FDA checking high-risk medical apps for safety

Last year, the FDA proposed a policy to test apps that included "very high-risk interventions" that did not cause any unintended consequences. The agency is...

As more medical-related mobile applications become available to consumers, the Food and Drug Administration is making sure the most high-risk apps are safe to use.

Last year, the FDA proposed a policy to test apps with “very high-risk interventions” that could lead to unintended consequences.

The agency is now expected to release final policy by the end of this year on which apps it will oversee, said Bakul Patel, senior policy advisor at FDA’s Center for Devices and Radiological Health, in an interview with The Federal Drive with Tom Temin and Emily Kopp.

So far, FDA has focused on apps that connect to medical devices. For example, one app that FDA approved was an ultrasound wand that connects to a smartphone, essentially creating a portable ultrasound machine. Another app allows doctors to view X-rays on tablets or smartphones.

Patel said it’s “unfeasible” for FDA to test every single medical-related app, so the low-risk ones would not fall under FDA oversight. Those apps include calorie- counting apps or apps that promote healthy lifestyles.

Bakul Patel
A House bill, meanwhile, would set up an Office of Mobile Health at FDA to support mobile development and ensure compliance with privacy regulations.

Rep. Mike Honda (D-Calif.) is planning to introduce the Healthcare Innovation and Marketplace Technologies Act, a spokesman said, but did not say when this bill will be introduced.

The bill also would provide loans to small businesses and clinics to purchase new medical technologies, as well as offer grants for innovator challenges.

“As we continue to improve our health care system, technology can and should play a prominent role in achieving better care for Americans,” Honda said in a statement emailed to Federal News Radio. “Investments, development, and adoption of technologies remain stagnant. Why have the principles of Silicon Valley, which I represent — competition, innovation, and entrepreneurship — not fully manifested themselves in the health care information technology space? This bill gets us closer to that space.”

Patel said FDA is working with developers now to ensure the apps that are developed “take data and make it meaningful.”

Mobile developers have special challenges when developing their apps. For example, if a patient is in the middle of a sensitive intervention using their smartphone and a call comes in, developers must take that into consideration.

“It boils down to, Can you manage the risk of your particular product or your particular application so it performs as you intent it to perform?” Patel said.


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