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Regulatory weaknesses

Regulatory weaknesses. A report of the typist for the Regulation Subgroup (i.e. no one has seen or approved this) Draft 07/02/13. Process over the next week. Discussion of the Regulations Subgroup over the next week:

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Regulatory weaknesses

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  1. Regulatory weaknesses A report of the typist for the Regulation Subgroup (i.e. no one has seen or approved this) Draft 07/02/13

  2. Process over the next week Discussion of the Regulations Subgroup over the next week: • Are the three regulatory systems – ONC, FCC and FDA – deficient in any way with regard to how HIT is regulated? (July 1, except reporting which will be on July 3) • 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? (July 3) • Do any of the three regulatory systems duplicate one another, or any other legal, regulatory or industry requirement? (July 3) • Is there a better way to assure that innovation is permitted to bloom, while safety is assured? (July 8)

  3. FDA issues where attention needed A = Ambiguous and B = Broken at the written law level

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

  5. FDA Program Administration • Apart from those regulatory issues, the subgroup has also identified an issue with how the agency administers the law. There is presently a weakness in the agency coordination of policymaking with regard to HIT software, and especially including mobile medical apps. This weakness includes: • inconsistencies in information shared with individual companies, and • unclear guidance more generally, including the lack of a final guidance on mobile medical apps.

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

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

  8. Bigger Picture Whether collectively the regulatory scheme in totality: • Fails to address some particular safety risk • Is too costly in relation to the risks it is designed to reduce • Is demonstrably too burdensome on innovation, apart from imposing costs We agreed not to get into politics or philosophy but instead stick to evidence driven policy.

  9. Cross agency issues where attention needed

  10. Next step Monday call will address the biggest of the pictures.

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