FDASIA Regulations Subcommittee - PowerPoint Presentation

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FDASIA Regulations Subcommittee

May 22, 2013Slide2

Agenda

4:00 p.m. Call to Order

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MacKenzie Robertson Office of the National Coordinator for Health Information Technology4:05 p.m. Opening Remarks – Brad Thompson and Julian Goldman, Co-Chairs 4:10 p.m. Discussion - Background on the task before the subgroup - Staying coordinated with the other two subgroups - Work already done by other organizations - Getting started on the questions presented5:25 p.m. Public Comment5:30 p.m. Closing Remarks; Adjourn

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Background

The committee is charged with

identifying the following:

Current areas of regulatory duplication, ambiguity, or oversight confusion.Current areas of regulatory success and “best practices.”Regulatory gaps in relation to identified patient safety and innovation needs. Relative strengths and weaknesses of our current regulatory structure as it relates to health it and patient safety.Strategies to improve efficiency and avoid duplicative regulatory processes.Non-regulatory activities (existing or potential) that should be considered.Is there anything else we ought to be considering?3Slide4

Which laws and regulations are relevant?

Three primary areas:

FCC

FDAONC4Slide5

Which laws and regulations are relevant?

But when it comes to considering issues of duplication, we have a wider focus:

HIPAA—privacy and security

Federal Trade CommissionPrivate standards and certification organizationsLaws governing marketing of regulated articles to HCPsTransparency requirements in relationships with HCPsState consumer lawsState regulation of medical devicesState product liabilityState boards of medicine and pharmacy5Slide6

In each regulatory area, we will focus on:

Scope questions.

What

gets regulated, and What falls within scope but isn’t actively regulatedTo what degree is it regulated?For example, FDA has three classificationsLifecycle regulationWhat are the requirementsPremarketManufacturingPromotionPost Market ReportingRemediation

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Strawman Patient safety risk assessment framework

From the subcommittee call on Monday, May 20

Now Outdated

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STRAWMAN Dimensions of Patient-Safety Risks

Purpose-user

Intended purpose of software

Intended userCharacterizing patient-harm riskMagnitude of riskLikelihood of risk situation arisingAbility to mitigate riskComplexity of development, implementation, usePost-marketing changesCustomizability of softwareIntegration with other system componentsWireless connectivity8Slide9

STRAWMAN Framework forAssessing Risk of Harm

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Strawman innovation risk assessment framework

Also outdated

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Innovation Risk Assessment Framework (examples)

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Input needed from taxonomy

subcommittee

To

get to a meaningful level, we will have to determine whether such areas as the following are within scope:UDICPOEMDDSMobile apps that act as accessories to medical devices (e.g. companion software for blood glucose meter)Mobile apps that transform a cell phone into a medical device (e.g. electronic stethoscope)CDSEHR Hospital IT networks of interoperable medical devicesWhat else?

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We stand on whose shoulders?

Report

of the Bipartisan Policy Center: An Oversight Framework for Assuring Patient Safety in Health Information Technology (2013)

A Call for Clarity: Open Questions on the Scope of FDA Regulation of mHealth: A whitepaper prepared by the mHealth Regulatory Coalition (2010), and subsequent policy papers, including mhealth use casesCDS Coalition analysis of the factors that cause a user to be substantially dependent on software (2013)Institute of Medicine (IOM) Report “Health IT and Patient Safety: Building Safer Systems for Better Care”S. Hoffman, “Finding a Cure: The Case for Regulation and Oversight of Electronic Health Record Systems,” 22 Harvard Journal of Law & Technology 103 (2008).13Slide14

We stand on whose shoulders?

A.

Krouse

, “iPads, iPhones, Androids, and Smartphones: FDA Regulation of Mobile Phone Applications as Medical Devices,” 9 Indiana Health Law Review, 731 (2012)Proceedings of joint meeting of FDA, Center for Integration of Medicine and Innovative Technology and the Continua Health Alliance, on Medical Device Interoperability: Achieving Safety And Effectiveness 2010Comments submitted to the International Medical Device Regulators Forum (IMDRF) on the Standalone Software Work Item by groups such as the mHealth Regulatory Coalition -- European Union working group.What else?

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Discussion questions

Identifying non-regulatory activities (existing or potential) that should be considered?

Identifying current areas of regulatory success and “best practices.” These are things we want to preserve or even expand.

Identifying relative strengths and weaknesses of our current regulatory structure as it relates to Health IT and patient safety.15Slide16

Public Comment

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