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 "Clinical Decision Support Remains Regulatory Gray Area."
Following is an excerpt:
Until the Food and Drug Administration provides further clarification on what types of applications would be viewed as clinical decision support, this software category will remain a regulatory gray area leaving developers unclear as to how to market these products. That is the consensus of stakeholders who met May 14 as part of a public meeting on a risk-based health IT regulatory framework proposed by federal agencies. ?...
"In my opinion, what's necessary now is detail," said Bradley Merrill Thompson, general counsel for the CDS Coalition, a group of stakeholders consisting of software providers, IT infrastructure manufacturers, healthcare payers, hospitals and other providers, as well as medical device manufacturers and trade groups. "What we're looking for is FDA guidance and it needs to be written at a level of detail where an entrepreneur can sit down with what's written and figure out whether they are regulated or not." ?...
However, Thompson argued against passage of such a law. "Our fear is that another statute simply adds another high-level, hundred thousand foot thing to be interpreted, when really what we need is down here at the ten thousand foot level--specific guidance helping us understand what's in and what's out." Toward that end, he urged the FDA to complete the guidance development process the regulatory agency began in 2011, when it held a regulatory hearing on the topic of developing a CDS guidance document.
