FDASIA Taxonomy SubgroupHIT Policy Committee FDASIA Workgroup On Site Meeting30 May 2013

Drag picture to placeholder or click icon to add

Drag picture to placeholder or click icon to add

Subgroup Co-Chairs

Patti Brennan Meghan Dierks

Charge 1

Charge, Anticipated Output of Subgroup

1

To identify the scope of Health IT that should be considered or included in deliberation by the full workgroup

… as the full workgroup develops strategy and recommendations on an appropriate, risk-based regulatory framework for health IT that promotes innovation, protects patient safety, and avoids unnecessary and duplicative regulation.

Taxonomy SubgroupCharge – Anticipated Output

To identify the scope of Health IT that should be considered or included in deliberation by the full workgroup

Taxonomy subgroup scope not to be interpreted as being the final recommendation for what is to be regulation

Taxonomy SubgroupCharge – Anticipated Output

Charge 2

Statutory Definitions 2

The term “health information” means any information, whether oral or recorded in any form or medium, that—

(A) is created or received by a health care provider, health plan, public health authority, employer, life insurer, school or university, or health care clearinghouse; and(B) relates to the past, present, or future physical or mental health or condition of an individual, the provision of health care to an individual, or the past, present, or future payment for the provision of health care to an individual.

Statutory DefinitionsHealth Information [ SSA § 1171(4); 42 U.S.C. 1320d ]

“The term ‘health information technology’ means hardware, software, integrated technologies or related licenses, intellectual property, upgrades, or packaged solutions sold as services that are designed for or support the use by health care entities or patients for the electronic creation, maintenance, access, or exchange of health information.”

Statutory DefinitionsHealth Information Technology [ HITECH Act (2009) ]

” … an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

— recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,

— intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

— intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."

Statutory DefinitionsMedical Device [ Federal Food, Drug and Cosmetic Act 21 CFR 800 -1299 ]

Scope Options 3

Scope Options Considered

EXISTING TECHNOLOGY FOCUS: Explicitly limit scope to existing, named types or categories of Health IT

EXCLUSIONARY FOCUS: Explicitly exclude named types of Health IT as Not-in-Scope; assume all else is In-Scope

PRESCIPTIVE/INCLUSIONARY FOCUS: Explicitly include named types of Health IT as In-Scope, assume all else is Out-of-Scope

Scope Options Considered

STATUTORY DEFINITION FOCUS: Explicitly state the scope as any software useable by patients or providers to create, maintain, access, or exchange health information

Explicitly exclude from scope products that meet definition of medical device, hence fall under existing regulatory framework

Scope Options Considered

USER TYPE FOCUS: Create a scope based on user type

FUNCTIONALITY/INTENDED USE FOCUS: Create a scope where scope driven by Health IT’s functionality and intended use

RISK-HARM FOCUS: Create a scope based on potential for injury or harm with failures, malfunctions, foreseeable misuse

Organizing Principles 4

Organizing Principles

Platform agnostic— e.g., Scope is not defined by

‘Wireless’/wired Mobile/fixed Installed versus Software as a Service (SaaS)

Avoid creating list of specific examples— Attempt to define generically— For product categories – focus on

functions/intended use

Organizing Principles

Part-Whole:— If ‘component’ or part is in-scope, the

whole is in scope

Scope Dimensions Considered

Product Categories ﹣ …

User Type﹣ …

Phases of product lifecycle﹣ …

Developer/ ‘Manufacturer’ Type﹣ …

Distribution Model﹣ …

Conditions of use﹣ …

Scoping 5

User Types

Health Care Providers – institutional and individual

Clinical Researchers using on human subjects

Patients under care by a provider

General public user/consumer under own use/health management

In Scope Potentially Out of Scope

Product Lifecycle

Design phase: use of risk-mitigating design controls, standards, requirements, documentation, labeling

Implementation-Installation: Configuration mgmt, interfacing with other systems, interoperability as systems-of-systems

In Scope Potentially Out of Scope

Product Lifecycle

Design phase Implementation-

Installation Maintenance: Routine

updates/upgrades, performance tuning, defect and safety-related corrective, enhancements and Δ to base functionality

In Scope Potentially Out of Scope

Product Lifecycle

Design phase Implementation-

Installation Maintenance Recall: Managing entire

install base (vs. index customer), maintaining configuration log

In Scope Potentially Out of Scope

Product Lifecycle

Design phase Implementation-

Installation Maintenance Recall End-of-Life Support:

De-installation of out-dated or non-conforming product (vis-à-vis contemporary standards)

