Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled "Not Much New in FDASIA Report, Congress Still Champing at the Bit."
Following is an excerpt:
The FDA, along with the FCC and ONC has finally released the report to Congress required by the FDA Safety and Innovation Act (FDASIA) of 2012. This FDASIA report, called "Proposed Strategy and Recommendations for a Risk-Based Framework," reiterates previously articulated FDA positions on regulatory discretion and avoiding regulatory redundancy between the FDA, ONC, and FDA. It's based on the work done by the FDASIA work group that began meeting nearly a year ago. ...
"The draft federal legislation removes from FDA oversight some very high risk clinical decision support software such as an app that a consumer might use to self diagnose melanoma," Bradley Merrill Thompson, an FDA medical device regulation expert and lawyer with EpsteinBecker, told MobiHealthNews in an email. "The FDA approach, on the other hand, is much more nuanced where they are proposing to develop a detailed guidance document that would give much more refined explanations for which CDS the agency regulates and which they do not. ... The current draft of the federal legislation is very sweeping in its regulatory scope, whereas the FDA plans to use a scalpel to carefully define what gets regulated." ...
For all of the public squabbling, Thompson thinks the report shows more agreement than disagreement about what's needed in mobile health regulation.
"I think it shows that people in industry, on Capitol Hill, and in the agencies are largely in agreement," he said in an email. "Indeed, it seems that all three sectors are saying about 90 percent the same things. The bottom line is that HHS, and the three agencies, are proposing a very light touch to overseeing innovation in health IT, and that has to be good news for all of the HIT developers producing wonderful, important, cutting-edge new technologies."
