The Office of the National Coordinator for Health Information Technology (ONC) has introduced significant updates to the healthcare regulatory landscape through the (HTI-1) Final Rule Certification Program Updates, Algorithm Transparency, and Information Sharing, released in December 2023. Similarly, Germany’s healthcare system is undergoing transformations to enhance interoperability and data exchange, as detailed in our article on ISiK Compliance. Key changes include the requirement to implement US Core Data for Interoperability (USCDI v3) by January 1, 2026, among others.
After attending Drummond’s webinar on the changes in requirements for ONC certification and examining the ONC materials on new rules, Edenlab analysts have concluded and explained the most significant updates to help you navigate the ONC’s Cures Act Final Rule and related deadlines for regulatory compliance.
What to do now to ensure compliance in 2027?
The volume of these changes can be overwhelming for EHR developers, who must simultaneously meet new requirements while continuing to maintain their systems. However, ensuring compliance with ONC’s HTI-1 final rule requirements in 2027 requires considering the stages for it now.
You can see the growing role of the FHIR standard in regulatory requirements. Despite the intricacies of these changes, Edenlab’s expertise in creating regulatory-compliant solutions, especially ONC-compliant ones, guarantees a smooth transition and ongoing compliance with evolving regulations. Significantly, we’ve already helped our clients successfully achieve ONC certification (for more details, check out details about Deploying a FHIR-Compliant Solution with a Custom Clinical Data Mapper for Elation Health).
Our ONC and HIPAA-compliant Kodjin FHIR Server aligns with any version of the US Core Profile since we monitor every regulatory change to ensure our product is up-to-date, ready for newer US Core versions, and meets all healthcare requirements for security and interoperability.
Contact us to discuss navigating these shifts effectively while ensuring seamless compliance and interoperability under the ever-changing regulatory landscape.