In Scope Potentially Out of Scope

Product Lifecycle

Design phase Implementation-

Installation Maintenance Recall End-of-Life Support Cybersecurity: Control

of PHI, assuring protection against malware-based risks

In Scope Potentially Out of Scope

Product Lifecycle

Design phase Implementation-

Installation Maintenance Recall End-of-Life Support Cybersecurity

Methods and modes of end-user training

In Scope Potentially Out of Scope

Developer/ ‘Manufacturer’ Types

Entity who develops/markets/licenses/distributes products with commercial interest

Healthcare provider* who develops products de novo for use on patients, even if no direct or indirect commercial interest

Healthcare provider* who modifies functionality of previously licensed, ‘finished’ products

In Scope Potentially Out of Scope

*institutional or individual provider

Developer/ ‘Manufacturer’ Types

Independent entity who develops/ advertises/distributes via public channel products intended for general public users, even if no commercial interest

In Scope Potentially Out of Scope

Developer/ ‘Manufacturer’ Types

Entity who develops/markets/licenses/distributes products with commercial interest

Healthcare provider* who develops products de novo for use on patients, even if no direct or indirect commercial interest

Healthcare provider* who modifies functionality of previously licensed, ‘finished’ products

Independent entity who develops/ advertises/distributes via public channel products intended for general public users, even if no commercial interest

Individuals who develop for personal private use

Individual who develops/distributes via private channel to limited individuals without commercial interest

Independent non-commercial developers who advertise/distribute via public channel products intended for general public users

In Scope Potentially Out of Scope

*institutional or individual provider

Distribution Model

Marketed-licensed-distributed-sold in a restricted manner, with credentialing requirements

Marketed-licensed-distributed-sold in a restricted manner, without credentialing requirements

Made available for download via an unrestricted public channel, with or without credentialing requirements

Available under a SaaS model

In Scope Potentially Out of Scope

General Conditions of Use

Intended use Foreseeable misuse

Non-foreseeable, willful misuse

Use clearly beyond labeled intended use

In Scope Potentially Out of Scope

General Conditions of Use

By prescription, recommendation or under direction of licensed/credentialed healthcare provider

Independently by general public consumer/user

For management of defined illness or chronic condition

? For health maintenance or fitness

In Scope Potentially Out of Scope

Specific Product Types - Categories

In Scope Potentially Out of Scope

Decision Tree ApproachFunctionality – Intended Use – Potential for Harm

Diagram

Does product currently meet FDA (Act 21 CFR)

definition of Medical Device (including MDDS)

?

NO

YES

Out-of-scope … defer to existing regulatory framework

Potentially in-scope

Diagram 2

Does malfunction, foreseeable misuse have potential to cause patient injury, via:• Delay or failure to present clinical data/ information at time of need• Presentation of outdated information• Patient-data mismatch ?

YES

NO

Potentially in-scope

Potentially out-of-scope

Diagram 3

Is the data/information that is managed by system the sole or 1o source of data at point of care (i.e., no alternate sources of data /info that can be used for confirmation) ?

YES

NO

Potentially in-scope

Potentially out-of-scope

Diagram 4

Through design and intended use, is patient or provider reliant on data/information to initiate or modify prescribed intervention or tx ?

YES

NO

Potentially in-scope

Potentially out-of-scope

Diagram 5

Through design and intended use, is patient or provider reliant on alerting or function about a change in clinical status and/or a need to initiate or modify tx ?

YES

NO

Potentially out-of-scope

Potentially in-scope

Products Types - Categories

Claims processing Health benefit eligibility Practice management / Scheduling

/ Inventory management Healthcare provider

communication tools (e.g., email, paging)

Population management tools Software using historical claims

data to predict future utilization/cost of care

Cost effectiveness analytic software

In Scope Out of Scope

Products Types - Categories

Diseases severity scoring algorithms

Electronic guideline distribution

Disease registries

In Scope Out of Scope

Products Types - Categories

EHRs (installed, SaaS) Hospital Information

Systems-of-systems Decision support algorithms Visualization tools for

anatomic, tissue images, medical imaging and waveforms

? Health Information Exchanges

Electronic/robotic patient care assistants

Claims processing Health benefit eligibility Practice management / Scheduling /

Inventory management Healthcare provider communication

tools (e.g., email, paging) Population management tools Software using historical claims data

to predict future utilization/cost of care

Cost effectiveness analytic software Diseases severity scoring algorithms Electronic guideline distribution Disease registries

In Scope Out of Scope

Strive to:— develop a framework that is able to

meet future undefined needs— avoid a discrete, static and specific

defined list of named products Favor the decision tree approach that emphasizes functionality as a primary scoping criterion

Words of Caution

Questions and Discussion