This week I’ve gotten several emails about my thoughts on the House’s Energy and Commerce hearing on mobile app regulation by the FDA. While I could come up with my own thoughts on the hearing, I prefer to recap by sending you over to the incomparable Brian Dolan’s lists: 5 take aways and 10 threads. Now you’re caught up. So today, as promised in a rather polarizing VentureBeat article, Rock Health came out with a slide deck on digital health regulation by the FDA. (Side Note: when did we start calling it digital health? (Second Side Note: When do we get to call technology enabled healthcare just health?)). I loved all the details they gave on how to go through the 510(k) and PMA process – to date, haven’t seen a group put out a free “how to navigate” the FDA presentation (so kudos Rock Health!).

FDA 101: A guide to the FDA for digital health entrepreneurs by @Rock_Health from Rock Health – produced by Malay Gandhi (@mgxtro) and Deborah Pascoe (@deborahpascoe).

A Few Comments:

Slide 1: In addition to the Mobile Medical Apps guidance I’d also suggest developers look at the Medical Device Data Systems and Design Considerations for Devices Intended for Home Use.

Slide 3: I’m not sure why the FDA’s birthday is relevant – Personally, I would have gone with when the Food, Drug, and Cosmetic Act was signed into law – 1938. FDCA is what expanded the FDA’s regulation authority to include devices and cosmetics. I guess Rock Health doesn’t share my love of flappers and the FDCA.

… following FDA regulations will actually make them a better company, with a higher quality process, and open the door to the entire healthcare market. – Geoff Clapp on Slide 23

Slide 4:

Rock Health Question: Why is the FDA looking at Digital Health?
Rock Health Answer: Widespread Availability & Public Interest

“Widespread Availability” and “Public Interest” are why the House Energy and Commerce Committee had a 3 day hearing on digital health. The FDA is a bit simpler – it looks at “digital” health because if something is a device, the FDA regulates it. That’s it.

Slide 5: Really not sure why they refer to the “current” definition of device. Device was codified way back in 1938’s FDCA section 201(h) and isn’t likely to change…

(h) The term “device” means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is— (1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them, (2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or (3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

So what’s this really mean? If you’ve got something that treats something with an ICD-9 code and isn’t a drug you’re a device. And if you are, you’re subject to the medical excise tax. What won’t be subject to the tax? Things that aren’t medical devices (as the laughable Hotair puts it: “the federal government is munificently resisting the temptation to tax our smartphones” just like they’re not taxing our fax machines. Or, for that matter, regulating our fax machines.).

device formula

Slide 6: Believe me, I really wanted to love this slide. Then I noticed that it wasn’t to scale and got sad.

MMA Vs Other Apps (not to scale)

MMA Vs Other Apps (not to scale)

Mobile Medical Apps vs Other Apps (Rock Health Numbers, to scale)

Mobile Medical Apps vs Other Apps (to scale)

Not such a big piece of the space, now is it? Since there isn’t a numbered estimate for the gray area of apps which “might” be regulated, I couldn’t scale that space.

Slide 7: Again, so close to loving this slide. I just wish patient/consumer Safety had made the list. Yes, they said “consumer confidence” but when we’re talking about FDA oversight, we’re talking about medical devices and patient safety. FDA approval does increase physician confidence, but they’re not the end user/consumer in this continuum.

Slide 9: CMS doesn’t regulate devices. Pay for them, sure, but regulate? Not so much. I suppose we can go to futuristic imagination land where everything is mobile and talk about how a future iteration of Meaningful Use may require a provider to use a mobile application per CMS specifications. Barring that, CMS isn’t regulating mobile. Setting reimbursement guidelines, yes. Regulating? No. I’d definitely worry about the FTC before I even though about CMS – particularity in relation to apps which aren’t even considered devices. More on that regulatory continuum can be found in my HIMSS13 presentation. 


Slide 12:  Once I read this article, I understood what they were getting at with this example.  I think my brain still had a problem with it because their Class I example didn’t have a mobile application associated with it. Glooko is a good example of the evolution of MMA stages – originally their system/cable was a Class I device – all the cable did was transmit data in its original form for recording. But they couldn’t do analytics on it which means its usefulness was limited. Recently they received Class II clearance for their Glooko Logbooks Chart product. And maybe in a few years Glooko will come out with an app that helps control an artificial pancreas device and have to get Class III approval. 

Glooko Example

In closing, great job to the Rock Health team for interviewing so many thought leaders in this space – really enjoyed the emphasis on the FDA being composed of real people (believe me, they are!)!

Author Note: The views in this blog are strictly mine and should not be attributed to any organization mentioned. I do not work for the federal government and the contents of this site do not represent the views of any federal agency. It is important to note that my ORISE fellowship is with the FDA’s Center for Drug Evaluation and Research and I do not have inside knowledge regarding the device approval process.