Today the FDA announced the issuance of the final guidance on mobile health apps. You can find a PDF of the full mobile medical app guidelines here. The guidance won’t come as a surprise to those of us familiar with the industry. The guidance is basically what we expected the FDA to do with mobile health applications. The FDA plans to only offer regulatory oversight to those mobile medical apps which they define as a medical device. Here’s how they describe it in their press release:
The agency intends to exercise enforcement discretion (meaning it will not enforce requirements under the Federal Drug & Cosmetic Act) for the majority of mobile apps as they pose minimal risk to consumers. The FDA intends to focus its regulatory oversight on a subset of mobile medical apps that present a greater risk to patients if they do not work as intended.
Mobile apps have the potential to transform health care by allowing doctors to diagnose patients with potentially life-threatening conditions outside of traditional health care settings, help consumers manage their own health and wellness, and also gain access to useful information whenever and wherever they need it.
Mobile medical apps currently on the market can, for example, diagnose abnormal heart rhythms, transform smart phones into a mobile ultrasound device, or function as the “central command” for a glucose meter used by a person with insulin-dependent diabetes.
“Some mobile apps carry minimal risks to consumer or patients, but others can carry significant risks if they do not operate correctly. The FDA’s tailored policy protects patients while encouraging innovation,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health.
They further went on to explain that the FDA will focus its oversight on mobile health apps that:
- are intended to be used as an accessory to a regulated medical device – for example, an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet; or
- transform a mobile platform into a regulated medical device – for example, an application that turns a smartphone into an electrocardiography (ECG) machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack.
Here’s the overarching premise of the FDA’s approach to mobile health app regulation, “We have worked hard to strike the right balance, reviewing only the mobile apps that have the potential to harm consumers if they do not function properly,” said Shuren. “Our mobile medical app policy provides app developers with the clarity needed to support the continued development of these important products.”
The last comment is what so many mobile health application developers have wanted. Hopefully this guidance will give them that assurance and clarity. Although, it’s a bit annoying when the final guidance document says “Contains Nonbinding Recommendations” at the top of every page. Legalese aside, I believe this document will provide the foundation for the FDA’s mobile health efforts going forward.