Should Mobile Health Apps Be Regulated By FDA?

App developers and mobile device makers better pay close attention because the FDA says it's looking for "greater regulatory clarity."
"FDA believes that clarity of our role is important for companies developing these innovative technologies," the FDA spokeswoman said. "By providing predictable, flexible and sensible oversight of certain mobile medical technologies, FDA hopes to promote innovation, while protecting public health."

The FDA's plans to provide "clarity" for mobile health application development "comes at an interesting time," said Monique Levy, VP of research at Manhattan Research, a healthcare and pharmaceutical research services firm.

"There's a shift in the market taking place, with mobile health apps and devices being primarily consumer products to tools to connect patients with clinicians with the ability to adjust clinical decisions," she said.

"Right now, it's the wild, wild West," Levy said. If the data that gets created and transmitted by and used from these apps affect patient care, questions include "how reliable is the data, how secure is it, what happens to the data if the dog knocks the device on the floor," she said. All these concerns raise the level of importance these devices and applications play in healthcare, from being "nice to have" for the consumer, to potentially critical tools for decision-making by clinicians, she said.

However, the other looming question for app developers is how intensive will any new FDA regulations be and whether the hurdles will stifle innovation, especially among promising startups and other smaller companies lacking deep resources to juggle compliance mandates.

As long at the regulations don't introduce insurmountable barriers to creativity, some clear rules from the FDA concerning mobile health apps could be positive for the industry, said Halle Tecco, managing director and founder of Rock Health, a non-profit "seed accelerator" launched earlier this year to help fund and mentor start-up mobile and web-based health developers.

"Too much ambiguity can be a hindrance in innovation" for health-related developments, Tecco said in an interview with InformationWeek Healthcare.

"If there are some rules in place, people are more comfortable to innovate," she said. That's because in healthcare, if a mobile device or application can be used to make diagnoses or treatment decisions, it's helpful to have some barometer of credibility that consumers and clinicians can look at when evaluating those products, she said.

Adhering to some level of guidelines from the FDA as they relate to mobile health apps could be like "a seal of approval" for manufacturers and developers, she said.

Hopefully, in its upcoming rules, the FDA will strike a balance between regulations that help keep patients and clinicians safe from irresponsible developments while allowing them to benefit from promising new innovations.

In the meantime, if you want to check out a few cool mobile health apps spotted by InformationWeek Healthcare editors, take a look at our slideshow.

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