1 / 11

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 ?

cassie
Download Presentation

Report of the Regulations Subgroup

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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

More Related