indian Healthcare Environment. As its pioneering project, the MCIT has moved to convene the major stakeholders in the industry and form a study group (coordinated by AHSL) to determine standards for health information in the country. The objective was to define the framework for healthcare information infrastructure for India, to make healthcare delivery system standardised, efficient, and within the reach of masses. The study focused on formulation of

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recommendations for capture, collection, transmission and dissemination of healthcare information throughout the country. The effort was to bring in standards to India that will not only help enhance the systems of healthcare delivery but also place India amongst the leading nations for healthcare information technology. 3.3 Collaborative effort of MCIT and AHSL The Ministry of Communication & Information Technology (MCIT) has undertaken an initiative to build the national framework for “Information Technology Infrastructure for Health” through health information standards. The Apollo Health Street Ltd. (AHSL), a subsidiary of the Apollo Hospital Group is supporting MCIT in defining the ITIH framework for India, as the implementation agency. Its role was to define, in collaboration with Department of Technology (DIT) and other working group members, the vision and framework for building Information Technology Infrastructure for Health in India. The approach of this project was “Consulting” in nature. The implementation agency brought in its expertise in healthcare, information technology, as well as in health informatics. Implementation Agemcy worked on this project since October 2002. At the end of the first workshop held in November 2002, the participating group recommended setting up Working Groups in the six areas for standards in capture, storage and dissemination of health information:

1. Clinical Standards 2. Data Elements 3. Health Identifiers 4. Minimum Data Sets 5. Healthcare Billing Formats 6. Messaging Standards for Exchanging Health Information

Two more working groups had been constituted to look into:

7. Legal framework for the privacy and security of health information

8. Health informatics education The implementation agency worked with nominated members in each working group for finalising the recommendations for ITIH for India. 3.4 ITIH Project Methodology The core team of the ITIH was instrumental in framing the overall project methodology and to discuss the same with professionals from various strata of healthcare, technology, government and other significant parties.

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The project framework was designed keeping in mind the perspectives of the following players who would be most impacted in the ITIH implementation process: • The Provider • The Regulator • The Payer • The Consumer • The Suppliers and Vendors of Healthcare Products, etc. The three-prong approach towards ITIH involved framing different methods to tackle three thrust areas: • The Health Information Standards • The Legal Framework • The Education Framework The project was structured in the following sequential steps:

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Data

Collection

Data

Analysis

Preliminary

Set

Info

Validation

Final

Set

Interviewed professionals

Industry Reports & Inputs

Global Examples

Internet

Brain Storming

Analysis Tools & Techniques

Validation Checks

Cross Country Analysis and Benchmarking

First Interactive Vision Workshop

Preliminary Recommendations

Formation of working groups

Website Creation

Recommendation vetting

Industry Feedback

Additional Inputs

Final Recommendation for ITIH

Final ITIH Workshop

The Final Recommendations have been arrived at through an iterative process that involved all key stakeholders


To kick start the project, the following steps were undertaken: Primary Research • Conducted interviews of about 200 professional from key areas. The

interviewees ranged from doctors, government officials, information technology professionals, legal experts, educational bodies, patients, pharmaceutical/ biotechnology firms, administrative staff, industry associations, payers, third party administrators, healthcare companies and other stakeholders.

• Formed sub-committees to work on each of the three thrust areas; work was distributed among various committees that had experts from relevant fields.

• Involved health and government agencies and most stakeholders to help support progress of the project and to get a balance view of the healthcare scenario.

Secondary Research

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• Involved full-time research analysts who pooled information from various sources, including the Internet.

• Conducted extensive research on the ITIH initiatives of other countries. Learned from key issues addressed by healthcare information frameworks of other countries.

• Conducted in-depth study of existing Indian reports on relevant industries.

• Analysed Indian scenario vis-à-vis ITIH framework Interactive Platform • Set up a dedicated website to facilitate interaction, broadcast and

inform progress amongst the working groups members and participants. URL: http://www.apollohealthstreet.com/itih/Home.asp

• Conducted telephonic interviews and conferences, interactive exchange of information over the Internet and intranet, meetings, and workshops

• Held brainstorming sessions (within the core team and amongst working groups).

• Conducted workshops. The objective of the first workshop was to finalise the vision statement and get a broad consensus on the formulation of the ITIH framework. This was followed by a 9-12 week effort wherein the project team refined the proposed solution and developed the final set recommendations that were presented in the second workshop.

3.5 First ITIH Workshop: November 2002

The Implementation Agency presented their findings and preliminary recommendations during the 1st workshop held on 15th November 2002 at the MCIT building in New Delhi. The response to the workshop was encouraging and the contribution to the progress of the project, critical. Over 40 members who represented different stakeholders for the ITIH initiative attended the workshop. Besides representation from MCIT and several State IT Secretaries, the Health Ministry was well represented through its affiliated bodies like the Directorate-General of Health Services (DGHS), several State Health Secretaries, Medical Council of India (MCI), Indian Council of Medical Research (ICMR), Indian Medical Association (IMA), premier institutes like the All India Institute of Medical Sciences (AIIMS) and others. The industry too was well represented at the workshop (e.g. Confederation of Indian Industry – CII), independent bodies like the World Health Organisation (WHO) and other private players like WIPRO, legal experts - Amarchand and Mangaldas Associates, etc. At the end of the workshop, the members recommended setting up Working Groups in 8 different areas of ITIH to take the recommendations

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forward. It was decided that the AHSL would work with all the 8 Working Groups for the next 3 to 4 months to arrive at the final recommendations. Interim Activity The Implementation Agency worked in tandem with the working groups to arrive at the final recommendations. After analysing and deliberating over various options and standards and ratifying the same with the working groups, the final recommendations were arrived at. Detailed interactions were held to vet and add value to the findings of the study. 3.6 Second ITIH Workshop: March 2003

The second workshop on Information Technology Infrastructure for Health for the Ministry of Communication & Information Technology was conducted on March 25, 2003 in New Delhi. The objective of the workshop was to share the final recommendations of the ITIH study, and to define appropriate standards for each stakeholder across diverse healthcare settings, towards building an Integrated Healthcare Information Network for India. Apart from the attendees of the first workshop, more members from both India and abroad, representing various stakeholders, marked their presence at the workshop to deliberate over the final recommendations of the ITIH study. 3.7 The Final Recommendations: A Summary

Final recommendations were submitted by the AHSL to the Ministry of Communications and Information Technology, for the following areas:

• Billing Formats • Clinical Data Representation • Data Elements • Health Identifiers • Messaging Standards • Minimum Data Sets • Health Informatics Education • Privacy and Confidentiality of Health Information

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The recommendations for each of the module are as follows: Billing Formats The final recommendations for Billing Formats consisted of defining eight important transactions that take place in the health insurance sector.

• TA-01: Enrollment and Disenrollment in a Health Plan • TA-02: Health Plan Premium Payments • TA-03: Eligibility Check/ Credit Authorisation • TA-04: Billing for Covered Services • TA-05: Claim Submission for Covered Services • TA-06: Healthcare Claim Status Query • TA-07: Health Care Payment and Remittance Advice • TA-08: Payment for Covered Services

Timelines for standardisation and migration were suggested for the same. Health insurance transactions requiring transmission of health information were standardised with mandatory standardised fields to be used across various stakeholders. They are:

• The Provider Billing Form (PBF 01) • The Patient Claim Form (PCF 01) • The Claim Submission Form (CSF 01)

Clinical Standards The final recommendations for clinical standards consisted of prescribing the code set to be implemented in the country for ITIH.

• ICD-10-CM was chosen for Disease Coding • ICD-10-PCS was chosen for Procedure Coding • LOINC was chosen for Clinical Observation Coding

Data Elements Taking examples from HL7 & X-12, many data element formats specified by these standards can be modified to suit Indian healthcare conditions. The following are the three broad areas of standards for data elements as recommended by the ITIH:

• Patient Demographics • Hospital Administration • Health Insurance

Health Identifiers Unique health identifiers were proposed to the following stakeholder to help achieve administrative simplification and to standardise the players across the healthcare spectrum.

• Healthcare Professionals • Healthcare Provider Organisations • Support Service Providers • Individuals • Employers • Payers

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Messaging Standards The telemedicine committee worked on messaging standards for Telemedicine as an application, and recommended that an Indian version of the Health Level 7 Standard should be developed to enable exchange of health data.

Minimum Data Sets

A minimum data set is a widely agreed upon and generally accepted set of terms and definitions making up a core of data acquired disease in a standard format. Two types of minimum data sets were recommended under the ITIH study:

1. MDS common across all diseases: The data collected is standard across all diseases and conditions such as referrals and demographics

2. Specific to some diseases: The data collected applies to specific diseases and conditions such as:

To initiate the standardisation activity, minimum data sets were recommended for following diseases common in India.

• Cancer • Diabetes • Cardio Vascular Diseases • Gastroenterology-related Diseases

The proposed “National Health Informatics Center”

5 digit alphanumeric code (Ex - MJ675)

Support Service Providers


4 digit alphanumeric code (Ex - P9J4)

Payers

Same format is continued 10 digit alphanumeric code (Ex - AADCA4278N)

Employers

Healthcare Providers & Payors

15 digit alphanumeric code (Ex - AP89.7865980255)

Individuals


4 digit alphanumeric code (Ex - AP89)

Healthcare Provider Organizations

State medical councils 10 digit alphanumeric code (Ex - KAP.019184)

Healthcare Professionals

Issuing Authority Description Identifier

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The Education Framework The success of the implementation of ITIH depends largely on the knowledge, skills and expertise in health informatics. ITIH mandates health informatics education on a four-tier level to cater to the requirements of people wishing to specialise in different aspects of the healthcare industry. The following are the recommended course structures.

The Crash Course: Basics in Health Informatics The Certificate Course: Basics + Compulsory modules The Diploma Course: Basics + Compulsory modules + Elective Modules + Dissertation The Post Graduate Diploma Course Basics + Compulsory modules + Elective Modules + Dissertation + Internship The Legal Framework (by Amarchand Mangaldas) Existing Indian laws do not address concerns relating to Health Information. To implement ITIH, it is imperative that a legal framework supports the standardisation activity. The legal framework recommendations, as suggested by ITIH include: Proposed Legislation: A proposal for a legislation defining health information, boundaries, security, consumer control, accountability, public responsibility, etc. The document consists of guidelines on framing a new health information law. Delegated Legislation: A draft version of ‘The Telemedicine Law, 2003’ as telemedicine is one of the areas identified under ITIH that requires a legal framework (covering most of the recommended ITIH) standards. 3.8 Implementation Roadmap: A Summary

Implementation of the ITIH will have a tremendous impact on the Indian healthcare scenario and healthcare players in the country. To implement the ITIH successfully, it is imperative that multiple stakeholders are aligned towards a common objective and goal; which is to deliver information to individuals, providers and planners when and where they need it, so that they can use this information to make informed decisions about their health. After deliberating over the final recommendations at the second ITIH workshop, the following steps were recommended in sync with the proposed implementation roadmap:

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As per the recommendations of the ITIH, the National Health Informatics Centre (NHIC) and State Health Informatics Centres (SHICs) should be set up to initiate the standardisation activity throughout the country. It is recommended that the proposed NHIC be a collaborative set up of the Ministry of Communications and Information Technology (MCIT) and the Ministry of Health and Family Welfare (MoHFW). The roll out period to implement ITIH in India spans over three years, involving timelines for each of the standard to be implemented and used in the country. The following critical areas are to be implemented in the proposed time frame.

• Health Identifiers: Implementing, pilot study and compliance. UHID at the stakeholders’ level involving Government and Providers

• Setting up the National Health Informatics Centre • Defining & publishing minimum data sets, conducting a Pilot Study

and rolling out the MDS. • Defining the data elements dictionary and ensuring compliance • Introduce billing formats, encourage use in various healthcare

settings at all levels • Develop health informatics courses and initiate the education system • Proposal mandates for ITIH to the Government, Providing Legal

framework for the hospital environment and the telemedicine environment

• Release HL-7 equivalent for India and encourage technical vendors to adopt technical standards

• Initiate research and publishing activity for ITIH awareness. Develop website for interacting and sharing the progress of the ITIH activity

All the above listed activities require continued support from the legal and educational framework. The agencies to help support the standardisation activity, both for education and legal support, are yet to be decided.

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4 Healthcare Scenario in India

4.1 Introduction The Indian healthcare sector, structured on three tiers, primary, secondary and tertiary is a combination of several disparate systems of healthcare delivery with government-run institutions on one hand and charity, missionary, corporate hospitals and numerous clinics on the other. With a turnover of around $2.8 trillion, the global healthcare industry is the largest service sector in the world. Similarly, the Indian healthcare industry is quite large and is estimated to be worth Rs.100,000 crore and constitutes approximately 5-6% of the Gross Domestic Product. Further, the industry is expected to grow at the rate of 13 per cent for the next six years which amounts to an addition of Rs 10,000 to Rs. 15,000 crore each year. Healthcare is delivered by a multitude of providers’ public and private currently working in isolation. There is limited networking among doctors or hospitals and they function as independent entities. This is primarily due to the fact that demand for a health care service far exceeds supply and providers are assured of high utilisation. The government infrastructure is large, but of poor quality in rural areas and is inequitable in urban centres. Healthcare providers in India are primarily stand alone as opposed to developed countries, where a few large networks own several healthcare providers. In India, private providers are fragmented and unregulated. Consequently, provision is generally of substandard quality. Healthcare scenario in India is undergoing a sea change. From the days of being a public/ charity-funded activity, healthcare has become an industry by itself. Like most developing countries, India spends 5.2% of its GDP on healthcare and is the largest service industry in terms of revenues and the second largest after education in terms of employment. The sector can increase its contribution even further to 6.5-7.2% of the GDP and increase employment by at least another 2.5 million by 2012.

(Source: McKinsey Healthcare Report)

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The healthcare sector’s investment needs are comparable to other infrastructure- intensive sectors. Social, economic and political policies have a telling effect on the sector. However the health outcomes in India, while showing an improvement over the past, are still poor. Key indicators such as life expectancy and infant mortality are still high than other developed countries which can be attributed to poor performance of the health system in terms of coverage, purchasing and delivery. It has been observed that over the last five years there has been an attitudinal change amongst a section of Indians who are spending more on healthcare. The level of awareness is also on the rise. It is expected that the healthcare provider business will witness a role out that will include day care facilities, diagnostic centres, hospitals and more medical schools. It is also expected that it shall include clinical research business that conduct clinical research for drugs. While the provider-side of the business has been growing rapidly, the healthcare service business has also started coming of age. Over the recent years, the significant developments have been the emergence of Third Party Administrators (TPAs) as well as entry of private insurance players in the health insurance segment. 4.2 Healthcare Institutional Framework in India

The Union Ministry of Health and Family Welfare is instrumental and responsible for implementation of various programmes of national importance like family welfare, prevention and control of major diseases etc. The Ministry assists States in preventing and controlling the spread of outbreaks and epidemics through technical assistance. In addition to centrally sponsored schemes, the Ministry formulates and implements various World Bank-assisted projects for the control of various diseases. The State Health System Projects are implemented through State Governments, though the Department of Health facilitates the States in availing external assistance. The Ministry comprises the following departments, each of which is headed by a Secretary: • Department of Health • Department of Family and Welfare, and • Department of Indian Systems of Medicine & Homeopathy The Directorate-General of Health Services (DGHS), a repository of technical knowledge, is attached to the Ministry. The DGHS also renders technical advice on all medical and public health matters and in implementation of various health schemes. Further, in order to implement policies and programmes of the Ministry in an effective manner, there are three subordinate offices located at various places in the country. The

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Ministry is also administratively concerned with 29 autonomous/ statutory bodies. There are also three public sector undertakings under the administrative control of the Ministry. The Ministry undertakes great tasks of bringing in healthcare within the reach of every man. The information requirements of the ministry are huge and there is always a need for timely and accurate data that needs to be made available on a regular basis to proactively contribute to the health of the nation. 4.3 Healthcare challenges in the Indian Context – IT perspective

The Indian healthcare sector has its own set of peculiarities. It is vast and very diverse. From an information perspective, the most pertinent challenges are the presence of disparate healthcare delivery mechanisms and prevalence of paper-based transactions across the healthcare spectrum. Healthcare sector is characterised by the presence of several disparate systems of healthcare delivery represented by government, charity, missionary and corporate hospitals and numerous clinics. The three tiers of Indian Healthcare Delivery System (Primary, secondary and tertiary) work in isolation in providing continuum of care to patients. Indian healthcare delivery system largely follows paper-based transactions/ information flow, with the exceptions of a few privately managed hospitals. The healthcare providers regularly transact and exchange massive health information with public health agencies, medical institutions, NGOs and insurance companies. The sheer variety of administrative systems (manual or computerised), when taken in the context of highly information-intensive industry like healthcare, makes these administrative processes highly inefficient and cumbersome. As a result, storage and retrieval of data becomes even more difficult. Lack of industry standards leads to further confusion and the basic infrastructure is unable to support the healthcare information needs of the nation. 4.4 Health status in India On the public heath front, thus far, the efforts of central or state governments have been mostly related to computerisation of hospitals for the delivery of medical care to individuals; relatively little attention has been paid, by either the private or the public sector, to technology applications that could improve the capacity of communities to carry out non-clinical or population-based functions of public health (i.e., services that identify local health problems, prevent epidemics and the spread of disease, protect against environmental hazards and assure the quality and accessibility of health services).

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Attention to these community-wide health services is important because about 10 percent of early deaths can be prevented by medical treatment. Population-based approaches, on the other hand, have the potential to prevent 70 percent of premature deaths through measures that target underlying risks such as tobacco, drug and alcohol use; diet and sedentary lifestyles; environment, occupation, and infectious risk factors. India’s healthcare is impacted by its diversity in geography and locations, demographics and associated cultures, economy, etc. The patient population exhibits distinct characteristics that are a function of the above factors. Infrastructure India’s poor health Infrastructure and services leave a lot of potential for growth in the sector. For example, to achieve the WHO norm of 1 bed per 300 people, India needs another 75,000 to 100,000 beds annually. Occupancy rates currently in Indian hospitals are a high 85-90%. The three-tiered Indian public healthcare system has about 117 tertiary medical colleges and hospitals, 1,200 ESI and PSU hospitals, 4,400 district and taluk hospitals, 2,400 Community Health Centres, 23,000 Primary Healthcare Centres, 132,000 Sub-centres, 1500 urban health posts, etc. Private healthcare practices have brought in remarkable changes in the systems of healthcare delivery and patient care services. In spite of a plethora of public healthcare facilities, the demand for private healthcare continues an upward spiral. Health infrastructure concentrated in urban areas (as 30% Indians stay in urban centres) resulting in concentration of about 68% hospitals and 80% beds in urban areas. Economic Status, Demographic Trends and Status The overall economic growth has been faster with the Gross National Product (GNP) per capita impacting the healthcare sector. There has been an increase in investment and expenditure on healthcare in the last decade. Population continues to grow, as the decline in the birth rate is not as rapid as the decline in the death rate. Due to increase in life expectancy at birth, the number of older persons in the population is now increasing, for which specific health facilities will need to be provided. Urban migration over the last decade has resulted in concentration of services there as well as decline in the living conditions. However the health outcomes in India, while showing an improvement over the past, are still poor. Key indicators such as life expectancy and infant mortality are still high compared to the developed world.

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Social Status The fast-changing economic situation, created by urbanisation, industrialisation and new economic liberalisation, has transformed the Indian social structure and values from a traditionally agrarian economy to a modern industrial order. This transformation has resulted in several social problems for individuals and groups such as older persons, the disabled, drug addicts, street children, child labour, HIV-infected populations, etc. About 35% of Indians who live below the poverty line are easy prey to communicable diseases, which are impacted by the state of public health. The IX Five Year Plan envisages a more holistic approach to these social problems with strategies aimed at specific target groups and problems. There is also an increased thrust in other development and poverty alleviation programmes. The main constraints to the social problems are the diverse population groups, low literacy and income levels and socio-cultural beliefs and practices, which adversely affect health. Government Government plays a critical role in healthcare. Apart from framing policies to make health a national priority, the Government is equipped to redistribute wealth on a large-scale in the form of taxation and budget. The Government is best positioned to finance (through tax) and provide care (through primary care network) and conduct public health programmes. The government owns large healthcare facilities, but lacks sound management practices. On the other hand, the private sector is fragmented and primarily consists of a conglomerate of small independent nursing homes. Though the private sector constitutes 66 per cent of the health sector, it only contributes 36 per cent bed capacity. Moreover, over 75 per cent hospitals have less than 30 beds, while just 5 per cent have more than 100 beds. Investment Climate in Healthcare Private players have realised the importance of the healthcare sector and its lucrative benefits. Investments have steadly increased over the past few years. The corporate culture too has added a new dimension to healthcare. ‘Corporate India’ is seriously giving professionals their due in terms of health benefits. Moreover, the new work culture has put onus on the corporates, struggling to retain talent, to lure professionals with better pay packs and healthcare benefits. Several private players with deep pockets have started entering the healthcare sector to capitalise on this demand, with around 5,000 beds already planned over the next three years.

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Insurance Sector Health Insurance, with about 2 million people having coverage in nation of over 1 billion, is one of the most promising areas in healthcare which is yet to be tapped. Unlike in developed countries, where insurance companies pay healthcare costs, 59% of health expenditure of India is self-paid. Apart from low awareness levels, insurance companies tend to focus more on social insurance, leaving the field open to a virtual monopoly of the General Insurance Company (GIC), which earns less than 1% of its premium income from health insurance.

Coverage, or prepayment for health needs is poor. Two-thirds of spending is out of a patient’s pocket. Private insurance, social insurance, community insurance and employer’s spend cover only 14% of the population. Despite the large number of licensees, international players have left the Indian market or adopted a ‘wait-and-watch’ policy. The low levels of activity in the health insurance could be attributed to regulatory and systemic barriers. There is no effective purchasing system because payers and providers are not integrated.

There is a need to standardise the functioning of the health insurance industry in India by the use of health information standards that deal with the capture, use, storage, exchange and dissemination of health information. There is a need to educate the masses and provide a regulatory support to realise the full potential of the available resources in health insurance. Markets India is also a preferred destination for quality healthcare services. People from nearby countries such as Sri Lanka, Nepal, Bangladesh and some Middle East countries flock to India for their medical needs. Already a significant number of people from these neighbouring countries are using hospitals here because of India’s ability to offer world-class treatment at about one-fifth the cost of developed countries. Indian doctors are one of the best in the world, and healthcare being also a knowledge-driven sector; the country could emerge as a major healthcare destination like IT. In India, the large and thriving middle class, estimated to be 100-120 million strong, can afford modern healthcare facilities and have now started demanding better health care facilities. With the demand for healthcare services spiralling upwards, there is a need to integrate the entire system of delivery of healthcare to the benefit of all parties involved. Human Resources Human resources form the crux of the healthcare industry. India currently faces severe shortage of qualified healthcare professionals. Increasing number of people joining the industry has also resulted in the ‘brain drain’, severely impacting the Indian healthcare system. According to available data, India has about 4.8 physicians and 4.5 nurses per 10,000 people.

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There is an increase in the demand for medical doctors, nurses, para-medics including laboratory technicians, radiographers and other health professionals. The main constraints are the shortage of funds, particularly for government institutions imparting medical education, and the problem of deployment of medical personnel to rural areas due to inadequate facilities to meet personal and professional needs. Other constraints include the low priority given to in-service training, inadequate staffing of training institutions, quality concerns among trainers and inadequate facilities in training institutions. There is a need to regulate the health education systems, standardise the processes, and uniquely identify each provider professional, record the inflow and outflow of healthcare professionals, etc to help regulate the human resource. Financial Resources Financial resources have been a major constraint for developing primary and secondary levels of health care, primarily provided by the Indian government. However, India’s financial outlay for health has been increasing over the successive Five-year Plan periods. Efforts have also been made to mobilise resources through various international organisations and UN agencies. The government has encouraged the involvement of private agencies in secondary and tertiary levels of health care. Regulations and Legal Framework While the courts have evolved certain principles using which it may be possible to attach liability to healthcare providers, these are inadequate to address a range of issues connected with the creation and use of Health Information because the existing principles address (to a limited extent) liability after misuse of the Health Information, and do not lay down standards for use of that information. There are no provisions made for administrative procedures towards implementing and regulation of Health Information. Liability is largely restricted to doctors (e.g. Consumer Protection Act), since existing principles do not take into account the wide range of other Healthcare Providers. The issue, type, and degree of penalties to be levied need to be addressed. The right to privacy has primarily been articulated in terms of the Fundamental Rights under Constitution. While the Supreme Court has not squarely addressed the issue of whether the actions of private individuals (Healthcare Providers) can be subject to the right to privacy, it may be necessary to provide specifically for the Right to Privacy in respect of Health Information.

