When is a mobile app a medical device? The future of healthcare may depend on the answer

I’ve spoken before on how mobile health apps and devices can expand the ability of healthcare providers to customize treatment for patients. An important part of making that happen is the ability of app developers to quickly get innovative products to market. But one big hurdle has been the uncertainty around regulation.

Mobile health apps exist in a gray zone between medical devices, which are highly regulated, and computer applications, which aren’t regulated much at all.  When an app is used to facilitate communication between a medical device, such as a blood pressure monitor and a mobile phone that transmits data to a physician’s office, does that app become part of a medical device? When does a mobile health app warrant regulation by the Food and Drug Administration (FDA) and other regulatory bodies around the world?

This is not a trivial question. The potential of medical apps to improve care and lower costs is enormous. We need creative, energetic app developers working on new ways to make this technology work for all of us. But if developers don’t know how these apps will be regulated, they’re going to spend their time on other pursuits rather than gamble on what regulators might do in the future.

FDA issues guidelines, but some question if the framework is appropriate for apps

In July 2012, the U.S. Congress passed The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), which directed the FDA to come up with a proposed strategy and recommendations within 18 months. It directed the FDA to create a risk-based regulatory framework pertaining to health IT that promotes innovation, protects patient safety, and avoids regulatory duplication.  The FDASIA report is due to be released near the end of this month.

A more detailed risk-based framework is proposed in a report by the Bipartisan Policy Center’s Health Project, which urged an approach that they believe protects patient safety without creating unnecessary regulation.

In September 2013 the FDA issued guidelines that regulate mobile apps based on the FDA’s assessment of potential to harm patients. Under these guidelines, an app that only records your diet and exercise information wouldn’t rise to the level of a regulated device. But an app that tells you to adjust your insulin dose based on a reading from a glucometer will likely be regulated.

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Gray area or appropriate flexibility?

In gray areas, where the FDA guidance still provides no clear answer, the agency has said it will exercise discretionary enforcement, essentially leaving open regulatory options if they believe the situation warrants it.

Some observers think this gives developers room to innovate, while allowing the FDA to step in where patients might be at risk. Others (including some members of Congress) see this gray area as just the kind of ambiguity and uncertainty that will discourage innovation, and they believe that the FDA should be precluded from regulating certain categories of apps altogether. 

The fast pace of app development, combined with the melding of lifestyle/medical and consumer/clinician functionality, offers great possibility for innovation; at the same time, it makes regulation of this area a challenge and stretches the limits of existing regulatory frameworks. The most recent FDA guidelines are not likely to be the final word on the subject, though they are the current rules of the road for developers.

In the meantime, some app developers will forge ahead despite ambiguity, while others may balk at the risks created by the remaining uncertainty. As well, some doctors may hesitate to use products that lack the FDA’s formal approval and associated liability protections.  It is critical that, in the end, a regulatory balance is found to allow innovations to improve health while maintaining patient safety protections.

How this debate plays out also has global significance. Regulatory agencies across the globe are watching what happens in the U.S., and the FDA’s actions will likely influence how other governments balance patient safety and the need to foster innovation.

Opportunity for mHealth startups

To help promising mHealth innovators get their products to market faster, Dell and Intel are sponsoring a pitch challenge for healthcare and life sciences startups developing mobile technologies that improve patient outcomes. Technologies of interest include healthcare analytics tools, clinical workflow management tools, mobile health applications, cloud-based solutions and wireless health monitoring devices. For more information, visit the Center for Entrepreneurs.  

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