Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, was quoted in an article titled ""Healthcare IT Discussion Stresses Local Implementation, Legislation."
Following is an excerpt:
Government officials and the health IT world met for three days recently to discuss future regulation. The talk focused on the best way to oversee software after it has been installed, implemented, and customized, as well as the potential need for legislation to define the regulatory field. But a lot of specifics remain unaddressed, stakeholders say. ?...
Questions on the best way to oversee software after it has been installed, implemented, and customized, as well as the desirability of using legislation to define the regulatory field, remained major topics of discussion at a three-day government meeting this month on health information technology regulation.
The overall lack of new action items coming out of the three-day meeting frustrated Bradley Thompson, a lawyer with Epstein Becker Green and a member of the 2013 workgroup that advised the three agencies on the draft framework. "I'm afraid that there was no real new content at this meeting, just further discussion," he said, in an email to "The Gray Sheet." During the meeting, Thompson had requested guidance documents on clinical decision support software and wellness, but he did not feel he was provided with clear responses.
In the email, Thompson continued that the lack of guidance "does not help entrepreneurs figure out whether their products are in fact regulated," and that, as a result, they were delaying work on new technologies.
"The ball is squarely in FDA's court for now, but it would seem that Congress is poised to take over if the agency doesn't get moving," he concluded, saying that some companies were beginning to support legislation to do the job if the agencies do not.
