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 "UK's Mobile Medical Apps Guidance Parallels FDA's." (Read the full version — subscription required.).
Following is an excerpt:
U.K. regulators on Wednesday published guidance explaining how they'll police the booming field of mobile medical apps, adopting an approach that in many ways appeared to dovetail with the U.S. Food and Drug Administration's policies. ?...
Bradley Merrill Thompson, a medical apps expert at Epstein Becker & Green PC, told Law360 that the U.K. appeared to have an "identical philosophical position" as the FDA's, in that apps functioning as devices won't get a free pass. ?...
However, the language used by the U.K.'s Medicines and Healthcare Products Regulatory Agency regarding automated reasoning seemed very broad and could affect software with few risks, Thompson added.
"That is a very sweeping definition that would include such things as Apgar score calculators [of newborn health], which FDA has expressly exempted," Thompson said.