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4.5 Future of Healthcare: An industry perspective With the demand for healthcare far exceeding supply, India’s healthcare industry is poised to grow by about 13 per cent per annum as per Confederation of Indian Industry (CII) estimates. The CII attributes the growth to rise in literacy rate, growing purchasing power and an increased awareness about health issues through the media. Despite these strides, India continues to bear a heavy burden of both communicable and non-communicable diseases. Furthermore, India is experiencing a slow epidemiological evolution from infectious and parasitic diseases to non-communicable diseases. The population to bed ratio in India is 1 bed per 1000, in relation to the WHO norm of 1 bed per 300. And it is estimated that there exists space for an additional 75,000 to 100,000 hospital beds. For the healthcare sector to augment its deliverables, there is a need to reorient India’s healthcare strategy and strengthen linkages between the government and private sector participants. Citing that good healthcare in India is in extreme short supply; the CII believes that it is this gap that presents vast opportunities to the corporates to bridge the gap. Among the major gaps, CII pointed out was the low density of doctors in India with only 43 doctors for every 10,000 people, as compared to the US which has 2,340 doctors per 10,000. A WHO report says India needs to add 80,000 hospital beds each year for the next five years to meet the demands of its population. The huge shortage of hospital beds outlines a major opportunity for the private sector. Major corporations like the Tatas, Apollo group, Fortis, Max, Wockhardt, Piramal, Ispat, Duncan and Escorts have made significant investments in setting-up state-of-the art private hospitals in cities like Mumbai, New Delhi, Chennai and Hyderabad. Indian companies are also looking at pumping investments in other countries and putting in efforts to tap foreign patients and thereby increase the country’s ForEx earnings Health Information Technology in India Indian health institutions have shown slow acceptance of health information technology systems at various levels. In spite of technological advances in the country and with most industries reaping the benefits of automating their work systems, India’s healthcare information technology lags behind due to lack of standardisation and polices on health care information technology. The disintegrated system of healthcare is in urgent need of standardisation of health information capture, use, storage and dissemination. In spite of using advanced systems, technology does not assist in effective data and information management practices. There is an urgent need for advanced technology systems in all visible areas of healthcare.

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5 Information Technology Infrastructure for Health (ITIH) The Information Technology Infrastructure for Health (ITIH) is a set of standards, guidelines and laws that simplify transactions between various healthcare entities. It adopts a set of technologies, standards, systems, values, and laws to support all facets of individual health, health care and public health. The ITIH framework prescribes appropriate standards for each stakeholder to build an Integrated Healthcare Information Network for India. It is a prestigious initiative to bring in value and benefits to all healthcare players and a billion Indians. The broad goal of the ITIH is to deliver information to individuals, providers and planners when and where they need it, so that they can use this information to make informed decisions about health and healthcare. It offers a way to connect distributed health data in the framework of a secure network. It also lays down the framework for collating and analysing population-based health data, collection, storage, transmission and dissemination of healthcare information throughout the country. The ITIH framework focuses on moving the healthcare information system from just information gathering to data processing to knowledge management to improved a decision-making entity and, finally prepares the ground for implementing an integrated delivery network in India. Implementation of the ITIH will have a tremendous impact on the Indian healthcare scenario. It will affect key players and stake holders such as the Government and public sector organisations, hospitals and relevant organisations of healthcare delivery, insurance, information technology, vendors, suppliers, etc. If well executed, the ITIH has the potential to place India in the League of Nations that have succeeded in improving healthcare. 5.1 Information Technology Infrastructure for Health: The Felt

need Indian healthcare sector, structured on a three tier (primary, secondary and tertiary), is characterised by the presence of several disparate systems of healthcare delivery represented by government, charity, missionary and corporate hospitals and numerous clinics. All the players currently work in isolation. Multiple entities play an important role in defining the healthcare landscape of India. Amongst others, it encompasses the following stakeholders:

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• Public health agencies at various levels • Health professionals and institutions • Insurance companies • Public and private healthcare organisations • Policymakers • Consumers – can be patients or the population in general etc. The diversity of participants in the healthcare industry and the complexity of their relationships with each other have frustrated the voluntary adoption of information technology and industry standards. The healthcare sector's reluctance to invest a percentage of its operating revenues in IT infrastructure may be attributable to technological, human, social, or economic barriers to implementation. The adoption of IT by the healthcare industry is also limited by political and legal constraints. States maintain a great deal of responsibility over the regulation of healthcare providers, but unfortunately they enact legislation and establish regulatory mechanisms that do not fully appreciate ensuing technological advances. On the public health front, the central and state governments have mostly focused on computerisation of hospitals for the delivery of medical care. Little attention has been paid, both by the private and the public sector, to technology applications that could improve the capacity of communities to carry out non-clinical or population-based functions of public health (i.e., services that identify local health problems, prevent epidemics and the spread of disease, protect against environmental hazards, and assure the quality and accessibility of health services). Attention to these community-wide health services is important because about 10 percent of early deaths can be prevented by medical treatment. Population-based approaches, on the other hand, have the potential to prevent 70 percent premature deaths by targeting underlying risk factors such as tobacco, drug, and alcohol abuse; diet and sedentary lifestyles; and environmental, occupational and infectious risk factors. The healthcare industry faces twin challenges: presence of disparate healthcare delivery mechanisms and prevalence of paper-based transactions across the healthcare spectrum. Disparate Systems: Indian Healthcare sector is characterised by the presence of disparate systems of healthcare delivery represented by government, charity, missionary and corporate hospitals and numerous clinics. The three tiers of Indian Healthcare Delivery System (Primary, secondary and tertiary) working in isolation from one another in terms of providing continuum of care to patients. Paper-based Transactions: Indian healthcare delivery system largely follows paper-based transactions with the exceptions of a few privately managed hospitals. These healthcare providers regularly transact with public health agencies, medical institutions, NGOs and insurance

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companies that involves exchange of massive health data. The numerous administrative systems (manual or computerised) when taken in the context of highly information-intensive industry like healthcare, makes these processes highly inefficient. As a result of these problems, storage and retrieval of data becomes difficult. Lack of standards leads to further confusion and the basic infrastructure fails to support the healthcare information needs of the nation. The collection and use of health information involves gathering and disseminating accurate and timely information on disease, healthcare of individuals, assessment of healthcare and public health needs and evaluation of programmes, services, institutions and providers and protecting that information from misuse or disclosures that cause harm to individuals to whom the information pertains. The creation and use of health information has been a matter of special concern to governments as well as other public bodies involved in the field of healthcare. Furthermore, it is also part of the larger concern about the right to privacy of individuals. Proper regulation of healthcare provision is imperative, especially in the light of commercialisation of healthcare services. It is of special importance in third world countries such as India in view of the wide and varied groups of stakeholders in the healthcare service industry.

5.2 ITIH and India It is an established fact that good IT solutions can improve the quality of services in the most cost effective manner. A sound IT strategy, as an enabler of the business of healthcare (and the healthcare strategy), supports productivity, quality and value to stakeholders of the healthcare systems. It is in this context that an Information Technology Infrastructure for Health (ITIH) is needed to complement the industry needs. The aim of the ITIH is to address all information needs of the stakeholders (government, hospitals, insurance companies, patients, vendors and others) while resolving the currently perceived issues in the existing system. The ITIH is intended to make healthcare delivery system more efficient. It is driven by the principles of standardisation and reaching out to the population at large. Key driving forces behind an ITIH are as follows: • Simplification of administrative processes • Sharing information between disparate systems • Create and maintain population-based data • Reduce data gathering and processing costs • Standardisation of health data – coding, reporting & transmission of

data • Setting standards for key stakeholders – Patients, doctors etc.

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• Improving efficiency of clinical systems • Providing greater access to healthcare in a cost-effective manner • Delivery of health-related information and services to remote locations 5.3 Benefits of Standardisation through ITIH Standardisation reduces transaction costs since it makes information available and accessible to all interested parties. The standardisation process increases quality, thereby increasing efficiency and accuracy of critical processes. It ensures uniformity of services across the healthcare spectrum and brings disparate systems on a level-playing field. The biggest advantage, however, is the decrease in administration overheads as disparate health systems share information. They can create and maintain population-based data too for research and analysis. The extent to which population-based public health can achieve its mission depends on the effective collection, analysis, use, and communication of health-related information. Information Technology plays a very important role in this mission. Information technology is also needed to educate and empower different groups about public health problems and to link them together to take effective action. Information Technology also plays a significant role in synergising the stakeholders towards a common goal. There is a need to educate and empower different groups and players on the benefits of adopting modern technologies so as to enable smooth transition of information and to achieve the ‘health for all’ goal. The starting point for the ITIH is to address the following constraints that plague India’s healthcare: • Lack of policies, legislations to protect privacy while permitting use of

health data • Lack of uniform, multipurpose data standards that meet the needs of

the diverse groups that record and use health information; • A workforce that lacks understanding about Health Informatics Many sectors, including social, economic and political policies, have an impact on the Indian Healthcare System. While the Health Ministry sets policies, strategies and manages the change processes in the healthcare system, the IT ministry plays the role of an enabler in the healthcare business.

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5.4 The Telemedicine Experience and ITIH Telemedicine uses information technology to deliver medical services and information to even remote locations. It offers both patients and physicians numerous economic and qualitative benefits. For example, telemedicine cuts travelling expenses typically associated with physician visits; enables patients to engage in preventive medicine; and increases access to healthcare for traditionally under-served communities. As part of the Government of India’s endeavour to offer modern technologies to the nation, the Department of Information technology (DIT), Ministry of Communications and Information technology (MCIT), has taken up an initiative to evolve standards for telemedicine under the aegis of the “Committee for Standardisation of Digital Information” to facilitate implementation of telemedicine systems using Information Technology Enabled Services (ITES). The standardisation committee is supported by a technical working group, consisting of members from different government and private institutions that have taken initiatives in the form of pilot projects in telemedicine, with a mandate to evolve and submit a document on suitable standards and guidelines for telemedicine practice in India. With the advances in technology, the delivery of healthcare to even remote locations has become feasible through telemedicine. Yet, the full potential of these advances cannot be reached without clinical and technical standards and guidelines. As telemedicine involves capture, storage, transmission and display/ broadcast of medical and health information, setting standards and framing proper polices can go a long way in exploiting technology for the benefit of the masses. For e.g. DICOM standards are used to transmit medical information such as images and HL7 is used to facilitate inter-communication between two separate healthcare entities. In the absence of such standard protocols and policies, exchange of information would have been impossible and telemedicine as a medico-technological advancement would have been rendered useless. Telemedicine is only one example of an application where ITIH will have a direct impact. In a much larger perspective, ITIH would impact each and every application involving healthcare information capture and exchange.

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6 Project Scope and Methodology

Implementation of ITIH will have a tremendous impact on the Indian healthcare scenario that will affect its key players and stake holders such as the Government and its Public Sector Organisations, Hospitals and relevant organisations of healthcare delivery, Insurance, Information Technology, vendors, suppliers, etc. The purpose of the project is to define the Information Technology Infrastructure for Health for India. The project consisted of developing this benchmark document based on the shared vision of ITIH amongst all the players of healthcare and its stakeholders. The document is backed by strong analytical focus and forms the basis for further stakeholder discussions. A project of this magnitude affects almost all the healthcare players in the country, and defining the framework for the same involved series of techniques and tools, requiring active participation of professionals and expertise from various strata and organizations. The core team of ITIH was instrumental in framing the overall project methodology and discussing the same with professionals from various strata of healthcare, technology, government and other significant parties. A special website was launched for the ITIH project. Through this website all the working group members can share project related documents and also ideas through discussion forums. The site is also used to broadcast messages to all the participants of this project. 6.1 Project Deliverables This Project had two key deliverables: • Developing a shared vision on ITIH • Developing a benchmark framework document for ITIH in India The project framework creates the basis for stakeholder alignment. The key efforts involved the following: • Analysis of stakeholders’ needs • Stakeholder objectives and constraints • Role/ influence of different stake holders in vision achievement • Analysis of potential synergistic solutions • Discussion with key stakeholders to understand their perspective and

communicate industry aspirations • Joint development of framework for ITIH through stakeholder

discussions • Development of a phased action plan to convert framework into reality

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The major areas of focus for the framework were identified as: The Standards supported by Legal and Educational framework: Standards • Defining function features and benefits of Standards • Defining criteria and guidelines for selection of the standards • Selection and finalisation of certain standards (where it is easily

implementable) that are key to building the ITIH • Defining an action plan for institutionalising the process of standard

specifications; especially where the impact is far reaching and the standard definition itself could take a long process

Legal framework The legal framework deals with issues related to information portability and accountability, security and privacy and confidentiality of healthcare information. It also highlights the issues in defining a regulatory framework that would need to be put in place for healthcare information. Education and Training Framework The education and training framework identifies the following: • Areas in the ITIH framework that would need specialised training • Curriculum for training in standards • Modalities of training All key stakeholders in the healthcare industry are likely to be impacted by the recommendations of the ITIH framework. It will have an impact on different entities such as: Hospitals, Public Health agencies (Governmental & NGOs), Health Insurance companies, IT solution vendors, software developers, education and training institutions etc. 6.2 Project Assumptions and Philosophy The ITIH project broadly involves the following essential players who would be the most impacted in the ITIH implementation process. The project framework was designed keeping in mind the perspectives of the following players: • The Provider • The Regulator • The Payer • The Consumer • The Suppliers and Vendors of Healthcare Products All the above parties have a stake in the ITIH and would be the most affected by any changes taking place in the healthcare scenario as they are currently functioning haphazardly and need to be streamlined. The project ensured that effort was not wasted in re-inventing the wheel but to learn from efforts (and the mistakes made) that went into defining

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health care information standards in different countries and chose the one that best suits the Indian healthcare environment. Indian Healthcare System has a two-fold advantage vis-à-vis other countries like the US: It can learn from work done by others and is not straddled by any legacy that needs to be redefined/ re-looked at. 6.3 Methodology The Project was structured to hold two workshops in Delhi. The objective of the first workshop was to finalise the vision statement and get a broad consensus on the formulation of ITIH framework. This was followed by a 4-month effort wherein the project team refined the proposed solution and developed the final recommendations. A final workshop with the stakeholders was conducted to ratify the recommendations of the group.

19

Data

Collection

Data

Analysis

Preliminary

Set

Info

Validation

Final

Set

Interviewed professionals

Industry Reports & Inputs

Global Examples

Internet

Brain Storming

Analysis Tools & Techniques

Validation Checks

Cross Country Analysis and Benchmarking

First Interactive Vision Workshop

Preliminary Recommendations

Formation of working groups

Website Creation

Recommendation vetting

Industry Feedback

Additional Inputs

Final Recommendation for ITIH

Final ITIH Workshop



Primary Research Conducted interviews with about 200 professional from key areas. The interviewees ranged from doctors, government officials, information technology professionals, legal experts, educational bodies, patients, pharmaceutical/ biotech firms, administrative staff, industry associations, payers, other healthcare companies and the parties and other stakeholders. Each individual was asked to prioritise the standards according to the impact of each standard on the Indian healthcare system. Impact being a function of: • Number of stakeholders in the healthcare industry affected • Necessity to achieve our healthcare goals • Indian healthcare goals • Cost effective healthcare • Appropriate medication • Simple administration process • Wider access

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In addition to interviews, the Implementation Agency also initiated the following steps: • Formed sub-committees to work on each of the three main areas:

Health Information Standards, Legal Framework and Education, Work was distributed amongst various committees that had experts from relevant fields.

• Involved health and government agencies, and most stakeholders to help support the progress of the project and to get a balance view of the healthcare scenario.

Secondary Research • Conducted extensive research on ITIH initiatives of other countries.

Learned from issues addressed by healthcare information frameworks of other countries.

• Full-time research analysts were used for Internet-based research and information collection.

• Conducted a in-depth study of existing Indian Reports on relevant industries.

• Analysed Indian Scenario vis-à-vis ITIH framework Interactive Platform • Set up a dedicated website to facilitate interaction, broadcast and

inform progress among working groups members and participants. URL: http://www.apollohealthstreet.com/itih/Home.asp

• Conducted telephonic interviews and conferences, interactive exchange of information over the Internet and intranet, meetings, and workshops

• Held brainstorming sessions within the core team and the working groups.

• Conducted workshops. The objective of the first workshop was to finalise the vision statement and get a broad consensus on the formulation of ITIH framework. This was followed by a 4-month effort wherein the project team refined the proposed solution and developed the final recommendations.

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6.4 Project Approach

Effective execution of ITIH depends on key elements such as health information standards, legal framework of the region in which providers operate and educational facilities to bring in the necessary change. The three-prong approach towards ITIH involved framing different methods to tackle three main areas: • Health Information Standards • Legal Framework • Education

Activity Health

Standards Legal

Framework Education

Collection of data from other countries

Y Y Y

Interacting with leading experts and professionals

Y Y Y

Internal analysis Y Y Y Ranking of information Y Y Y Industry Inputs Y Y Y Reviews and second opinion Y Y Y

Description of project methodology for each area is as follows:. 6.4.1 Health Information Standards Lack of uniform, multipurpose standards for the structure, content, and transmission of health data seriously impairs administrative efficiencies of the sector as a whole. It also impairs development of integrated information systems to support population-based public health. Hence, developing a host of standards for coding, reporting and transmitting health data forms a key part of ITIH. Standards to be implemented would need to be clearly defined for the ITIH. Scope of the project included the following: • Defining function features and benefits of standards • Defining the criteria and guidelines for selection of the standards • Selection and finalisation of certain standards (where it is easily

implementable) • Defining a concrete action plan for institutionalising the process of

standard specifications where the impact is far reaching and the standard definition itself is a longer process

The different areas that were considered for standardization under this project are given below:

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Clinical Terminology standards Disease codes Procedure codes Clinical observation codes

Identifiers Individuals Providers Physicians Payors

Billing Formats Forms for Bills/ Claims

Minimum Data Sets

Messaging Standards

Data Elements

The practices of other countries were studied with respect to the standards. The Implementation Agency developed a framework to choose the initiative of a particular country that can be implemented in India, based on: technical richness, cost and ease of implementation in the country Methodology for defining standards • Collected data relevant to the health informatics environment • Classified data elements according to their importance: Mandatory/

Recommended / Facilitating. Select the data elements that are mandatory.

• Classified the data into Domain specific, Technical, Facilitating and Application based. Focus on domain specific data elements for the workshop

• Prioritised a small number of data elements • Generated a comprehensive list of standards for the selected data

elements • Developed a framework to choose a standard for each data element

and chose the standards for the selected data elements • Identified the localisation effort required to implement the short-listed

standards • Developed an implementation plan, with an agenda for each of the

stakeholders to be involved in the localisation effort 6.4.2 Legal Framework

Legal framework to support privacy and confidentiality of an individual’s health data is a must in any ITIH. Public concern about privacy of health data is a critical issue, especially in an era of computerised medical records and Internet communications. So, a legal infrastructure for preserving the privacy and security of health data in automated, networked systems or for linking and making anonymous the health data in secure environments is a pre-requisite for the ITIH. Legal frameworks in specialised application solutions such as Telemedicine would also need to be worked out separately. The legal framework deals with issues related to security and privacy, confidentiality etc. It highlights issues in defining state-level policies and

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regulations. The framework suggested would lay a special emphasis on e-government management systems as well. The project also suggests a legal framework for specific application solutions by taking Telemedicine as an example. India lacks legal support to players involved in health care and to govern the interests of the parties along the spectrum of healthcare. There is a need for more comprehensive and effective regulations to bring standardisation. To assist develop an effective healthcare legal mechanism and to bring effectiveness and efficiency in the conduct of the healthcare players, the following methodology was used: • Identified existing legal standards for ITIH in India • Identified existing legal standards for ITIH in other countries: the US,

the UK, Australia, Canada and the Philippines • Conducted a gap analysis of ITIH in India and other countries • Identified issues that need to be addressed in the Indian legal system • Identified the authorities that should be involved in the localisation

effort • Identified the authorities that should be involved in implementing the

standards • Developed an implementation plan 6.4.3 Education Professionals who are unfamiliar with (or have limited access to) information technology and existing decision support and communication tools relevant to healthcare cannot function effectively either in private or public health domain. They are unlikely to take full advantage of technology that is available to them or contribute innovative ideas for applying information infrastructure to population health. Facilitating advanced public health applications of information technology will require health professionals with advanced informatics training. So, preparing a right workforce with the right expertise required for supporting the ITIH in the areas of health informatics is a key element of the ITIH. The project recommends the way in which education would need to be imparted. It also gives a broad framework of the Health Informatics course that should be followed. In the education related recommendations, special emphasis will be on how to prepare the right workforce with the right skill sets that would be essential for supporting the ITIH in the areas of health informatics. Method • Identified existing ITIH education initiatives in India • Identified HII education initiatives in other countries: US, UK, Canada,

Australia and Philippines

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• Conducted a gap analysis of HII in India and other countries • Identified the issues that need to be addressed in the Indian education

system • Identified the agencies that should be involved in the localisation effort • Identified the agencies that should be involved in implementing the

standards • Developed an implementation plan

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7 ITIH Vision for Indian Healthcare System

“To define Information Technology Infrastructure for Health in

India that will standardise the capture, storage and exchange of

health information in an environment supported by a robust legal

framework and a mature health informatics education system that

will bring administrative simplification and improve patient care

services by providing a continuum of care”

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8 Global Examples of ITIH

The ITIH has made a significant impact in some countries by bringing in value and benefits to all the players involved. It was imperative that global experiences in setting up ITIH were studied for considering India as the next best candidate for ITIH. The intention of the study was to avoid re-inventing the wheel and draw analogies and experiences from other nations. The study of global examples helped avoid the stumbling blocks that other nations encountered while setting up the ITIH. 8.1 Benchmarked Countries

For this project, lessons have been drawn from a range of countries evolved frameworks (US) to emerging frameworks (Philippines). The following are examples of countries have taken initiative towards bringing in standardisation in the healthcare industry with the help if ITIH.

35

ITIH – A GLOBAL SNAPSHOT

USA

• Enacted HIPAA in 1996 to defined a health information infrastructure

• standardisationwas necessary to bring in administrative simplification

UK

• Defined its health information strategy in 1998.

• First priority was given to electronic health records followed by a national electronic health library

Canada

• established an ‘Advisory Council on Health Infostructure’ in 1997

• Focus was to set up a nationwide health information highway that could significantly improve the quality, accessibility and efficiency of health services

Australia

• Endorsed a national action plan for the health sector –‘health online’ in 1999.

• Focus was a basis for a national strategic approach to health information, involving new ways of delivering health services

Philippines

• Embarked on its HII exercise in 1999 through its ‘Computer Research and Information Technology for Health Program’.

For this project, lessons have been drawn from a range of countries –From evolved frameworks (US) to emerging frameworks ( Philippines)For this project, lessons have been drawn from a range of countries –From evolved frameworks (US) to emerging frameworks ( Philippines)

36

ITIH IN INDIA VIS-À-VIS BENCHMARKED COUNTRIESSTANDARDS

HII Initiative

National Standards

USA

ICD 10 CM

CPT/ HCPCS

ICD-10-PCS

HL7

CPRI

LOINC

ULMS

DICOM

IEEE 1073

X12

NDC

NCPDP

NMDS

UK

READ

OPCS 4NHS Clinical Terms

SNOMEDDICOMCEN TC

251H 320 / 323

HL 7ATC

NSFCMDSEACAGMHMDS

EMR

Canada

ICD 10

HL7

EMR

MDS

Australia

ICD 10

EMR

India

ICD

Philippines

ICD 10

HL7

DEEDS

NPI

India has a long way to go in adopting health information standards. The current limited exposure to standards is primarily due to the statutory requirements of organizations such as WHO for statistical purposes

India has a long way to go in adopting health information standards. The current limited exposure to standards is primarily due to the statutory requirements of organizations such as WHO for statistical purposes

United States of America

• In 1996, the United States enacted the Health Insurance Portability &

Accountability Act (HIPAA) and decided that standardisation was essential to put in place administrative procedures. Though the US had a legal framework in place to deal with information by way of the Enactment of Data Protection Act, 1978, the HIPAA incorporated new developments.

