FDA checking high-risk medical apps for safety

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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

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.

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
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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About the Author:

Paul Khunkhun, serving Southern California since 1998. Paul is the owner of MDIS. He is a Board Certified Ultrasound Sonographer with RDCS and RVT credentialing. He is also pending ICAEL accreditation.

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