eHealth Information: Federal eHealth Information: Federal Activities and Implications for Activities and Implications for

State PolicyState Policy

Susan M. ChristensenSusan M. ChristensenSenior AdvisorSenior Advisor

CSG Health Policy ForumCSG Health Policy Forum

On Mental Health Care and WellnessOn Mental Health Care and WellnessMay 31, 2006May 31, 2006

OverviewOverview

Terminology – Getting on the Same Terminology – Getting on the Same PagePage

Federal LandscapeFederal Landscape AHRQAHRQ Privacy and TrustPrivacy and Trust ResourcesResources Legal IssuesLegal Issues Appendix: Case Study – Legal IssuesAppendix: Case Study – Legal Issues

Terminology: HIE v. HITTerminology: HIE v. HIT

No longer just about putting electronic medical records No longer just about putting electronic medical records in hospitalsin hospitals Electric health information systems across Electric health information systems across allall care care

settings, as well as payers settings, as well as payers Linking them together – interoperability for Linking them together – interoperability for health health

information exchange (HIE)information exchange (HIE) For HIE, communities and states (and some regions) For HIE, communities and states (and some regions)

are developing networked systemsare developing networked systems To do this, it’s not just about investing in the To do this, it’s not just about investing in the

technology (HIT) technology (HIT) ; we must research how to do so in a ; we must research how to do so in a way thatway that Maximizes the value we hope to realize – clinically, Maximizes the value we hope to realize – clinically,

economically, and for population healtheconomically, and for population health Assures that security and privacy protections are Assures that security and privacy protections are

“baked into” HIE “baked into” HIE

HIE Policy IssuesHIE Policy Issues

In addition, a new market is being created, In addition, a new market is being created, with all the technical and policy issues that with all the technical and policy issues that entails, such asentails, such as Standards for data exchangeStandards for data exchange Assuring consumer participation and patient Assuring consumer participation and patient

protectionsprotections Security concernsSecurity concerns New business arrangements, new relationships New business arrangements, new relationships Disconnect between payment systems and new Disconnect between payment systems and new

relationships/care delivery modelsrelationships/care delivery models

What’s the situation?What’s the situation?

Federal LeadershipFederal Leadership

President’s Executive Order President’s Executive Order 13335 13335 (April 2004) (April 2004) – federal leadership for the development of a – federal leadership for the development of a nationwide interoperable electronic health nationwide interoperable electronic health information system:information system:

Created Office of the National Coordinator for Health Created Office of the National Coordinator for Health Information Technology in HHS (ONC)Information Technology in HHS (ONC)

ONC is required to develop a national strategic plan to support:ONC is required to develop a national strategic plan to support: Public-private collaboration to develop, adopt and implement Public-private collaboration to develop, adopt and implement

standardsstandards Evaluate benefits of HIT Evaluate benefits of HIT Address privacy and security issuesAddress privacy and security issues

ONC serves as principal advisor to Secretary on national HIT ONC serves as principal advisor to Secretary on national HIT policy, coordinates federal activities, and coordinates public-policy, coordinates federal activities, and coordinates public-private outreach and consultationprivate outreach and consultation

NOW

WORKGROUPS

COMMUNITY

ONC

INFRASTRUCTURE

20052004

FHA Strategic Plan

Health IT Policy Council Established

NHIN RFI Summary

Health IT Strategic Framework

JUL MAR SEP OCT JAN FEB MAR . . . DEC

Interoperable Electronic Healthcare

Records

Community Established

Review Workgroup Recommendations

2007 2014

2006 GOALS

Make Recommendations to the Community

Workgroups Established

Contracts Awarded

ONC Health IT Roadmap To-DateONC Health IT Roadmap To-Date

Recommendations for:• Biosurveillance• Consumer Empowerment• Chronic Care• Electronic Healthcare Records

• 2006 Strategic Plan

• NHIN Architectures• Standards Implementation Guidance• Ambulatory Care Certification Criteria

