HIMSS calls for Modest Implementation Deadline Delay for New Requirement in ONC Certification Proposed Rule

HIMSS recommended a modest delay in the implementing and reporting timeline for the sweeping changes proposed by the Office of the National Coordinator’s (ONC) Health Information Technology (IT) Certification Program.

The delay would accommodate the volume of work required to successfully develop, implement, and test these certification changes across the healthcare ecosystem, without risks to quality, safety, and patient privacy. Healthcare Information and Management Systems Society (HIMSS) is a global advocate for digital health transformation.

ONC released the Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing Proposed Rule, widely known as HTI-1, on April 18, 2023. HTI-1 proposed a Dec. 31, 2024, implementation deadline for a wide range of new certification criteria for Certified Health IT, including:

• Raise the baseline version of the United States Core Data for Interoperability (USCDI) from Version 1 to Version 3

• Update existing certification criteria including decision support interventions (DSI); ensure patient requested restrictions in sharing their electronic health information; standardize “Sex for Clinical Use” (SFCU) “Name to Use” and “Pronouns” for documentation; electronic case reporting; and the use of standardized Application Programming Interface (APIs) for patient and population services

• Launch the Electronic Health Record (EHR) Reporting Program or “Insights” for manufacturers of Certified Health IT to maintain their certification, with reporting kicking off in 2025

• Modify exceptions to information blocking regulations

In a public comment letter submitted to ONC on June 20, 2023, HIMSS stated its support of the proposed new and revised certification criteria, adoption standards, and launch Insights program. These changes will facilitate a nation-wide interoperability.

HIMSS, however, called for a modest delay of one year for the implementation deadline for most of the new certification requirements, pushing it to Dec. 31, 2025. This would allow for time to successfully complete the extensive work required to implement and test the new and revised criteria across the healthcare ecosystem in a manner ensuring that quality, safety and patient privacy are not compromised; and that healthcare delivery sites caring for underserved communities aren’t left behind.

HIMSS also calls on ONC to delay the adoption of the decision support intervention and predictive decision support to Dec. 31, 2026. This would allow time for sufficient real-world testing and the development of standardized methods for capturing source attribution for DSI by end-users and third-party manufacturers.

 Among the key points of the HIMSS response:  

• HIMSS supports the adoption of all proposed certification criteria and standards as a means to enable nation-wide interoperability.

• HIMSS does not want healthcare providers acting in good faith to be penalized because of insufficient implementation time because of delays associated with standards development, vendor timelines, and staffing shortages impacting the healthcare community.

• HIMSS recommends a revised, two-stage implementation timeline for proposed new certification criteria, standards adoption, and reporting:

Year 1 Implementation and Reporting

• All certification criteria, including Fast Healthcare Interoperability Resources 1 (FHIR), and Bulk FHIR and other than DSI, must be implemented in Certified Health IT no later than Dec. 31, 2025.
• Insight reporting on Stage 1 certification criteria will kick off in October 2026. FHIR and Bulk FHIR certification criteria reporting would be required as a part of 2026 reporting.

Year 2 Implementation and Reporting

• DSI and Predictive DSI certification criterion must be implemented in Certified Health IT no later than Dec. 31, 2026
• Insight reporting on Stage 2 (DSI/Predictive DSI) criteria will kick off in October 2027
• This modest delay will allow:
  • A thoughtful, complete, and realistic implementation cycle for all healthcare providers utilizing Certified Health IT consistent with market supplier and healthcare system capabilities at the present time
• Real-world testing of privacy protections for data elements captured in United States Core Data for Interoperability (USCDI) v3, which are often considered sensitive information, i.e., social determinants of health, sexual orientation, and gender identity
• Additional time to convene the healthcare community to develop a rules-driven, standardized mechanism for delivering the data segmentation required to ensure patient requested restrictions to their electronic health information
• Additional time to develop a standardized approach for capturing source attribution for decision support interventions, especially when submitted by third parties and end-users not subject to certification requirements; and a feasibility study to determine the value of including a user-interface to provide feedback on decision support interventions
• And the adoption of a regimented cadence for publishing additional substantive changes to the Certification program, including assurance that substantive changes will include a minimum 18-month implementation period
• HIMSS calls on the healthcare community to start the work of implementing these proposed changes as soon as a final rule is published and encourages the industry to be nimbler in adopting future advancements facilitating nation-wide interoperability.

HIMSS also calls on ONC to:

• Collaborate with CMS to incentivize end-user participation in real world testing through scoring bonuses in CMS value-based care and quality reporting programs
• Publish a long-term roadmap for implementing USCDI+, a version of USCDI which includes the nuanced clinical terminology to support the collection of digital quality measures in the future
• Invest in improving processes for standards and implementation guide development
• Note that several sectors, particularly those caring for the underserved and elderly populations are poorly positioned to take on additional cost and regulatory burden associated with the sweeping proposed changes

HIMSS is encouraged by ONC’s proposed steps to deliver nationwide interoperability. HIMSS welcomes an ongoing dialogue with ONC to digitally transform the healthcare ecosystem of the United States through the power of information and technology.