Personal health and wellness apps on mobile devices are here to stay. Because of the proliferation of mobile technologies and consumer demand, there’s no putting that genie back in the bottle (see The Problems With Bringing Apps To The Consumer Experience? The Volume, The Evidence & The Model and Consumer-Directed Therapies – Where Consumer Use Has Outpaced Science). That said, the creators of these apps, which increasingly includes payer and provider organizations, are in a grey area. What app functions need licensure or approval? What app functions pose liabilities for the producer or sponsors?
To date, the U.S. Food and Drug Administration (FDA) hasn’t shown much interest in establishing rigorous regulation and enforcement around mobile health apps, which we’ve reported on before (see Is There Any Regulation Of Health Care Apps?). Last fall the FDA did release draft guidelines to clarify the department’s position on mobile medical devices and mobile medical apps — they are making moves to “establish principles for clinical evaluation of scientific validity, clinical performance, and analytical validity” for the clinical algorithms that power apps, or software-as-a-medical device (see Answering The Question Of What Digital Medicine Works). Apps that are currently in the FDA’s sights are limited — and they include medical apps that are intended to be used as an accessory to a regulated medical device and those that transform a mobile platform into a regulated medical device.
But, now states are getting into the action. As a recent Wired magazine article pointed out (see Wellness Apps Evade the FDA, Only to Land In Court), the New York Attorney General’s office settled last month with three health app makers that allegedly misrepresented their products to consumers and had troubling practices and policies around privacy. And these weren’t “fly by night” shops: One of the companies that settled was Runtastic, a subsidiary of athletic apparel company Adidas; another, Cardiio, came out of the Massachusetts Institute of Technology’s Media Lab.
The terms of the settlement themselves weren’t particularly significant — the three companies agreed to pay $30,000 in penalties altogether and adjust the language in their ads and privacy policies. So why is this important? Because it could represent a new precedent in legal oversight for these apps. What this could mean is that after this settlement, it could become more common for prosecutors representing the states to bring lawsuits against makers of these apps for failing to deliver promised results and/or offering appropriate disclaimers. And other government entities — such as the FDA or Federal Trade Commission (FTC), the regulatory agency for consumer fraud protection — could get more involved in due course.
If your organization is looking at sponsoring some type of branded app, or endorsing an app made by others, what should you consider? Answering that involves two different lines of strategy. First you can select an app that already exists on the market — for more on that check out App Potential and App Potential For Treatment Tech.
Second, you can create your own app, and as I mentioned from the Wired article, those apps may someday have to comply with a vast new collection of regulations that vary from state to state. Whether that actually comes to pass or not, here are three precautionary tips for any behavioral and mental health provider organizations or payer organizations that venture into the world of apps development:
- Watch Your Language: Particularly, in any promotional or descriptive copy you develop for the app, don’t unequivocally make guarantees if there’s a chance your product won’t be able to deliver on them.
- Consult Your Lawyer(s): Have in-house attorneys or an external legal representative review promotional copy. Also, you should have them write and review terms and conditions, privacy policies, and other legal documents related to the product.
- Be Transparent About Data: If you’re collecting substantial amounts of consumer data through the app for any reason (be it research, future promotions, etc.), let users know why you’re doing it as clearly as possible.
For more on the subject of mobile health technologies, check out these resources from the OPEN MINDS Industry Library:
- Digital Health – What Physicians & Consumers Want
- Fitting ‘Invisibles’ Into Your Tech Planning
- Adding Technology To Improve Medication Adherence
- Consumer Health Tech: If You Build It, Will They Come?
For more on the latest developments in the health care tech sector, check out these resources from the OPEN MINDS Industry Bulletins (see Industry Bulletins: Tech Updates). And mark your calendar for the session, “Managing Personal Technology & Building Your Online Presence” on September 26 at The 2017 OPEN MINDS Executive Leadership Retreat, in Gettysburg, Pennsylvania.