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Report of the Regulations Subgroup

Report of the Regulations Subgroup. Draft, not final or approved 07/19/13. Questions considered. Are the three regulatory systems – ONC, FCC and FDA – deficient in any way with regard to how HIT is regulated ?

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Report of the Regulations Subgroup

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  1. Report of the Regulations Subgroup Draft, not final or approved 07/19/13

  2. Questions considered • Are the three regulatory systems – ONC, FCC and FDA – deficient in any way with regard to how HIT is regulated? • Are there ambiguities in the three regulatory systems that need to be clarified so that HIT vendors and others can proceed more easily to innovate? • Do any of the three regulatory systems duplicate one another, or any other legal, regulatory or industry requirement? • Is there a better way to assure that innovation is permitted to bloom, while safety is assured?

  3. FDA issues A = Ambiguous, B = Broken at the written law level, C = Existing mechanism for immediate relief

  4. FDA issues A = Ambiguous, B = Broken at the written law level, C = Existing mechanism for immediate relief

  5. Current FDA Program Mechanisms that Could Enable Innovation • FDA should actively establish a policy of “Enforcement Discretion” for lowest-risk HIT, where enforcement of regulations is inappropriate • FDA should assess exemption from GMP for lower-riskHIT • FDA should expedite guidance on HIT software, mobile medical apps and related matters • FDA lacks internal coordination on HIT software, and mobile medical apps policies and regulatory treatment • FDA should utilize external facing resources to proactively educate the public about how policies and regulation impact HIT and MMA • There may exist a need for additional funding to appropriately staff and build FDA expertise in HIT and mobile medical apps

  6. ONC issues A = Ambiguous, B = Broken at the written law level, C= Capability that is underused

  7. FCC issues A = Ambiguous and B = Broken at the written law level

  8. Cross agency issues *See interoperability FDA Pre-IDE regulatory research project: http://www.mdpnp.org/MD_PnP_Program___MDISWG.html

  9. Improvements to adverse event reporting A = Ambiguous and B = Broken at the written law level *See http://www.mdpnp.org/uploads/HITSA_draft_Goldman_2011.pdf

  10. Big picture improvements • FDA Classification • Take the taxonomy workgroup report and classify all of it as unregulated (enforcement discretion) by FDA (Class 0) except as follows: • MDDS • Medical device accessories (to be defined clearly by FDA) • Certain forms of high risk CDS (to be defined clearly by FDA) • Higher risk software use cases per the Safety WG report, including those where the intended use makes the software risky • For the regulated software, it will be important for FDA to improve the regulatory system as outlined on slides 3-5. • This classification would be provisional, to be re-examined in 3-5 years to consider • The enhanced data collected under changes made pursuant to slide 9 • The development of active private sector initiatives in slide 11

  11. Big picture improvements • In lieu of FDA regulation for HIT as delineated in the slide before, we recommend that FDA/ONC/FCC use their collective powers of persuasion to encourage and organize private sector oversight including, • Creation and adoption of needed standards • Private certification of interoperable products to be used in networks • A public process for customer rating HIT • Local responsibility for oversight of end user modifications

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