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 “For Health IT Firms, Regulatory Questions Abound.”
Following is an excerpt:
Regulatory questions abound as companies and public agencies alike contend with the rising role that portable devices, Web-based computing and other fast-evolving technologies play in people’s care.
From smartphone applications that count calories to for-medical-use-only products like AFrame’s monitor, such devices have complexity and expectations that vary wildly. So where will regulators draw the line?
Thompson, an attorney at Epstein, Becker & Green, represents a group of corporations and nonprofits called the mHealth Regulatory Coalition. The group is asking the FDA to identify those products that are subject to regulation based on how they function, how they are marketed and how they interact with other health products.
“A lot of people who put money into this innovation say, ‘Look, I’ve got to know am I buying into a regulated article or am I not’ because the pathways to market can be very different,” Thompson said last week at the Health IT Congressional Symposium, hosted by the TechAmerica Foundation.
“FDA is, to their credit, I think trying to look at how to approach these technology areas to allow innovation and protect the patient,” Thompson said. “That’s a classic conundrum. That’s not new. Everything FDA does is balancing innovation against the patient’s safety.”