In today’s interconnected healthcare landscape, the seamless exchange of electronic health information is paramount. This necessity brings to the forefront the critical question: Are There Regulations Around Health Care Share Programs? The answer is a resounding yes, and a significant development in this area is the ONC’s HTI-1 final rule. This rule, stemming from the 21st Century Cures Act, introduces vital updates to the ONC Health IT Certification Program, aiming to enhance interoperability, transparency, and access to electronic health information.
A groundbreaking aspect of the HTI-1 final rule is its focus on Algorithm Transparency. For the first time, regulations are being established for artificial intelligence (AI) and predictive algorithms embedded within certified health IT. Given that ONC-certified health IT supports a vast majority of hospitals and physician offices nationwide, these transparency requirements are poised to promote responsible AI usage. Clinicians will gain access to essential information about the algorithms they rely on, enabling them to assess these tools for fairness, validity, and safety, ultimately fostering better and more informed decision-making in patient care.
The rule also adopts USCDI Version 3 as the new standard for the ONC Health IT Certification Program by January 1, 2026. This update to the United States Core Data for Interoperability emphasizes the importance of more accurate and comprehensive patient data. USCDI v3 is designed to advance equity in healthcare, reduce disparities, and bolster public health data interoperability by improving the quality and completeness of patient characteristic data exchanged.
Further strengthening health information sharing, the HTI-1 final rule brings Enhanced Information Blocking Requirements. By refining definitions and exceptions related to information blocking, the rule aims to facilitate smoother information exchange. A notable addition is a new exception encouraging secure, standards-based electronic health information exchange under the Trusted Exchange Framework and Common Agreement (TEFCA). This measure is intended to streamline and secure the sharing of vital patient data across different healthcare entities.
Finally, to ensure accountability and provide insights into the practical application of certified health IT, the rule implements New Interoperability-Focused Reporting Metrics. This “Insights Condition” mandates developers of certified health IT to report specific metrics as part of their program participation. These metrics will offer valuable visibility into how certified health IT is being utilized in real-world care delivery settings, contributing to continuous improvement in interoperability and health information exchange.
In conclusion, the ONC’s HTI-1 final rule represents a significant stride in regulating health information sharing. By focusing on algorithm transparency, data standardization with USCDI v3, enhanced information sharing rules, and interoperability metrics, this rule sets a new benchmark for how electronic health information is accessed, exchanged, and utilized across the healthcare ecosystem, ultimately benefiting both providers and patients.
