San Jose Democrat Working on Bill To Create Oversight for Health Apps

Rep. Mike Honda (D-San Jose) plans to introduce in the U.S. House of Representatives a bill that calls for a new FDA office specifically designed to regulate health applications on smart phones and other mobile devices.

The new regulatory office in Honda’s bill, expected to be introduced at the beginning of the next session, would oversee apps designed for consumers, as well as those used by health professionals. According to a spokesperson in Honda’s office, there is not enough oversight for apps that consumers use to access health information.

“The office will be located in the FDA Office of the Commissioner, much like many other specialty offices (like the Office of Women, Office of Minority Health) are,” Honda’s spokesperson Michael Shank wrote in an email. The office’s goal would be to streamline regulation of what the FDA defines as health care technology, according to Shank.

“Dozens of major companies and trade alliances” might be interested in backing the bill, but no names have yet been released, according to Shank.

Last year, FDA proposed regulations on health care apps. The proposed regulations extend to smart devices that could be used for diagnostic purposes by doctors or smart devices that can display medical information, such as X-rays. The current regulations are limited to devices used by health care professionals. Regulations are expected to take effect in December.

While the FDA regulations are considered by some to be a first step in enforcement, no specific office or definition for consumer apps exists.

The bill could meet resistance from some stakeholders who argue that regulation of health-related technology could stifle innovation.

Bradley Thompson, an attorney who represents a group of stakeholders in the medical and technologies fields, such as Kaiser Permanente, MedApps, and Nokia, wrote:

” … We agree with the FDA that general health and wellness products, electronic health records, personal health records and general IT products should not be regulated,” Thompson wrote in an advisory email to Bakul Patel, policy advisor for the Center for Devices and Radiology at FDA.

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