FDA to Regulate Mobile Health Apps

FDA regulate blog post bottom picThe U.S. Food and Drug Administration (FDA) plans to regulate medical devices connected to smartphones. Consumer devices such as the iPhone and app stores like iTunes and Google Drive will remain clear of oversight, an FDA official told the House of Representatives’ Subcommittee on Oversight and Investigations on March 21, since those devices are not connected to any medical reading or device.

The exact regulations haven’t been decided yet but the FDA mentioned that the mobile health app regulation will be “narrow” and carried out “judiciously.” This essentially means that the specific areas of regulation will not be overbroad or too expansive which would then possibly affect or impede the sales of smartphones.

The area of concern for the FDA is a small subset of mobile medical apps that present a potential risk to patients if they do not work as intended which includes scanners, monitors or other clinical medical devices. These apps are of concern since people could potentially get the wrong information which could then affect their life if they subsequently get the wrong treatment or even not seek treatment. For ex) a mobile app connected to a CT scanner can be inaccurate and that can cause a patient to not seek proper medical guidance. Such a consequence is too significant not to regulate to ensure complete oversight. New examples of such mobile apps includes ones that measure patients’ vital signs or control devices such as infusion pumps; such apps can be based on inaccurate programming such as a defect of a drug infusion pump which could then cause a drug overdose. I actually do agree with the FDA on this overhaul since the specific areas they are looking at regulating. could delay lifesaving diagnosis and treatment through an inaccurate or malfunctioning mobile medical app that uses a sensor to diagnose especially since these apps are all fairly new, in beta mode or haven’t fully been tested in a mass market state or even researched.

The FDA seeks to strike the right balance by providing a risk-based, focused approach to the oversight. During the three days of hearings on Capitol Hill for the law, lawmakers explored how far mobile health app regulations by the FDA should go. Fortunately, most of what we consider and actually use as mobile health apps wont be regulated and this includes electron health records (EHRs) apps as well as wellness, fitness and general medical resource apps. However, the FDA has been criticized for the delay in finalizing its guidelines on regulating mobile apps. The FDA has even acknowledged that they need to publish the final regulatory guidelines as soon as possible to clear away the uncertainty that some claim is depressing the market or driving m-health companies overseas.

The key prerogative for the FDA now should be to fulfill their responsibility of protecting consumer and patient safety without unnecessarily burdening industry and suppressing innovation. The government should aim to strike a balance of oversight of medical apps while still encouraging innovation. In fact, mobile health app developers don’t consider the proposed regulations overreaching and look forward to possible FDA approval to establish legitimacy for their apps. More protective regulation coupled with ample opportunities for innovation would mean that the mobile health app can still continue on growing and positively and proactively shaping the health care industry as we know it!

© 2017 Jackie Arnett Elnahar RD.
ALL RIGHTS RESERVED.