By Bradley Merrill Thompson, Partner, Epstein Becker & Green, P.C.

“Under the Federal, Food, Drug, and Cosmetic Act, HIT software is a medical device.” That’s according to Dr. Jeff Shuren, the new director of the Device Center within FDA. Yikes. Dr. Shuren testified yesterday at a hearing of the HIT Policy Committee, Adoption/Certification Workgroup. The workgroup invited numerous speakers from different sectors to discuss the safety of HIT, and possible regulatory approaches.

Dr. Shuren's conclusion portends a new and perhaps more demanding regulatory environment for mHealth. Over the last several months, I've written a series of articles in MobilHealthNews to outline FDA requirements that might apply, depending on the circumstances, to the hardware and software used in mHealth. Notice how I qualified that. I’ve suggested that manufacturers should be aware of certain nuances in FDA law related to intended use claims and other limits on the scope of FDA regulation.

But in his written statement, Dr. Shuren did not equivocate. He did not limit his conclusions, for example, depending on the specific intended uses for the HIT. He just swept it all into FDA regulation and moved on. I don't know whether Dr. Shuren and I would truly disagree on the scope of FDA regulation if we discussed it, but he seems to want to move quickly past that to talking about how FDA should regulate this area.

On the eve of the hearing, Sen. Grassley, the ranking Republican on the powerful Senate Finance Committee, sent out letters revealing his interest in FDA regulating HIT. The events of this week are significant enough that I want to depart from the planned schedule of articles to discuss what happened, and its implications for mHealth.

What happened?

At the hearing yesterday, after expressing his view that HIT software is a medical device, Dr. Shuren observed FDA has "largely refrained from enforcing our regulatory requirements with respect to HIT devices." That, Dr. Shuren suggests, is about to change. In explaining the change of heart, he revealed FDA has received 260 voluntary reports of HIT-related malfunctions with the potential for patient harm. Of those reports, 44 included injuries and six even reported deaths. In a table attached to his written testimony, he provided de-identified examples of these reports, several of which involved one patient's data being substituted for another's. Since FDA at this juncture only relies on voluntary reports, Dr. Shuren asserted this might be the tip of an iceberg.