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 “Critics Attack FDA for Overly Modest Health IT Regulatory Framework.”
Following is an excerpt:
It’s not often that a regulatory body is seen as under-reaching, rather than over-reaching, but that’s the theme that emerged at a workshop for health care information technology groups, government entities and patient safety organizations on Wednesday.
Speakers at the meeting praised the spirit of a government-issued “risk-based regulatory framework” for its willingness to allow the health IT industry to regulate itself so as not to stifle innovation. But they raised doubt as to whether the report had gone too far. It was released in April by the ONC, the FCC and the FDA.
Health IT companies and software aren’t sophisticated enough yet to know which standards to apply, many speakers said, and given the potential risks of the technology, government mandates are required to establish common best practices across the industry. Just as cars and airlines have government-delineated safety standards, health IT will need them, as well, they argued. …
In a discussion about identifying high-risk clinical decision support software, attorney Bradley Merrill Thompson of D.C.-based Epstein Becker & Green said the FDA needs to return to creating a guidance document for CDS, which the agency started to do in 2011.
Thompson represents the mHealth Regulatory Coalition, which wants the FDA to publish final guidance on mobile medical apps as soon as possible. He said he was disappointed that the report didn’t include language on mHealth guidance.