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 "Rep. Honda Reintroduces Bill to Create FDA Office of Wireless Health."
Following is an excerpt:
Rep. Mike Honda, D-Calif., released a new version June 13 of the "Health Care Innovation and Marketplace Technologies" Act, which address perceived problems in the health information technology marketplace.
The bill proposes an Office of Wireless Health within FDA to help coordinate efforts in wireless and digital health, in addition to creating several grants and loans programs administered through the Office of the National Coordinator at HHS.
In an email, Bradley Merrill Thompson, a lawyer with the mHealth Regulatory Coalition wrote, "The Honda legislation may help, [but] it doesn't address the specific issues that concern us most," including the lack of clarity around where wellness claims end and disease claims begin, and unresolved questions about the regulation of mHealth accessories and modular development of software.
Thompson said that the bill should explicitly state that mobile health technology will fall under the Office of Wireless Health's purview.