Postmarket Responsibilities for Medical AI: Part II — What Industry Should Do in Commercializing Medical AI

Towards Data Science

Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, authored “What Industry Should Do in Commercializing Medical AI,” part two of the three-part series, “Post-Market Responsibilities for Medical AI” in Towards Data Science.

Following is an excerpt:

In Part I of this series of articles, I described the tension that exists between FDA and industry with regard to the appropriate level of FDA oversight of medical AI. I explained that it presently seems likely that FDA will ask Congress for more postmarket authority so that it can oversee the commercialization of medical AI in a much deeper way, despite the fact that FDA already has substantial authority.

In this, Part II, I propose an alternative. I propose that industry adopt best practices to assure that patients are getting the best possible care, self-regulating as it were. In Part III, I will make the case for limiting the FDA’s oversight to its existing statutory authority.

There are four areas where industry should actively take measures during the commercialization phase to assure the safety and effectiveness of its AI-based medical devices. …

  1. Pursue Enhanced Postmarket Vigilance
  2. Share information with users
  3. Report to FDA Problems That Meet the Legal Reportability Test
  4. Permit FDA to Inspect the Company’s Data and Records

Related reading:

“Part I – FDA’s Plan to Increase Its Oversight,” by Bradley Merrill Thompson.

“Part III — FDA Should Not Expand Its Oversight of Commercialized AI,” by Bradley Merrill Thompson.