FDA makes clear it won’t regulate apps like Apple’s HealthKit

By: Brian Dolan | Jun 16, 2014        

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Brian Dolan, Editor, MobiHealthNewsAs MobiHealthNews noted last week in the introduction to our In-Depth report on Apple’s Health app feature set, the FDA made a rare move on Wednesday by adding a new description for a type of mobile medical app that it would not regulate as a medical device. The FDA has actually added a total of four such new descriptions to its list in 2014.

It just so happened that the latest app description to make it on the list is a fairly close match to what Apple’s Health app is.

Here’s the app description the FDA added last week: “Mobile apps that allows a user to collect, log, track and trend data such as blood glucose, blood pressure, heart rate, weight or other data from a device to eventually share with a heath care provider, or upload it to an online (cloud) database, personal or electronic health record. [Added June 11, 2014].”

In mid-March the FDA also quietly added three other descriptions for apps that it said it would not regulate for provider-facing immunization record keeping apps, drug-to-drug interaction apps for providers, and provider-facing charting apps. 

The first: “Mobile apps for providers that help track or manage patient immunizations by assessing the need for immunization, consent form, and immunization lot number [Added March 12, 2014].”

The second: ‘Mobile apps that provide drug-drug interactions and relevant safety information (side effects, drug interactions, active ingredient) as a report based on demographic data (age, gender), clinical information (current diagnosis), and current medications [Added March 12, 2014].”

The third: “Mobile apps that enable, during an encounter, a health care provider to access their patient’s personal health record (health information) that is either hosted on a web-based or other platform [Added March 12, 2014].”

It is encouraging to see that the FDA is updating and adding to its regulatory primers for mobile medical apps. The changes in March came just a few weeks before the FDA presented Congress with its final report on FDASIA findings, and the most recent addition appears to be tied to Apple’s HealthKit and Health app announcements. Hopefully additional and ongoing acts of clarity from the FDA does not require Congressional or Big Tech prodding each and every time.