In the face of repeated demands from developers, entrepreneurs and investors, the United States Food and Drug Administration has now specified the types of mobile applications which it says come under its regulatory oversight. The FDA has not however fully clarified just how its various recommendations will be enforced.
Two years after publishing a first draft,the FDA has now come up with ‘final guidance’, comprising a list of recommendations in the field of m-health apps. Given the legal void to date and the confusion brought about by dealing with issues on a case by case basis, the United States health regulatory authority is trying to bring greater clarity to a market which numbers over 40,000 apps and is estimated to be worth some $26 billion by 2017. The uncertainty surrounding the regulatory issues has been slowing down the growth of this market, despite the fact that the Obama administration is strongly encouraging innovation in order to combat deficiencies in medical care and make hospital budgets stretch further.
Apps to be regulated like traditional medical instruments
The FDA is focusing its recommendations on two types of software applications, whose use approximates to that of traditional professional medical equipment. Firstly this means applications developed to be used as an accessory to a regulated medical device, e.g. an app that enables a doctor to make an analysis or diagnosis using a tablet or to send/receive a patient’s medical information via a mobile device. The second group includes any app that actually transforms a mobile platform into a regulated medical device, a clear example being the AliveCor app which enables a mobile device to create electrocardiograms. These two categories are to come under FDA regulatory oversight and such apps will be assessed for compliance according to the same criteria as for any other medical equipment. By contrast, the FDA has no intention of regulating fitness or wearable technology apps such as activity tracker Fitbit andonline calorie counter and diet plan app MyFitnessPal. Explained Jeffrey Shuren, Director of the FDA’s Center for Devices and Radiological Health: “We wanted to achieve the right balance and include only those applications which could potentially harm the user.”
Clarity still lacking on FDA enforcement
The FDA’s move to clarify the situation has reassured many investors and app developers, as Corey Ackerman, President and COO of mobile healthcare App Store Happtique underlines: “Investors expect a certain degree of clarity from the regulators and this guidance should provide them with some reassurance.” However, the firms concerned are still asking how exactly the guidance will be enforced. The FDA has not yet given out any details on how long the grace period for coming into compliance will be, nor any idea of the costs involved. The regulator has announced that the compliance process for apps will not involve costly testing if a similar device already exists on the market, but no timeline has been given and the pre-market application process will be carried out on a case-by-case basis. Nevertheless, an official spokesperson stressed that the FDA intends to provide extensive ‘education’ in order to bring all the apps falling under its regulatory oversight into compliance with the rules, explaining: “Our goal is to help developers understand how to follow our guidance and provide clarity on what they need to submit.”