At a recent Twitter chat of the Health Care Communications & Social Media group ( see the August 21, 2011 chat ) , one of the questions considered by the group prompted a heated discussion over the province of the U.S. Food and Drug Administration (“FDA”) to regulate phone/iPad applications. For the uninitiated, there have been a slew of new apps that have entered the market, some of them approximating medical devices, while others have merely added to the wellness and personal diary category. The growing sophistication of the apps into the medical device arena has prompted the FDA to develop a draft guidance to provide oversight and regulatory clarity.
During the Twitter chat mentioned above, some individuals thought the FDA’s action was intrusive and would stifle innovation. Given the potential for economic benefit in the growing health care field, I doubt this concern holds too much water. The fundamental issue at play here is if the app itself is a medical device. In section IV of the draft guidance concerning the rule’s scope, the FDA states that this concerns mobile medical devices defined as those app which:
- are used as an accessory to a regulated medical device; or
- transform a mobile platform into a regulated medical device
The FDA goes on to say what its rule does NOT cover. I am paraphrasing below, but if you read the scope itself , it provides good examples in defining these exclusions:
- apps that are copies of medical books, texts, or teaching aids (e.g. Physician’s Desk Reference or flash cards)
- apps that only log, record, offer evaluations or suggestions on “maintaining general health or wellness”
- apps that automate general office operations (billing, inventory, appoitments, insurance transactions, etc.)
- apps that are general tools and NOT marketed for a particular medical condition (e.g. an audio recording or note taking pad)
- apps that serve as electronic health records or a personal health record system
A lot of the hubbub during the Twitter chat concerned stifling innovation in this burgeoning space. However, what many in the group did not recognize is that we already rely on the FDA to regulate medical devices, so as technology changes and encompasses apps, so too must the FDA’s purview of these tools. A cursory look at some apps makes the FDA’s interest valid:
Smartheart: This is being represented by the manufacturer (SHL Telemedicine) as a self-service heart monitor, and as the smallest ECG. It operates by performing an electrocardiogram and allows the user to send the reading to his doctor.
IBG Star Monitor App: This involves an iPhone, an attachable iBGStar device, and the iBGSTar Monitor App. When used in concert together, the system allows patients to test their blood sugar wherever they are, record notes and send the data to their doctors.
Fujifilm Synpase Mobility: This app allows doctors to view radiology films in 2D, 3D and to use MIP/MPR as in a clinical setting from Androids, iPhones, and iPads.
Reliance on any of these tools to diagnose or treat patients makes them clearly medical devices, and well within FDA’s control. What is still up in the air are those “wellness” apps that happen to encroach into the clinical space and are used to diagnose and treat patients. I posed that question during the FDA’s July 19th chat on Twitter concerning their new draft guidance:
I’m still waiting. And therein lies the ambiguity that will beset developers as they race to market. Will they have to submit their apps for approval as a medical device? For the wellness apps that could be used as clinical instruments, the guidelines might not be precise enough. In the example I was thinking of I imagined a pedometer as part of an obesity treatment (exercise aid) or as part of an obesity clinical study where exercise logging was a requirement or an outcome. Plus there’s the issue of the long slogging process of device approval, involving clinical trials. Granted the process is important to ensure safety, but I openly wondered if a shorter path is possible.
I am still waiting on that too. While the FDA sorts all this out, you are invited to offer your remarks at the FDA’s website where it is gathering public comments. Join in to get the last word. By the way, the docket number for this is FDA-2011-D-0530-0002 and at Regulations.gov you can enter your comments electronically.