Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in mHealth Intelligence, in “CDS Coalition Floats Guidelines for Mobile Health App Design.”
Following is an excerpt:
Bradley Merrill Thompson, an attorney for the Washington, D.C. firm of Epstein, Becker & Green and legal counsel for the CSD Coalition, says the 21st Century Cures Act gives the healthcare industry the opportunity to regulate itself.
“Congress took this action in part because it is consistent with the dividing line between FDA regulation of medical devices, and state oversight of the practice of medicine,” he wrote in a commentary accompanying the proposed guidelines. “When the software takes over the decision-making, FDA takes over the regulation. On the other hand, when the healthcare professional remains firmly in control, state oversight of the professions is enough, without FDA intruding.” …
Thompson says it’s up to the industry to police CDS software by helping developers and providers plan and design their products. This, in turn, will give providers the confidence to use and prescribe mHealth apps, and will give consumers the confidence to use them.
“The coalition’s goal is to develop a framework that will provide consistency in user empowerment across software developers,” he wrote. “The key for this unregulated portion of CDS is ensuring that the healthcare professionals can gather and analyze the information needed to make the best recommendations to their patients.”