The Office of Management and Budget is reviewing a proposed one-year delay for updates to the Common Rule that have been in limbo since the Trump administration took office.
Changes to the Common Rule were finalized by the previous administration on Barack Obama’s last day in office and then quickly put on hold by the White House as part of a broad regulatory freeze. The final rule included a number of modernized changes to the 1991 regulation that oversees the ethics of biomedical and behavioral research. The changes were scheduled to take effect on Jan. 1, 2018.
OMB indicated it is reviewing a proposal from the Department of Health and Human Services that would delay implementation for one year “while allowing the use of three burden-reducing provisions during the delay year.” The review was first reported by Politico.
The American Medical Informatics Association (AMIA), which had grown impatient over the lack of clarity regarding the final rule said it “appreciates and supports” the one-year delay and looks forward to “learning which provisions will be available for use before January 2019.”
“Combined with rapid adoption of electronic health records (EHRs) by care providers and dramatic improvements in computing technology, we believe the final revisions to the Common Rule are necessary to improve discovery of new health insights and advance healthcare transformation,” the group said in an emailed statement.
In June, AMIA sent a letter to then-HHS Secretary Tom Price and OMB Director John Mulvaney asking the officials to finalize updates to the Common Rule, noting that it would allow researchers to access and leverage patient data to drive new medical discoveries. The organization argued that the updates were critical to the success of national research initiatives like the National Institutes of Health's "All of Us" campaign.