The Cures Act Final Rule: Interoperability-Focused Policies that Empower Patients and Support Providers

Elise Sweeney Anthony | March 9, 2020

Today, the Office of the National Coordinator for Health IT (ONC) announced the release of the 21st Century Cures Act: Interoperability, Information Blocking, and the ONC Health IT Certification Program Final Rule, which implements provisions from the 21st Century Cures Act passed by Congress. We thank Congress for the passage of the Cures Act and we look forward to implementing the final rule, which promotes patient access to their electronic health information, supports provider needs, advances innovation, and addresses industry-wide information blocking practices.

The need is evident. We use technology in so many facets of life. We send email, buy airline tickets, keep up with friends and family on social media, and order food from the convenience of our smartphones. Some of these tasks–like online banking–even involve sensitive data that is transmitted through application programming interfaces (APIs) using privacy and security protocols. Yet, obstacles continue to be encountered by patients trying to access their own electronic health information (EHI). It is time to change that paradigm.

The final rule supports the use of modern day technology to meet the needs of patients and providers. For example, the rule sets in place new provisions for certified health IT developers who now will be required to establish a secure, standards-based API for use by providers and to support a patient’s access to core data in their electronic health record.

Placing patients at the center of care is critical to all that we do at ONC and the final rule continues to advance that goal, including through provisions that support the ability of patients to securely and easily obtain their EHI at no additional cost when electronically accessed (e.g., by using the smartphone application of their choice).

Not only is the rule released today a step forward for patients, it advances the needs of health care providers as well. It will help accelerate innovation and competition, and will help deter the information blocking that many providers face when attempting to provide informed care for their patients. As part of bringing the information blocking provision to life, we finalized eight common sense exceptions that are responsive to public comment and that identify reasonable and necessary activities that do not constitute information blocking.

In addition, the final rule updates requirements for developers that participate in the ONC Health IT Certification Program, including the addition of provisions related to the ability of a health IT user to communicate regarding certain aspects of their health IT. For example, subject to certain limitations, we have finalized provisions that support the ability of health IT users to communicate visually through screenshots and video that identify particular issues—such as issues regarding usability, user experience, interoperability, and security.

The final rule also adopts the U.S. Core Data for Interoperability (USCDI), which sets a new baseline for interoperability and includes “clinical notes” among other data important for clinical care. The USCDI will help to improve the flow of EHI and help ensure that the information can be effectively understood when it is received. Over time, it will be updated to expand the baseline set of interoperable data available nationwide.

We received more than 2,000 comment submissions on the proposed rule. From the Health Information Technology Advisory Committee to the many individuals and organizations who submitted their thoughts, we thank each and every one of you. We also thank our federal partners who provided countless hours of input. We look forward to transitioning to the implementation phase of this rulemaking, which will help to both place data in the hands of the patient and advance the interoperability needed by care teams.

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