What if the solution to the mHealth/digital health logjam of approvals at the US Food and Drug Administration (FDA) is to take clinical and health software completely out of their approval purview–and hand it to the National Institute of Standards and Technology (NIST), which is not a regulatory body but a standards-development organization. That is the solution proposed by the PROTECT Act of 2014 (Preventing Regulatory Overreach to Enhance Care Technology), proposed by Senators Angus King (I-Maine) and Deb Fischer (R-Nebraska). It’s put some of the better known organizations into a swivet, along with high profile attorney and mHealth legal expert Bradley Merrill Thompson with Epstein, Becker & Green. Possibly little to no regulation would be applied to EMRs, clinical support software and wearables/fitness apps–which is promptly being conflated by the usual suspects to heavy-duty equipment such as CT scanners. FDA also finalized its guidance last September on telehealth and telemedicine applications, which this would render irrelevant. The Washington betting is that this Senate bill will go exactly nowhere, but it’s indicative of the jockeying for position this Editor is seeing within the present government and now with advocates/lobbyists [TTA 13 Feb]. MedCityNews, FierceMobileHealthcare
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Donna:
EMRs have never been regulated by the FDA. Medical books have never been regulated and the conversion of those books into Apps should not be regulated. However, users of those Apps should make sure the formulas are accurate. Clinical Decision Support software has been regulated and restricted to physicians. Cardiac arrhythmia software has been regulated and Apps/devices incorporating that technology should be. What this all means is that well-meaning legislation that hopes to stimulate innovation could well create real danger due to the complexity of the problem. Consumer- focused smartphone apps which purport to diagnose skin cancer are nothing but dangerous. The FDA is a bureaucracy and needs oversight so they don’t over-reach like with their original draft guidance. Dumb legislation is not the answer.