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 "Public vs. Private Oversight of Mobile Health."
Following is an excerpt:
Government regulation of mHealth was the topic of a three-day series of hearings March 19-21 convened by the US Energy and Commerce Committee. Anyone with a stake in mHealth had a stake in the hearings, which set out to determine whether or not smartphones and tablets with medical applications qualified as medical devices, which would then be subject to the 2.3% medi¬cal device tax as part of the Affordable Care Act (ACA). The hearings also examined whether the FDA is the correct organization to conduct any review of medical apps, or if that task is better suited to a separate regulatory body. ?...
Any talk of moving oversight away from the FDA was really just part of the politicizing of the con¬versation, according to Bradley Thompson, one of the founding members of the mHealth Regula¬tory Coalition. Thompson, like most of the other experts called to testify, said that any high-risk mobile health application used in a clinical setting should fall under FDA jurisdiction, the body with the most experience evaluating medical devices. What constitutes high-risk is the question various commissions and experts hope the FDA will clarify by the end of the year. When Chilmark Research spoke with Thompson, he noted that any legislation coming from the hearings would likely be de-regulatory in nature, setting the industry up for more self-regulation, which is already starting to happen.
