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 "Mobile Health Apps: Blackburn's SOFTWARE Act Would Limit FDA's Power, Ensure Regulatory Restraint."
Following is an excerpt:
In October, FDA introduced the SOFTWARE Act, which defines three different categories of mHealth software: Medical, clinical, and health. Under the SOFTWARE Act, only medical software would require FDA approval. "Medical software" is software that directly changes the structure or functioning of the body, or would do so if followed, or includes the use of a regulated therapy without physician involvement. ?...
I interviewed Brad Thompson, the mHealth Regulatory Coalition's general counsel, who told me that his members are not against new legislation — but only as, if, and when needed. The mHealth Regulatory Coalition includes AT&T, Verizon, Roche, and WellDoc, an emerging health IT company.
One of Mr. Thompson's criticisms of the SOFTWARE Act is that it defines three different categories of mHealth software, but that these boundaries are blurry, and the technologies are converging. He also also points out that the SOFTWARE Act might deregulate more than its authors intend.