• Currently, American follows standards such as ICD 10 CM, CPT/ HCPCS, ICD-10-PCS, HL7, CPRI, LOINC, ULMS, DICOM, IEEE 1073, X12, NDC, NCPDP, NMDS, etc.

• Educational Framework: AMIA promotes development & application of medical informatics in the health care administration. About 14 Universities offer medical informatics courses

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United Kingdom § The United Kingdom has outlined its health strategy in 1998 with

according top priority to create electronic health records and a national electronic health library.

§ Currently, it follows standards like: READ, OPCS 4, NHS Clinical Terms, SNOMED, DICOM, CEN TC 251, H 320 / 323, HL 7, ATC, NSFCMD, SEACAG, MHMDS, EMR.

§ The British government, through the Health Records Act, 1990, gave a legal framework to its health information strategy. Likewise, to create an educational framework, the Centre for Health Informatics and Multi-professional Education (CHIME) and Medical Informatics Group (MIG) offer education in Health Informatics. The Britain Medical Informatics Society (BMIS) upgrades network infrastructure and integrates systems in a multi-vendor environment.

Canada

• The North American country set up Advisory Council on Health Info Structure in 1997. The prime objective of the Council was to establish a health information highway that could improve the quality, accessibility and efficiency of health services. Canada prescribes to ICD 10, HL7, EMR, MDS, etc.

• To strengthen its legal framework to deal with electronic health data, Canada passed a legislation to protect health-related information, Personal Information Identification Protection and Electronic Documents Act, 2000.

• To create an able and professional workforce, Canadian universities like the Dalhousie University offer Master of Science in Medical Informatics. On the other hand, Canadian Organization for Advancement of Computers in Health (COACH) promotes effective utilisation of IT in healthcare.

Australia

• Australia devised an action plan, health online, in 1999 with focus on creating a strategic approach to health information. The action plan also tries to evolve new ways of delivering health services.

• The ICD 10, EMR, etc are the medical standards currently practiced in Australia. The island nation enacted the Privacy Act, 2001, to protect health data relating to its citizens.

• Australia’s Center for Medical Informatics (CMI) offers medical informatics courses for undergraduates & graduates. The Health Informatics Society of Australia Ltd (HISA) promotes healthcare through health informatics via a national network of individuals and groups.

Philippines • The Philippines embarked on its journey to create a health information

infrastructure in 1999 through the ‘Computer Research and Information Technology for Health Program’. Though it is yet to create a legal framework to deal with health-related electronic information, the

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Philippines uses ICD 10, HL7, DEEDS, NPI, etc., to administer healthcare.

• The Philippines Medical Information Society (PMIS) conducts workshops, training and education on health informatics. The International Health Network of Philippines (IHNP) provides health services through efficient use of health informatics.

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8.2 HIPAA: USA Thrust on Standardisation

The Health Insurance Portability & Accountability Act (HIPAA) of 1996 (August 21), Public Law 104-191, which amends the Internal Revenue Service Code of 1986, is also known as the Kennedy-Kassebaum Act. Under a heading Title II, it includes a section, Administrative Simplification, requiring: • Improved efficiency in healthcare delivery by standardising electronic

data interchange, and • Protection of confidentiality and security of health data through setting

and enforcing standards. More specifically, HIPAA calls for standardisation of electronic data on health of patients, administration and financial transactions. It also calls for creating unique health identifiers for individuals, employers, health plans and healthcare providers. It prescribes security standards to protect confidentiality and integrity of ‘individually identifiable health information’, past, present or future. Compliance deadlines for HIPAA - Most entities get 24 months to comply from the effective date.. Normally, the effective date is 60 days after a rule is published. The compliance date for Transactions Rule is October 16, 2002 or October 16, 2003, if compliance extension plan is submitted per ASCA. HIPAA provides legislation to protect workers who leave their jobs from losing their health insurance (Portability) cover, and to protect integrity, confidentiality, and availability of electronic health information (Accountability). Confidentiality: Keeping all transfers of information private. Ensuring that information is not made available or disclosed to unauthorised individuals. Integrity: Ensuring that data has not been changed or altered en route or in storage. Authentication: Making sure the person sending the message is who he or she claims to be. Non-repudiation: Once a transaction occurs neither the originator nor the recipient can deny that it took place. Authorisation: Allowing authenticated users access to network information and resources based on defined privileges. The HIPAA legislation had four primary objectives: • Assured health insurance portability by eliminating job-lock due to pre-

existing medical conditions • Reduce healthcare fraud and abuse • Enforce standards for health information • Guarantee security and privacy of health information

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As per the HIPAA Guidelines, healthcare organisations are impacted in several ways: • Forced to address federally mandated rules • Must change the way of business, both internally and externally • Need new trusted tools in place to ensure compliancy • Have to quickly train and motivate existing staff to rapidly meet

changing needs • Ensure they have a secure infrastructure that remains compliant • Enable patients’ to be in control of their healthcare information

Compliance Overview

The HIPAA law will require healthcare organisations to standardise administrative transactions, using the ANSI X12 standard. For HIPAA compliance, the organisations would have to first create organisational awareness. They have to assess an organisation’s information security systems, policies and procedures. Based on the assessment, an action plan, with set deadlines and timeframe, must be formulated. Once the blueprint is ready, the organisation then proceeds to create a technical and management infrastructure to implement the action plan. Implementing a comprehensive action plan includes developing new policies, processes and procedures. It also involves building”chain of trust” agreements with service organisations. Redesigning a compliant technical information infrastructure, acquiring new, or adapting, information systems, developing new internal communication infrastructure and training and enforcement are the other elements of the HIPPA law. 8.3 Case Example: Billing Formats in the US Context In the US, the Health Care Financing Administration (HCFA), created on March 9, 1977, to consolidate the administration of the largest Federal health programs, Medicare and Medicaid, was named the Centers for Medicare & Medicaid Services (CMS) on June 14, 2001. The history of health insurance related standards in the US context dates back several years. 8.3.1 Medicare: US's largest health insurance program Medicare has two parts. They are – Medicare Part A & B:

1. Hospital insurance or Medicare Part A which helps pay for care in a hospital, skilled nursing facility, home health care & hospice care, and

2. Medical insurance or Medicare Part B helps pay for doctors, outpatient hospital care and other medical services.

Most people do not have to pay for hospital insurance. They mostly pay for medical insurance on a monthly basis. Most people get hospital insurance automatically when they turn 65. They do not have to pay a monthly payment called a premium for Part A because they or a spouse paid Medicare taxes while they were working. If the patient (or spouse) did not

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pay Medicare taxes while working and are 65 or older, it still may be possible to take hospital insurance. Enrolling in part B or medical insurance is a subscriber’s choice. He/she can sign up for Part B anytime during a 7-month period that begins 3 months before they turn 65. Formats for Claims Submission to Medicare There are 4 types of forms to submit claims to Medicare: • HCFA 1450/UB92 now called CMS-1450 – This form is used to submit

claims for Medicare Part A • HCFA 1500 now called CMS 1500 – This form is used to submit claims

for Medicare Part B • CMS-1491 - The CMS-1491 (Request for Medicare Payment-

Ambulance) form and instructions is used to bill Medicare, Part B covered ambulance services. Medicare, Part B covered ambulance services can also be billed on Form CMS-1500.

• CMS-1490S - The CMS-1490S (Patient's Request for Medicare Payment) form and instructions is used only by Medicare beneficiaries for billing Medicare covered services. Please note that providers and suppliers are required by law to submit Medicare claims on behalf of the beneficiary. If the beneficiary wishes to submit a claim, they must do so on Form CMS-1490S. The beneficiary must also attach to Form CMS-1490S any bill(s) they receive from providers/suppliers.

The UB-92 form and instructions are used by institutional and other selected providers to complete Medicare, Part A paper claim for submission to Medicare Fiscal Intermediaries. The paper UB-92 (Form CMS-1450) is neither a government printed form nor distributed by the CMS. The National Uniform Billing Committee is responsible for the design of the form. There are 86 fields in the UB92 form. The important fields are: Locator 01 - Provider Name & address Locator 04 – Type of Bill Locator 05 – Tax ID Locator 12 – Patient Name Locator 17 – Admission date Locator 19 – Type of admission Locator 20 – Source of admission Locator 44 – CPT or HCPCS code Locator 45 – Service date Locator 46 – Units of service Locator 47 – Total charge Locator 51 – Provider number Locator 58 – Insured’s name Locator 59 – Patient’s relationship to the insured Locator 60 – Insured’s identification number Locator 62 – Insured’s group number

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Locator 67 – Principal diagnosis code Locators 68-75 – Other diagnosis code Locator 82 – Attending physician ID & name. HFCA 1450 FORM (UB 92)

8.4 Standards for Electronic Transactions (for Billing) under HIPAA

The US Congress and the healthcare industry have agreed that standards for the electronic exchange of administrative and financial health care transactions are needed to improve the efficiency and effectiveness of the healthcare system. The Health Insurance Portability and Accountability Act of 1996 (HIPAA) required the Secretary of Health and Human Services to adopt such standards. As required by HIPAA, the Secretary of Health and Human Services is adopting standards for the following administrative and financial healthcare transactions: • Health claims and equivalent encounter information. • Enrollment and dis-enrollment in a health plan. • Eligibility for a health plan.

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• Health care payment and remittance advice. • Health plan premium payments. • Health claim status. • Referral certification and authorization. • Coordination of benefits. Standards for electronic transactions and code sets – For filing electronic UB 92 claims, under HIPAA, the ASC X12N 837 - Health Care Claim: Institutional, Version 4010, 004010X096 would be the standard National standards will encourage electronic commerce in the healthcare industry and ultimately simplify the processes involved. This will result in savings from reduction in administrative burdens on health care providers and health plans. Today, healthcare providers and health plans that conduct business electronically must use many different formats for electronic transactions. For example, about 400 different formats exist today for healthcare claims. These standards will make electronic data interchange a viable and preferable alternative to paper processing for providers and health plans alike.

Electronic transactions must go through two levels of scrutiny:

• Compliance with the HIPAA standard. The requirements for compliance must be completely described in the HIPAA implementation guides and may not be modified by the health plans or by the health care providers using the particular transaction.

• Specific processing or adjudication by the particular system reading or

writing the standard transaction. Specific processing systems will vary from health plan to health plan, and additional information regarding the processing or adjudication policies of a particular health plan may be helpful to providers.

Such additional information may not be used to modify the standard and may not include:

• Instructions to modify the definition, condition, or use of a data element or segment in the HIPAA standard implementation guide.

• Requests for data elements or segments that are not stipulated in the HIPAA standard implementation guide.

• Requests for codes or data values that are not valid based on the HIPAA standard implementation guide. Such codes or values could be invalid because they are marked not used in the implementation guide or because they are simply not mentioned in the guide.

• Change the meaning or intent of a HIPAA standard implementation guide.

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Medical code sets adopted under HIPAA Under HIPAA, a "code set" is any set of codes used for encoding data elements, such as terms, medical concepts, medical diagnosis codes, or medical procedure codes. Medical data code sets used in the health care industry include coding systems for diseases, impairments, other health-related problems and their manifestations; causes of injury, disease, impairment, or other health-related problems; actions taken to prevent, diagnose, treat, or manage diseases, injuries, and impairments; and any substances, equipment, supplies, or other items used to perform these actions. Code sets for medical data are required for data elements in the administrative and financial health care transaction standards adopted under HIPAA for diagnoses, procedures, and drugs. International Classification of Diseases, 9th Edition, Clinical Modification, (ICD-9-CM), Volumes 1 and 2 (including The Official ICD-9-CM Guidelines for Coding and Reporting), as updated and distributed by HHS, for the following conditions: • Diseases. • Injuries. • Impairments. • Other health related problems and their manifestations. • Causes of injury, disease, impairment, or other health-related

problems. International Classification of Diseases, 9th Edition, Clinical Modification, (ICD-9-CM), Volume 3 Procedures (including The Official ICD-9-CM Guidelines for Coding and Reporting), as updated and distributed by HHS, for the following procedures or other actions taken for diseases, injuries, and impairments on hospital inpatients reported by hospitals: • Prevention. • Diagnosis. • Treatment. • Management. National Drug Codes (NDC), as updated and distributed by HHS, in collaboration with drug manufacturers, for the drugs and Biologics. Code on Dental Procedures and Nomenclature, as updated and distributed by the American Dental Association, for dental services. The combination of Health Care Financing Administration Common Procedure Coding System (HCPCS), as updated and distributed by HHS; and Current Procedural Terminology, Fourth Edition (CPT-4), as updated and distributed by the American Medical Association, for physician services and other health related services. These services include, but are not limited to, the following: • Physician services. • Physical and occupational therapy services.

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• Radiological procedures. • Clinical laboratory tests. • Other medical diagnostic procedures. • Hearing and vision services. • Transportation services including ambulance. The Health Care Financing Administration Common Procedure Coding System (HCPCS), as updated and distributed by HCFA, HHS, for all other substances, equipment, supplies, or other items used in health care services. These items include, but are not limited to, the following: • Medical supplies. • Orthotic and prosthetic devices. • Durable medical equipment.

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8.5 Key Learning for India Going by the degree of permeation of standards and polices in the developed countries, it is obvious that India has a long way to go in adopting health information standards. The power of IT cannot be exploited without implementing a robust framework for information infrastructure. To ensure the success of the ITIH initiative in India, involvement of multiple government agencies is critical. Also, the concerns of all stakeholders need to be addressed in the very beginning.

48

TIMELINE FOR ITIH ADOPTION IN BENCHMARKED COUNTRIES

1. Clinical Terminology 2. Identifiers3. Drug

Databases4. Drug

Interactions5. Messaging

standards

6. Electronic health records

7. Technical Standards

8. Billing formats

9. Minimum Data Sets

10. Lab Formats

11. Privacy & Security laws

1. Clinical

Terminology 2. Identifiers

3. Drug Databases

4. Drug Interactions

5. Messaging standards

6. Electronic health records

7. Technical Standards

8. Billing formats

9. Minimum Data Sets

10. Lab Formats

11. Privacy & Security laws

1990 02010099989796959493929119851980

1

9 5 2 11

2

5 1191

9 11 51

1

6

6

9

6

7

11

6

5

1

9

050403

1 92 11

USUS

UKUK

AustraliaAustralia

CanadaCanada

IndiaIndia

PhilippinesPhilippines

India can leapfrog to a state in which many other countries now are, if ITIH is implemented immediately !

India can leapfrog to a state in which many other countries now are, if ITIH is implemented immediately !

Standardisation activity is rampant in most nations. However, many countries have their legacy systems to sort and fine tune the requirements of standardisation. India, on other hand, can start from a clean slate as it does not have any legacy system to clean up. Learning from global examples, analysing their approaches, implementation activities and mistakes, India is in the best position to implement ITIH, avoiding the pitfalls of many countries. India is all set to leapfrog into the League of Nations that reap the benefits of standardised systems.

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9 Overview of Recommendations

Health information exists in diverse forms and formats resulting in the current state of lack of integrity and reliability of health information in the country. Lack of uniform standards for structure, content, and transmission of health data seriously impairs administrative functions and the efficiency of the sector. In order to build infrastructure for the Information Technology for Healthcare in India, it is imperative to define standards for health information, covering various entities, functions, and organisations, to take the initiative forward. The following key areas need to be standardised under ITIH:

1. Billing Formats 2. Clinical standards 3. Data Elements 4. Health Identifiers 5. Messaging standards for exchanging health information 6. Minimum Data Sets

Identifiers

• Patient Id

• Provider Id

• Payer Id

• Health Plan Id

• Pharmacy Id

Codes & Terminology

• Disease Codes

• Procedure Codes

• Observation Codes

• Drug Codes

• Nursing Codes

Content & Formats

• Patient Enrollment –Registration

• Patient Medical Records

• Billing Formats

• Minimum Data Sets

• Lab Formats

Messaging

• HL7, EDI, EDIFACT

Categories of Standards required for health information

Security & Access Control

• Authentication

• Access Control

• Non Repudiation

• Privacy Protection

Standardisation of the six key areas alone is not enough to ensure implementation and success of the ITIH. To support the standardisation process and to keep the ITIH functional and progressive, two additional areas need to be implemented simultaneously to ensure standardisation of health information: § The Education Framework § The Legal Framework

The Implementation Agency worked with nominated members in each working group to finalise the recommendations for the ITIH framework. Keeping in mind the interest of various stakeholders in healthcare, including patients, the ITIH study presents the following set of recommendations for eight modules. The results of the extensive study are summarised in the following sections.

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9.1 Billing Formats

Introduction

Billing and content formats are standards for health insurance claims processing consisting of transactions, content definitions, data dictionaries and transaction standards. By defining formats for content and billing, the ITIH mandates use of certain standards for information exchange, bringing in administrative simplification and also ensuring protection of privacy and security of patient information. The recommendations for standardisation in the Indian health insurance context, has been arrived at by studying the existing scenario, its associated issues and various global examples that helped define standardised data elements, forms and formats.

Methodology

The methodology adopted to arrive at final recommendations included both qualitative and quantitative techniques. To devise billing formats for India, Standard Billing Formats of other countries (for e.g. the US) were studied in detail. The study identified existing data for an Indian format and addressed issues specific to this country. After various working groups discussed the preliminary recommendations, a set of final recommendations was arrived at and an implementation plan was developed.

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Transactions in Health Insurance have been classified as following:

Transaction No

Description of Transaction

Initiating Entity

Participating Entity

Current Implementation

Current Formats

TA-01 Enrollment/ Disenrollment in Health Plan

Individual/ Corporate

Insurer Paper Insurer specific formats

TA-02 Health Plan Premium payments


Insurer Paper Checks/ Drafts

TA-03 Eligibility check/ credit authorisation

TPA Provider Paper/ Fax/ Electronic

TPA specific formats

TA-04 Billing for covered services

Provider Individual/ TPA

Paper Provider specific formats

TA-05 Claim submission for covered services

Individual/ TPA

Insurer Paper Insurer specific formats

TA-06 Claims status query Individual/ TPA

Insurer Phone/ Paper

No formats

TA-07 Health care payment and remittance advice

Insurer TPA Paper Checks/ Drafts

TA-08 Payment for covered services

TPA Provider/ Individual/ Corporate

Paper Checks/ Drafts

Billing Formats (along with data elements) should be so defined that it ensures easy migration from a paper-based environment to an electronic one in the future. Billing Format should take into account the existing structure and information exchange needs in the Indian context – Formats have to be India-specific – It cannot be adopted from other countries. Formats should be based on using codes wherever possible (eg. Diagnosis, Procedures etc.)

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Final Recommendations • TA-01: Enrollment and Disenrollment in a Health Plan • TA-02: Health Plan Premium Payments • TA-03: Eligibility Check/ Credit Authorisation • TA-04: BILLING FOR COVERED SERVICES • TA-05: CLAIM SUBMISSION FOR COVERED SERVICES • TA-06: HEALTH CARE CLAIM STATUS QUERY • TA-07: Health Care Payment and Remittance Advice • TA-08: Payment for Covered Services

The proposed standards for health insurance transactions are as follows:

Transaction No


Initiating Entity


Current Implementation

Current Formats



Insurer Electronic Uniform Format to be decided





TPA Provider Electronic Uniform Format to be decided



Electronic

Provider Billing Format - 01


Individual/ TPA

Insurer Electronic

Claim Submission Format- 01




Insurer TPA Electronic Uniform Format to be decided



Electronic Uniform Format to be decided

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TA-01: Enrollment and Disenrollment in a Health Plan Enrollment and disenrollment in a health plan transaction is the transmission of subscriber enrollment information to a health plan to establish or terminate insurance coverage. Standard for enrollment and disenrollment in a health plan Currently there is no standard format in India. Each insurer has a specific format. The corporate submits the required information on paper or in a soft copy (MS Excel or Word file). The policy is issued manually/using the computerized system of the Insurer in paper format and handed to the corporate. Recommended Format A uniform format incorporating the following elements needs to be agreed upon by all stakeholders: § Names of employees to be covered § DOB/ Age § Address § Marital Status § Sex § Dependents details § Employee ID § UHID (Universal Health Identifier) § Corporate ID (PAN) § TPA ID § Health Plan ID § Insurance Amount § Applied for date

Messages in this format will be electronically transferred to the Insurer and confirmation for the enrolled persons will flow back to the provider. The extra data passed back would be: § Insurance ID § Insurance start date § Insurance end date

Similarly, flow will hold good also for disenrollment. In this case only UHID, Insurance ID, Health Plan ID and Corporate ID need to be sent to the Insurer. The Insurer will revert with a confirmation and the Insurance Termination Date as well as the amount refunded (if any)

- 57 -

TA-02: Health Plan Premium Payments Health plan premium payment transaction is the transmission of any of the following from the entity that is arranging for the provision of health care or is providing health care coverage payments for an individual to an insurer: (a) Payment. (b) Information about the transfer of funds. (c) Detailed remittance information about individuals for whom premiums are being paid. Standard for health plan premium payments. Currently all payments are done through local cheque/ draft accompanied by a covering letter. There is no standard format. Recommended Format A uniform format covering the following elements needs to be agreed upon by all stakeholders: § Payment amount § Payment date § Payment mode § Payment Reference Number § Health Plan ID § List of UHID’s for which payment is being given § Payment routing details

Messages in this format will be electronically transferred to the Insurer and the confirmation for enrolled persons will flow back to the provider.

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TA-03: Eligibility Check/ Credit Authorisation The eligibility check/ credit authorisation for a health plan transaction is the transmission of either of the following: (a) An inquiry from a health care provider to a TPA to obtain the following information about a benefit plan for an enrollee such as eligibility to receive health care under the health plan, coverage of health care under the health plan, request for an authorisation for a specific amount to be sanctioned for health care, etc. (b) A response from a health plan to a health care provider's inquiry as described above. Standards for Eligibility Check/ Credit Authorisation for a health plan. Currently there is no uniform standard for the above interaction. The TPA gives the format for request to each provider on the network. The provider faxes across the authorisation request to the TPA after filling in details of the patient and medical necessity. Based on this request, the TPA faxes the authorization letter to the provider. Some TPAs have made this process electronic such that the authorisation can be received on the Web. Recommended Format A uniform format covering the following elements needs to be agreed upon by all stakeholders: § Patient UHID § Policyholder UHID § Name § Address § Hospital ID § Hospital Name § Hospital Address § Health Plan ID § Corporate ID § Authorisation Request Date § Date of required admission § Expected duration § Provisional Diagnosis § Treatment to be given § Referring doctor name § Referring doctor address § Referring doctor phone no § Attending doctor name § Attending doctor address § Attending doctor phone no § Case History § First report of injury date § Last Menstrual Period (for Maternity cases) § Expected date of delivery (for Maternity cases) § Expected cost

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§ Break-up of expected cost § Amount of authorization needed

Messages in this format will be electronically transferred to the TPA and the confirmation for the authorized amount will flow back to the provider along with an authorization number. Hence, the extra fields flowing back will be: § Authorised amount § Authorisation number § Name of authorizing doctor § TPA office location ID § Date of authorization

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TA-04: Billing for covered services. The billing for covered services transaction is the transmission of the following: (a) A request to obtain payment, and (b) the necessary accompanying information from a health care provider to a TPA for health care provided to a patient covered under health plan administered by the TPA. Standards for billing for covered services There are no standards for billing for covered services. Each hospital has its own format for billing which is generated manually in most cases. The paper bill is handed over to the patient/ TPA. Recommended Format A uniform format covering the following elements needs to be agreed upon by all stakeholders: Policy Holder Information § Name § UHID § Address (Street, City, State, Pin code)

Patient Information § Name § Relation to policyholder § UHID of the patient

Provider Information § Name § Address § Provider Identification Number

Provider Representative § Name § Date § Signature

Claim Information § Admission date and time § Patient status § Authorisation number § First occurrence date § Discharge date and time § Patient paid amount § Principal diagnosis § Other diagnosis information § Notes

Policy Holder / Patient § Name § Date § Signature

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Recommended Format for Provider Billing Proposed Provider Billing Format (PBF-01) shows the data sent from provider to TPA. The TPA will acknowledge the receipt with a receipt ID.