• Recommendations Report to the Secretary of HHS

Four Major HHS ContractsFour Major HHS Contracts

HHS has entered into four significant contracts: HHS has entered into four significant contracts: http://www.hhs.gov/healthit/contracts.htmlhttp://www.hhs.gov/healthit/contracts.html

Harmonize industry-wide health IT standards (ONC)Harmonize industry-wide health IT standards (ONC) Develop a conformance certification process for Develop a conformance certification process for

health IT (ONC)health IT (ONC) Assess and develop plans to address variations Assess and develop plans to address variations

business policies and state laws related to privacy and business policies and state laws related to privacy and security (AHRQ)security (AHRQ)

Four contracts to develop nationwide health Four contracts to develop nationwide health information network (NHIN) prototypes that can be information network (NHIN) prototypes that can be used to test specialized network functions, security used to test specialized network functions, security protections and monitoring, and demonstrate protections and monitoring, and demonstrate feasibility of scalable models (ONC)feasibility of scalable models (ONC)

Agency for Healthcare ResearchAgency for Healthcare Researchand Quality (AHRQ)and Quality (AHRQ)

MissionMission

To improve the quality, safety, To improve the quality, safety, efficiency, and effectiveness efficiency, and effectiveness

of health care for all of health care for all AmericansAmericans

Research at HHS:Research at HHS:Where Does AHRQ Fit In?Where Does AHRQ Fit In?

NIHNIH -- basic biomedical bench research and “efficacy” clinical trials -- basic biomedical bench research and “efficacy” clinical trials AHRQAHRQ -- “effectiveness” of healthcare services and the healthcare -- “effectiveness” of healthcare services and the healthcare

delivery systemdelivery system CDCCDC -- the public health system and community-based -- the public health system and community-based

interventionsinterventions

Other federal partners – Other federal partners – CMS CMS (Medicare and Medicaid)(Medicare and Medicaid), , HRSA HRSA (capital (capital and resources, workforce)and resources, workforce), and , and ONCONC (collaboration and (collaboration and coordination on health IT)coordination on health IT)

Intersection of Safety, Intersection of Safety, Quality and Health ITQuality and Health IT

AHRQ

Support diffusion of HIT to •41 states•40 million Americans

Improve medication safety•CMS e-prescribing demos

Provide HIT technical support to safety net

•Community health centers • Critical access hospitals• Public hospitals

Privacy and Security

Focus on Adoption of Health ITFocus on Adoption of Health IT

AHRQ’s work focuses on the AHRQ’s work focuses on the marriagemarriage of Health IT systems with of Health IT systems with the way work is done in health carethe way work is done in health care

Need to prepare for the impact of Need to prepare for the impact of new Health IT systemsnew Health IT systems Health IT is “Health IT is “oneone part technical, and part technical, and twotwo

parts culture and work process parts culture and work process change.” change.”

Opportunity to design new and better Opportunity to design new and better workflows – and review work workflows – and review work patterns that may never really have patterns that may never really have been examined. been examined.

State and Regional HIT State and Regional HIT DemonstrationsDemonstrations

Five-year state-based contracts: Five-year state-based contracts: Help states develop secure statewide networksHelp states develop secure statewide networks Ensure privacy of health informationEnsure privacy of health information Make an individuals’ health information more Make an individuals’ health information more

available to health care providers available to health care providers FY04: Five states awarded $1M/yearFY04: Five states awarded $1M/year

ColoradoColorado IndianaIndiana Rhode IslandRhode Island TennesseeTennessee UtahUtah Delaware added in FY05Delaware added in FY05

AHRQ National Resource Center for AHRQ National Resource Center for Health Information TechnologyHealth Information Technology

Provides technical and expert support to health IT Provides technical and expert support to health IT grantees, contractors, and selected other federal grantees, contractors, and selected other federal grantees (HRSA, CMS, IHS)grantees (HRSA, CMS, IHS)

Contract award to NORC (up to $18.5M over 5 years), Contract award to NORC (up to $18.5M over 5 years), in partnership with:in partnership with:

Vanderbilt UniversityVanderbilt University Center for IT Leadership (Partners) Center for IT Leadership (Partners) Indiana UniversityIndiana University Foundation for the eHealth InitiativeFoundation for the eHealth Initiative CSCCSC Burness CommunicationsBurness Communications

healthit.ahrq.govhealthit.ahrq.gov

Approaching the “Trust” Issue Approaching the “Trust” Issue

Why is this important to people? What are people thinking? Why is this important to people? What are people thinking? What is the “threat”? What is the “threat”?

