Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice in the Washington, D.C., office, comments on the formation of the mHealth Regulatory Coalition.
According to the article, the regulatory environment facing the mobile health industry is one of the sector’s biggest barriers. Thompson and Dane Stout, executive director of the Anson Group, have formed a “temporary” mHealth Regulatory Coalition that aims to work with the FDA to determine where that line should be drawn and to subsequently make that information readily available. The group plans to disband once it accomplishes it objectives, hopefully within the next six to 12 months.
“About 50 people participated in the opening meeting,” Thompson said. “About half participated in-person while half of the group phoned in.” Thompson noted that this meeting was open to all comers so the second meeting might be a better indication of how large the group really is. The attendees decided on three key objectives for the coalition. The objectives each focus on three different dimensions of FDA policy: The difference between medical and wellness claims, the limits of FDA’s accessory rule and the regulation of software.