Authorisation Number:Policy Holder Information Patient InformationName: Name:Individual Identification Number (UHID): Relation:Address: Individual Identification Number (UHID):

Tel:City State: Pin: E-mail:Provider InformationName: Provider Identification Number (UPIN / MCI No.):Address:

City State: Pin:Claim InformationAdmission Date: Time: Notes:Patient Status:First Occurance Date:Discharge Date: Time:Patient Paid Amount:Principal Diagnosis:Other Diagnosis Information:Procedure code: Procedure Description

Serviceline InformationService Description Amount Discount Net Amount Patient paid amount Balance due Remarks

List of Enclosures (Please Tick) Comments / Remarks/ ObjectionsPreauthorisation / First Admission ReportDischarge SummaryHospitalization Bills with breakupsInvestigation ReportsConsultation bills with ReceiptIf Surgery, Surgery Bills with ReceiptMedicine Bills with PrescriptionsOT Pharmacy BillsOthers

Provider Representative Policy Holder / PatientName: Name:Date: Date:

Signature: Signature:

Provider Billing Form (PBF 01)

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The following is the data dictionary for the above fields listing the name, type of information along with examples

Data Dictionary for Provider Billing Format (PBF-01) DATA ELEMENT DESCRIPTION FORMAT EXAMPLES

Authorisation Number

Enter the Authorisation Number for the case.

Authorisation Number given by TPA in a 10 letter standard format The first three letters represents the TPA.

FHP9999999.

Policy Holder Information

Name: Enter the Full name of the Policy Holder.

First name, Middle name if any, Last name

Rajiv Sharma

Individual Identification Number (UHID):

Enter the Universal Health Identification Number allotted to the Policy Holder

4 alphanumeric characters representing the Provider code followed by a dot and 10 digits representing the serial code

APJ1.9000000034

Address: Enter the Full postal address

Include Street, City, State and Pin code

86-B, Santhome High Road, Chennai - 600 028.,Tamil Nadu.

City: 7 digit city code

State: Enter the appropriate code allotted for the respective state.

Standard two alphabet codes will be assigned for each state

AP for Andhra Pradesh, DL for Delhi

Pin Code: Enter the correct PIN code along with the address.

Use standard format for six digit Pin Code with no spaces. 600016

Patient Information


First name, Middle name if any, Last name e.g. Rajiv Sharma

Relation

Enter the description of the relationship of the patient with the policy holder

Relationship code

Self (S), father (F), mother (M), wife (W), Son (O), Daughter (D) etc




APJ1.9000000034

Tel Enter the telephone number of patient if any

Include STD code with telephone number

040-8607777

Email Enter email address of patient if any Enter complete email address [email protected]

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Provider Information

Name Enter the Full Name of the Provider.

Name of the Organization in Full Sri Ramachandra Medical College & Research Institute

Address Enter the Full Postal Address of the Provider.


Sri Ramachandra Medical College & Research Institute 1, Ramachandra Nagar, Porur, Chennai-600 116.Tamil Nadu

Provider Identification Number

Enter the Universal Provider Identification number (UPIN) that has been allotted to the Provider

City Enter the Appropriate City Code

7 digit city code allotted for each city

State Enter the appropriate code allotted for the respective state.

Standard two alphabet codes will be assigned for each state.

AP for Andhra Pradesh

Pin Code Enter the correct PIN code along with the address.

Use standard format for six digits Pin Code with no spaces.

500016 for Begumpet, Hyderabad

Claim Information

Admission date and time

Enter the date and time of admission of the patient

Use DD-MM-YYYY format, Use AM / PM format

25-09-2002 and 10:30 AM

Patient Status**: Enter the Status of the Patient. Enter Single letter code for Status

Status can vary from discharged (D), expired (E), transferred (T), admitted (A) etc.

First Occurrence Date

Enter the date of the first occurrence of the illness

Use DD-MM-YYYY format 25-09-2002 and 10:30 AM

Discharge date and time

Enter the date and time when the patient was discharged.


25-09-2002 and 10:30 AM

Patient Paid amount:

Enter the amount of money paid by the patient

Use Rupee and Paise format. Rs. 5340.60

Principal Diagnosis Use the correct first and second level ICD diagnosis codes

Use the appropriate ICD 10 code format

7 digit alphanumeric classification system e.g. A00-A09 for intestinal infectious diseases

Other Diagnosis Information

Use the correct first and second level ICD diagnosis code

Use the appropriate ICD 10 code format

7 digit alphanumeric classification system e.g. A00-A09 for intestinal infectious diseases

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Procedure Code Use the correct level 1 and 2 ICD-10-PCS codes

Use the appropriate ICD -10-PCS code format

2 digit alphanumeric classification system e.g. 6D

Procedure Description

Describe the Procedure carried out on the patient

Open Text e.g. "CABG"

Notes Any relevant notes or remarks addressed to the Insurer.

Open Text

e.g. "We will be sending you the post hospitalisation review bills later this week. Please treat them as part of the same claim".

Service Line Information

Service Description

Enter description of the service rendered. In case of Consultant visits, Enter the Name of Consultant

Open Text Consultant Visit x 4 (by Dr. H. Dixit)

Amount Enter the Total Amount for the service rendered (T = Units x Rate)


Discount: Enter the Discount if any given by the hospital.

Use Rupee and Paise format. Rs.101.00

Net Amount Enter the Net Amount (Net Amount = Total charges - Discount).


Patient Paid amount:

Enter the total amount of the balance that needs to be paid


Balance due Enter the total amount paid by the patient Use Rupee and Paise format. Rs.5216.02

Remarks Enter any relevant remarks

Text e.g. Please ensure payment within 15 days"

List of enclosures Tick the documents which have been attached to the bill

Text

Comments/Remarks/Objections

Enter any relevant remarks

Text e.g. “Please ensure payment within 15 days"

Provider Representative

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Name Enter the Full Name of the Provider. Text

Sri Ramachandra Medical College & Research Institute.

Date Enter the date of submission

Date in DD-MM- YYYY format 25-09-2002 and 10:30 AM

Signature Signature of person responsible Text Signature

Policy Holder/Patient

Name Enter the Full Name of Policy holder/ Patient

First Name, Middle Name if any, Last Name Rajiv Sharma


Date in DD-MM- YYYY format 29-09-2002

Signature Signature of policy holder/ patient

Text Signature

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An Example of Patient Claim Form (PCF 01)

Policy Holder Information Patient InformationPolicy No. Name:Name:Individual Identification Number (UHID): Relation:Address: Individual Identification Number (UHID):

Tel:City State: Pin: E-mail:Claim InformationAdmission Date: Time: Discharge Date: Time:First Occurance Date: Diagnosis:Bill detailsSno. Name of Hospital/Clinic/Doctor Service/Product Bill No. Bill Date Amount Claimed *Claim type

Total Amount:List of Enclosures (Please Tick) Comments / Remarks/ Objections

Preauthorisation / First Admission ReportDischarge SummaryHospitalization Bills with breakupsInvestigation ReportsConsultation bills with ReceiptIf Surgery, Surgery Bills with ReceiptMedicine Bills with PrescriptionsOT Pharmacy BillsOthers

Policy HolderName:

Date:

Signature:

Patient Claim Form (PCF 01)

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The following is the data dictionary for the above fields listing the name, type of information along with an example.

Data Dictionary for Patient Claim Form (PCF 01)

DATA ELEMENT DESCRIPTION FORMAT EXAMPLES

Policy Holder Information

Policy No Enter the policy number Format as allotted by the Insurance company



Rajiv Sharma




APJ1.9000000034

Address: Enter the Full postal address


86-B, Santhome High Road, Chennai - 600 028.Tamil Nadu.

City: 7 digit city code





Use standard format for six digit Pin Code with no spaces.

600016

Patient Information


First name, Middle name if any, Last name e.g. Rajiv Sharma

Relation

Enter the description of the relationship of the patient with the policy holder

Relationship code Self (S), father (F), mother (M), wife (W), Son (O), Daughter (D) etc




APJ1.9000000034

Tel Enter the telephone number of patient if any

Include STD code with telephone number

040-8607777

Email Enter email address of patient if any

Enter complete email address

[email protected]

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Claim Information

Admission date and time Enter the date and time of admission of the patient


25-09-2002 and 10:30 AM

First Occurrence Date Enter the date of the first occurrence of the illness

Use DD-MM-YYYY format

25-09-2002 and 10:30 AM

Discharge date and time Enter the date and time when the patient was discharged.


25-09-2002 and 10:30 AM

Diagnosis Enter the principal diagnosis details.

Open Text "Appendicitis"

Bill Details

Name of Hospital/ Clinic/ Doctor Enter the name of the Hospital/Clinic/Doctor

Open Text Ramchandra Medical College, Chennai

Service/Product



Bill No Enter the bill number Alphanumeric e.g. AB02354 Bill Date Enter the bill date Open text 12/9/02

Amount Claimed Enter the total claimed amount.

Use Rupee and Paise format.

Rs.5216.02

Claim Type Enter the type of claim Text

e.g. Pre/Hosp/Post for pre-hospitalization/ Hospitalization and post Hospitalization respectively

Total Amount Enter the total claimed amount


List of Enclosures Tick the documents which have been attached to the bill

Text

Policy Holder

Name Enter the Full Name of Policy holder/ Patient

First Name, Middle Name if any, Last Name

Rajiv Sharma


DD-MM- YYYY format 29-09-2002

Signature Signature of policy holder/ patient

Text Signature

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TA-05: Claim submission for covered services. The claim for covered services transaction involves the following: (a) A request to obtain payment, and the necessary accompanying information from a TPA to an insurer for health care provided to a patient covered under health plan of the insurer and (b) An acknowledgement number allocated by insurer for future tracking Standards for Claim submission for covered services. Claim submission happens manually through paper claims. Each insurer has its own paper-based format for claim filing. All medical reports/ prescriptions/ bills etc. are sent together with the claim. The insurer manually allocates a claim number after entry into the register, which can be used for claim tracking. Recommend Formats A uniform format covering the following elements needs to be agreed upon by all stakeholders: Claim identification number Insurer Information § Name § Insurer ID § Branch Name § Address (Street, City, State, Pin code)

Health Plan Information § Health Plan Type § Health Plan Identification Number § Group Name / Corporate Name § Group/Corporate Identification Number (PAN)

TPA Information § Name § Address § TPA Identification Number

Payee Information § Name § Address § Payee Type § Payee ID Number § Payment amount

Submission Details § Name § Date § Signature

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Recommended Format for Claim Submission Proposed Claim Submission Format (CSF-01) shows the data sent from TPA to Insurer. The Insurer will acknowledge the receipt with an acknowledgement ID.

Authorisation No.: Claim Identification No.:Insurer InformationName: Insurer ID: Branch name:Branch Address: City: State: Pin:Health Plan InformationPolicy Number: Endorsement No. Serial No.Health Plan Type:Group/ Corporate Name: Address:Group/ Corporate Identification Number(PAN):

City: State: Pin:TPA InformationName: Address:TPA Identification Number:

City: State: Pin:Service Line Information

TotalPayment Information

Payee1 Payee2 Payee3NameAddress

CityStatePinPayee TypePayee ID Number Payment AmountBalance details Sum Insured Previous balance Amount settled Balance left

Settlement DetailsName:

Date:

Signature:

Claim Settlement Form (CSF 01)

Code Description Units Rate Amount Claimed Amount Disallowed Amount Settled Remarks

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The following is the data dictionary for the above fields listing the name, type of information along with an example.

Data Dictionary for Claim Submission Form (CSF 01)

DATA ELEMENT DESCRIPTION FORMAT EXAMPLE

Authorisation Number Enter the Authorisation Number for the case.

Authorisation Number given by TPA in a 10 letter standard format The first three letters represents the TPA.

FHP9999999.

Claim Identification Number:

A uniform number system will be assigned for Claim ID numbers

Insurer information

Name: Enter the Name of the Insurance Company Text

National Insurance Company

Insurer ID Enter the Insurer's Identification Number

Standard Code to be assigned by IRDA

Branch Name Enter the Insurer's Branch Code To be Assigned by each Insurer

Branch Address Enter the Full postal address of the Branch

Enter City, State and PIN code in correct format

National Insurance Company 3, Middleton Street Calcutta - 700 071 West Bengal

City: Enter the city code for the city 7-digit number code will be assigned for each city.





Use standard format for six digits Pin Code with no spaces.

600016

Health Plan information

Health plan type: Enter the Type of Health Plan Single Alphabet for Type

Corporate, Individual or Group ( C,I,G)

Policy Number Enter the Policy Number Defined by the Insurance company

Endorsement No Enter the Endorsement Number Defined by the Insurance company

Serial No Enter the Serial Number Defined by the Insurance company

Group Name / Corporate Name:

Enter the Name of the group or corporate Text

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Group / Corporate Identification Number (PAN):

Use PAN for Corporates, for Group code for a Group common number needs to be evolved

Use PAN format, for a Group common number needs to be evolved

TPA Information

Name: Enter the Name of the TPA Text Family Health Plan Ltd.

Address: Enter the Full postal address Include Street, City, State and Pin code

Family Health Plan Ltd, 35,Sai Enclave, Banjara Hills, Road-12, Hyderabad. 500034. Andhra Pradesh, India.

City/ State/ Zip code: Enter the correct city, state and PIN codes

7-digit City code, 2 letter state code and PIN code

TPA Identification Number: Enter the TPA ID No allotted by IRDA

To be allocated by IRDA

Service Line Information

Code Enter the correct service code. Five digit alphanumeric code

Code for Room rent- Deluxe Room is RM001 where RM is the service line code and 001 is the type of room. See Note below for codes for Sample services **

Description



Units Enter the Appropriate units for Service line.

Use the correct two digit code

e.g. 01 for Bottles, 02 for Days etc.

Rate Enter the Rate per unit for the Service rendered.


Amount claimed Enter the total amount claimed by the Insured

Use Rupee and Paise format.

Rs. 5340.61

Amount Disallowed Enter the total amount disallowed Use Rupee and Paise format. Rs. 5340.62

Amount Settled Enter the total amount settled Use Rupee and Paise format.

Rs. 5340.63

Remarks Enter any relevant remarks Text e.g. " Telephone charges disallowed"

Payment Information

Payee

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Name: Name of the Party to whom payment needs to be made by the Insurer.


Rajiv Sharma

Address: Full name of City, Use Standard state and PIN code

Enter City, State and PIN code in correct format

86-B, Santhome High Road, Chennai - 600 028.,Tamil Nadu.

City: Full name of the City Use 7 digit City code allotted

State: Enter standard code for state.



Pin:

Payee Type:

Enter Appropriate Hospital/Individual/ Corporate/TPA or Group (H, I, C, T, G) code

Single Alphabet code

H, I, C, T, G for Hospital/Individual/ Corporate/TPA or Group

Payee ID number Enter UPIN/ PAN/ UHID respectively for the payee

Appropriate UPIN/PAN/UHID format

Payment Amount: Enter the Amount paid. Use Rupee and Paise format.

Rs. 5340.60

Balance details

Sum Insured Enter the total Sum Insured Use Rupee and Paise format.

Rs.100000.00

Previous balance Enter the amount of balance available


Amount settled Enter the amount settled Use Rupee and Paise format.

Rs.10000.00

Balance left Enter the balance left after deducting the amount settled


Settlement Details

Name Full name of person who is submitting the claim. Text R. Srinivas

Date Date of submission DD- MM- YYYY format 29-09-2002

Signature Signature of person who is submitting the claim.

Text Signature

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TA-06: Health Care Claim Status Query A health care claim status transaction is the transmission of either of the following: (a) An inquiry to determine the status of a health care claim. (b) A response about the status of a health care claim. Standard for health care claim status query. Currently all querying by patient/ TPA is done either telephonically or on paper. There is no standard format for this. Recommended Formats A uniform format covering the following elements needs to be agreed upon by all stakeholders: § Patient UHID § Patient Name § Claim ID § Acknowledgement ID § Date of Claim Submission § Health Plan ID § TPA ID

Messages in this format will be electronically transferred to the Insurer. The Insurer will revert with details on the status of the claim and details of any payment made. The extra data sent back would contain: § Status of claim (cleared, not processed, pending clarification,

awaiting documentation, claim denied, payment made etc.) § Reason for delay/denial, if any § Payment Amount § Payment Date § Payment ID

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TA-07: Health Care Payment and Remittance Advice The health care payment and remittance advice transaction is the transmission of either of the following for health care: (a) The transmission of any of the following from an Insurer to TPA:

(1) Payment. (2) Information about the transfer of funds. (3) Payment processing information.

(b) The transmission of either of the following from an insurer to a TPA:

(1) Explanation of benefits. (2) Remittance advice.

Standards for health care payment and remittance advice. Currently there are no standards for either Payments or Explanation of Benefits (EOB). Payment is typically in the form of local check/ draft. Single payment/ group of payments are accompanied by a covering letter which might/ might not contain information on claim denial (EOB) Recommended Formats A uniform format covering the following elements needs to be agreed upon by all stakeholders: § Payment amount § Payment date § Payment mode § Payment Reference Number § Health Plan ID § Patient UHID § Claim Id § Payment routing details § Explanation of Benefits

The Insurer will electronically transfer messages in this format to TPA.

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TA-08: Payment for Covered Services The Payment for Covered Services transaction is the transmission of either of the following for health care: (a) The transmission of any of the following from a TPA to Provider - sometimes it maybe to an individual/ corporate (for non-network hospitals)

(1) Payment. (2) Information about the transfer of funds. (3) Payment processing information.

(b) The transmission of either of the following from a TPA to Provider:

(1) Explanation of benefits. (2) Remittance advice.

Standards for health care payment and remittance advice. Currently there are no standards for either Payments or Explanation of Benefits (EOB). Payment is typically in the form of local check/ draft. Single payment/ group of payments are accompanied by a covering letter which might/ might not contain information on claim denial (EOB) Recommended Format A uniform format covering the following elements needs to be agreed upon by all stakeholders: § Payment amount § Payment date § Payment mode § Payment Reference Number § Health Plan ID § Patient UHID § Claim Id § Payment routing details § Explanation of Benefits

The TPA will electronically transfer messages in this format to the provider.

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Implementation

The following steps have been proposed for implementing the billing formats final recommendations under the ITIH. The transition from paper-based transactions to an electronic format can be phased in the order of priority and ease of implementation.

Transaction No


Initiating Entity


Proposed Phase 1

Proposed Phase 2



Insurer Paper/ Electronic

Electronic



Insurer Paper Electronic


TPA Provider Paper/ Electronic

Electronic



Paper Electronic


Individual/ TPA

Insurer Paper Electronic


Insurer Paper/ Electronic

Electronic


Insurer TPA Paper Electronic



Paper Electronic

The following is the proposed implementation time line for adopting the health identifier standards to be used in the above formats. S.No Type Description 1 Individual Universal Health Identifier (UHID) 2 Provider Universal Provider Identification Number (UPIN) 3 Doctor SMC/ MCI Number 4 Corporate Permanent Account Number 5 Insurer Insurer Id 6 TPA TPA Id 7 Health Health Plan Id

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§ There has to consensus amongst various entities on the proposed billing formats at the committee of insurers – (TA 04 & TA 05).

§ All health insurance companies to make compliance to formats a

mandatory requirement as part of their agreement with the TPAs

§ Committee of Insurers also to endorse the proposed minimum data sets for other (non-billing) transactions. (TA 01, TA 02, TA 03, TA 06, TA 07 and TA 08)

o Proposed data set to be communicated to all TPAs and insurance companies and MIS data to be collected based on this only

§ TPAs to get into a similar compliance agreement with the Providers

(Hospitals) as part of their contract o In the short term where hospitals derive minimal business

from insurance clients, there would be resistance to adhere to new guidelines

o TPAs should facilitate adherence by working closely with the providers, and doing it on their behalf if need be

o As insurance business grows, providers will automatically follow the defined guidelines.

For more information, please refer Annexure 1a: Billing and Content Format Annexure 1b: Proposed Formats and Standards for the Indian Health Insurance Segment

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9.2 Clinical Standards

Introduction

Clinical data representation standards, or Code sets, are a systematic representation of health information. These standard codes are structured in a predefined format and represent information such as a patient’s illness, the physician’s observation about the illness, diagnostic tests required to ascertain the illness, results of the diagnostic tests, treatment procedure and instructions to the para-medical staff. A plethora of clinical standards are used in the health sector to codify information related to diseases, procedures, clinical observation, drugs, nursing procedures, consumables, surgeries, etc. Most countries have adopted code sets in accordance with their requirement and nature of use. After studying various global examples of medical code sets, the project identified three critical areas for standardisation. For the purpose of the ITIH study, the following three areas of medical coding were studied in depth: § The Disease Codes § The Procedure Codes § The Clinical Observation Codes

Methodology The following were the steps taken towards recommending the clinical standards to be adopted by India. To set clinical standards for India, the study examined Clinical Standards in five benchmarked countries (the US, the UK, Australia, Canada and the Philippines). After interaction with different stakeholders in the Indian healthcare industry, the study zeroed in on three critical clinical standards: Disease Codes, Procedure Codes, and Observation Codes. Later, the study ranked initiatives of different countries and identified the one most suited for India and developed a framework to implement the initiative. The preliminary recommendations were shared with working group members. After many brainstorming sessions, a final set of recommendations was arrived at incorporating the inputs of the working groups.

Methodology of Comparison between Various Clinical Standards The each code set was studied for the following parameters:

1. Technical Richness of the Code Set 2. Commercial Viability

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3. Ease of Implementation 4. Ownership, Validity and other issues

11

METHODOLOGY OF COMPARISON BETWEEN VARIOUS CLINICAL STANDARDS

Technical Richness

Coverage

(Number of codes in a particular standard / Number of diseases that a particular standard covers)

Clinical Specificity

(Detailed explanation for various permutations and combinations of each disease)

Inter-relationship

(Dependency of one standard on another standard?)

Commercial Viability

Cost of Acquisition

(Cost of procuring the license / Royalties to be paid for the use of the standard)

Ease of Implementation

Worldwide Usage

(Global usage of the standard)

Familiarity in India

(Knowledge of the Standard in India)

Scope for modification

(Flexibility of the standard to be localized)

Ease of Switching

(Effort required to switch to a new standard)

Readiness

(Ability of the standard, to be implemented immediately)

Others

Validity

(Frequency of updation)

Ownership

(Name of the Country/Organization owning the standard)

Technical Richness Each code set was reviewed for the quality of representation and extent of coverage and depth. Technical Richness analysis consisted of: § Coverage (Number of codes in a particular standard/ Number of

diseases a particular standard covers) § Clinical Specificity (Detailed explanation of various permutations

and combinations of each disease) § Inter-relationship (Dependency of one standard on another)

Commercial Viability Cost and expense factor was an important consideration to finalise the code sets for India. Commercial viability included: § Cost of Acquisition such as cost of procuring licence,

maintenance costs, royalties to be paid for use of the standard, etc)

Ease of Implementation To implement a clinical standard in India would be a massive effort involving various entities such as the providers, payers, etc. The ease of implementation was an important criterion, which in turn included following sub-parameters such as: § Worldwide Usage (Global usage of the standard) § Familiarity in India (Knowledge of the Standard in India)

Others Factors such as the ownership of the codes or organisation governing the activity, frequency of updating the codes, etc are important in finalising the code sets for India.

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Clinical Data Standards > Disease Codes Disease coding is translation of medical terminology of the condition of a patient/ diagnosis into a code. A disease code describes an illness, injury or condition of the patient, which helps in uniform documentation, billing and re-imbursement, clinical audits, health records, research purpose, etc. Disease codes were the first initiative of the healthcare industry to maintain standards in capturing and disseminating health information. The use of disease codes dates back to 1948 when the World Health Organisation (WHO) designed the ICD coding system to promote international comparability in the collection, processing, classification and presentation of mortality and morbidity statistics. Many countries such as the USA, Canada, Australia and New Zealand later modified ICD codes to suit their requirements. Data code sets used in the healthcare industry include coding systems for diseases, impairments, other health-related problems, and manifestations; causes of injury, disease, impairment, or other health-related problems. Some of the common systems of disease codes are ICD-9 CM, ICD-10 CM, SNOMED-CT, Read, ICPC, etc. Very few organisations in India use disease codes, the use of which has been restricted to the development of healthcare statistics. The objectives of simpler administrative purposes and exchange of health information using disease codes have to be achieved yet. Benchmarked Disease Codes Many code sets used in various countries were studied and filtered based on certain criteria. The following codes were considered for comparative study for recommending it to the ITIH.