Can we break it down? Is HIPAA compliance enough? Can we break it down? Is HIPAA compliance enough? Why not? Why not?

How to react?How to react? Who should be involved?Who should be involved? What message?What message? Guidance for leadership?Guidance for leadership?

““Trust” v. “Privacy” v. HIPAATrust” v. “Privacy” v. HIPAA

Clarify the issues:Clarify the issues: HIPAA – legal requirementHIPAA – legal requirement Additional legal privacy requirementsAdditional legal privacy requirements

FederalFederal StateState Contractual Contractual

Privacy – common law, ethics, good business, Privacy – common law, ethics, good business, protections beyond basic HIPAA complianceprotections beyond basic HIPAA compliance

Trust – broader public concern about security and Trust – broader public concern about security and reliabilityreliability

Privacy and Security ContractPrivacy and Security Contract In September 2005, AHRQ awarded “Privacy and Security In September 2005, AHRQ awarded “Privacy and Security

Solutions for Interoperable Health Information Exchange”Solutions for Interoperable Health Information Exchange” Overall contract managed by RTI International in partnership Overall contract managed by RTI International in partnership

with NGAwith NGA 18-month period; $11.5 million18-month period; $11.5 million RTI will subcontract with up to 40 states to: RTI will subcontract with up to 40 states to:

Identify within the state business practices that affect electronic health Identify within the state business practices that affect electronic health information exchangeinformation exchange

Propose solutions and implementation plansPropose solutions and implementation plans Collaborate on regional and national meetings to develop solutions Collaborate on regional and national meetings to develop solutions

with broader applicationwith broader application Provide final report on overall project outcomes and Provide final report on overall project outcomes and

recommendationsrecommendations

Contract PurposesContract Purposes Identify variations in organization-level business privacy and security Identify variations in organization-level business privacy and security

policies and practices that affect electronic clinical health information policies and practices that affect electronic clinical health information exchange (HIE)exchange (HIE) For those that are “best practices”, document and incorporate into For those that are “best practices”, document and incorporate into

proposed solutionsproposed solutions For those with a negative impact, identify source of the policy or For those with a negative impact, identify source of the policy or

practice and propose alternativespractice and propose alternatives

Preserve privacy and security protections as much as possible in a Preserve privacy and security protections as much as possible in a manner consistent with interoperable electronic health information manner consistent with interoperable electronic health information exchangeexchange

Incorporate state and community interests, and promote stakeholder Incorporate state and community interests, and promote stakeholder identification of practical solutions and implementation strategies identification of practical solutions and implementation strategies through an open and transparent consensus-building processthrough an open and transparent consensus-building process

Leave behind in states and communities a knowledge base about Leave behind in states and communities a knowledge base about privacy and security issues in electronic health information exchange privacy and security issues in electronic health information exchange that endures to inform future HIE activitiesthat endures to inform future HIE activities

Connecting for HealthConnecting for HealthCommon FrameworkCommon Framework

A set of free resources: 16 policy guides and technical documents A set of free resources: 16 policy guides and technical documents designed to advance HIE in a private and secure manner. designed to advance HIE in a private and secure manner. Technology neutral Technology neutral Includes model contract language for HIE agreements Includes model contract language for HIE agreements

The Common Framework puts forth a model of HIE that:The Common Framework puts forth a model of HIE that: Protects patient privacy by allowing health information to remain Protects patient privacy by allowing health information to remain

under local control – avoiding the need for a large, centralized under local control – avoiding the need for a large, centralized database or creation of a national patient IDdatabase or creation of a national patient ID

Avoids large-scale disruption and huge up-front capital investments Avoids large-scale disruption and huge up-front capital investments by making use of existing hardware and softwareby making use of existing hardware and software

