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 "Int'l Approach Floated for Medical App Regulation." (Read the full article — subscription required.)
Following is an excerpt:
An international group of regulators on Wednesday released a proposed framework for a consistent approach to mobile medical apps and other software that functions as a medical device, aiming to harmonize general concepts in a burgeoning field. ?...
Bradley Merrill Thompson, a leading medical software expert and attorney at Epstein Becker Green, told Law360 that the report was important in that it represented international agreement on issues that for the most part are still being fleshed out within individual countries.
"It is very significant to have the major developed and developing nations gather together to produce a consensus position," Thompson said.
At the same time, Thompson offered a critique of the report's lucidity, describing its structure as highly complicated and perhaps less useful as a result.
"It identifies some of the important factors that should be used in classifying software," Thompson said, "but does so in an incredibly complex manner that is difficult to apply."