Bradley Merrill Thompson Quoted in Article, “Who Should Oversee mHealth Regs?”Healthcare IT News July 15, 2013
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 "Who Should Oversee mHealth Regs?"
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.
That, however, is not what the mHealth Regulatory Coalition wants. In a letter issued after the HIT stakeholders' plea and directed to HHS Secretary Kathleen Sebelius, the coalition urged the FDA to issue its final guidance as soon as possible.
"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."