fdasia taxonomy subgroup
DESCRIPTION
FDASIA Taxonomy Subgroup. HIT Policy Committee FDASIA Workgroup Virtual Meeting 14 June 2013. Follow-on Activities. Reviewed/consolidated feedback and discussion points from on-site meeting Reviewed additional materials forwarded to subgroup: - PowerPoint PPT PresentationTRANSCRIPT
FDASIA Taxonomy SubgroupHIT Policy Committee FDASIA Workgroup Virtual Meeting14 June 2013
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Follow-on Activities
Reviewed/consolidated feedback and discussion points from on-site meeting
Reviewed additional materials forwarded to subgroup:— Bipartisan Policy Center Health Innovation Initiative,
Draft/Work-in-Progress: “Defining and Characterizing Risk of Health Information Technology”
Teleconference with additional group-level discussion, consensus building
Scope Dimensions
User Type﹣ …
Phases of product lifecycle﹣ …
Developer/ ‘Manufacturer’ Type﹣ …
Distribution Model﹣ …
Conditions of use﹣ …
Intended use﹣ …
Product Categories ﹣ …
New as of 31 May 2013
Miscellaneous- …
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
No Change From 31 May 2013
Product Lifecycle
Design phase Implementation-
Installation Maintenance Availability-Downtime
Hazard Recall End-of-Life Support Cybersecurity
In Scope Potentially Out of Scope
New as of 31 May 2013
Product Lifecycle
Design phase Implementation-
Installation Maintenance Availability-Downtime
Hazard Recall End-of-Life Support Cybersecurity
Methods and modes of end-user training
In Scope Potentially Out of Scope
Consensus
Miscellaneous
Regulation around Privacy (HIPAA)
In Scope Potentially Out of Scope
New as of 31 May 2013
Developer/ ‘Manufacturer’ Types Entity who
develops/markets/licenses/distributes products with commercial interest
Entity who develops/ advertises/distributes via public channel products intended for general public users, even if no 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
Individual who develops for personal private use
Individual who develops/distributes via private channel to limited individuals without commercial interest
In Scope Potentially Out of Scope
*institutional or individual provider
Clarification and refinement
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
No Change From 31 May 2013
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 research purposes on human subjects
? For health maintenance or fitness
In Scope Potentially Out of Scope
New as of 31 May 2013
General Conditions of Use
Intended use Foreseeable misuse
Non-foreseeable, willful misuse
Use clearly beyond labeled intended use
In Scope Potentially Out of Scope
No Change From 31 May 2013
Specific Product Types - Categories
In Scope Potentially Out of Scope
Decision Tree ApproachIntended Use - Functionality – Potential for Harm
Diagram
Is use intended to inform or change decision making about:
- initiating - discontinuing - modifying
care interventions or personal health management ?
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 2
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 2
Through design and intended use, is patient or provider reliant on data/information to initiate or modify prescribed intervention or treatment ?
YES
NO
Potentially in-scope
Potentially out-of-scope
Examples of Scoping Using Decision Tree Approach
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
Examples of Scoping Using Decision Tree Approach
Diseases severity scoring algorithms
Electronic guideline distribution
Disease registries
In Scope Out of Scope
Examples of Scoping Using Decision Tree Approach
EHRs (installed, SaaS) Hospital Information Systems-
of-systems Decision support algorithms Visualization tools for
anatomic, tissue images, medical imaging and waveforms
Health Information Exchanges— advanced functionality
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
Diagram
Does product currently meet FDA (Act 21 CFR)
definition of Medical Device (including MDDS)
?
NO
YES
Potentially in-scope
Potentially in-scope
Possible revisions or re-engineering of risk assessment and regulatory framework around certain products — Currently explicitly regulated by FDA— Meet definition but through
enforcement discretion, regulatory framework is not actively enforced
Explicitly Enter Into ScopeFor Deliberation and Discussion
Examples:— Software only products— Archiving systems— MDDS— Calculators
Explicitly Enter Into ScopeFor Deliberation and Discussion
Rationale:— Boundaries very blurred— In some cases, nearly identical
functionality and risk profile for explicitly regulated and non-regulated/non-enforced products
— Examples: PACS
Explicitly Enter Into ScopeFor Deliberation and Discussion
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
Final Conclusions
Be cautious of wide-spectrum use cases that span a risk-spectrum within a single functionality— E.g. prescribing or alerting functions, but are
used on both negligible-risk and high-risk medications/drugs
Consider that any products that relies on patient lookup/patient data retrieval/data-patient matching should be evaluated for risks of patient-data mismatch
Final Conclusions
In preparation:— Matrix and formal decision tree tool
Final one-page summary of taxonomy, process and rationale
Final Conclusions
Questions and Discussion