Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, was quoted in an article titled “Role of FDA in Regulating Clinical Decision Support Tools Debated at Meeting.”
Following is an excerpt:
Federal regulators, health information technology developers and hospital administrators May 14 debated which types of clinical decision support software (CDS) tools should be regulated by the Food and Drug Administration during the second day of a three-day public hearing on the Department of Health and Human Services’s proposed strategy for regulating health IT.
Technology developers and health IT industry association representatives said the FDA should distinguish between CDS designed to give information to health-care providers during a clinical intervention and those that send data directly to medical devices and other health IT systems, such as electronic health records, to determine their risk to patients. ?…
Health IT industry associations and providers during the hearing debated how to distinguish between health management CDS and medical device or other high-risk CDS functions. Health care attorney Bradley Merrill Thompson, with Epstein Becker & Green PC in Washington, said the highest-risk CDS tools act automatically on other software, creating what he called an “accessory bond.” What is problematic, he explained, is that users of those products aren’t consulted before changes are made that affect the software.
He said CDS tools that simply provide information to physicians should be considered moderate risk because the clinician can act as a “learned intermediary” to catch any possible errors from the CDS tool.
Thompson said an exception to this could be when providers depend on CDS software to perform a calculation they couldn’t reasonably perform themselves, such as determining radiation amounts for procedures.