This month, Rep. Mike Honda (D-Calif.) plans to introduce a bill that would establish a new FDA Office of Mobile Health, Kaiser Health News reports (Gold, Kaiser Health News, 9/26).
Last year, FDA released a set of proposed guidelines on the regulation of certain mobile medical apps. According to FDA officials, oversight is necessary for apps that pose risks to patients if they do not work as designed (iHealthBeat, 4/17).
The agency could release its final regulations on mobile medical apps later this year (iHealthBeat, 7/27).
In July, President Obama signed the FDA Safety and Innovation Act. The new law establishes a commission of several government agencies to develop a strategy for regulating mobile health apps. However, the commission's report is not due to be released for another 16 months, likely after FDA releases its final regulations.
According to Honda's office, a new FDA Office of Mobile Health is necessary to provide support to the mobile health industry before FDA releases its final regulations on mobile health apps.
The proposed office would:
- Provide recommendations on issues related to mobile health applications; and
- Create a mobile health developer support program at HHS to ensure that app developers abide by privacy regulations, including HIPAA rules (Kaiser Health News, 9/26).