Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in mHealthIntelligence, in “FDA Eases Guidelines for New mHealth, Telemental Health Treatments,” by Eric Wicklund.
Following is an excerpt:
April 21, 2020 – With the Coronavirus pandemic putting a strain on the mental health of both patients and providers, federal officials are easing up on regulations for mHealth and apps and telehealth services to push more telemental health services to market. …
The FDA’s action drew praise from Bradley Merrill Thompson, an attorney and digital health expert with Epstein Becker Green, who noted both the short-term and long-term effects.
“FDA has taken some very practical steps to address a rather urgent need,” he said in a recent e-mail.
“What’s interesting about this guidance document is that FDA seems to be doing simultaneously two different things,” he said. “First, for the duration of the COVID 19 emergency, they are essentially waiving most regulatory compliance for what they would call computerized behavioral therapy devices, and even devices that do not meet that definition but are closely related. But second, it would appear that FDA is also on a more permanent basis beyond the end of this COVID 19 emergency clarifying the scope of what constitutes wellness products. I consider both steps hugely important.”
Thompson has in the past been critical of the FDA, who he says mandate more clinical testing than necessary for certain telemental health apps and devices. Relaxing those requirements during an extreme situation, he says, “is a very practical reaction.”
He further points out that the FDA is keeping some requirements in place – including verification, validation and hazard analysis – so that digital health companies can’t simply create something from scratch and push it onto the market.
“This guidance addresses a truly urgent need,” he concludes. “I think just about everyone appreciates that social distancing as well as the economic stresses that are impacting people today are extraordinary. It also addresses the common sense need to create vehicles that allow people to get some help when they cannot visit their regular doctor or other health professional.