The Office of the National Coordinator for Health Information Technology (ONC) has enacted a final rule integral to the Electronic Health Record (EHR) Reporting Program under the 21st Century Cures Act. As a division of the Department of Health and Human Services (HHS), ONC has introduced the rule that includes new Conditions and Maintenance of Certification requirements for health information technology (health IT) developers engaged in the ONC Health IT Certification Program. The rule also updates various certification criteria and standards recognized by the Program.
The new rule focuses on enhancing the interoperability of health information technologies, promoting algorithm transparency, and supporting the access, exchange, and use of electronic health information (EHI). By updating the certification criteria for decision support interventions, patient demographics and observations, and electronic case reporting, the rule aims to enhance these aspects of health IT. The rule also introduces a new baseline for the United States Core Data for Interoperability (USCDI) standard, transitioning to Version 3. This change is indicative of an ongoing commitment to improve the functionality and efficiency of health IT systems. One main objective of the rule is the enhancement of information sharing under the information blocking regulations. This focus is intended to facilitate more straightforward and effective communication and data sharing within the healthcare sector. The ONC anticipates that these improvements will lead to better patient outcomes by enabling more efficient care coordination and management.
Effective from February 8, 2024, the rule’s implementation is expected to create a more competitive market, increasing consumer choice and encouraging innovation in the health IT sector. The updates to technical standards and certification criteria are seen as major steps in achieving these goals. The rule aligns with several administration executive orders, reflecting a governmental commitment to improving healthcare through enhanced technology. The adoption of USCDI v3 under the new rule will aid in achieving the objectives of Executive Orders focusing on public health data and health equity. The inclusion of data elements related to patient demographics and social determinants of health in USCDI v3 demonstrates a conscious effort to capture a range of patient characteristics. This inclusion is expected to help data users identify and address disparities in health outcomes, thereby contributing to the overall goal of health equity.
Incorporation by reference of certain publications listed in the rule was approved by the Director of the Federal Register, illustrating a milestone in the rule’s journey towards implementation. This step ensures that the rule is grounded in up-to-date, relevant literature and best practices in health IT.The ONC, under the guidance of Michael Lipinski of the Office of Policy, has taken positive steps with this final rule. The rule’s focus on improving interoperability, enhancing health IT certification, and reducing burden and costs for health IT developers and users is expected to have far-reaching impacts on healthcare. By streamlining processes and encouraging the adoption of modern, efficient technologies, the rule aims to contribute to the overall improvement of health outcomes and patient care.
