Hospitals are not exempt from FDA app regulation, legal experts warn

Hospital CIOs need to be careful about the apps they're creating, FDA experts warn.

Brad Thompson, an FDA attorney with EpsteinBeckerGreen in Washington, D.C., was emphatic in comments at the World Congress Leadership Summit on mHealth in Boston this morning: Healthcare providers who create health apps can be considered mobile medical app manufacturers just like software firms, development companies and other firms, under the new FDA guidance released last week.

A few other questions Thompson laid to rest:

What if the hospital doesn't plan to sell the app?

Thompson's response: It doesn't matter. Whether it's given away free, or sold on the wider consumer market, the FDA is regulating the risk to patients, not the sales mechanism. Even hospitals that create internal apps for use only by their own staff will still have to satisfy the FDA regulatory process, if their apps qualify as mobile medical apps.

What if the hospital contracts out for the app, and hospital IT staff doesn't write the actual code?

Thompson: It doesn't matter. The new FDA guidance indicates that if the hospital specifies what the app is supposed to do, called a "specification developer," then it is considered a manufacturer, also.

Does it matter if the app accepts information directly from a connected medical device, or if the data is inputted by the patient separately?

Thompson: No. Connecting accessories to medical devices is a key component of the new FDA guidance; and it's something that may make many smartphone apps into regulated medical apps. 

That's not the only way, though, that a smartphone can become a regulated device, Thompson points out. A smartphone also is considered mobile medical device if it provides any kind of clinical decision-support. Smartphones that allow patients to input their own data, like glucose readings, and then perform analysis on that data are providing clinical decision support, he says. And in that way, they end up as potentially regulated devices, despite the lack of a physical link to a medical device.

Healthcare providers may have an advantage in getting their apps through the FDA's regulatory process, however, says Robert Havasy, an IT analyst with Partners HealthCare System's Center for Connected Health in Boston. Given that the FDA's primary concern with apps is their risk to patient health, an app created by a physician, hospital or group of healthcare researchers "may be viewed differently than an app created by a couple of developers in their garage," he says. 

The best way to keep a hospital-created app from being regulated by the FDA is to reduce the perceived risk it poses to patients, Thompson says. Regulators aren't swayed by how valuable an app is, or how innovative, simply how safe.