As Reston-based AFrame Digital looked to bring its wrist watch health monitor to market, the company thought it might be exempt from the Food and Drug Administration’s more arduous clearance process.
Still, chief executive Cindy Crump turned to the agency for guidance.
“The FDA came back to us with the determination that it is a change in fundamental technology for this type of device, so they said we would need to go through the . . . FDA clearance process,” she recalled.
AFrame Digital’s device was ultimately given the green light and the product has been sold to several assisted living and rehabilitation facilities. Many other companies also hope to capitalize on such trends in health technology.
But 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?
“In the near future, we plan to provide draft guidance for public comment prior to finalizing, which will provide clarity for manufacturers as they continue to develop innovative, health-related mobile apps,” an agency spokeswoman wrote in a statement.
“By providing predictable, flexible and sensible oversight of certain mobile medical technologies, FDA hopes to promote innovation, while protecting public health,” the statement said.
Bradley 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.
Nevertheless, there is risk. Patients have to rely on health care software and devices to transmit information both accurately and securely so as not to compromise the quality or privacy of care.
“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.”
But at last week’s symposium, Merrill Matthews Jr., a health ethicist and visiting scholar at the Institute for Policy Innovation, said the pace at which technology evolves may be too quick for the regulatory agency to stay in step.
“The FDA plays a critical role out there, certainly with medical devices that are going to have a strong health input,” Matthews said. “Having said that, I don’t think anyone has ever accused the FDA of being a fast-moving organization.”
He added, “Some of these new technologies coming out, you’re on 3.0 or 4.0 before the FDA would even realize you exist and begin to figure out whether [regulation] is going to be applicable.”