Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Bloomberg BNA Health Care Daily Report, in “Industry Wants HHS Scrutiny of Health Information Technology Office,” by James Swann. (Read the full version – subscription required.)
Following is an excerpt:
If the ONC starts regulating EHRs for safety and effectiveness, an argument could be made that the FDA would be better positioned for the job, Thompson said.
Thompson said all clinical software needs to work together, and the riskiest clinical software is already regulated by the FDA as a medical device. So if interoperability issues need to be addressed in EHRs, it would make sense to have the FDA take care of this as well, Thompson said.
Interoperability refers to electronic health systems being able to exchange information easily and securely.
“ONC has been trying to figure out for a couple of years what it should be when it grows up, and I think this letter is raising legitimate questions about future structure and coordination,” Thompson said.
The problem of duplicated work and coordination was raised in the Food and Drug Administration Safety and Innovation Act of 2012, Thompson said, and while the FDA, the ONC and the Federal Communications Commission considered the issues, they never issued a final report.