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Regulatory weaknesses. A report of the typist for the Regulation Subgroup (i.e. no one has seen or approved this) Draft 07/01/13. Coordination. This is the point at which we need to truly start integrating the work products of the subgroups .
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Regulatory weaknesses A report of the typist for the Regulation Subgroup (i.e. no one has seen or approved this) Draft 07/01/13
Coordination • This is the point at which we need to truly start integrating the work products of the subgroups. • We need to look at the safety issues and assess whether they are addressed • We need to consider the elements of innovation that need to be protected and describe regulatory features that protect them • This is also the point at which we need to make sure we do not duplicate each other’s work.
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)
Started by • Examining the work of the Safety & Innovations Subgroup • Safety grid • Innovation features • Held 5 sessions on— • FDA regulation • ONC regulation • FCC regulation • Other federal and state regulation and private efforts
Questions considered on July 1 For FDA, FCC and ONC, identify regulatory requirements that: • Are broader or more onerous than need to be to assure the safety of HIT • Fail to be risk-based, for example by either failing to utilizing available mitigation or failing to identify appropriate risk aggravating circumstances. • Are insufficient in some specific way to assure the safety of HIT • Unnecessarily interfere with some specific needed feature of innovation • Miss or omit a sensible opportunity to promote innovation
FDA issues where attention needed A = Ambiguous and B = Broken at the written law level
FDA issues where attention needed A = Ambiguous and B = Broken at the written law level
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.
ONC issues where attention needed A = Ambiguous and B = Broken at the written law level
FCC issues where attention needed A = Ambiguous and B = Broken at the written law level
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.
Gaps where attention needed A = Ambiguous and B = Broken at the written law level
Next step Wednesday call will be a deep dive into reporting and the prioritization of the ambiguities that need clarification
