This past July, the FDA issued a draft guidance on how it might regulate certain medical apps. The legal implications of the proposed guidelines is the subject of the most recent entry in the HIMSS/AMDIS Physician Community Podcast Series, hosted by Dr. Marlowe Schaeffer-Polk, an attorney, physician and co-founder of Medlawguard, and Mr. John Steinbach, Chief Technology Officer and co-founder of Medlawguard.
The discussion covers a lot of the background to mobile medical app regulations that we’ve reported on in the past few years, but it serves as a helpful review for those looking for a quick refresher.
“Law is like paper. It’s very static…restrictive, finite. Technology is very dynamic, innovative, and interoperable,” Schaeffer-Polk said during the podcast, noting that those differences cause friction when intersecting in the healthcare field. The FDA was created in the early 20th century, Schaeffer-Polk said, to create very rigid legal guidelines for medical practice that are slow to adapt to rapidly changing tech.
“In order for it to be regulated under the law, that product must meet the statutory definition of a medical device, and only then does it become subject to FDA regulation,” Schaeffer-Polk said.
Why is it so important to be called a medical device? In the draft guidance, the FDA defined a mobile medical app as one that meets the definition of “device” according to the FD&C Act, and for this set of draft regulation it also must be “used as an accessory to a regulated medical device” or it must “transform a mobile platform into a regulated medical device.”
Schaeffer-Polk notes that from a legal standpoint, the word “intended” is worthy of close scrutiny. “A scale that you step on to get your weight can either be a medical device or not a medical device, depending upon its intended use,” she said. A scale used to simply track weight is not a medical device, but a scale that wirelessly transmits the weight of someone with chronic heart failure, for example, could be reviewed by a physician and considered a medical device.
You can access the podcast and hear the entire discussion here.