The U.S. Food and Drug Administration (FDA) has provided some leeway for mobile health technology (mHealth) but still has a major role in setting future boundaries.
“FDA is trying to balance two things,” said Marc Scheineson, partner in Alston & Bird’s Health Care Group and head of the firm’s Food and Drug Law Practice. “They are trying in a rapidly developing marketplace to not discourage innovation and that’s coming more from the White House and HHS/ONC and on the other side trying to draw some bright lines to the extent that it can generalize to give some certainty to technology companies about which side of the line they’re on and what the cost and regulatory pathways would be.
“It remains to be seen whether they stay on their side of the line,” he continued. “The agency is a conservative, an aggressive and an incremental regulator. It likes to see technology and have a piece of the development of those products, especially if they are going to be patient-specific and diagnostic in setting.”
Regulatory oversight of mHealth isn’t limited to the FDA, though.
“The FTC gets a piece of this on the advertising side because they regulate the ads for non-restricted medical devices, the 510(k) devices that come in as substantial equivalents and not needing human clinical trials as a PMA would need,” Scheineson added.
Mobile health devices and applications are already in use by consumers but much less so by providers. Scheineson noted the disconnect could be the result of mHealth developers not knowing how to work with the FDA.
“It’s very easy for FDA to get in the way,” he said. “They are sort of an 800-pound gorilla with a lot of weight to throw around, but they should be viewed constructively as a development partner. To the extent that companies want to do it right, FDA reviewers are the experts on clinical studies and their structure. The agency is pretty open and has reached out.
“Smart companies that are pretty sophisticated and really want the technology to work will come forward [proactively.] If you’re looking long term, which is hard to do in the IT businesses if you don’t have the right idea, you can design a paradigm that will be verifiable.
“What a lot of companies try to do is get to the market as quickly as they can and maybe have less functionality in their designs and products, and once they have revenue coming in they use that revenue to do some clinical research or evaluate a product in a way that will allow them to make more direct diagnostic or stronger health claims.
“If you approach the FDA and seek their advice, they can be constructive players,” Scheineson explains. “The two rules of thumbs are: (1) don’t ask open-ended questions, have a regulatory framework in mind that is justified and get them to endorse that if you can and (2) if you ask them a question, you got to listen to their answer.”