Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in MobiHealthNews, in “Roundup: 12 Healthcare Algorithms Cleared by the FDA,” by Dave Muoio.
Following is an excerpt:
Every day sees strides across the field of artificial intelligence, and healthcare is just one of the many industries looking to smart automation as a means to reduce burden and improve results. The last year in particular has brought a wealth of new healthcare focused software tools to the forefront, and as such has ignited debate on how these algorithms are being reviewed and regulated by the FDA.
“FDA is lagging in the production of guidance to explain its approach for these newer products. This is a problem, because Commissioner Gottlieb himself in a blog post noted well over a year ago that individual decision-making by FDA is not enough for digital therapeutics to thrive,” Bradley Merrill Thompson, a lawyer at Epstein Becker & Green who also leads CDS Coalition, an industry group, wrote in an email on the subject.
“Industry has been asking since 2015 for better guidance on the use of software-based algorithms in connection with drug administration. The commissioner, starting in April 2018, has been promising new guidance focused on the use of software with drugs, and in fact reiterated that promise only a couple weeks ago. But the concern is that the new guidance may not be focused on the issues of greatest concern to industry. We shall have to wait to see.”
Thompson also noted that while the agency is relying on its 510(k) regulatory pathways in the meantime, the heterogeneity of these nontraditional tools has resulted in an ever-growing number of De Novo clearances and device classifications. Below, MobiHealthNews has collection of 12 algorithm clearances — five De Novo, seven 510(k) — spanning the breadth of digital health.
