HHS' Office of the National Coordinator for Health Information Technology on Thursday released plans to extend compliance dates for its long-awaited information-blocking rule on account of the COVID-19 pandemic.
The agency issued an interim final rule delaying compliance deadlines for the rule's information-blocking provisions and health IT certification requirements until at least 2021.
"We are hearing that while there is strong support for advancing patient access and clinician coordination through the provisions in the final rule, stakeholders also must manage the needs being experienced during the current pandemic," ONC chief Dr. Don Rucker said in a statement.
"To be clear, ONC is not removing the requirements advancing patient access to their health information that are outlined in the Cures Act Final Rule. Rather, we are providing additional time to allow everyone in the health care ecosystem to focus on COVID-19 response," he added.
The delay is designed to give healthcare providers more time and flexibility to respond to the COVID-19 pandemic, according to ONC.
"Recognizing the urgency of this situation, and understanding that caring for patients with COVID-19 is of utmost importance, ONC is issuing this IFC to extend certain compliance dates and timeframes," the interim final rule reads.
Healthcare organizations since the spring had been raising concerns about the compliance deadlines outlined in the rule, arguing that their staffs were focused on COVID-19 response.
"The COVID-19 pandemic continues to monopolize our members' time and attention, and has strained resources, drastically limiting our members' ability to prepare," wrote a coalition of eight healthcare trade groups, including the American Hospital Association, the Federation of American Hospitals and the American Medical Association, in a September letter to ONC. "The time that had been set aside to focus on preparing for the pending information blocking and interoperability mandates has been overtaken by the all-encompassing effort required to fight this disease."
Not all healthcare stakeholders advocated for a delay. Some healthcare experts had cited COVID-19 as a reason to push forward with data-sharing regulations—not stall them.
Rucker on a call with provider groups Thursday said that the healthcare industry would have been in a better position to respond to COVID-19 had provisions from the information-blocking rule been implemented earlier, echoing an argument he had made in the spring; however, the agency has decided to push back deadlines given the reality of the pandemic, he said.
The extensions represent ONC's effort to balance patients' need for interoperability and data access with "the operational realities of health information technology resources," which have been stretched thin during the pandemic, he said.
On account of COVID-19, providers have had to reprioritize IT efforts, focusing staff and resources on building infrastructure for remote work and telehealth.
ONC's interim final rule marks the second time the agency has delayed enforcement of the information-blocking rule, which was released in March.
In April, the agency said it would exercise enforcement discretion for three months following initial dates outlined in the rule. CMS in April said it would give providers an additional six months to comply with provisions to improve data sharing included in its companion interoperability rule.
ONC's new rule, as an interim final rule, will become effective immediately upon publication in the Federal Register, skipping the notice of proposed rulemaking process.
ONC's interim final rule has not yet been published in the Federal Register. Public comments on the interim final rule will be due 60 days after the rule is published.
Under the interim final rule, providers won't be required to come into compliance with the regulation's information-blocking provisions until April 2021. Health IT vendors will also have to comply with conditions and maintenance of certification requirements related to application programming interfaces in April 2021.
New standardized API functionality won't be required until December 2022.
Rucker on a call with reporters Thursday said he doesn't anticipate further delays of the information-blocking and interoperability regulations, regardless of when the pandemic subsides. The extensions were determined based on the "healthcare IT capacities of providers," not the duration of the pandemic, he explained.
"The reason we came up with the extension, and the magnitude of the extension, was really based on the overall healthcare IT workload engendered by COVID," Rucker said. Now that providers have had time to focus on their immediate IT concerns in the wake of COVID-19, "this is really a time to focus on some of the provisions in the Cures Act," he said.
ONC's rule, a provision of the 21st Century Cures Act, is designed to make it easier for providers and patients to exchange health data, in large part by requiring providers to adopt standardized APIs—protocols that connect IT systems like electronic health records with third-party apps—and by defining what constitutes blocking health information.