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 Loosens Grip in Latest Win for Digital Health Firms." (Read the full version – subscription required.)
Following is an excerpt:
The U.S. Food and Drug Administration on Friday vowed not to regulate a sizable class of hardware and software products that store medical device data, a gesture that experts say will spur innovation at small businesses and potentially undercut congressional efforts to curb the agency's authority over digital technologies.
In draft guidance, the FDA said it won't police so-called medical device data systems, which can collect, store and transfer information about patient health, such as vital signs or other clinical measurements. The exemption will also cover devices that house and communicate images, such as those from an MRI or ultrasound. …
Friday's move is "consistent with the notion that FDA is getting out of the broad health IT management sphere and leaving that to ONC," Thompson said. …
"I really wish they would just bite the bullet and engage in rulemaking," Thompson said. "If they did that, I think it would demonstrate that there's no need for Congress to act."
