During the fourth annual mHealth World Congress in Boston this week, stakeholders raised questions about FDA's plans to regulate mobile health applications, CMIO reports.
Last year, FDA issued a draft guidance on its plans to regulate mobile medical apps. The agency could release the final regulations later this year (Gale, CMIO, 7/25).
During the meeting, stakeholders raised concerns about:
- A lack of clarification on how FDA will determine which health apps require regulation;
- The challenges of protecting the privacy and security of personal health information on mobile devices (Wicklund, Government Health IT, 7/26); and
- The costs that medical app developers could incur if their products require FDA approval.
Bakul Patel -- policy adviser at FDA's Center for Devices and Radiological Health -- said the agency hopes to issue mobile health regulations that strike a balance between:
- Encouraging innovation;
- Protecting patient safety; and
- Promoting public health.
Patel noted that FDA will focus its regulatory efforts on mobile health apps that pose a risk to patient safety. He said, "Even though certain mhealth tools may meet the definition of a medical device, they don't pose great concern or patient risk." Patel added, "At the end of the day, we are focused on a small portion of tools that actually mimic medical devices" (CMIO, 7/25).