The Department of Health and Human Services, along with 15 other federal agencies, has issued a six-month delay to an Obama-era rule that provides health informatics researchers with greater access to EHR and patient-reported data.
HHS posted the interim final rule (PDF) to the Federal Register on Wednesday, just days before updates to the Federal Policy for the Protection of Human Subjects, known as the Common Rule, were scheduled to take effect. The updates were issued as a final rule during President Barack Obama’s last days in office with a Jan. 19, 2018 implementation date. But a regulatory freeze issued by the Trump administration left the rule in limbo.
However, the notice also left open the possibility the rule could be delayed past July, noting that federal agencies are "in the process of developing a proposed rule to further delay implementation of the 2018 Requirements." In October, the Office of Management and Budget was reviewing a HHS proposal to delay Common Rule updates for one year.
Wednesday’s update pushes the compliance date to July 19, 2018, which came as a relief to the American Medical Informatics Association (AMIA), which advocated for a delayed compliance date. The trade group had grown impatient over the last year with the lack of clarity from HHS regarding the rule.
“The six-month compliance delay is a necessary step towards getting this critical research rule back on track after languishing for a full year,” AMIA said in a statement emailed to FierceHealthcare.
Among other changes, the 2017 updates will allow researchers to obtain broad consent for patient-reported data, including real-time data generated from mobile devices. It also allows permits access to EHR data to conduct low-risk studies on quality care.
“While the additional time will allow federal officials and the clinical research community to develop a coordinated implementation strategy and much-needed guidance, it will be important that Common Rule provisions meant to improve the availability of data for secondary research, while strengthening protections for research participants, proceed in a timely fashion,” AMIA added.