Bradley Merrill Thompson Quoted in “FDA Stays Hands-Off in Long-Awaited Health IT Report”Law360 April 3, 2014
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 "FDA Stays Hands-Off in Long-Awaited Health IT Report." (Read the full article — subscription required.)
Following is an excerpt:
The U.S. Food and Drug Administration on Thursday unveiled an eagerly anticipated report on how it will police a vast universe of health information technology, promising to strictly monitor only highly sophisticated products while deferring most oversight to other regulators and private industry. ?...
Bradley Merrill Thompson, an Epstein Becker Green attorney and member of the working group that helped develop the report, told Law360 that the FDA's disavowal of oversight for health management software was a strikingly hands-off move.
"That's a huge statement that's very broad," Thompson said.
The FDA did, however, say it would continue to scrutinize products in a third category of "medical device health IT," which constitutes only a sliver of the digital health market but is viewed as potentially risky. Products in the area include advanced diagnostic software, certain mobile medical apps, systems that analyze electrocardiograms, and platforms that help guide radiation treatment or robotic surgery.