Bradley Merrill Thompson Quoted in Article, “Who Should Regulate mHealth?”Government Health IT July 12, 2013
Bradley Merrill Thompson, Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled "Who Should Regulate mHealth?"
Following is an excerpt:
Not everyone is eager to see the U.S. Food and Drug Administration issue its final guidance on mobile medical app regulation.
While the mHealth Regulatory Coalition and several mHealth advocates have asked the FDA to release its long-delayed guidance — which has been in the works since the agency issued preliminary guidelines in late 2011 — a coalition of roughly 120 health IT stakeholders has asked the government to put the brakes on the FDA until a much more wide-ranging study of HIT regulations is finished.
In fact, some are wondering if the FDA is the right agency to oversee mHealth regulation.
"The MRC believes the timely release of the final guidance will benefit industry, stimulate investment, help ensure patient safety and is consistent with the views expressed by Congress and the desires of the broader mHealth community," wrote Bradley Merrill Thompson, a Washington DC attorney and coalition member, in the June 21 letter. The guidance, he said, "is needed by industry and will help unlock investment in the mHealth market. Many investors and companies are reluctant to invest significant time and money in mHealth technologies until the regulatory framework is clear."
"(Sebelius') objectives are different from the FDA regulatory framework on mobile medical apps. The secretary is charged with making broad policy recommendations on a comprehensive strategy for all Health IT," the MRC concluded in a position paper that accompanied Thompson's letter. "FDA's guidance, on the other hand, is focused on providing specific details of whether different mobile medical apps will be regulated or not — this is the level of regulatory detail app developers need now."