ONC, CMS Release Proposed Rules on Interoperability, Information Blocking, Patient Access

February 15, 2019

On February 11, the Office of the National Coordinator for Health IT (ONC) released its long-anticipated proposed rule on information blocking, interoperability, and the Health IT Certification program.

The proposed rule would implement certain provisions of the 21st Century Cures Act, including conditions and maintenance of certification requirements for health information technology (health IT) developers under the ONC Health IT Certification Program (Program), the voluntary certification of health IT for use by pediatric health care providers, and reasonable and necessary activities that do not constitute information blocking. It would also modify the 2015 Edition health IT certification criteria and Program in additional ways to advance interoperability, enhance health IT certification, and reduce burden and costs.

According to ONC, the proposed rule is designed to increase innovation and competition by giving patients and their healthcare providers secure access to health information and new tools, allowing for more choice in care and treatment. It calls on the healthcare industry to adopt standardized application programming interfaces (APIs), which will help allow individuals to securely and easily access structured electronic health information (EHI) using smartphone applications. This provision requires that patients can electronically access all of their EHI (structured and/or unstructured) at no cost. Finally, to further support access and exchange of EHI, the proposed rule implements the information blocking provisions of the Cures Act. The rule proposes seven exceptions to the definition of information blocking.

At the same time, CMS released a proposed rule on interoperability and patient access. According to CMS, the proposed rule is intended to signal their commitment to the vision set out in the 21st Century Cures Act and Executive Order 13813 to improve access to, and the quality of, information that Americans need to make informed health care decisions, including data about health care prices and outcomes, while minimizing reporting burdens on affected plans, health care providers, or payers. Some of the proposed changes and updates include patient access to data through APIs, health information exchange and care coordination across payers, access to published provider directory data, care coordination through trusted “exchange networks,” and a provider digital contact information index.

ASCO is analyzing both these rules and will be responding to both agencies during the open notice-and-comment rulemaking time period. Please stay tuned to ASCO in Action for the latest updates.