HHS, ONC finalize interoperability rules, mandating health record access

Patients will soon have free digital access to their health records thanks to the finalization of two new interoperability rules finalized by HHS and the National Coordinator for Health Information Technology (ONC). The rule also dictates how patient information is exchanged across the healthcare system.

HHS and ONC proposed the new interoperability and information blocking rules in early 2019, implementing provisions based on the 21st Century Cures Act and following the MyHealthEData initiative.

One of the biggest provisions of the rule is providing free access to health records to patients through application programming interfaces (APIs).

The proposed rule was met with some opposition from healthcare providers and vendors, including Epic, one of the largest EMR companies. Epic CEO Judy Faulkner penned a letter to HHS Secretary Alex Azar in February arguing against the interoperability rule and asking for a longer timeline to comply with the standards. About 60 other health systems signed on to the letter.

Other critics of the rule have voiced concern over patient privacy and security. The proposed rule received roughly 2,000 comments during the public comment period, with many also addressing the privacy issue, according to CMS Administrator Seema Verma, who spoke with reporters Monday morning about the final rule. The agencies took those comments into consideration and enhanced security requirements in the final rule, “specifically around API developers,” she said.

“ONC’s final rule established secure, standards-based [API] requirements to support a patient’s access and control of their electronic health information,” the announcement reads.

The overall goal of the rule is to avoid information blocking that can be considered anti-competitive behaviors by healthcare providers, instead allowing free and easy flow of health information. Payers will be required to implement the Patient Access API beginning Jan. 1, 2021.

“Patients own their data,” Verma said Monday.

The rule also requires payer-to-payer data exchange by 2021, which means if a patient moves to a new plan, their old plan must send all their health information with the patient.

One of the biggest changes for hospitals is likely new notification requirements as part of the conditions of participation (CoPs), which dictate requirement for hospitals to meet in order to participate in Medicare/Medicaid. As part of the final rule, hospitals will have to notify another healthcare facility or community provider or practitioner when a patient is admitted, transferred or discharged. The rule, which goes into effect in six months, will enhance care coordination and aims to improve patient outcomes with better follow-up care.

See the ONC final rule here.

Find the final rule from HHS here.