1. ICD-10-CM (International Classification of Diseases-10th Version with Clinical Modification) was chosen for benchmarking, as it was the improved version of ICD-9-CM.

2. SNOMED (Systematized Nomenclature of Medicine) covered a large number of disease codes and was very comprehensive in comparison to other code sets.

3. Read Codes are comprehensive and currently used in the UK. 4. ICD-9-CM (International Classification of Diseases-9th Version

with Clinical Modification) was recommended by HIPAA for disease coding. It is the modified version of ICD codes to suit the US healthcare industry.

5. ICPC codes were specific to primary healthcare, therefore were not considered for comparative study. (See Annexure 2, slides27-40)

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WHY WAS ICD-10 & SNOMED CONSIDERED FOR A DETAILED STUDY

ICD 10 Very well known and used worldwide

READ Specific to UK . Will be replaced by SNOMED by 2003

SNOMED Very comprehensive

ICD 9 CM ICD codes modified to suit to US requirements, hence not suitable for India.

ICPC Very narrow scope, specific to Primary Care.

Comparison of Benchmarked Disease Codes The five benchmarked codes were compared with one another on four parameters: commercial viability, technical richness, ease of implementation, validity and ownership, etc. The rating scale was graded from 1 to 9, in the order of increasing favourability.

COMPARISON OF VARIOUS DISEASE CODES

Disease Code


Technical Richness


Others Weighted Ranking

ICD 10 8.5 5.0 8.0 8.5 7.5

READ 2.5 6.8 4.0 4.0 4.2

SNOMED 4.5 6.8 4.6 4.0 5.0

ICD 9 CM 6.5 6.3 5.4 2.0 5.4

• Ranking Scale : 0 – 9 , 0 being least favorable and 9 being most favorable

Key Learnings: § ICD-10-CM was the most favourable code set for implementation

in India as it scored high on all the four parameters. It is free for use and implementation and was most common disease code set.

§ Read codes have now merged with SNOMED-RT to form SNOMED-CT.

§ SNOMED-CT was an ideal code set but required computerisation for use and the frequency of update was twice a year.

§ ICD-9-CM is currently being used but may soon be replaced by the updated version ICD-10CM (See Annexure 2, slide 26)

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Recommended Standard for Disease Codes The above analysis of disease codes have resulted in selecting the ICD-10CM as the recommended standard for disease codes to be implemented in India.

CLINICAL DATA RERESENTATION STANDARDS DISEASE CODES

Currently followed in India

• None

Recommended for India

• ICD-10

Benchmarked Codes

• ICD-10

• ICD-9-CM

• Read

• SNOMED

Why ICD-10 ?

• Most widely used disease coding system in the world

• Relatively inexpensive to procure (for Government of India for implementing nationwide)

• Can be modified to suit India’s specific requirements

• Easier to switch to ICD coding system than to any other system

• Easy to implement in India The ICD is the oldest system of medical coding existing in various versions and modified forms to suit the requirements of the region. It is a classification system developed collaboratively between the World Health Organisation (WHO) and 10 international centres so that medical terms reported by physicians, medical examiners and coroners on death certificates can be grouped together for statistical purposes and promotes international comparability in the collection, classification, processing and presentation of statistics. The International Classification of Diseases, Clinical Modification (ICD-CM) is used to code and classify morbidity data from in-patient and outpatient records and physician offices. The single-level diagnosis ICD-10 aggregates illnesses and conditions into 259 mutually exclusive categories, most of which are clinically homogeneous. Some heterogeneous categories were necessary; these combine several less common individual conditions within a body system. The ICD 10 has approximately 12,000 codes with five levels of detailing. The ICD-10 codes are arranged according to anatomical system or “etiology”

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It uses alphanumeric codes with a single letter followed by two numbers at the three-character level (A00-Z99). This has significantly enlarged the number of categories available for classification. The ICD-10 codes are ready and can be implemented on receiving permission from the WHO. The government of any country can approach the World Health Organisation and seek permission to use the ICD-10 codes and can get it either free or at a very nominal price. Reasons for selecting ICD Codes for ITIH § Most widely used disease coding system in the world § Relatively inexpensive to procure (for Government of India for

implementing nationwide) § Can be modified to suit India’s specific requirements § Easier to switch to ICD coding system than to any other system § Easy to implement in India § Codes can capture maximum information about a disease. § Codes are simple. § Codes cover most of the conditions and diseases.

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Clinical Data Standards > Procedure Codes Procedural coding is translation of medical terminology of the procedure performed into a code. All procedures performed on a patient have to be recorded and reported to appropriate entities and procedural coding is the best possible way of documenting the information. Procedure codes are concentric pieces of information that may be numeric or alpha numeric implying that the information about the procedure performed is easily referenced, non ambiguous, uniform, and understood world wide. They assist in informed delivery of patient care, uniform documentation, billing and payments, patient health records, clinical audit, Epidemiology & research, etc. Many countries are increasingly adopting them. Procedure code systems are undergoing rapid changes in terms of structure, content and coverage to accommodate growing healthcare needs, e.g.. HIPAA. Most common systems of procedure coding are being championed by (the US) entities such as AMA (American Medical Association), AHIMA, CMS (Center for Medicare and Medicaid Services, formerly known as HCFA), College of American Pathologists (CAP), etc. Procedural coding is currently not done in India. However, the benefits of standardising procedures and services will soon compel Indian providers to adopt them. Benchmarked Procedure Codes Many code sets used in various countries were researched based on certain criteria for comparative study. The following codes were considered for comparative study for recommending it for the ITIH.

1. ICD-10-PCS (International Classification of Diseases-10th Version- Procedural Coding System) was chosen for benchmarking as it was the improved version of ICD-9-PCS/ ICD-9-CM Vol. 3.

2. SNOMED (Systematized Nomenclature of Medicine) covered a large number of procedure codes and was very comprehensive in comparison to other code sets. SNOMED-RT codes merged with Read codes to form SNOMED-CT.

3. Read Codes were comprehensive and are in use in the UK. Read codes are now merged with SNOMED-RT to form SNOMED-CT.

4. Current Procedural Terminology (CPT) and Healthcare Financing Administration Common Procedure Coding System (HCPCS, 3 Levels) are two related coding systems specific to America recommended by the HIPAA. The ICD-9 PCS is used for in-patient procedural coding, whereas the CPT is used for outpatient procedures. The CPT4 is limited in content and scope, therefore, CPT-5 is proposed. HCPCS has 3 levels, the third level will be phased out by the this year-end.

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5. OPCS codes were specific to surgical procedures, therefore, were not considered for the study.

ICD 10 PCS Highly specific and updated version of ICD-9 PCS.

CPT/ HCPCS Two related coding systems specific to USA.

SNOMED-CT Very comprehensive. Includes Read Codes

OPCS-4 Codes related to surgical procedures only

READ Part of SNOMED-CT Codes

Why ICD-10 PCS and SNOMED-CT were considered for comparative study

Comparison of Benchmarked Procedure Codes The five benchmarked codes were compared against one another on four parameters: commercial viability, technical richness, ease of implementation, validity and ownership, etc. The rating scale was graded from 1 to 9 in the order of increasing favourability

COMPARISON OF VARIOUS PROCEDURE CODES

Procedure Code


Technical Richness


OthersWeighted Ranking

ICD 10 PCS 9.0 7.8 5.2 7.5 7.3

SNOMED-CT 4.5 7.8 5.8 7.0 6.1

CPT/ HCPCS 4.5 6.5 4.6 6.0 5.3

Ranking Scale : 0 – 9 , 0 being least favorable and 9 being most favorable

Key Learnings § ICD-10-PCS ranked the highest for factors such as cost,

coverage, in-depth information etc. § SNOMED was a close contender with ICD-10-PCS but it required

computerisation to be implementable and was expensive to procure and maintain.

§ CPT and HCPCS scored low as they were two related systems of coding designed specifically to accommodate the health reimbursement mechanism in USA. (See Annexure 2, slides 42-48 & 51-58)

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Recommended Standard for Procedure Codes The analysis of disease codes have resulted in selecting ICD-10-PCS as the recommended standard for procedure code to be implemented in India under the ITIH.

11

CLINICAL DATA RERESENTATION STANDARDS PROCEDURE CODES


• None


• ICD-10-PCS

Benchmarked Codes

• ICD-10-PCS

• CPT

• HCPCS

• SNOMED

Why ICD-10 PCS?• High level of specificity and wider coverage of codes

• Relatively inexpensive (free) to procure for Government of India for implementing nationwide

• Improvement over ICD-9 PCS system of coding• Can be modified to suit India’s specific requirements• Easy to implement in India

ICD-10-PCS stands for the International Classification of Diseases, Tenth Revision, Procedure Classification System (ICD-10-PCS). It was developed in 1996 – 1998 and is maintained by the Center for Medicare & Medicaid Services (CMS), formerly known as The Health Care Financing Administration (HCFA) and 3M HIS. The ICD-10-PCS is a freestanding, 7-digit procedural coding system designed to replace ICD-9 PCS (ICD-9 CM Vol. 3), which is currently in use to document in-patient procedures in the USA, since 1979. It has 7 levels of information to reach for the precise code and covers the following areas of information related to the procedure: § Section: Overall classification § Body System: Mostly anatomical categories of medical discipline § Root Operation: Specifies the underlying objective of the

procedure § Body Part: The part of the body/ organ/ site of procedure

performed § Approach: The way the procedure began on the site § Device: Devices that remain after the procedure is completed.

Instruments that describe how a procedure is performed are not specified in the device character

§ Qualifier: Provides additional information to a particular procedure. It has a unique meaning for individual procedures

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The familiarity of the ICD-10 PCS in India is currently low. It is not used in any country, but there has been growing interest in adopting the standard for various countries as it offers quality information. It lies in the public domain and does not have a licence fee. The codes, available in hard and soft formats, can be modified to suit Indian requirements after approval from the CMS. Reasons for selecting ICD-10-PCS Codes for ITIH § High level of specificity, in-depth information and wider coverage

of codes § Relatively inexpensive (free) to procure for Government of India

for implementing nationwide § Improvement over ICD-9 PCS system of coding § Can be modified to suit India’s specific requirements § Easy to implement in India

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Clinical Data Standards > Clinical Observation Codes Clinical observation is the process of learning, observing and recording data about a person’s physical and mental health by watching him. An observation can be one of many data types. The main ones are text, numbers and codes. Clinical observation coding helps in assisting a physician, better documentation, decision making, healthcare statistics, patient health record, strategic health planning, etc. Observation codes can also be found in other systems of coding such as CPT/ HCPCS, ICD-10 PCS, etc. Common systems for observation codes are LOINC, SNOMED-CT, Read, Medcin, ICIDH, DSM, etc and most of the systems are undergoing changes in terms of structure, content and coverage to accommodate new trends in healthcare. Many countries are increasingly adopting clinical observation codes. Clinical Observation Coding is currently not done in India. The benefits of standardising clinical observation will soon compel Indian Providers to adopt them. Since the awareness levels are low, enough feedback and data are not available for comparison with the Indian context. Benchmarked Clinical Observation Codes Many code sets used in various countries were researched and were filtered based on certain criteria, for comparative study. The following codes were considered for comparative study for recommending for ITIH.

1. SNOMED (Systematized Nomenclature of Medicine) covers clinical observation codes. SNOMED-RT merged with Read to form SNOMED-CT.

2. Read Codes are comprehensive and are in use in the UK. Read codes are now merged with SNOMED-RT to form SNOMED-CT.

3. LOINC (Logical Observation Identifiers, Names and Coding) are standard codes and nomenclature for identifying laboratory and clinical terms

4. ICIDH (International Classification of Impairments, Disabilities and Handicaps) covers Codes related to disabilities, impairments and handicap

5. Medcin is a set of clinical terms supplied ready-to-use.

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SNOMED-CT Very well known and used worldwide

Medcin Not enough information available for comparison, not popular compared to other systems

LOINC Very comprehensive and widely used

Read Now merged with SNOMED-RT to form SNOMED-CT

ICIDH Codes related to Disabilities, Impairments and Handicap

Why SNOMED-CT and LOINC were considered for a comparative study

Comparison of Benchmarked Clinical Observation Codes The five benchmarked codes were compared against one another on four parameters __ commercial viability, technical richness, ease of implementation, validity and ownership, etc. The rating scale was graded from 1 to 9, in the order of increasing favourability

Observation Code


Technical Richness


OthersWeighted Ranking

LOINC 8.5 8.3 8.0 8.5 7.5

SNOMED-CT 3.5 8.8 5.4 6.5 5.8

Medcin 4.5 7.5 4.4 6.0 5.4

Ranking Scale : 0 – 9 , 0 being least favorable and 9 being most favorable

Comparison of Various Clinical Observation Codes

Key Learnings § LOINC ranked the highest as it was the most common system for

observation coding and is widely used in many countries. § SNOMED-CT, which is an amalgamation of Read Codes and

SNOMED-RT also ranked high but the ease of implementation required computerisation.

§ Medicin ranked the lowest in comparison because of less usage, computerisation issues and lack of enough information to analyse.

Recommended Standard for Clinical Observation Codes The analysis of disease codes have resulted in selecting LOINC as the recommended standard for disease codes to be implemented in India.

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12

CLINICAL DATA RERESENTATION STANDARDS OBSERVATION CODES


• None


• LOINC

Benchmarked Codes

LOINC

SNOMED

Medcin

Why LOINC?• High level of specificity and wider coverage of codes

• Relatively inexpensive to procure (for Government of India for implementing nationwide)

• Can be modified to suit India’s specific requirements

• Easy to implement in India

• Used in many countries

LOINC (Logical Observation Identifiers, Names and Coding) is a consortium of laboratories, system vendors, hospitals, and academic institutions and a voluntary effort housed in the Regenstrief Institute for Health Care, an international non-profit medical research organisation associated with the Indiana University. They are standard codes and nomenclature for identifying laboratory and clinical terms. The LOINC database currently contains about 32,000 observation terms. Nearly 20,000 of these observational terms relate to laboratory testing. It is not dependant on any other system for observation codes. LOINC does not deal formally with the values reported for these observations/measurements, some of which are valued as numbers and some of which are valued as codes or text. Most of these coded answers will be sourced from other systems such as SNOMED, CPT4, ICD-9-CM, and other systems. LOINC is currently used in Australia, Brazil, Estonia, Germany, New Zealand, Ontario & British Columbia, Portugal, Switzerland, and is available in languages such as English, German, French, Italian, and Spanish. The Regenstrief Institute maintains the LOINC database and its supporting documentation. The LOINC database and Users' Guide is available for free use for any purpose by users and vendors from the organisation’s Internet Web site. It is copy written to prevent development of multiple variants. The LOINC is currently not in use in India and awareness about it is extremely low.

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For the purpose of adoption, LOINC can be modified to suit Indian conditions Reasons for selecting LOINC codes for ITIH § High level of specificity and wider coverage of codes § Relatively inexpensive to procure (for Government of India for

implementing nationwide) § Can be modified to suit India’s specific requirements § Easy to implement in India § Used in many countries

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SNOMED: An Ideal Code Set SNOMED stands for Systematised Nomenclature of Medicine, which is a structured nomenclature and classification of the terminology used in human and veterinary medicine produced by the College of American Pathologists (CAP), the world’s largest organisation of pathologists. SNOMED codes have a wide coverage in terms of diseases, procedures, clinical observation, body structure, organism, Pharmaceutical/biologic product, environments and geographical locations, specimen, etc., almost covering all types of health-related information that could be coded. Adopting SNOMED implies a one-time solution to all medical coding needs of the organisation, as there is an array of types of codes required by various providers to choose from. SNOMED codes are comprehensive and increasingly being adopted by many countries. However, SNOMED adoption was not feasible due to reasons such as: § Computerisation was required in order to use the codes, as they

are available only in the soft format. This is not possible in the Indian context.

§ The cost of acquiring SNOMED was prohibitively expensive for an Indian set-up.

20

SNOMED-CT CODES: VAST COVERAGE; DIFFICULT TO IMPLEMENT

• A structured nomenclature and classification of the terminology used in human and veterinary medicine.

• Produced by the College of American Pathologists (CAP)

• Available in soft formats only. Difficult to implement in India

• Expensive to procure. Cost of SNOMED includes the entire set of codes for diagnosis, procedures, observation, etc.

• Nation-wide deployment would cost approximately $170,000/ year

• License and Pricing Structure:

• Broad Coverage: Codes related to1. Disease 2. Procedure 3. Body Structure 4. Organism 5. Finding 6. Observable entity7. Specimen 8. Substance 9. Pharmaceutical / biologic product 10. Physical object 11. Physical force 12. Measurable 13. Events 14. Social context 15. Environments and geographical locations 16. Staging and scales

• Readily Available

• Mapped to most other coding systems.

• Updated regularly

DisadvantagesAdvantages

For Hospitals:Sites: Admissions Price/SiteSmall < 5,000 $2,500Medium 5,000 - 15,000 $6,000Large 15,001-25,000 $11,000Extra large >25,000 $15,000

For Clinics:Size Encounters (visits) PriceSmall <100,000 $550Medium 100,000-200,000 $1,250Large 200,000-300,000 $2,500Extra Lrge >300,000 $3,500

SNOMED is an all round coding system, but expensive to implement in India Because of the above limitations, SNOMED ranked lower in comparison to ICD-10-CM for Disease Coding, ICD-10-PCS for Procedure Coding, and LOINC for Clinical Observation Coding.

For more information, please refer Annexure 2: Clinical Standards

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9.3 Data Elements

Introduction

Numerous users in myriad formats collect health information. Healthcare today is plagued by umpteen problems due to lack of standard guidelines for data. For e.g., Performance monitoring and outcome research are two areas hit hard by the inability to link data sets from various sources. There is a need to standardise the definition of data, collection procedure, and storage process as it is shared by various entities and in different formats. Standardised data sets can serve many purposes in the current and future healthcare arena. The identification, definition, and implementation of standardised data in the healthcare and healthcare information fields are important in the evolving healthcare sector, where there is a need to follow individuals through a continuum of care and at multiple sites. Data elements are small pieces of data of an individual/ entity captured at various points by various entities. For example, Information contained in the patient registration form such as Name, Date of Birth, Age, Sex, Marital Status, Address, Nationality, Name of Consulting Doctor, Referred Doctor, Health Insurance, etc. Data Elements provide the basis for data exchange and sharing. They are also a technical reference for development of health information systems and baseline data description to facilitate understanding and utilisation of health data. Data elements are required to ensure uniformity in recording health data and to reduce cost of sharing and communicating health information in a heterogeneous environment. It is also essential to reduce the cost of developing and maintaining health information systems by providing common definitions to data elements. There is a plethora of data element standards used throughout the world. Most countries have adopted standards in accordance with their specific requirement and nature of use. A few healthcare providers use data element standards in India. However, uniformity and standardisation of the procedures are yet to be achieved. There are some data elements for which formats cannot be defined due to regional differences. In such cases, standards such as HL7 have left it to the discretion of the user to define a format as per their local requirements. There is a felt need to standardise data elements in the healthcare billing and Health Insurance areas. Taking examples from HL7 & X-12 that are

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USA-specific, many data element formats specified by these standards can be modified to suit Indian healthcare conditions. For the purpose of the ITIH study, the data elements were studied in depth with various global examples.. The following is the list of data elements recommended by the ITIH. Patient Demographics § Patient Registration Number (UHID) § Patient Name § Age § Sex § Marital Status § Date (Ex- Date of Birth) § Time (Ex- Time of Birth) § Blood Group § Religion § Race § Location Code § Address Type § Communication address

Hospital Administration § Doctor Identification Number § Specialty/Department § Patient Discharge Type § Pharmacy Identification Number § In Patient Identification Number § Medico Legal Case Type § Admission Type § Type of patient care

Health Insurance § Provider Identification Number § Insurer Identification Number § Plan Identification Number § Group / Corporate Identification Number § TPA Identification Number § Relation to policyholder § Patient Payer Type

Methodology To churn out the essential data elements from the vast number of data elements in use throughout the world, a funnel-down approach was adopted to identify elements required for immediate standardisation. An in-depth research resulted in pooling of many data elements. Also, a range of organisations were contacted such as the health plans/ insurers, TPAs, Government, trade or professional associations, employers, data standards organisations, etc.

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POTENTIAL CANDIDATES FOR STANDARDISATION

700+

150+

32

There are currently 700+ data elements and formats in the healthcare environment that can be standardized

Most commonly used data elements and formats in today’s HIS and Health Insurance environment are in the 150+ range

Through secondary research, internal analysis and opinions of reputed people from the healthcare industry, AHSL has identified 32 data elements, formats for which if standardized will create the maximum positive impact on our healthcare

The data elements collected from various sources were subjected to analysis in terms of consideration of the general availability, reliability, validity, and utility of data elements, etc. Through secondary research, internal analysis and opinion of reputed people from the healthcare industry, the AHSL has identified 32 data elements, formats for which, if standardised, will create maximum impact on our healthcare.