Supports better informed policymaking around HIESupports better informed policymaking around HIE Establishes trust among collaborating organizations by applying Establishes trust among collaborating organizations by applying

well-vetted model contract language to fit their needswell-vetted model contract language to fit their needs

Series of activities to disseminate and provide education for how Series of activities to disseminate and provide education for how to use: AHRQ website, teleconferences, workshopsto use: AHRQ website, teleconferences, workshops

healthit.ahrq.gov and www.connectingforhealth.orghealthit.ahrq.gov and www.connectingforhealth.org

Vanderbilt Center for Better Vanderbilt Center for Better Health ModelHealth Model

Developed workshop design to explore trust issues, Developed workshop design to explore trust issues, come to consensus, and make recommendations or come to consensus, and make recommendations or develop workplan for moving forwarddevelop workplan for moving forward Goal: state/community controls the process and the outcomeGoal: state/community controls the process and the outcome Statewide: used principles in CFH model as kickoff for Statewide: used principles in CFH model as kickoff for

discussion about privacy and trust among stakeholders in discussion about privacy and trust among stakeholders in disparate HIEs across statedisparate HIEs across state

Another new statewide initiative: used workshop to do Another new statewide initiative: used workshop to do concrete planning for both technology and governance in new concrete planning for both technology and governance in new HIE HIE

http://www.volunteer-ehealth.org/AHRQ/12142005/http://www.volunteer-ehealth.org/AHRQ/12142005/index.htmindex.htm

http://www.mc.vanderbilt.edu/vcbh/ds/0606_privacy/http://www.mc.vanderbilt.edu/vcbh/ds/0606_privacy/ Working with AHRQ to make the workshop “portable”Working with AHRQ to make the workshop “portable”

Differing Approaches – Legal Differing Approaches – Legal IssuesIssues

Recognize that one approach, i.e., legislation, is not appropriate Recognize that one approach, i.e., legislation, is not appropriate for every issuefor every issue Federal legislation and mandatesFederal legislation and mandates National or regional consensusNational or regional consensus Model state lawsModel state laws State innovation through demonstrations or regulationState innovation through demonstrations or regulation Model contractsModel contracts Private agreementsPrivate agreements

Coordinate among initiatives; use them in combinationCoordinate among initiatives; use them in combination

SummarySummary

Communities can and should make their Communities can and should make their own choices about HIEown choices about HIE

The decision process on policies and The decision process on policies and implementation is as much a part of the implementation is as much a part of the solution as the technologysolution as the technology

Call on national initiatives for what they Call on national initiatives for what they can offer to save money and accelerate can offer to save money and accelerate the process the process

http://healthit.ahrq.govhttp://healthit.ahrq.gov

For additional information:For additional information:Susan ChristensenSusan Christensen

susan.christensen@ahrq.hhs.govsusan.christensen@ahrq.hhs.gov

Case Study – One StateCase Study – One State

Workgroup of stakeholders assumed time frame two years Workgroup of stakeholders assumed time frame two years hencehence

Identified potential key legal, regulatory, and policy areas Identified potential key legal, regulatory, and policy areas that could still be of concern as regional health information that could still be of concern as regional health information exchange implementation progressesexchange implementation progresses

Stratified issues by national, regional, local or private in Stratified issues by national, regional, local or private in nature (i.e., best resolved at what level to be most nature (i.e., best resolved at what level to be most effective?), and split them into technical and non-technical effective?), and split them into technical and non-technical categoriescategories

Identified proposed approach: Identified proposed approach: legislationlegislation, , rule-makingrule-making, , consensusconsensus, , private agreementprivate agreement, or some combination, or some combination

Model legislation would be appropriate for many of the Model legislation would be appropriate for many of the consensusconsensus issue areas, except data and communication issue areas, except data and communication standardsstandards

Technical IssuesTechnical IssuesIssue AreaIssue Area NationalNational Regional/StateRegional/State PrivatePrivate

