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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