HHS Finalizes Two Rules to Promote Patient Control and Access to Health Data

On March 9, 2020, the Department of Health and Human Services (HHS) finalized two rules aimed to promote patient access to their health data. One rule, the Interoperability and Patient Access Final Rule, was issued by the Centers for Medicare & Medicaid Services (CMS) and can be accessed here. The other rule, the Cures Act Final Rule, was issued by the Office of the National Coordinator for Health Information Technology (ONC) and can be accessed here. HHS believes these final rules will grant patients true access to their health data, an oft pursued goal for HHS and an integral aspect of the shift towards a value-based healthcare system. The final rules also contribute to fulfilling Executive Order (EO) 13813, issued on October 12, 2017. The EO states, in part, that government rules should work to improve access to and the quality of information necessary for making informed healthcare decisions.

Boosting Patient Access.

A major overarching goal of both final rules is to permit patients to access their health data to promote patients’ ability to coordinate their own care. For instance, the ONC final rule is designed to drive interoperability and require use of modern computing standards and application programming interfaces (APIs) to provide patients with access to their health information via smartphone apps.

At the core of each final rule is a focus on patient control of their own electronic health information (EHI). In fact, the ONC final rule requires that patients  can access their EHI at no cost. The ONC believes such control will drive patient-facing healthcare IT economy. The final rules require both public and private entities to share health data with patients and other parties, while maintaining a continued focus on the security of patient health information (PHI).

The ONC Final Rule

The ONC final rule is designed to drive interoperability and require use of modern computing standards and application programming interfaces (APIs) to provide patients with access to their health information via smartphone apps. The ONC final rule explicitly distinguishes between what constitutes information blocking practices (e.g., anti-competitive behaviors) and what reasonable and necessary activities do not constitute information blocking. The ONC final rule is also designed to permit providers using certified health IT to communicate about health IT usability, user experience, interoperability and security including screenshots and video (with certain limitations).

The ONC final rule also requires electronic health records (EHRs) to provide clinical data to promote new business models of care. This aspect of the ONC final rule is meant to advance common data through the U.S. Core Data for Interoperability (USCDI).

The CMS Final Rule

The CMS final rule is designed to require insurance plans to share health data with their patients in a form accessible by smartphone.

For more information regarding HHS’ final rules promoting patient control and health data access, please contact Clinton Mikel, Esq. at (248) 996-8510 or by email at CMikel@thehlp.com.