Data and communication Data and communication standardsstandards

Adopted at the national Adopted at the national levellevel; ; potential public/ potential public/ private collaboration for private collaboration for identificationidentification; ; mandatory mandatory for Medicare to drive for Medicare to drive take-up;take-up; common common standards identified for standards identified for MedicaidMedicaid

Adopted for Medicaid by Adopted for Medicaid by state programsstate programs

Participation in Participation in identification and identification and incorporation into productincorporation into product

Safety standards for Safety standards for items like drugs and items like drugs and devicesdevices

SameSame SameSame SameSame

Standards enforcementStandards enforcement Enforcement by regional Enforcement by regional exchanges as exchanges as requirement for userequirement for use; ; possibly mandatory for possibly mandatory for Medicaid Medicaid

CertificationCertification Requirements and Requirements and administration/enforcemeadministration/enforcement at regional levelnt at regional level; ; possibly mandatory for possibly mandatory for Medicaid Medicaid

Bioterrorism/ defense Bioterrorism/ defense systemssystems

Developed and funded Developed and funded federallyfederally

Portions developed and Portions developed and funded at state/regional funded at state/regional level in collaboration with level in collaboration with federal effortsfederal efforts

Non-Technical IssuesNon-Technical Issues

Issue AreaIssue Area NationalNational Regional/StateRegional/State PrivatePrivate

Research on HIT policy, Research on HIT policy, standards and valuestandards and value

Funding,Funding, dissemination dissemination and oversight; and oversight; demonstrationsdemonstrations

Funding and Funding and adoptionadoption Funding and adoptionFunding and adoption

Payment reformsPayment reforms Medicare payment Medicare payment reformreform; ; Medicaid reform; Medicaid reform; FEHBP contractsFEHBP contracts

Adopt Medicaid reforms; Adopt Medicaid reforms; SCHIPSCHIP and and employee employee coverage reformscoverage reforms

Pay for performance and Pay for performance and IT utilizationIT utilization

Startup fundingStartup funding Tax incentives, loans, Tax incentives, loans, grantsgrants, and , and demonstrationsdemonstrations

Licensure for health Licensure for health professionalsprofessionals

Leader in developing Leader in developing standardized content that standardized content that supports information supports information exchangeexchange

Adoption and Adoption and enforcement of licensure enforcement of licensure rules rules

Professional organization Professional organization and payer support of and payer support of “model” rules“model” rules

Liability protections/ Liability protections/ accountabilityaccountability

Leader in developing Leader in developing standardized contentstandardized content

Adoption and Adoption and enforcementenforcement

Underserved populations Underserved populations Model legislation that Model legislation that supports interoperability supports interoperability

Outreach, funding and Outreach, funding and enforcementenforcement

HIE StructureHIE Structure

Issue AreaIssue Area NationalNational Regional/StateRegional/State PrivatePrivate

Governance/ structureGovernance/ structure Leadership in developing Leadership in developing standardized options that standardized options that support regional health support regional health information exchangeinformation exchange

State option to adopt by State option to adopt by statutestatute or or rulemakingrulemaking

Private agreements can Private agreements can supplement or reflect supplement or reflect state option, or may be state option, or may be stand-alone in absence stand-alone in absence of state actionof state action

Responsibility/ Responsibility/ accountabilityaccountability

Leadership in developing Leadership in developing standardized options that standardized options that support regional health support regional health information exchange information exchange and interoperability and interoperability

State option to adopt by State option to adopt by statutestatute or or rulemakingrulemaking

Taxing authorityTaxing authority Leadership in developing Leadership in developing options that support options that support regional health regional health information exchangeinformation exchange

State option to adopt by State option to adopt by statutestatute

Funding authorityFunding authority Leadership in developing Leadership in developing options that support options that support regional health regional health information exchangeinformation exchange

State option to adopt by State option to adopt by statutestatute or or rulemakingrulemaking

Private agreements can Private agreements can supplement or reflect supplement or reflect state option, or may be state option, or may be stand-alone in absence stand-alone in absence of state actionof state action

LiabilityLiability Leadership in developing Leadership in developing standardized content to standardized content to support interoperability support interoperability

State option to adopt by State option to adopt by statutestatute