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Needed Regulatory Changes

Needed Regulatory Changes. A report of the typist for the Regulation Subgroup (i.e. no one has approved this) Draft 07/11/13. 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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Needed Regulatory Changes

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  1. Needed Regulatory Changes A report of the typist for the Regulation Subgroup (i.e. no one has approved this) Draft 07/11/13

  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 and B = Broken at the written law level

  4. FDA issues A = Ambiguous and B = Broken at the written law level

  5. FDA Program Administration • FDA lacks internal coordination of policy on HIT software, and mobile medical apps • Inconsistent regulatory treatment and information dissemination by FDA officials, reviewers and staff to public inquiries about HIT, mobile medical apps • FDA should coordinate internal understanding of policy positions and regulations to maximize consistency and help eliminate ambiguity and misinformation • FDA should utilize external facing resources to proactively educate the public about how policies and regulation impact HIT • CDRH Learn, Device Advice, DSMICA should be used more effectively • FDA lacks policy and guidance on HIT software, mobile medical apps • Lack of informational policy material or timely guidance documents on HIT • Lack of final guidance on 2011 Mobile Medical Apps • Lack of updated guidance on issues that affect HIT: 2007 Draft RF Wireless Tech, 1997 Deciding When to Submit Change (510(K) Modification) • FDA should actively establish policy of “Enforcement Discretion” for lowest-risk HIT, where enforcement of regulations is inappropriate • Enforcement Discretion is deregulatory and immediate • Enforcement Discretion would quickly provide transparency and eliminate regulatory ambiguity and industry fear • FDA should assess exemption from GMP for lower-risk HIT

  6. ONC issues A = Ambiguous and B = Broken at the written law level

  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

  10. Big picture improvements • Classification--FDA should classify in clear terms any HIT software that qualifies as a medical device • Take the taxonomy workgroup report and classify all of it as unregulated (enforcement discretion) by FDA (Class 0) except for certain carve outs, 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 • This classification would be provisional, to be re-examined in 3-5 years to consider • The enhanced data collected under changes made pursuant to the slide before • The development of active private sector initiative in the slide that follows

  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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