The business of smartphone health apps is growing exponentially. Here at Children’s, I coordinate and supervise a team of software developers who are helping our clinicians build apps. While I love the innovation and excitement health apps bring, the regulation is just starting to catch up with the industry. That makes the future uncertain.
The Food and Drug Administration’s proposed mobile health app guidelines, published in July, are a step in the right direction. But many concerns remain. In taming the Wild West, will the FDA go too far into overregulation? Will the new rules stifle the growing industry of app development by small startups or internal hospital developers? Can we continue innovating in the current state?
Consumers feel the uncertainty too. When considering the use of an app, how do you know whether it’s providing correct information? Where is that information coming from? Is it safe to put your personal information into the app? Who else is accessing your information and where are they sharing it?
These concerns are reflected in letters of feedback to the FDA’s draft guidance (PDF); the public commenting period closed last month. Most feedback was aimed at making sure people are using secure, accurate health apps, without discouraging app development
Two major groups, the Healthcare Information and Management Systems Society (HIMSS) and the mHealth Regulatory Coalition, weighed in. Both groups requested that the FDA provide more detailed information about how it plans to regulate mobile health products.
The mHealth Regulatory Coalition’s feedback (PDF) focused on how to adjust and clarify the proposed regulations to better support and promote investment and innovation in the industry. One issue raised was how to evaluate an app’s intended use. For example, is the app just for reading text, such as the numbers of a lab result? Or is it for diagnosing a condition? The FDA language is so broad that it is hard to determine exactly which apps constitute medical devices and which will require extensive oversight and regulation. “The FDA should focus on regulation of moderate- to high-risk devices, exempting or excluding low-risk products,” the Commission wrote. (A potentially high-risk product might be a mobile radiology app, whose quality could be compromised by small screen size, lower contrast ratio, etc.)
HIMSS’s comments (PDF) focused on the fact that many health-app developers lack knowledge of how the FDA currently regulates medical devices. The group encouraged the FDA to educate hospitals, health systems and providers on FDA processes, specifically:
• The intended definition of a medical device as outlined in the Food and Drug Act.
• What triggers transform a mobile medical application or a computer into a medical device for regulatory purposes.
• When a mobile medical application would be considered an accessory to an existing mobile medical device, such as a stethoscope or ultrasound probe that is run by an app.
• For applications not intended to have a medical use, how the FDA approaches notifying users that the app is not intended as a medical decision maker or clinician substitute.
We have begun app development at Children’s even though we don’t yet know whether our apps will require FDA regulation as medical devices. The first mobile app to connect to our clinical information system, BEAPPER, displays lab results to emergency physicians. Based on the wording in the FDA’s proposed regulations, this could constitute information for medical decision-making. If so, we would be considered FDA medical device manufacturers and would have to go through years of regulation to get the app approved. Such hurdles might force us to remove our app from use.
So I fear overregulation will reduce innovation and end the development of many worthwhile healthcare apps. At the same time, I look forward to the final release of the FDA guidelines, since this will end the uncertainty and could help accelerate and provide necessary guidance for an exciting industry.
Elizabeth Phillips, MSHI, is the Program Manager for the FastTrack Innovation in Technology (FIT) Awards within the Innovation Acceleration Program at Children’s Hospital Boston. Her team provides development resources for the creation of custom clinical software solutions. In addition, she facilitates a forum designed to enable internal communication and collaboration in the development of clinical mobile apps.