Healthcare Technology Featured Article

September 27, 2012

Congress Considering Special Role for FDA to Approve mHealth Apps


The Food and Drug Administration (FDA) ensures the safety of all food and drugs in this country and also regulates all medical devices and advises on other healthcare-related issues.

However, the organization has not yet taken a strong stance on which mobile health (mHealth) apps it should approve. While there are already tens of thousands of mHealth applications available for download on smartphones and tablets, the FDA acknowledges that it can be hard to know “which ones actually deliver on their health claims and provide accurate information,” according to a story by Jenny Gold.

mHealth apps are so popular because they nix the need to go sit in a doctor’s office for who knows how many hours, wait for a prescription, and then take it to the drugstore to fill it.

In June, Congress asked for more time for a study of the FDA’s authority to regulate mobile apps before allowing it to do so, Eric Wicklund revealed.

Yet, a bill set to be introduced in the U.S. House of Representatives later this month is hoping to take care of all that. Gold reported that the bill’s goal is to make the agency’s evaluation process easier and more efficient.

Named the Healthcare Innovation and Marketplace Technologies Act (HIMTA), the bill would establish a special office of mobile health at the FDA “to provide recommendations on mobile health app issues,” and create a mobile health developer support program at the Department of Health & Human Services to help app developers make sure they are operating within privacy regulations, including the federal law HIPAA that sets privacy standards.

"Currently, our healthcare system works against small-to-large startup entrepreneurs with a multitude of barriers to entry," Rep. Mike Honda, D-Calif., who is introducing the bill, said in a statement. “Why have the principles of Silicon Valley, which I represent – competition, innovation and entrepreneurship – not fully manifested themselves in the healthcare information technology space? This bill gets us closer to that space.”

The FDA did begin to regulate some medical apps last year and released a first draft of guidelines, requiring mobile apps developers making medical claims to apply for FDA approval.

The final regulations have not yet been released, but some developers have complained that the approval process will be too slow. Medical devices, which the FDA regulates in a similar way, wait six to 20 months for approval, according to the Government Accountability Office.

 That’s not all that concerns IT professionals. Gold said in her story that Joel White worries that the FDA lacks the regulatory structure to “not only protect patient safety but also avoid killing off innovation in a market that’s explosively dynamic.” White, the executive director of the Health IT Now Coalition, which includes the computer chip maker Intel, pharmacy benefit manager Medco, Verizon, Aetna and the U.S. Chamber of Commerce, told Gold he’d prefer to see the government set up a separate, more nimble agency to regulate mobile health, a new entity that bypasses the FDA entirely.




Edited by Jamie Epstein






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