FDA commissioner: mHealth requires scientific evidence

FDA Commissioner Margaret Hamburg began her keynote on the final day of the mHealth summit in Washington, D.C., by joking about her qualifications to speak: She only got an iPhone two weeks ago, she said. 

"I may be a late adopter, but I recognize that the world is transforming," said Hamburg (pictured right). "Certainly, the FDA has understood the value of scientific computation to support our mission and the advancement of health."

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The FDA supports the growing complexity of products that come before them for review, Hamburg said. And as a physician, she "certainly appreciates" the promise of mHealth.

But Hamburg stressed that each new medical product needs hard scientific evidence and data--and involves balancing risks and benefits, study and evaluation.

And Hamburg said she "strongly believes" the industry's focus can't just be the latest new things, "no matter how jazzy they are."

She encouraged the audience to keep in mind that innovation isn't just something new--it's something that will truly make a difference in people's lives.

"It's very important to put all of what we can do into context of what we must do," Hamburg said "These goals are not inconsistent."

The FDA must ensure healthcare apps are safe, effective and reliable. The recently-released final medical app guidance makes clear that if a mobile platform is a medical device, the FDA will continue to regulate it. It's about the functionality, not the platform, Hamburg said, and for the many mobile apps that are less risky for consumers to use, such as weight trackers, the FDA will exercise discretion.

The fundamental goal is to make sure best available science and technology is harnessed for consumers and patients, Hamburg said.

"Medicine alone without proper context, thought and appropriate care will fall short," Hamburg said. "It's up to all of us to make sure [mHealth] is used appropriately."

Robert Kaplan, director of the Office of Behavioral and Social Sciences research at the National Institutes of Health, also spoke Wednesday morning on balancing between the exciting mHealth development world and the world of rigid standards and evidence.

"The evidence standards promoted by people in our community are quite rigid," Kaplan said. "Most of my colleagues feel if a study wasn't conducted in a certain way, it's not evidence they believe in."

Technologies aren't perfect, but they're getting better quickly, Kaplan said. Everyone has to work together to merge the two worlds--the mHealth world, "bubbling with excitement," and the evidence-based medicine world, "held back by skepticism."

Kaplan mentioned that NIH plans to announce an initiative that would allow people to enroll in studies on their cell phones soon. 

"We see synergies between technology and innovation," Wendy Nilsen, health scientist administrator at NIH, said of the upcoming announcementand. NIH wants to evaluate mobile phones to accelerate research, reducing its time and cost, she said, but an official announcement is forthcoming.

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