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 "Health Industry Groups Largely Support Proposed Framework for Health IT Oversight."
Following is an excerpt:
Health-care industry groups generally support the proposed framework released earlier this year by three federal agencies for overseeing health IT products, saying the report rightly called for limited regulation. Overwhelmingly, the nation's top health-care groups support the Food and Drug Administration Safety and Innovation Act (FDASIA) working group's recommendation that health information technology products be regulated by the FDA as medical devices in rare circumstances and when they pose the greatest risks to patients.
While some groups have lobbied for limited oversight of CDS, others have called for more scrutiny because the products might be used in making diagnostic and treatment decisions.
Bradley Merrill Thompson, an attorney with Epstein Becker and Green PC, in Washington, said in comments on the framework that many questions about CDS remain unanswered in the proposal. Thompson represents health IT industry groups that include the CDS Coalition, the CDS Consortium, Continua Health Alliance, the mHealth Regulatory Coalition and the Wireless-Life Sciences Alliance, all of which signed onto the comment letter. He said the decision to regulate CDS software should involve a three-part test that asks:
- whether a CDS product meets the FDA definition of a medical device;
- whether the product is risky enough to merit regulation; and
- whether the risk posed by the product is substantial.
