Bradley Merrill Thompson, a Member of the firm in the Health Care and Life Sciences practice in the Washington, DC, office, was quoted in an article titled “mHealth Industry Response to FDA Mobile Medical App Policy Begins to Gel.”
Following is an excerpt:
Mobile health and telemedicine stakeholders have much to say about FDA’s recently released draft guidance for regulating mobile medical apps. Meeting at the first annual American Telemedicine Association Policy Summit in Washington, D.C., July 27, they quickly zeroed in on top concerns.
“This is all about setting priorities,” said Brad Thompson. The mHealth Regulatory Coalition earlier this summer released its own draft guidance on how mobile health apps should be regulated by FDA. According to Thompson, the coalition still plans to forward its draft proposal to FDA later this summer.
The meeting attendees also seek greater assurance from FDA that it will stay within its scope of authority and not try to regulate matters outside its purview, such as data privacy or radiofrequency interference.
Last summer, FDA and the Federal Communications Commission formally agreed to coordinate the regulatory process in areas where their jurisdictions overlap. For mHealth matters left unaddressed by FDA’s recent draft guidance, Thompson suggested that regulation may need to be rewritten to provide greater clarity.