9

BENCHMARKED DATA ELEMENT STANDARDS


• Existing standards for data elements followed in India

• We identified these standards through various interviews with hospitals and vendors

HL7 & x12N

• HL7’s formats of clinical data elements, used within a hospital

• X12’s formats of data elements, used in Billing & Insurance Claims

• HL7 and X12 are an international set of open standards for communication that allows health information systems developed independently, to automatically "talk" with one another

• NCVHS – National Committee on Vital Health Statistics. NCVHS advises the Department of Health and Human Services, USA, in the area of health data and statistics

• AIHW – Australian Institute of Health & Welfare

NCVHS

• NCVHS’s core data elements list

• NCVHS in consensus with leaders in the field came up with a small set of data elements that are often considered the core of many data collection efforts

AIHW

• AIHW’s national data dictionary

• It contains standard definitions for more than 200+ data elements

• These will used in any data collection effort throughout Australia

• AIHW followed ISO standards while defining the formats for various data elements

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Recommendations After a thorough analysis of global examples, the study recommended the following data elements for India: Patient Demographics > Name Name of an individual § First Name § Middle Name § Surname § Prefix (to identify persons in important professions. E.g.: Doctors)

Patient Demographics > Patient Identifier A numeric or an alphanumeric number to identify an individual § 15-digit alphanumeric code recommended by the ITIH Working

Committee § First 4 digits represent the identifier-issuing entity § Last 10 digits represent a numeric or alphanumeric number

Some major healthcare providers and payers are already issuing unique identifiers to their customers. These identifiers are usually the 6-10 digits codes. The 15-digit code uniquely recognises a healthcare provider and also gives the option of using it’s the existing registration formats by slight modification. The 10-digit code will also make user acceptance easy when the country migrates to the ideal 10-digit alphanumeric identifier. Patient Demographics > Age Age of an individual § YY/MM/DD (Years / Months / Days)

Age of newborn babies is calculated in days. Medication/ nutrition for babies differs depending on their age (medication for a day old baby will be different from that of a ten-day-old baby) Patient Demographics > Gender The social description of sex: male-ness or female-ness and all that they imply in a social context; not biological (sex). § Female § Male § Other

o Eunuch § Not stated

“Other” would include members of the eunuch community. “Unknown” would be applicable when the gender of the person is not mentioned. Patient Demographics > Marital Status Marital/ conjugal status of a person under the law or as registered by the state

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§ Single § Married § 1st Marriage § 2nd Marriage

o Concurrent wife o Non concurrent wife

§ Beyond 2nd Marriage o Concurrent wife o Non concurrent wife

§ Separated § Divorced § Widowed § Unknown/Not Stated

The Indian Constitution allows males of certain religions to have more than one wife. A person may marry more than once (Reasons: divorce/death). Married males may live with their first wife and not with their second wife and vice versa. A couple may be living separately, although they are legally married. A widow or widower needs to be represented. Patient Demographics > Date Date § DD/MM/YY (Day / Month / Year)

India has been following the British format since the last 250 years. There is no need or incentive to shift to a different date format now. As of today, all medical equipment vendors support different date formats. Adopting a new format will be a very expensive and cumbersome exercise. Patient Demographics > Date Time § HH/MM/SS (Hours / Minutes / Seconds)

The same format can be continued. There are hardly any circumstances in the medical field where time has to be measured more precisely, ex - one hundredth of a second. Patient Demographics > Blood Group Differences in human blood due to the presence or absence of certain protein molecules called antigens and antibodies, determined by individual's inheritance, gives rise to various blood groups. § O+ve § O-ve § A+ve § A-ve § B+ve § B-ve § AB+ve

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§ AB-ve § N § M § MN

New blood groups have been discovered. Patient Demographics > Religion A personal set or institutionalised system of principles, attitudes, beliefs, and practices for the community to which one belongs, held to with ardour and faith § Hindu § Muslim § Sikh § Christian § Buddhist § Jain

People of different religions have different lifestyles, food habits and genetic lineage. Knowledge of religion can help doctors prescribe medication suited to people of certain ethnic backgrounds Patient Demographics > Race A family, tribe, people, or nation belonging to the same stock; class or kind of people unified by community of interests, habits, or characteristics § American Indian/Eskimo/Aleut § Asian or Pacific Islander § Black § White § Other § Unknown/Not stated

There has been an increase in the number of foreigners taking medical treatment in India. Lifestyles, disease profiles, genetic lineage may vary from race to race Having knowledge of a patient’s race can help diagnose a patient’s problems better Patient Demographics > Region Region A geographic area formed by grouping of smaller areas based on certain characteristics § North

o UP, DL, J&K, HA, HP § South

o AP, KA, TN, KL § West

o GJ, MA, RJ, GO

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§ East o WB, OR

§ Central o MP, BI

§ North East o NG, AS, MG

Disease profiles vary from geographical locations within India. Diagnosis will be easier if regional locations within India are known. Region-wise health data will also make health statistics more robust Patient Demographics > Location A numeric or alphanumeric code uniquely identifies an area where an individual or an institution is located § Location codes

Location codes have to be developed for India. They can pinpoint a location more precisely. Currently, Pin Codes are the closest location identifiers. However, they have certain limitations. For e.g., they do not always specify one location; in certain cases, several areas have one pin code. Patient Demographics > Address Type Nature and function of a place where a person resides or from where an organisation operates § Current or Temporary § Permanent § Parents’ address § Mailing Address § Office/Business § Not Stated

Mailing address could be a Post Box Number or an address different from the residence of the patient. Patient Demographics > Address for Communication Address for communicating with an individual or an organization § Current or Temporary § Permanent § Parent’s address § Mailing Address § Office/Business § Not Stated

A woman moves to her husband’s house once married and her mailing address will change too. (See Annexure 3, slides 13-26) Hospital Administration > Doctor Identification Number An alphanumeric number to identify a doctor

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§ 10-digit healthcare professional ID § Recommended by the ITIH project

The MCI registration number is unique to a state, the same number can be repeated in another state as well, hence, the need for a unique physician ID. Hospital Administration > Doctor Identification Number Divisions of clinical work, which may be defined by body systems (dermatology), age (paediatrics), clinical technology (nuclear medicine), clinical function (rheumatology), group of diseases (oncology) or combinations of these factors. Same as the ones followed currently in the country. Hospital Administration > Type of Care Care and support provided to individuals based on the type of treatment and the place of treatment § Ambulatory § Rehabilitation § Isolation § Paediatric/neonatal intensive care § Intensive Care § Surgery § Emergency § Observation § General/family practice § Family Planning

Information about type of patient care helps in allocating time and resources effectively for better health care Hospital Administration > Patient Discharge Type Method of relieving the patient from active medical/ health care provided by medical/ health care facility § Routine Discharge § Discharge to home/ self care § Discharged and asked to come back § Discharged/Transferred to another hospital § Inpatient care § Outpatient care § Discharge against medical advice § Expired

To develop and maintain longitudinal medical records, it is important to know more details about the discharge of a patient. Hospital Administration > Inpatient Identification Number A unique alphanumeric number to identify a patient admitted in the inpatient department of a healthcare set up. Each hospital generates its own IPID but it is possible that these numbers may be repeated. In

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Patient Identification Number (IPID) can be generated using UHID + a unique alpha numeric number Hospital Administration > Medico Legal Case Type A complex medical or health case characterised by its involvement, intervention or association of law and related entities, necessitating intervention of police or legal persons for enabling justice to the deprived party. § Accident § Road § Burns § Drowning § Poisoning § Animal attacks § Suicide

o Burns o Poisoning o Drowning o Strangulation

§ Homicide § Terrorist Attack § Other

Terrorist attacks have become common in many parts of the country and hence should be included. Hospital Administration > Admission Type Type of granting admission rights to the patient depending upon the severity of condition, complexity of treatment and frequency of visits § Emergency § Inpatient § Outpatient § Pre-admit § Recurring Patient § Obstetrics

“Admission Type” will enable the health care organization to prioritise the care to be given to different patients. More options in “Type of care” will enable the health care organization to identify the patient more accurately Health Insurance > Hospital Identifier An alphanumeric number to identify a hospital 4-digit healthcare provider code Recommended by the ITIH project Health Insurance > Insurer Identification Number An alphanumeric number to uniquely identify an insurer 4-digit payer code Recommended by the ITIH project

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Health Insurance > Pharmacy Identification Number An alphanumeric number to uniquely identify a pharmacy 5-digit support services provider code Recommended by the ITIH project Health Insurance > Plan Identification Number An alphanumeric number to uniquely identify a health plan Health Plan Identifier recommended by the ITIH project Health Insurance > Corporate Identification Number An alphanumeric number to uniquely a Corporate PAN account holder. Health Insurance > Third Party Administration Identification Number An alphanumeric number to uniquely identify a Third Party Administrator 4-digit payer code Recommended by the ITIH project Health Insurance > Relation to Policy Holder The way an individual is related to the person who is claiming reimbursement for him / her § Self § Spouse § Employee § Guardian § Relative

o Son o Daughter o Brother o Sister o Mother o Father o Uncle o Aunt o Grandfather o Grandmother

Various relationships come under the heading of relative. An Employer could insure its employee. Guardian could be a person who is neither related nor an employer Health Insurance > Relation to Policy Holder Nature of the payer § Self § Employer § Insurance § Hospital § No charge (charity, special research, teaching) § Other

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Patient Payer Type helps in processing information faster and avoids duplication. (See Annexure 3, slides 31-45)

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Implementation

The General Insurance Corporation and the Department of Information Technology will have a major role to play in implementing the recommendations across the country in a phased approach General Insurance Council The GIC will have to oversee the standardisation of formats for billing and insurance process claims. It must also be entrusted with the task of ensuring that all insurance companies, administrators and hospitals follow the prescribed formats. It requires about two months with periodic checks to reach its given task. Department of Information Technology The Department of Information Technology will have to ensure that all vendors related to healthcare-related information systems follow the standards for data elements. To perform this task, a three-month timeframe is required. Ministry of Health & Family Welfare The Ministry of Health and Family Welfare will have to create standard formats for healthcare provider environment. It would require at least two months, with periodic audits, to achieve the desired goals. Vendors Vendors would have to incorporate standard formats for data elements. Time required to ensure standard formats was about three months. For more information, please refer Annexure 3: Data Elements

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9.4 Minimum Data Sets

Introduction

A minimum data set (MDS) is a widely accepted set of terms and definitions making up the core of data acquired for medical records. It is primarily used for developing statistics for different types of analyses and users A minimum data set is the minimum amount of health information required about a patient to profile a disease in a standard format. Minimum data sets ensure that the health information is precise, unambiguous and acceptable to all stakeholders. The MDS are represented in such a manner that they can be easily analysed and conclusions drawn from the data. An MDS usually contains the following information: § Referrals § Demographics § Risk Factors § Complications § Treatment § Outcomes

Minimum data sets vary from one speciality to another and cover information required by the medical professional for treatment purpose. Ready availability of such information, which is both retrievable and qualitative, ensures many benefits such as: § Ensures uniform recording of health data. § Ensures that critical information required to profile a disease is

not omitted. § Provides an evidence-based information system for better

decision-making. § Doctors can use past experiences from a variety of scenarios

to suggest appropriate treatment. § Planners and policy-makers can allocate resources more

effectively for health programmes that are effective. § Reduces cost of sharing and communicating health data in a

varied systems environment. § Could be the most critical decision-making management tool in

the industry.

Methodology Every country has its own specific health problems and health conditions. India’s health pattern and diseases are different from other countries. Therefore, the first step was to identify the most common/ key diseases for which a minimum data set could be prescribed under the ITIH.

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Minimum data sets researched so far

Country

MDSUSA UK Canada Australia

Cancer ….. Yes. Yes …..

Diabetes ….. Yes ….. Yes

Cardio Vascular ….. ….. ….. Yes

Countries benchmarked for Developing Minimum Data Sets for India

METHODOLOGY

Minimum data sets used in the UK, Australia, Canada, etc., were studied for various conditions and diseases. Formats used in the UK and Australia were chosen for an in-depth analysis to develop India-specific MDS with the help of renowned Indian physicians. The outcome was shared with the working group members to ratify the MDS. A set of final recommendations was proposed.

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Recommendations Minimum Data Set formats are of two types:

1. Common across all diseases 2. Specific to some diseases

MINIMUM DATA SET FORMAT

• REFERRALS• DEMOGRAPHICS

• DISEASE ASSESSMENT– DISEASE STAGE– RISK FACTORS– COMPLICATIONS

• TREATMENT• OUTCOMES

Co

mm

on

to

al

l dis

ease

sS

pec

ific

to

ea

ch d

isea

se

Diseases Covered

• Cancer

• Diabetes

• Cardio Vascular Diseases

• Gastro

Common across all diseases: The data collected is standard across all diseases and conditions such as § Referrals § Demographics

Referral information includes details such as: § Source of referral § Referrer’s code § Referred to § Referee’s code § Referral type § Specialty function code

Demographic information includes details such as: § Family name/ Surname § Forename / First name § Family name/ Surname at birth § Sex § Ethnic § Category § Date of birth § Age § Country of birth § Marital status § Height § Weight

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§ Health identifier § Permanent Address § Postcode of Permanent address § Employment status § Social support § Socio economic status § Literary status § Annual income

Specific to some diseases: The data collected applies to specific diseases and conditions such as: § Disease assessment § Disease stage § Risk factors § Complications § Treatment § Outcomes

To initiate the standardisation activity in the minimum data set area, the following list of diseases were chosen, as they are common in India. § Cancer § Diabetes § Cardio Vascular Diseases § Gastroenterology -related Diseases

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Recommendation > Minimum Data Set for Cancer Condition

Example of a Minimum Data Set format for Cancer

Administrative

Demographics

Referral

Referral

Outcomes

Clinical Status Assessment

Clinical Trials

Clinical Trials

Care Planning

Management Plan

Death Details

Death Details

Treatment

Surgery and other procedures

Pathology details

Chemotherapy and other drugs

Teletherapy

Brachytherapy

Specialist pallative care

Diagnostic

Imaging

Diagnosis

Staging

DISEASE STATUS § Clinical Assessment § Cancer Status § Treatment Stage

RISK FACTORS § Smoking profile § Drinking profile § Physical activity § Tobacco Chewing § Family History (Familial Inheritance) § Environment Factors § Genetic Disorders

COMPLICATIIONS § Cancer Site § Cancer Stage

TREATMENTS § Surgery § Chemotherapy § Radiotherapy § Combination treatment § Palliative Therapy

OUTCOMES § Tumor status § Death Date § Death Location

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§ Death Cause Recommendation > Minimum Data Set for Cardio Vascular Disease DISEASE STATUS § Clinical Assessment § Psychological & Functional status

RISK FACTORS § Family History of CVD § Dyslipidaemia

Lipid Profile § Hypertension

Blood Pressure § Diabetes § Physical activity § Overweight/ Obesity § Smoking § Unconventional Risk Factors

COMPLICATIIONS § Stroke / TIA § Peripheral artery disease § Amputation due to peripheral artery disease § Renal disease § Previous myocardial infarction § Cardiac failure § Atrial fibrillation and other atrial arrhythmias § Ventricular arrhythmias

TREATMENTS § Antihypertensive drug therapy § Lipid lowering therapy § Aspirin or other antiplatelet drug therapy § Cardiac failure therapy § Ischaemic heart pain therapy § Anti-arrhythmic therapy § Previous thrombolytic therapy

DISEASE STATUS § Death Date § Death Location § Death Cause § Morbidity § Discharged

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Recommendation > Minimum Data Set for Diabetes DISEASE STATUS § Year of Diagnosis § Type of Diabetes § Currently Pregnant § Management Method § Family History of Diabetes § If on Insulin: Since (year)

RISK FACTORS § Physical activity § Family History (Familial Inheritance) § Obesity / Overweight § Hypertension § Lipids § Control/Hba1c § Pregnancy

COMPLICATIIONS § Diabetic Neuropathy § Diabetic Nephropathy § Diabetic Retinopathy § Amputation § Coronary Artery Disease § CVA § Severe Hypoglycaemia § Erectile Dysfunction

TREATMENTS § Lifestyle § Diet § Oral Hypoglycaemics § Insulin § Combined Treatment

OUTCOMES § Diabetic Complications § Death due to diabetic complications

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Recommendation > Minimum Data Set for Diabetes DISEASE STATUS § Congenital § Traumatic § Infective / Inflammatory § Neo Plastic § Miscellaneous

RISK FACTORS § Smoking § Alcohol Consumption § Dietary Habits § Inherited Factors § Environmental Factors

COMPLICATIIONS § GI Bleed § Obstruction § Perforation § Fistula Formation § Infection § Multi Organ Failure

TREATMENTS § Conservative – Alteration of Food habits § Conservative – Alteration of Life Style § Conservative - Medication § Surgical § Combined § Alternative Modalities

OUTCOMES § Multi Organ Failure § Death due to complication

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Implementation Implementation and use of the MDS requires an integrated approach involving health informatics and medical professionals. There is a need to define MDS in a proper structured way to record data accurately. Since MDS continue to evolve with the changing healthcare environment, it is imperative that medical associations should take the responsibility of developing and improving the MDS standards. For example, the Cardiologists Society of India could actively be involved in developing and improving the MDS relevant to cardiology. They should also be actively involved in monitoring the usage and capture of information. However, the following pitfalls should be avoided to ensure efficient use of the MDS: § Responsibility delegated to people with little power. § Interdisciplinary team members do not fully understand its

potential. § Management does not use it as a decision support vehicle. § Even its critical financial importance often is unappreciated.

For more information, please refer Annexure 4: Minimum Data Sets

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9.5 Health Identifiers A unique way of identifying/ representing an entity in the healthcare industry is by using a numeric or alphanumeric code. A standard identifier is extremely important for administrative simplification of the healthcare business. It is an opportunity to apply standards to manage information that will ultimately improve the health and well being of all. Standard health identifiers help identify hospitals, clinics, physicians, pharmacies, health plans and employers. They aid patient care by providing the right information at the right time, and also help in building longitudinal medical records of individuals. Health Identifiers help simplify administrative processes like medical claims processing and exchange of population-based health data. If each entity such as the hospital, insurer, individual, etc, is given a unique identification number/code, it results in administrative simplification and reduces burden on all parties involved in the transaction. Benefits to patients: § Improved continuity of care § Improved integrity, comprehensiveness and completeness of the

information held in records § Better quality data for:

o Evidence-based decision-making o Evaluation of service quality and health outcomes

§ Enhanced privacy: o Easy to index and search results using an identifier than to

use names and addresses o The ability to easily scramble numerical identifiers or

replace with a numerical pseudonym ('pseudonymisation') Benefit to providers: § Information can be accessed only by the provider (at a particular

location) authorised by the consumer § Ensures that a provider is a bona fide health professional (via

links to professional registration bodies or other appropriate sources)

§ Better accountability (such as to establish duty of care) § Efficient payment of any relevant professional fees or rebates § Development of clinical practice guidelines and research

Types of Identifiers Identifiers are of different types for different entities. The number of characters, the type of code, the issuing authorities etc., differs for each type of health identifiers. Some of the identifiers relevant to healthcare are: § Identifiers for individuals § Identifiers for healthcare providers

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o Hospitals o Physicians

§ Identifiers for support service providers o Pharmacies o Diagnostic Centres

§ Identifiers for employers § Identifiers for Payers

o Insurance Firms o Third Party Administrators

SCOPE OF THE ITIH IDENTIFIERS MODULE

• Individuals • Employers• Healthcare Providers• Support Service Providers• Payers

Healthcare Providers• Organizations

• Hospitals• Nursing Homes• Clinics• Rehabilitation centers• Primary Health Centers

• Healthcare Professionals• Physicians*• Nurses• Dentists

Payers• Insurers• Third Party Administrators• Brokers

• Pharmacies• Blood banks• Diagnostic Centers• Laboratories

* Physicians category includes physicians, surgeons, physiotherapists, dieticians, and psychologists


Most benchmarked countries have implemented some form of identifiers or the other. While the implementation for providers and payers was easy, implementation of identifiers for individuals has been a contentious issue. The main concern was the security and privacy of the individual identifier

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SCOPE OF THE ITIH IDENTIFIERS MODULE

• Individuals • Employers• Healthcare Providers• Support Service Providers• Payers

Healthcare Providers• Organizations

• Hospitals• Nursing Homes• Clinics• Rehabilitation centers• Primary Health Centers

• Healthcare Professionals• Physicians*• Nurses• Dentists

Payers• Insurers• Third Party Administrators• Brokers

• Pharmacies• Blood banks• Diagnostic Centers• Laboratories

* Physicians category includes physicians, surgeons, physiotherapists, dieticians, and psychologists


Almost all the benchmarked countries have implemented some form of identifiers. While implementation of identifiers for providers and payers was easy, implementation of identifiers for individuals has been a contentious issue. The main concern was the security and privacy of the individual identifier

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Methodology

One of the most critical elements in the standardisation of health identifiers is the authority that issues identifiers to various entities. For implementing the ITIH in India, candidates who would issue health identifiers were short listed and analysed for the capacity and potential to issue the standards. Health identifier formats, existing in many countries were studied and countries such as the US, the UK, Australia, Canada and the Philippines were benchmarked for in-depth analysis and their applicability to Indian healthcare environment.

8

IDENTIFIERS BENCHMARKED

Country

IdentifierUSA UK Canada Australia

Individuals

& Corporates… NHS

Number …..

Providers

NPI

UPIN

NABP Number

…MINC for

physicians

…

Payers &

Intermediaries… … … …

Philippines India

…PAN, UHID in

Apollo Hospitals

…

Registration numbers: for Doctors, Hospitals & Pharmacies

…

Registration numbers: Insurers,

TPAs

• NHS Number – National Health Service Number number in UK• NPI (Ph) - National patient identifier• NPI (US) - National Provider Identifier• UPIN - Unique Physician Identifier Number• NABP Number – National Association of Boards of Pharmacy Number• MINC – Medical Identification Number for Canada• PAN – Personal Account Number

The findings lead to short-listing the following health identifiers and their formats for the Indian scenario. These were shared as preliminary recommendations with the working groups. The health identifiers were chosen based on the following criteria: § Atomic - Single data item, no sub elements having meaning § Concise - Short and easy to remember § Unique - No two entities should have the same identifier § Content Free - No dependency on possibly changing or unknown

information § Longevity - Can support identification of a large number of entities

in the foreseeable future § Valid - will not change in the foreseeable future § Permanent - Need not be reassigned, even after a person's death § Standard - Compatible with existing ways of identifying entities

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§ Unambiguous - Should not use alphabets and numbers that can be confused with

§ Verifiable - Can determine validity without additional information § Assignable - Can be assigned by trusted authority after a proper

authentication § Usable - Can be Processed by both manual and automated

means § Cost effective - Minimal resources required to issue new

identifiers § Easy to implement § Secure - Can encrypt and decrypt securely § Governed - Has an entity responsible for overseeing system

Recommendation philosophy

Alphanumeric codes are used to represent a very large number of entities in a short and concise format. To reduce confusion and data entry errors, numbers and alphabets that looking alike have been omitted from the standard alphanumeric characteristic set. Ex – 5 & S, 1 & I, 0 & O, etc. § The following 30 letters and numerals only should be used for

coding identifiers o ABCDEFGHJKLMNPQRTUVWXYZ o 2346789

The following recommendations along with the implementation plan, including inputs from the working committees, were evolved.

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Recommendations Healthcare Providers > Healthcare Professionals The recommended health identifiers for the healthcare professionals make use of the existing identification format and processes. Currently, all the existing registration numbers are issued by the respective state medical councils and this should continue but in a modified format to ensure easy implementation. All the existing registration numbers consist of 5 digits and this would continue until each state has more than 1 lakh professionals in each category, i.e. another 20 years approximately. § The incremental effort for issuing identifiers in the new format is

very less. § The incremental effort for converting old registration numbers into

the new identifier effort is very less. § All professionals have to prefix their existing registration numbers

with the 2-digit state code followed by the code for their type of activity

Healthcare Professionals identifier format 10-digit alphanumeric code - SST.IIIIII § SS - State code § T - Type of activity of the healthcare professional § . - Delimiter § IIIIII - Registration number from the state of graduation

Existing Format Examples § Health identifier of a doctor: KA19184 § Health identifier of a nurse: AP044453

New Format Example

Doctor: KAP.019184 § KA - Karnataka § P - Physician § 019184 - Registration number with the Karnataka medical council

Nurse: APN.044453 § AP - Andhra Pradesh § N - Nurse § 044453 - Registration number with the Andhra Pradesh Medical

Council Issuing Authority § Respective state medical councils will issue identifiers to all

healthcare professionals who graduated from their state Minimum Data Set § Name of the individual

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§ Sex § Date of birth § Graduate degree § Year of graduation § Mother's maiden name

Global examples: USA § Unique Physician Identification Number: § 6-digit alphanumeric number

Canada § Medical Identification Number for Canada: § 9 digit alphanumeric code, last digit is a check digit § MxxxxxxxC

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Healthcare Providers > Healthcare Organisations Healthcare organisations are linked to individual health identifiers, as they are also the issuing authorities. Since the 'Point of Care' is linked to the individual health identifier, it should be short, making it easy to remember and transact. The healthcare organisations should be given a 4-digit identifier so that it can assign 8,10,000 points of care. There are about 40,000+ points of care today. Healthcare Organizations identifier format 4 digit alphanumeric code - IIII § IIII - Randomly generated alphanumeric number

Existing Format Example § Hospital: 8035/1979 § Nursing Home: 265/85

New Format Example § Hospital: PMBX § Nursing Home: ANCV

Issuing Authority § The proposed "National Health Informatics Centre" will issue

identifiers to all healthcare points of care. § Both, payers and points of care will fall under the same category

of "identifier issuers", hence a similar identifier format Minimum Data Set § Name of the provider organisation § Location § Year of incorporation § Services offered

Global examples USA § National Provider Identifier: § 8-digit alphanumeric number, last digit is a check digit § Each NPI is also given a 2-digit alphanumeric location code

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Healthcare Providers > Support Service Providers Currently, there are over 5 lakh support service providers such as diagnostic centres, blood banks, etc in the country and this segment is growing rapidly. A unique identifier with 4 digits can identify only 8 lakh service providers whereas 5 digits can uniquely identify 240 lakh service providers, therefore a 5-digit code is recommended under the ITIH. This identifier is different from "Points of Care' identifier (which is a 4 digit alphanumeric identifier) Support Service Providers identifier format 5 digit alphanumeric code - IIIII § IIIII - Randomly generated alphanumeric number

Existing Format § Pharmacy: 474/HD/AP/97RWRX

New Format Pharmacy: NN5B3 Issuing Authority § The proposed "National Health Informatics Centre" will issue

identifiers to all healthcare support service providers Minimum Data Set § Name of the healthcare support service provider organisation § Location § Year of incorporation § Services offered (Diagnostics, Blood Bank, Pharmacy,

Laboratory) Global examples USA § National Association of Boards of Pharmacy Number: § 7 digit number § First two digits denote the state, Next 4 digits denote a serial

number and the last digit acts as a check digit

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Individuals Each individual/ patient-seeking healthcare will be given a unique health identifier. It is important to select identifiers that satisfy minimum requirements in terms of: § Infrastructure to issue an identifier § People to issue an identifier § People and processes to support: § Exchange of health information § Reporting of health information

Currently, the registration number given to patients in many hospitals today are between 6-10 digits. By allotting 10 digits for the second part of the individual identifier, we are giving points of care the discretion to use their existing registration formats by slight modification. It is strongly suggested that the 10-digit code be numeric. However, if some companies are already using an alphanumeric format and the cost of switching to a numeric code is high, they could continue with the alphanumeric code. The 10-digit serial number will also make user acceptance easy when the country migrates to the ideal 10-digit alphanumeric identifier Individual identifier format 15 digit alphanumeric code - PPPP.IIIIIIIIII § PPPP - 4 digit alphanumeric identifier of the issuer § “.” Is a Delimiter § IIIIIIIIII - 10-digit serial number

Existing Format Example § None

New Format Example ANH3.7865980255 Issuing Authority An individual can get a health identifier from any healthcare point of care, insurer or insurance broker authorised to issue a health identifier. They could be: § Hospitals § Nursing Homes § Hospital Clinics § Primary Health Centres § Insurers § Brokers

Minimum Data Set In order to be issued a health identifier every individual must furnish the following details to the issuing authority: § Name § Sex

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§ Date of birth § Place of birth § Mother's maiden name

Global examples USA § Universal Health Identifier (Under Consideration): § 29 digit alphanumeric number § First 16 digits are a random number followed by a delimiter § Next 6 digits are allocated for check digits § Next 6 digits are allocated for an encryption scheme

Alternative format The following is an alternative consideration to the recommended individual health identifier that would be ideal as it is short and easy to remember and The identifier should be issued by a central agency § 10 digit alphanumeric code - PPPPPPPP

37

COMPARISON OF THE TWO ALTERNATIVES

10 d

igit

co

de

AA

SP

C83

53Q

15 d

igit

co

de

AP

BK

.678

754R

GV

P

Most Favorable Least Favorable

* Transaction includes : Capture, Storage and Use in both hard and soft formats

Cost Effective

Speed of adoption

Ease of use in IT Env.

