AppleWatch mHealth apps avoid FDA medicaldevice Regs. leveraging existing FTC regulated Fitness & Smartphone apps

It is interesting to see the apps coming out on the Apple Watch positioning themselves as mHealth apps. These apps do not seem to be breaking much new ground.  Instead they seem to be leveraging existing smartphone apps:

  • WebMD's and Medisafe already have apps that track what medications you have taken on your smartphone.   Adding a watch based interface that lets you make the update to your smartphone without pulling it out of the pocket may be helpful to older demographics particularly those like Medication Alarm that have an alarm mode– but older demographics are likely not to be early adopters of the rather expensive Apple Watch.
  • HealthTap extends its existingiPhone app that lets you get a 1:1 conversation with a doctorto the Apple Watch – but at $180/hr it's a somewhat expensive solution that is likely to feel challenged as the PPACA brings more and more people into actual primary care coverage. 
  • Trinity Health's "cFHR™ Watch App from CareEvolution" uses Healthkit but leverages CareEvolutions existing HIEBus Health Information Exchange and brings the somewhat controversial Anthem healthcare into the mix
  • Apple's own health entries  are currently limited to basically fitness tracking which you also see from a number of other vendors from coaching 5k Runners to hydration apps and cardio tracking apps.  
  • DrawMD has an existing set of apps that can be used to educate patients on what various anatomical features and conditions look like, but like theNEJM Image Challenge still require the iPhone for the actual imaging, 

As both Forbes  and the Wall Street Journal have documented, actual HEALTHCARE apps on the Apple Watch are not meeting the hopes and expectations many raised in anticipation of the Apple Watch launch.

The main reason for this is that many commentators and entrepreneurs did not fully understand the implications of the FDA's Wellness Guidance.  As we document in our Free mHealth Checklist download (register here) as well as in our Free mHealth Regulatory  Webinar on April 30th,   the FDA's intention was to minimize mHealth regulations by exempting "fitness" and "wellness" applications.  However Medical Device Innovators are finding these exemptions to be quite narrow as the industry moves into automatic diagnosis and using mobile platforms for full capability medical devices.

As a result the regulations in this area are changing rapidly.  ClearRoadmap™ 's Pathways tool is precisely designed to keep you up-to-date on these changes.  Because  while the FDA has indicated it does not wish to be heavily involved in regulating Software-as-a-Medical-Device type mobile apps, it has indicated that these apps will be regulated by the FTC (Federal Trade Commission).  

Recently we have seen a variety of FTC enforcement actions including ones with multi million dollar fines:

  • Jungle Rangers maker Focus Education entered into a consent order with the FTC regarding its claims requiring Focus Education to restrict itself to only those claims it can prove via clinical research
  • Accretive Health settled with the FTC and the state of Minnesota for $2.5 Million for violations of patient medical information after a data breach
  • In February the FTC went after MelApp and MoleDetective for making unsupportable (aka "misleading" ) claims.   And while the fines of $17,963 and $3,930 are not in the realm of the Accretive Health App, anyone who has launched a mobile health app knows that these sort of fines are enough to kill a project


As soon as you start tracking data that is INTENDED to be used diagnostically , you ARE subject to not only HIPAA controls on how that data is managed, and the breach notifications associated with it but you also are subject to Medical Device Regulations. If the FDA doesn't regulate you, the FTC very well might.  And if neither agency directly regulates you, a failure to comply with the FDA's diagnostic tool regulations can expose you to private civil liability as well.

While tools like ClearRoadmap™   provide guidance through this regulatory distinction and complexity   – even the simplest certification processes are at least 3 month processing by the FDA plus the additional time and expense to collect the data and prepare the submissions.  The lowest cost estimates we have seen are $40,000 for a simple submission. 

This last is the particular barrier to true mHealth applications.   There is a rule of thumb that the typical mobile app development budget is around $100,000.   This is a function of the ability to get your application recognized and how frequently people expect an application to be updated.   

If 40% of your application budget goes to getting through the regulatory process, you really do not have a lot of feature function budget left. This suggests that we will be seeing the real "medical" health apps coming not from the smartphone app industry, but from sources where the value of the app allows more investment.  We have already seen one such source being the medical research community taking advantage of Apple's ResearchKit (something we have blogged aboutbefore-LINK1, LINK2 ) .  Another such source of true mHealth applications might be the insurance industry, where improving the health of their clients directly affects their bottom line enough that spending more than $100,000 on an app makes sense.

To better understand the regulatory issues is a great starting point.

In summary, it is not surprising that Apple backed off from actual Healthcare applications and why Google has avoided the healthcare space entirely once they understood the regulatory issues involved.

Bottom line message is in ClearRoadmap you can find clinical trial information for devices, to better understand the evidentiary data that Drs may need to justify using the app in their hospitals