As the FDA ponders whether to regulate mobile health apps as medical devices, industry stakeholders are coming together to develop a guidance document on the scope of what they perceive the federal agency's authority over such software should be. The private-sector mHealth Regulatory Commission "is intended to be a temporary organization--lasting perhaps one year--comprised of participants from existing trade associations and sponsor companies that have an interest in obtaining clear guidance from FDA on the scope of FDA regulation of m-health technologies," according to a founding statement.
The organization plans on disbanding as soon as the FDA publishes a proposed guidance on regulation.
The association has invited groups such as the Continua Health Alliance, the American Telemedicine Association, the mHealth Initiative, HIMSS, the West Wireless Health Institute, the Wireless‐Life Sciences Alliance and CTIA to join and also is open to companies with an interest in mobile healthcare. There's a kickoff meeting planned for July 8, in Washington, D.C.
Right now, the founding statement and other details are only available to members of the Wireless Health group on business networking site LinkedIn. Others may contact Executive Director Dane Stout at [email protected] or General Counsel Bradley Thompson at [email protected].
For further details:
- see this post on the Telecare Aware blog
- read the founding statement on LinkedIn (group membership req.)