Ease of use in Non IT

Env.

Ease of adoption

Ease of Maintena

nceOverallSecurity

The implementation challenges in executing the above are humungous All the identifiers for all individuals in India (100 crore+) will have to be routed through this central authority and the above method will slow down the process of issuing identifiers and lead to more administrative inefficiencies.

- 126 -

Employers The existing format used to identify companies is robust enough to cover a large number. Since the companies are already familiar with the 10-digit format, there is no felt need to change the existing format. Also, the number of companies that don't have a Permanent Account Number (PAN) are very few, the incremental effort of issuing PANs to them is also very less. Employer identification number format 10 digit alphanumeric code - IIIIIIIIII § IIIIIIIIII - Employer identifier

Existing Format Example

Corporate Pan Number: AADCA4278N New Format Example Same as before

- 127 -

Payers Payers/ Health insurance companies should be allotted a unique health identifier to help identify the payer in most health transactions with minimum of effort. Since payers and points of contacts issue individual identifiers, it is necessary to have the same identifier format for both these entities. Also the total number of payers and their branches is less (less than 15,000) issuing new identifiers will not be very difficult. Payers' identification number format 4 digit alphanumeric code - IIII § IIII - Randomly generated alphanumeric number

Existing Format Example § Insurer: 113 § Third party administrator: 13

New Format Example § Insurer: P67L § Third Party Administrator: PGF7

Issuing Authority § The proposed "National Health Informatics Centre" will issue

identifiers to all payers § Alternatively, IRDA can issue unique identifiers to all the branches

of the payers. A select range of number can be allotted for payers only or all payer identifiers could start with the alphabet "P"

§ Both, payers and points of care will be fall under the same category of "identifier issuers", hence a similar identifier format

Minimum Data Set

§ Name of the payer § Type of insurance activity § Location § Year of incorporation

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Security Mechanism for Health Identifiers One of the major concerns for the implementation of the health identifiers at the national level is the security and confidentiality of health information. To address this concern, many security measures and solutions were analysed and the following methods can be incorporated. Encryption: This is the process of changing a health identifier using a predetermined logic in order to avoid misuse by unauthorised people. Electronic data is usually encrypted when transferred over an open network such as the Internet Check Digits: Check digits are used to validate if a health identifier is stored in the format it actually is. They can avoid data entry errors. They can validate if a health identifier sent by one entity to another is the same. It is suggested that every health identifier be concatenated with 4 digits for security measures. The last digit should be allocated for a check digit. The penultimate 3 digits should be allocated for a key that will be used for encryption and decryption of the identifier. Security Measures by transacting parties

Security steps: Sender’s side

3 9 6 B Z 2 K 9 9 K . . . .

5 2 9 D M 3 V 7 8 M A 8 Q .

5 2 9 D M 3 V 7 8 M A 8 Q Y

A health identifier as it is

A health identifier in its encrypted form. The last 3 digits in red are the key to decrypt the

identifier. Let’s say A1 is the algorithm to encrypt the identifier

Encrypted health identifier with a check digit(shown in blue). The check digit

ensures that the order of the digits in the encrypted format & the key is maintained.

Let’s say A2 is the algorithm to generate the check digit

Step 1

Step 2

5 2 9 D M 3 V 7 8 M A 8 Q YSend the encrypted health identifier through

a secured network using security such as 128 bit secured socket layer

Step 3

5 2 9 D M 3 V 7 8 M A 8 Q YReceive the encrypted health identifier

through a secured network using security such as 128 bit secured socket layer

Step 1

5 2 9 D M 3 V 7 8 M A 8 Q YAlgorithm A2 is used to match the order of

the encrypted health identifier and the corresponding value of the check digit. If the

values match, decryption will be done

Step 2

5 2 9 D M 3 V 7 8 M A 8 Q . A reverse algorithm RA1 is used to decrypt the encrypted health identifier using the

three digit key

Step 3

3 9 6 B Z 2 K 9 9 K . . . . A health identifier as it is

Security steps: Receiver’s side

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Boundaries of Identifier formats The following is the list of recommended codes to represent each state/ union territory in India, in alphabetical order. LOCATION NAME CODE ANDAMAN & NICOBAR AN ANDHRA PRADESH AP ARUNACHAL PRADESH AR ASSAM AS BIHAR BH CHANDIGARH CH CHHATTISGARH CT DAMAN DIU DD DELHI DL GOA GA GUJARAT GJ HARYANA HR HIMACHAL PRADESH HP JAMMU & KASHMIR JK JHARKAND JH KARNATAKA KA KERALA KL LAKSHADWEEP LA MADHYA PRADESH MP MAHARASHTRA MH MANIPUR MN MEGHALAYA ME MIZORAM MZ NAGALAND NL ORISSA OR PONDICHERRY PY PUNJAB PB RAJASTHAN RJ SIKKIM SI TAMIL NADU TN TRIPURA TR UTTAR PRADESH UP UTTARANCHAL UT WEST BENGAL WB The following is the list of suggested codes for healthcare professionals based on their activities Healthcare Professionals Code Physicians P Nurses N Dentists D

- 130 -

Implementation Involving Stakeholders In Defining Health Identifiers Medical Council of India § To issue physician identifier based on the existing registration

numbers issued by different state medical councils § Time Line: 3 Months for practicing professionals, ongoing basis

for future identifiers Drug Control Authority of India § To issue pharmacy identifier based on the existing drug licence

numbers issued by state drug control offices § Time Line: 3 Months for practicing professionals, ongoing basis

for future identifiers Ministry of Health & Family Welfare § To issue hospital identifier based on the existing registration

numbers and location/pin codes § Issue health identifiers for individuals § Time Line: 6 Months, ongoing basis

General Insurance Council § To issue identifiers to Insurers and TPAs based on the existing

registration numbers § To issue identifiers to Health Plans, based on the existing policy

numbers § Time Line: 3 months to 1 year

Income Tax Department § To issue identifiers to all employers based on PAN number § To issue PAN numbers to all companies § Time Line: 3 Months to 1 year

Responsibilities of The National Health Informatics Center & State Medical Councils National Health Informatics Centre § Define the framework for health information standards § Develop quality parameters for implementing health information

standards § Conduct periodic audits of various healthcare providers to ensure

quality of health information § Issue identifiers to concerned healthcare entities

o Healthcare organisations o Support service providers o Payers

§ Develop health reports for analytical and decision-making purposes

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State Medical Councils § Issue identifiers to the concerned healthcare professionals

o Physicians o Dentists o Nurses

§ Encourage and ensure the adoption of health information standards

§ Develop health reports for analytical and decision-making purposes

A BALANCE OF LOCAL & CENTRAL HEALTH INFORMATICS AGENCIES WILL DRIVE THE IDENTIFIERS IMPLEMENTATION

National Health Informatics Center

State Medical Councils

Healthcare Professionals

Points of Care

Support services

Payers

Individuals

For more information, please refer Annexure 5: Health Identifiers

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9.6 Messaging Standards Messaging Standards are standard protocols to exchange information between two health information systems. They are required to access health information from different knowledge repositories easily, reduce costs of maintaining data of different formats and facilitate interaction between two healthcare entities. For e.g. hospitals with different medical equipment and software can understand and refer to health information generated in other healthcare environments Types of Messaging Standards/ Benchmarked for ITIH study: Text messaging standards § HL7 § X12 § IEEE

Imaging standards § DICOM

Methodology For the ITIH study, the various messaging standards in practice worldwide were analysed and lessons were drawn for the Indian conditions. The preliminary findings were presented to the various working groups to finalise the final recommendations and evolve a road map for implementation. Key Learnings • There are no competitors in messaging standards. Each well-known

standard focuses on a specific area • HL7 dominates text-based messaging between various medical

information systems within a hospital environment • X12 dominates text-based messaging between hospital finance

departments and the payers, i.e., Insurers or Third Party Administrators • ASTM focuses on security and privacy of health information • DICOM is the universally accepted standard for exchange of images

between two different medical information systems (See Annexure 6, slides 8-23)

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Combination of Hl7 & X12 spanning the Entire Indian Healthcare Spectrum

PMRIPMRI

Patient Registration, Admissions

Patient Registration, Admissions

BillingBilling

Clinical ContentClinical Content

Orders & Results

Orders & Results

RadiologyRadiology

Hospital PharmacyHospital

Pharmacy

Knowledge Bases

Knowledge Bases

Physiological Monitors

Physiological Monitors

Medical DevicesMedical Devices

Bedside ComputerBedside

Computer

LaboratoriesLaboratories

HL7

IEEE

HL7

HL7

HL7

HL7

HL7

HL7

IEEE 1073ISO 11073

IEEE 1073ISO 11073

HL7DICOM

PayersPayers

Retail Pharmacies

Retail Pharmacies

ProvidersProviders

NCPDP Retail ASC X12N

NCPDP Script

ASC X12N

The Telemedicine Committee is working on finalising the recommendations for messaging standards for telemedicine as an application. However, it should be noted that an Indian version of the HL7 would need to be developed separately. For more information, please refer Annexure 6: Messaging Standards

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9.7 The Education Framework

Introduction The success of the implementation of the ITIH depends largely on the medico-technical literacy levels of the workforce. The ITIH mandates Health informatics education to ensure that all practicing medical professionals, patients and payers are well aware and adopt healthcare standards. It is also necessary that all prospective medical graduates be introduced to the concepts of health informatics so as to comply with legal guidelines. The thrust of Health Informatics education is on: § Use of health information standards § Storage of health information in electronic health records § Research and extrapolation of health information for better

healthcare § Legal implications on the development and use of health

information

Methodology § Identified existing ITIH education initiatives in India § Studied ITIH education initiatives in other countries: USA, UK,

Canada, Australia and Philippines USA § University Of Pittsburgh § University Of Columbia § University Of Minnesota § University Of Stanford § University Of Texas

UK § King’s College London § City University, London § Royal Free University

Canada § Dalhousie University § University Of Victoria

Australia § University Of Tasmania § Monash University

Philippines

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§ Designed the health informatics education framework for India § Shared preliminary recommendations with the working group § Finalised the recommendations and developed an implementation

plan Key learnings of the study: The Health Informatics education is still "balkanised". Each health profession (medicine, nursing, healthcare administration, etc.) sees itself as unique and believes that it must define its own curriculum and operate its own programmes. As a result, there is little or no agreement on a "core curriculum" common to all health disciplines. Every year, a very small number of HI professionals is produced at most, 30-40 per from the largest programmes currently available. There is a substantial gap between the supply and demand of Health Informatics professionals worldwide.. Most courses require basic awareness of computers, MS Office applications and the Internet. Unless a longer duration course is chosen, the individuals enrolled for the current courses may not be able to get a holistic picture of healthcare and the role of health informatics in it.

- 136 -

Recommendations § Caters to the requirements of people wishing to specialise in

different aspects of the healthcare industry o Clinicians o Healthcare Managers o Healthcare Technologists o Healthcare Researchers

§ Gives a holistic picture to all incumbents § Operations, Research, Finance, Technology in Healthcare § Very flexible options to acquire knowledge of health informatics

based on the convenience of the incumbent and the degree of specialisation required

Pg. Diploma

Diploma

• 24 months duration

• 14 Modules – 10 core and 4 electives

• Dissertation on a chosen subject (3 months)

• 3 months internship with any healthcare organization

• 12 months duration

• 9 modules – 6 core and 3 electives

• Dissertation on a chosen subject (3 months)

Certificate• 6 months duration

• 6 modules

• All modules will be compulsory

Crash Course• 2 weeks duration

COURSE STRUCTURE

- 137 -

Education Framework > Crash Course To give a quick introduction to Health Informatics and its implications on Indian Healthcare Industry: Target: Any individual interested in getting a quick overview of health informatics Duration: 2 Weeks Eligibility: Any graduate. Exposure to healthcare to be preferred Mode of Delivery: Instructor Institutes: All the universities and colleges offering degree and diploma programmes in any life sciences/ Hospitals and their associated companies/ Healthcare industry associations Certified by: Medical Council of India/ Selected universities and colleges. Ex - AIIMS Course Curricula § Indian healthcare scenario § Healthcare delivery system § Healthcare delivery infrastructure § Changes in healthcare financing § Health Information Standards § Introduction to health information standards § Flow of information between all the stakeholders: Providers,

Payers, and Patients § Standards: Data Formats/ Clinical Data Representation/Messaging § Legal implications of health information § Privacy and Confidentiality of health information § Case study § Simulated example where health information standards are used

- 138 -

Education Framework > Certificate Course Certificate course is designed to educate individuals about the fundamentals of Health Informatics. The course provides basic knowledge to work in a health informatics setting. The individual can then focus or specialise in a particular field through live work experience. Target:: Working professionals in healthcare and allied industries Duration: 6 Months (Full-Time)/ 12 Months (Part-Time) Eligibility: Any degree or diploma holder in life sciences; Students in their final year can also apply and get a conditional offer; for individuals without life sciences background, 1 yr experience in a healthcare setting; Basic knowledge of Computers, MS Office applications and Internet Mode of Delivery: Instructor-/ Online Institutes: All universities and colleges offering degree and diploma programme in any life sciences/ Hospitals and their associated companies/ Healthcare industry associations Certified by: Medical Council of India/ Selected universities and colleges. Ex - AIIMS Course Curricula § Health Information Standards § Healthcare Data Management § IT strategy and systems in healthcare § Health Informatics Applications § Legal implications of health information § Healthcare Economics

- 139 -

Education Framework > Diploma Course To educate the individual about the fundamentals of Health Informatics along with an option to specialise in selected aspects of Health Informatics through taught courses and research. Target: Students, Working professionals Duration: 12 Months (Full-Time)/ 24 Months (Part-Time) Eligibility: Any degree or diploma holder in life sciences. Students in their final year can also apply and get a conditional offer for individuals without life sciences background, 1-yr experience in a healthcare setting. Basic knowledge of computers, MS Office applications and the Internet. Mode of Delivery: Instructor/ Online Institutes: Selected universities and colleges offering degree and diploma programmes in any life sciences subject/ Selected hospitals and their associated companies/ Selected healthcare industry associations Certified by: Medical Council of India/ Selected universities and colleges. Ex - AIIMS Course Curricula (6 Core Modules) § Health Information Standards § Healthcare Data Management § IT strategy and systems in healthcare § Health Informatics Applications § Legal implications of health information § Healthcare economics

Three optional Modules to be selected from the list below: § Research principals & Skills in Healthcare § Statistical methods in health informatics § Biomedical Signals § Imaging § Modelling § Clinical Decision Making § E-Healthcare § Project Management § Management and Leadership for Health Informatics § Web Standards and security § Quality in healthcare informatics § Healthcare Decision Support Systems § Bio informatics § E-Learning § Managing change § Health Knowledge Management

- 140 -

§ Epidemiology § Healthcare Insurance § Bio Statistics § Health Information Systems

- 141 -

Education Framework > Post Graduate Diploma Course In addition to the skills and knowledge gained in the Diploma, an individual can get develop a rounded perspective of Health Informatics, preparing them for senior roles in Management and IT. Individuals develop a more realistic understanding of Health Informatics through a 3-month internship in any healthcare organization Target: Students, Working Professionals Duration: 2 Yrs Full Time Eligibility: Any degree or diploma holder in a life sciences subject, Students in their final year can also apply and get a conditional offer, 1 yr experience in a healthcare setting for people without a life sciences background, Basic knowledge of Computers, MS office applications and Internet Mode of Delivery: Instructor Led/ Online Institutes: Selected universities and colleges offering degree and diploma programs in any life sciences subject/ selected hospitals and their associated companies/ selected healthcare industry associations Certified by: Medical Council of India/ Selected universities and colleges. Ex - AIIMS Course Curricula (12 Core Modules) § Health Information Standards § Healthcare Data Management § IT strategy and systems in healthcare § Health Informatics Applications § Legal implications of health information § Healthcare economics § Management and Leadership for Health Informatics § Quality in Health Informatics § Research principals & Skills in Healthcare § Statistical methods in health informatics § Project Management § Health Information Systems

Six Optional Modules to be selected from the list below: § Biomedical Signals § Imaging § Modelling § Healthcare Decision Support Systems § Web Standards and security § E-Healthcare § Bio informatics

- 142 -

§ E-Learning § Managing change § Health Knowledge Management § Epidemiology § Clinical Decision Making § Healthcare Insurance § Bio Statistics

For more information, please refer Annexure 7: Education Framework

- 143 -

9.8 The Legal Framework

Defined in Association with Amarchand Mangaldas & Cyril Shroff

Introduction The existing Indian law does not adequately address concerns relating to Health Information. The experiences of countries such as the United States of America and the United Kingdom provide direction for enactment of a legislation that would address these concerns. It must be borne in mind that in India, Health Information is not integrated with technology to the extent that it is in western countries, and it is necessary to keep in mind the specific modes of creation and use of Health Information as are prevalent here. Furthermore, it is necessary to understand the specific problems or experiences of Indian patients and Healthcare Providers prior to framing a legislation that addresses these issues. Proposed Law Regulating Health Information Broad provisions that the proposed legislation should contain are set out below. These are indicative in nature, and would need to be further refined/adapted in light of the experiences of the different stakeholders in the field of Health Information. The law should: § Define Health Information: Range of information generated,

collected, and maintained about individual patients § Provide criminal and civil sanctions for improper possession,

brokering, disclosure, or sale of Health Information with penalties sufficient to deter perpetrators.

o Civil penalties must be related to failure to comply with privacy standards prescribed by law

o Criminal penalties must be consequent to a higher standard of misuse of Health Information, such as knowingly violating patient privacy, obtaining protected Health Information under false pretences, or obtaining or disclosing protected Health Information with the intent to sell, transfer, or use it for commercial advantage, personal gain, or malicious harm

§ Establish rules for patient education about information practices as

applied to Health Information: Access to information, amendment, correction and deletion of information, and creation of databases

§ Establish requirements for informed consent by patients to

disclosure of Health Information; Healthcare Providers and institutions should be required to give patients a clear written explanation of how they may use and disclose their Health Information

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§ Address the custodian’s duty to the patient, and the patient’s rights to Health Information through the custodian

§ Permit patients to see and get copies of their records, and request

amendments. In addition, it should mandate that a history of non-routine disclosures must be made accessible to patients

§ Structure the law so that it can be applied to the information at the

point of abuse, not simply to the “home” institution that originally had custody of the Health Information

§ Establish protocols for access to Health Information by secondary

users, and determine their rights and responsibilities in the information they access

§ Decide whether routine disclosures without specific consent are

permissible even for treatment, payment and healthcare operations (such as internal data gathering by a provider or healthcare plan)

§ Specify exceptional circumstances in which the disclosure need

not be permitted or permitted individually by patient § Establish supervisory authority to which complaints can be made

about the unlawful release or use of Health Information o must be endowed with delegated legislative powers, quasi-

judicial powers, and the power to impose fines § Standardise health information capture and exchange across

Healthcare Providers o authority will administer the system of important for

efficiency, cost reduction, and security o can introduce standards in stages, and allocate different

time periods for compliance o administer the system of penalties for failure to follow these

standards. § Address problems associated with AIDS-related information

o However, it may not be advisable to set up higher standards of confidentiality and care for Health Information related to AIDS than the comparable standards for other types

Licensure The purpose is to maintain a certain minimum level of expertise and quality in the provision of healthcare through telemedicine. § Separate license may be desirable to set up a separate licensing

process for the practice of telemedicine because of technological complexities in telemedicine.

§ If not, licensure provisions may be confined to the requirements for doctors practicing outside India, who are not licensed to practice traditional medicine or telemedicine under Indian law

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Supervisory Authority Authority to be constituted by the legislature, or an existing body that the legislature selects. § Since the Indian Medical Council is the plenary body in the matter

of medical education, it would be well equipped to undertake responsibilities of licensure.

§ Must have the power to issue, control, and enforce technological standards to be followed in the practice of telemedicine, and the power to impose fines and punishment for unlicensed practice or if the standards are not followed, in addition to de-credentialing consequences for the institution/individual

Provision to Accommodate Provisions to accommodate situations when telemedicine is practiced across borders - several approaches are possible: § Mutual recognition (agreement between countries which agree to

accept the licence awarded by the home country of the doctor, and will allow him/her to practise in their country)

§ Reciprocity (Where a country A agrees to accept the licences awarded in country B for practice in A, provided that B accepts A’s licences to its doctors for practice in B as well)

§ Registration (Doctor submits to legal regime governing medical negligence and malpractice in the country where the patient resides or communicates from, but not the licensing requirements for doctors in that country)

§ Limited licensure (Doctor can obtain limited licensure through a licensed referring doctor in the country where the patient resides or communicates from - limit can either be by virtue of the practice area, or the type of telemedicine to be practiced, or time period)

Liability Liability determined with respect to the existence of the doctor-patient relationship, and traditional requirements for negligence. Factors for existence of doctor-patient relationship: § statutory definition - should take into consideration:

o legislative treatment of referring doctors, specialists, and persons supervised by a doctor licensed to practise telemedicine)

o circumstances in which a doctor practicing telemedicine from outside India will be subject to Indian laws on both licensing requirements and malpractice provisions

§ whether the doctor and the patient have met § whether the doctor examined the patient § whether the patient's records were viewed by the doctor § whether the doctor knows the patient's name § whether the doctor was paid a fee § whether the patient has failed to follow the doctor's advice (If so, no

relationship will normally be considered to have arisen)

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§ whether the doctor-patient interaction arose because of an emergency situation where the doctor was forced to treat the patient

Medical Negligence Determination Factors to determine medical negligence - normal requirements for negligence § Existence of duty of care § Failure to fulfill duty § Consequent damage

Confidentiality Is advisable to provide that all the requirements of confidentiality applicable to the traditional practice of medicine under the laws of India, as well as technical standards to be specified under this legislation should be complied with by doctors practicing telemedicine.

