Apr 8
2024
Concerns and Uncertainty In the Wake of Sweeping HTI-1 Rule
By Stephanie Jamison, Executive Committee Chair and Public Policy Leadership Workgroup Vice Chair, EHR Association.
In the months that have passed since the Office of the National Coordinator for Health Information Technology (ONC) issued the final Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) rule, the health IT sector has been working diligently to meet the earliest compliance timelines even as it continues an in-depth analysis of the regulatory impact on both developers and the providers who use certified technology.
For the EHR Association, that analysis has given rise to several concerns and ambiguities that need to be addressed to ensure HTI-1, which was published in the Federal Register on Jan. 9, 2024, achieves ONC’s stated goal of advancing patient access, interoperability, and standards.
The new regulations are an important step toward implementing key provisions of the Cures Act and enhancing ONC’s Certification Program. However, there are several aspects of HTI-1 that we believe may have unintended consequences for certified EHR technology (CEHRT) developers and users.
Decision Support Interventions (DSI)
One significant area of concern is with regulations around DSI, which carry the earliest compliance deadlines. While the scope of DSI requirements was narrowed in the final rule, many of the compliance timelines are still insufficient for developing, testing, and implementing the necessary upgrades.
The first deadline is Dec. 31, 2024. That is when CEHRT developers must deliver DSI capabilities to maintain certification. Achieving compliance will necessitate substantial development efforts, including in novel areas for the program like AI/ML for predictive DSIs. Other areas of concern include requirements for:
- Developing an end-user feedback function for evidence-based DSIs, including an export capability for machine-readable formatted feedback data.
- Developing support for a significantly expanded set of data concepts for which selection of evidence-based DSIs must be available.
- Developing support for enabling the selection of predictive DSIs using any data expressed in the USCDI.
- Producing nine new source attribute data points for all evidence-based DSIs supplied by developers and more than 30 source attribute data points for all developer-supplied predictive DSIs.
- Developing support for customer users to access and modify source attribute information provided by developers for those DSIs they supply.
- Developing support for enabling customer users to record and modify their own source attribute entries in the system for DSIs they create or implement on their own.
- Developing detailed intervention risk management policies and procedures for ongoing management of predictive DSIs supplied by developers.
Meeting these requirements within the 12-month timeframe presents a formidable challenge for CEHRT developers – a challenge amplified by the lack of a certified companion or other resource guide to support developers with compliant updates. Also coming into play are current CMS requirements governing providers’ use of CEHRT that would force developers to deliver updated technology to their customers well in advance of the ONC deadline.
To alleviate these challenges, we are urging ONC to consider implementing an enforcement discretion period of six to 12 months. This would provide much-needed relief for CEHRT developers and healthcare providers alike, while still ensuring that meaningful progress is made toward real-world implementation of DSI provisions by the 2024 deadline.