Post on 16-Jan-2016
description
FDASIA Taxonomy Subgroup
HIT Policy Committee
FDASIA Workgroup On Site Meeting
30 May 2013
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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﹣ …
Developer/ ‘Manufacturer’ Type﹣ …
Phases of product lifecycle﹣ …
Conditions of use﹣ …
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 base functionality, customers who
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 standards non-conforming product
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 (institutional or individual provider) who develops products de novo for use on patients, even if no direct or indirect commercial interest
Healthcare provider (institutional or individual provider) who modifies functionality of previously licensed, ‘finished’ products
In Scope Potentially Out of Scope
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 (institutional or individual provider) who develops products de novo for use on patients, even if no direct or indirect commercial interest
Healthcare provider (institutional or individual 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
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
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
Questions and Discussion
To meet future undefined needs, avoid the list, and favor the decision tree approach
Words of Caution