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Delegated Legislation Besides the important provisions regulating the rights and liabilities of the stakeholders involved in the creation and use of Health Information, certain other procedural and technical aspects would also need to be enumerated, which may be specified in rules/regulations issued under the statute. Computerization increases the quantity and availability of data and enhances the ability to link the data, raising concerns about new demands for information beyond those for which it was originally collected. The potential for abuse of privacy by trusted insiders to a system is of particular concern. Organization practices could even be laid down by each organization/institution, and need not be provided for under rules/regulation, if it is considered desirable to retain greater flexibility with regard to these practices. Technical Practices and Procedures § Individual authentication of users § Access controls based on legitimate need-to-know § Audit trails (maintaining access logs) § Physical security and disaster recovery (limiting physical access,

carefully storing backup data) § Protection of remote access points (controlling external access) § Protection of external electronic communications (not sending

personally identifiable data over public networks) § Software discipline (virus-checking, controlling software

installation) § System assessment (testing security on an ongoing basis)

Organizational Practices § Security and confidentiality policies § Security and confidentiality committees § Information security officers § Education and training programs § Sanctions § Improved authorization forms § Patient access to audit logs

For more information, please refer Annexure 8 a: Health Information And Telemedicine: Legal Framework Annexure 8 b: Draft Version Of Telemedicine Law

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9.9 Implementation Road Map for ITIH The ITIH framework aims to take the Indian healthcare information system from an information gathering entity and data processing set up to knowledge management systems for improved decision-making and finally, to prepare the ground for implementing an integrated healthcare delivery network in the country. The implementation of the ITIH has made significant impact in some countries by bringing in value and benefits to all the players involved. Implementation of the ITIH in India will also have tremendous impact on the Indian healthcare scenario and the healthcare players in the country. It will affect key players and stake holders such as the Government and its Public Sector Organisations, Hospitals and relevant organisations of healthcare delivery, Insurance, Information Technology, vendors, suppliers, etc and the effects will be seen across home care, ambulatory care, emergency care, stakeholder interactions, research and many other areas. To implement the ITIH successfully, it is imperative that the multiple stakeholders work towards a common objective. The broad goal of ITIH is to deliver information to individuals, providers and planners, when and where they need, to make available information required to aid and support decision making for health and healthcare. The ITIH initiative, taken by the MCIT, was taken forward by drawing a brief outline of the implementation road map. The following chapter is an attempt to define the best possible course of action in implementing ITIH, keeping in mind the stakeholders’ perspectives as well as protecting the interests of all players concerned. This road map covers the plausible steps, which various organisations and professionals need to take, to later reap in the benefits of the project. Since the implementation of the ITIH is not mere use of various standards and procedures across the health spectrum, but also the sustainability of benefits and to continually keep progressing along with advancing technologies and healthcare scenarios, an effective legal system and a robust educational system are the most critical requirements of such an implementation exercise. The legal system of the country would help regulate various disparate systems and enforce certain rules and restrictions to the benefit of all parties involved in bringing in standardisation. And to compliment the efforts, an educational system, that is in sync with the changing healthscape and emerging trends, would provide the required expertise and ensure self-sufficiency within the country. The content of this chapter is an outcome of intensive research for ITIH in the Indian context, including critical inputs by various professionals and organisations and global examples of similar exercises.

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The Implementation Roadmap > Current Status of ITIH

49

CURRENT STATUS OF ITIH

Our framework today, identifies the standards that constitute a ITIH, defines the broad scope of each constituent and the further work

to be done

Each of the constituents need to detailed further keeping in view their use in different healthcare settings. An application based

approach can bring focus and expedite further development

Benefits of ITIH can be achieved only when we reach the ground level !

There is a long way to !

Benefits of ITIH can be achieved only when we reach the ground level !

There is a long way to !

3,000 FT

300 FT

30 FT

Ground level

The recommendations need to be in the form of working “tool kits” that can be used by various stakeholders for implementing

health information standards

Hospitals should be capturing and exchanging health information in a standardized manner.

The ITIH is proposed by the Government of India to bring in standardisation across the healthcare spectrum of the country with a macro-level focus. Drawing an analogy with the altitude and the drill down activity required to implement the ITIH, the following is a brief on the next tentative steps to be taken to reach the micro-level of the implementation process: • Our framework, today, identifies the standards that constitute a ITIH,

defines the broad scope of each constituent and the further work to be done

• Drilling down further into the details, each of the constituents needs

to be detailed with their relevance of use in different healthcare settings. An application-based approach that can address the requirements of most healthcare settings can bring focus and expedite further development

• The recommendations made should be readily implementable in the

form of user-friendly working “tool kits” and can be used by various stakeholders for implementing health information standards

• The acid test for the success of the ITIH is the end usage of the

standards. Hospitals and other providers should capture and exchange health information in a standard manner. The benefits will follow.

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The Implementation Roadmap > Implementation Plans

IMPLEMENTATION PLANS

SET UP A “NATIONAL HEALTH INFORMATICS CENTER”SET UP A “NATIONAL HEALTH INFORMATICS CENTER”

Increase the awareness of ITIHIncrease the

awareness of ITIHDetail ITIH modules

further keeping in view a clinical/

business objective

Ex – Claims Processing

Detail ITIH modules further keeping in

view a clinical/ business objective

Ex – Claims Processing

Implement pilots in small & impact

areas

Implement pilots in small & impact

areas

Sustainability of the success of ITIH is largely dependant on the detailed planning and organising of resources, including the human expertise. There is a need for a central body to help initiate and carry out the activities of the ITIH and, therefore, it was suggested that a nodal agency, the National Health Informatics Centre (NHIC) be set up to develop and monitor Health Informatics in the country. It was one of the prime recommendations to help take the ITIH initiative forward. The three important functions of the NHIC, with respect to ITIH, would be: • To increase awareness about ITIH amongst stakeholders and most

importantly, the masses; the centre would take over the task of educating while carrying on other implementation activities.

• Drilling down further into the details, the NHIC will draw out various

implementation plans, best suited to the type of the healthcare setting and specific activities. Individual ITIH modules for various healthcare settings will be created to address the requirements of varied operational practices and their business objectives.

• The NHIC will be involved in carrying out pilot studies in sporadic

regions throughout the country for the implementation of the ITIH. To test the waters, pilot modules will be prepared and tested in various healthcare settings and progress on the overall implementation plan will be made accordingly.

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Objective of the National Health Informatics Centre

• To promote standardisation of creation, capture, storage and dissemination of health information in the Indian health industry

• To educate all stakeholders on the importance of health information standards and their usage

• To provide a legal environment that will protect the privacy and confidentiality of health information

• To maintain a central repository of national health information

Services to be offered by the NHIC • Research: Identifying best practices in implementing health information

standards • Implementation • Issuing health identifiers • Accreditation: Making sure all payers and promoters are complying with

standards. Issuing compliance certificates. • Legal protection: Helping the ‘abused’ in the process of ‘ fighting’ for

justice • Publications: Publishing the latest standards and formats • Collaboration: Working with international organisations and projecting

India’s stance in international fora • Coordination: Working with partner organisations such as the MCI,

AICTE, ICMR, IRDA, ISRO, etc. to take forward the ITIH initiatives across the country

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The Implementation Roadmap > Organisation Structure of NHIC

53

ORGANIZATION STRUCTURE (I)

National Health Informatics Center

State Health Informatics Center

Partners(IRDA,, AICTE, etc.)

Partners(IRDA,, AICTE, etc.)

MOHFWMCIT

• In areas that are not related to health, NHIC should partner with industry associations to ensure smooth implementation of ITIH in the country

• MIS of state level ITIH implementation initiatives

• Escalation of queries or implementation challenges

• MIS of state level ITIH implementation initiatives

• Escalation of queries or implementation challenges

54

ORGANIZATION STRUCTURE (II)

Data Standards & Formats

NHIC

IdentifiersTechnical Standards

Education Legal

Data Elements

Minimum Data Sets

Clinical Terminology

Billing Formats

• Not full fledged departments in NHIC

• There will be representatives from NHIC who will look into these two areas

• Education will be led by AICTE, Legal will be led by Law Ministry

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The Implementation Roadmap > Organisation Structure of NHIC

ORGANIZATION STRUCTURE OF SHIC

Project Nodes

SHIC

Project Nodes

Project Nodes

Project Nodes

HR/Admin/ IT/Support

• Generalists, who will act as “single windows” for all enquiries and implementation support

• For specialist help, they will contact the NHIC

Apart from setting up the central authority like the NHIC, there is a need for a state-level body to carry out the implementation of the ITIH activities across the country. The National Health Informatics Centre, at the central level forms the apex structure while the State Health Informatics Centre (SHIC) will co-ordinate the ITIH activities at the state level. The responsibility of ensuring smooth implementation of ITIH rests on the SHICs. The SHIC consists of many project nodes, which are the critical activity areas handling different aspects of implementation. The nodal points act as a single-window set up, coordinating all the activities through out the state, at all levels and handling enquiries, implementation support issues, etc. The ITIH is not a one-time activity but a continuous process of advancement and upgrading. In order to have a community that will contribute to the development of health information standards, a NHIC / SHIC membership can be introduced at various levels: • Healthcare providers • Payers • Employers • Individuals

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Responsibilities of State Health Informatics Center

• Issue identifiers to the concerned healthcare professionals o Physicians o Dentists o Nurses

• Help various entities implement health information standards. Play the role of a compliance manager.

• Conduct education programmes to increase awareness of health information standards

• Conduct periodic audits of various healthcare providers to ensure quality of health information

• Generate health reports for analytical and decision- making purposes • Coordinate with the NHIC for rolling out identifiers

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The Implementation Roadmap > Inter-linkage of Standards

58

MANY STANDARDS ARE INTERLINKED

Authorisation Number:Policy Holder Information Patient InformationName: Name:Individual Identification Number (UHID): Relation:Address: Individual Identification Number (UHID):

Tel:City State: Pin: E-mail:Provider InformationName: Provider Identification Number (UPIN / MCI No.):Address:

City State: Pin:Claim InformationAdmission Date: Time: Notes:Patient Status:First Occurance Date:Discharge Date: Time:Patient Paid Amount:Principal Diagnosis:Other Diagnosis Information:Procedure code: Procedure Description

Serviceline InformationService Description Amount Discount Net Amount Patient paid amount Balance due Remarks

List of Enclosures (Please Tick) Comments / Remarks/ ObjectionsPreauthorisation / First Admission ReportDischarge SummaryHospitalization Bills with breakupsInvestigation ReportsConsultation bills with ReceiptIf Surgery, Surgery Bills with ReceiptMedicine Bills with PrescriptionsOT Pharmacy BillsOthers

Provider Representative Policy Holder / PatientName: Name:Date: Date:

Signature: Signature:

Provider Billing Form (PBF 01)

UHIDUHID

Minimum Data SetMinimum Data Set

Data ElementData Element

DiagnosisDiagnosis

Observation Codes

Observation Codes

Lab FormatsLab Formats

Many of the standards proposed for the ITIH are interlinked. The use of one standard in most cases mandates the use of another dependant standard(s). Some standards are complimentary to the other while some are a sub set of other standards. The interlinking feature in the recommended standards of the ITIH ensures their best possible utilisation of the benefits. For example, in the above-recommended billing form for the hospital (PBF01), there is a visible interlinkage of the standards. • The use of the Provider Billing Form requires the use of UHID

(Universal Health Identifier) that provides the minimum data required to register an individual as a patient.

• The UHID number in turn contains Minimum Data Sets that capture the required information in a set format.

• The minimum data sets in turn are composed of various data elements or pieces of information of the patient.

• In the Diagnosis section of the PBF 01, the data required is entered in the form of codes called the Disease codes, which are the chosen clinical standards. The doctor, with the help of observation codes or lab formats, reaches the diagnosis.

There is a chronological use of various standards, one leading to another. Therefore, to ensure that the provider billing process is efficient, the data has to be accurate, captured in time and in the recommended method.

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Implementation Roadmap > Standardising Claims Submission Process

60

IMPACT OF STANDARDISING THE CLAIMS SUBMISSION PROCESS

As per the billing formats suggested by the ITIH project, a claims submission involves the use of two forms, which have some “items” that can be

standardized

SexLocation Codes

Type of insurance activity

Year of incorporation

Due to the dependencies of one item on another, in order to achieve the above, one must also standardize the following “items”

• TA – 05 : Claims submission for covered services

• Payer ID (Insurer/TPA)• Provider ID

• TA – 04 : Billing for covered services• Name• UHID

• Address• Relationship to policy holder

• Date• Diagnosis

• Procedure

In relation to the nature of interlinked standards, the following is the impact of standardising the claims processing activity. Claims Processing deals with a range of activities ranging from capturing patient information, submitting the claims to the insurance company in a required format, billing for the covered services, determining the patient’s eligibility, etc. The above two formats have some elements in common such as the name, identifiers, etc. By standardising some of the basic information elements such as gender, location codes, etc, consistency can be ensured in the two forms leading to smooth transmission of data across various entities.

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Implementation Roadmap > Interlinkage between different items

INTERLINKAGES BETWEEN DIFFERENT ITEMS IN FORMS TA-05 & TA-04

UHID

Minimum Data Set

Diagnosis

Procedure

Relation to policy holder

Type of insurance

activity

Name

Sex

Date of birth

Location Code

Payer ID (Insurer / TPA)

Provider ID

Year of incorporation

Minimum Data Set

Minimum Data Set

In relation to the nature of interlinked standards, the above billing example shows the inter-connectivity between various pieces of information. Administrative simplification will the be the direct outcome of adopting the recommended standards which include the data elements, health identifiers, minimum data sets, clinical data representation formats, etc.

In the above illustration, • Provider Identifier is a unique number allocated to the healthcare

provider. This provider identifier is a minimum data requirement in the billing form to identify the provider for the purpose of billing and claims processing.

• UHID is a universal health identifier allocated to a person/ patient. The UHID is a result of minimum information captured from the individual such as Name, Age, Date of Birth, etc, which are again minimum data/ information required.

• Similarly, the other pieces of information such as the location codes, types of insurance activity, etc, are required for processing.

The entire set of information in the above slide is a sequence of data capture that happens at various locations, but only once, at different entities. All the standards get interlinked at various stages of information as the individual progresses from one stage to the other. The end result of the standards is to ensure that data captured once can be used across various entities, and can be accessed anywhere.

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Implementation Roadmap > TimeLine Timelines have been drawn for tentative steps to be taken towards implementing the ITIH. Implementation of the ITIH cannot be taken forward without the involvement of various stakeholders. Therefore, it is imperative that the multiple stakeholders are aligned towards a common objective and goal. The following are the three immediate steps towards ITIH:

1. Creating Awareness Awareness of the ITIH is crucial in involving more stakeholders in standardisation and this can be created through

• Advertisements – Print, and online advertisements • Publications – White papers, articles • Workshops

Time Frame: 3 months

2. Building the National and State Health Informatics Centre MCIT & MOHFW should build the NHIC in order to take forward ITIH in India and as a proof of concept, a SHIC for one state should be launched Time Frame: 6 months

3. Implementing Pilot Projects

Select a small healthcare setting, to implement some ITIH recommendations in collaboration with State Government – Health & IT Departments Time Frame: 12 months

The above three actionables include a series of time-driven steps. The following is the implementation road map for the ITIH. This tentative schedule of proposed events is subject to change.

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Standard

Month 01 –

Month 03

Month 04 –

Month 09

Month 10 –

Month 15

Month 16 –

Month 21

Mon 22 – Mon 27

Mon 28 – Mon 33

Mon 34 – Mon 39

Mon 40 – Mon 45

UHID

All TPAs Plan Enrollments Government Providers

NHIC

Launch NHIC

Launch SHIC

Declare HIPAA

Equivalent milestone for India

Minimum Data Sets

Defining and Publishing Minimum Data Set Formats

Pilot Study of Minimum Data Sets

Full Roll out of Minimum Data Sets

Data Elements

Defining the

National Data

Dictionary

Ensure Vendors

Compliance with

Standards

Allow one year for total compliance by all vendors for data standards

Clinical Terminology Standards

Pilot studies for Disease Codes and Clinical Observation Codes

Disease + Procedure + Observation codes in use by large hospitals

Disease + Procedure + Observation codes in use by small and medium hospitals

Health Identifiers

Set up UHID issue

system

Pilots for Professional

Identifier issue

Full roll out of identifiers for healthcare Professionals

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Standard

Month 01 –

Month 03

Month 04 –

Month 09

Month 10 –

Month 15

Month 16 –

Month 21

Mon 22 – Mon 27

Mon 28 – Mon 33

Mon 34 – Mon 39

Mon 40 – Mon 45

Health

Identifiers (contd.)

Issue Identifiers to payors and providers &

monitor UHID use

Issue Identifiers to health support service

providers

New Payers and Providers to issue

Individual Identifiers. Old identifiers to be

converted into new format in 2 years

Billing Formats

Introduce Billing

Formats at TPA and Insurance

Companies

Encourage use of Standards Billing formats

in Corporate Hospitals and Nursing homes

Encourage use of Standards

Billing formats in Govt Hospitals at secondary

and tertiary level

Encourage use of Standards

Billing formats in Govt

Hospitals at Primary Level

Education

Develop ‘Refresher

Course Content’ and offer

Develop ‘Certificate

Course Content’

and offer it

Develop ‘Diploma and PG Diploma Course Content’ and offer it

Develop Quality

parameters to rank and

accredit institutions

Include Health

Informatics in all medicine/

health related courses

Legal

Proposal Mandate for ITIH to the Govt

Legal Framework for Hospital

Environment

Legal Framework

for Tele- Medicine

environment

Messaging Standards

Release HL7

equivalent for India

Encourage Healthcare vendors to

adopt technical standards. Time till 2004 to comply.

Research and Publications

Awareness Creation for ITIH

Develop Website for interacting and sharing progress info

For more information, please refer Annexure 9: Implementation Roadmap

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10 Working Members & Groups of ITIH

The purpose of the ITIH project was to define the Information Technology Infrastructure for Health for India by developing a benchmark document based on the shared vision of ITIH amongst all the players of healthcare and its stakeholders. The ITIH project involves various organisations related to health, technology, government, etc, from all over the country and abroad. To conduct a project of this magnitude, that would affect almost all the healthcare players in the country, would have been impossible without the contribution of the working group members from various organisations. In addition to the Implementation Agency Apollo Health Street Limited (AHSL), the following is the list of active participants in the ITIH project:

• AIIMS All India Institute of Medical Sciences • AMSS Amarchand Mangaldas Shroff & Sons • DGHS Directorate General of Health Services • DIT Department of Information Technology • ESIC Employee State Insurance Corporation • GIPSA General Insurers Public Sector Association • ICMR Indian Council of Medical Research • IMA Indian Medical Association • IRDA Insurance Regulatory and Development Authority • ISRO Indian Space Research Organization • MCI Medical Council of India • MCSI Medical Computer Society of India • MOHFW Ministry of Health & Family Welfare • MSH Management Sciences for Health • NIA National Insurance Academy • SGPGI Sanjay Gandhi Post Graduate Institute of Medical Sciences • TAC Tariff advisory committee (IRDA) • WHCIT Wipro Healthcare IT • WHO World Health Organization

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The following is the table of the various working groups from both India and abroad that have played pivotal role in coming up with the final recommendations for the future of ITIH for India. The organisations are grouped under common head/ working group name.

Data

Elements

Clinical

Standards

Identifiers Minimum

Data Sets

Billing

Formats

Legal Frame

Work

Education

Frame

Work

Technology

WIPRO DGHS WIPRO ICMR GIC AMSS MCI Telemedicine

Committee

MCIT AIIMS IRDA DGHS GIPSA IRDA AIIMS MCIT

GIC Ministry of

Health

ESI AIIMS Ministry of

Health

MCI MSH MCSI

Ministry of

Health

WHO Ministry of

Health

Ministry of

Health

GIC NIA NASSCOM

WHO SGPGI WHO WHO Ministry of

Health

Ministry of

Health

Delhi govt

ESI SGPGI Didar Singh WHO ISRO

SGPGI ICMR

SGPGI

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10.1 About the Implementation Agency

Apollo Health Street Limited (AHSL) provides technology solutions to healthcare industry. AHSL, was incorporated in 1999, and is a subsidiary of Apollo Hospitals Enterprise Limited (AHEL).

Objectives AHSL has identified the following objectives for serving the healthcare industry globally:

• Leverage India's world-class facilities to provide value for money solutions to the global health care industry.

• Provide end-to-end technology solutions to various stakeholders in healthcare industry in India and abroad.

• Cater to the information needs of multiple user groups: individuals, patients, doctors, clinics, hospitals, corporate firms, pharmaceutical companies, insurance companies, students, etc.

• Bring interactivity between the user groups and crate communities of care (e.g., Patients with similar conditions/interests, doctors, sharing cases/ research, etc.

• Network the Health Care Delivery System (Integrated Delivery Networks)

• Work towards setting Standards of Information in healthcare

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10.2 Core-Project Team for ITIH From Department of Information Technology, Ministry of Communications & Information Technology:

Name: Mr. S. Lakshminarayan, IAS Designation: Additional Secretary, Department of Information

Technology, Ministry of Communications & Information Technology, Govt. of India

Qualification: Masters in Chemistry Post Graduate Diploma in Advanced Social & Economic Studies, University of Manchester (UK)

Area of Interest: Information Technology, e-commerce, International cooperation in IT, Telemedicine

E-mail: [email protected] Telephone: +91-11-24363078

Name: Mr. B. S. Bedi Designation: Senior Director, Dept of Information Technology,

Ministry of Communications & Information Technology, Govt. of India

Qualification: Bachelor of Technology (B.Tech), IIT, Delhi. Master of Technology (M.Tech), IIT, Delhi.

Area of Interest: Information Technology in Healthcare, e-Health & Telemedicine Applications

E-mail: [email protected] Telephone: + 91-11-24360582

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From Apollo Health Street Ltd: Name: Ms. Sangita Reddy Designation: Managing Director, Apollo Health Street Ltd Qualification: Bachelors (Nutrition and Dietetics) Masters (Hospital Administration), Rutgers University, USA. Area of Interest: Healthcare Technology, Health Policy and Administration E-mail: [email protected] Telephone: +91-040-23607777 Name: Dr. Vikram Jit Singh Chhatwal Designation: Chief Executive Officer, Apollo Health Street Ltd Qualification: MBBS, Jawaharlal Nehru Medical College, Belgaum. Ph.D, National University of Singapore, Singapore.

Masters in Business Administration (MBA), Ecole Nationale des Ponts et Chaussees, Paris.

Area of Interest: Healthcare Integrated Delivery Networks, Health Policy E-mail: [email protected] Telephone: +91-040-23552350 Name: Mr. Arnab Sen Designation: Vice President, Apollo Health Street Ltd Qualification: Bachelor of Technology (B.Tech), IIT Delhi Masters in Business Administration (MBA), IIM Calcutta. Area of Interest: Healthcare Technology, Healthcare Informatics E-mail: [email protected] Telephone: +91-040-23554728 Name: Mr. Arvind Chittumalla Designation: Manager – Health Informatics, Apollo Health Street Ltd Qualification: Bachelors (Civil Engineering) from Osmania University Masters (Business Administration), University of Hull, UK. Area of Interest: Healthcare-BPO, Health Informatics, & Knowledge

Management E-mail: [email protected] Telephone: +91-040-23554728 Name: Mr. Jaideep Nair Designation: Manager – Telemedicine, Apollo Health Street Ltd Area of Interest: Healthcare Informatics E-mail: [email protected] Telephone: +91-040-23554728 Name: Ms. Ishrath Humairah Designation: Jr. Manager, Apollo Health Street Ltd Qualification: Bachelors (Commerce) from Osmania University

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Masters (Hospital Administration), Apollo Institute of Hospital Administration.

Area of Interest: Health Technology (Research & Innovation), Health Policy & Administration, Geriatric Health and Direct Patient Care. E-mail: [email protected] Telephone: +91-040-23554728

Name: Mr. Shreyas Mehta Designation: Researcher, Apollo Health Street Ltd Qualification: Masters in Business Administration (MBA), ICFAI Business

School

Name: Mr. Alok Sharma Designation: Researcher, Apollo Health Street Ltd Qualification: Masters in Business Administration (MBA),ICFAI Business

School

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List of Annexure - Volume II

Please Refer for the following

Annexure 1: Billing Formats Annexure 2: Clinical standards Annexure 3: Data Elements Annexure 4: Minimum Data Sets Annexure 5: Health Identifiers Annexure 6: Messaging Standards Annexure 7: Education Framework (Amarchand & Mangaldas) Annexure 8a: Legal Framework for the privacy & security of health information Annexure 8b: Proposed Legislation for Telemedicine Annexure 9: Implementation Roadmap

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