Nick Barger, PharmD

5 Things to Know About the ONC HTI-1 Proposed Rule

You might have heard that the Office of the National Coordinator (ONC) for Health Information Technology recently released a proposed rule aimed at advancing healthcare through interoperability and technology upgrades. If you’ve been wondering what this means for health IT vendors, we have you covered. The ONC published “Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing” (HTI-1) on April 11, 2023, to update implementation related to the 21st Century Cures Act, expand interoperability, and promote health equity.  

 

Here are the five main themes of the proposed rule and what they mean for electronic health record (EHR) and health IT developers. 

 

1. Goodbye Certification Editions, Hello ‘Edition-less’ Certification! 

The ONC is shaking things up by adopting a more flexible, rolling certification criteria called “edition-less” certification. This way, health IT developers can more quickly adopt new standards and work hand in hand with healthcare professionals to customize updates for their systems. It also makes things easier for other Health and Human Services (HHS) programs that rely on ONC health IT certifications. To help everyone switch over to this “edition-less” style, the ONC is proposing dates to phase out the previous, year-themed editions.  

 

2. New Certification Standards and Functionality Updates: What’s the Scoop? 

By adding new required functions to the health IT certification program, the ONC aims to improve the functionality and interoperability of health IT systems by enhancing the exchange of health information to improve patient safety and empower patients to access their own health data. The ONC also is reducing barriers for health IT developers to adopt newer versions of standards so providers may experience the benefits more quickly. 

 

3. Decision Support Intervention (DSI) and Algorithmic Transparency: A Must in the Age of AI 

As healthcare increasingly relies on algorithms and artificial intelligence, the ONC is paying close attention to transparency and accountability. The proposed rule introduces requirements to ensure algorithms don’t contribute to health disparities or decrease health equity, DSIs (such as clinical decision support tools and other AI-driven applications) include in-workflow access to supporting evidence for unbiased decision-making, and new vendor reporting requirements to enhance patient safety.

  

4. Welcome to the New Insights Condition and Updated Maintenance of Certification Requirements (EHR Reporting Program) 

The Cures Act, signed into law in 2016, established the EHR Reporting Program, which mandates transparent reporting to assess the performance of certified health IT systems. The proposed rule establishes a new “Insights Condition” and updates the maintenance of certification requirements. By requiring EHR developers to submit system performance data, the ONC can evaluate the real-world impact of these systems and ensure they meet the needs of healthcare providers and patients in future rules.  

 

5. Information Blocking Rules: Time for an Update! 

To further promote interoperability and reduce barriers to health information exchange, the proposed rule includes updates to clarify exceptions to information blocking, provide additional guidance to healthcare providers, and strengthen enforcement of these rules to ensure seamless data flow across the healthcare ecosystem.  

 

What Does It All Mean? 

The ONC’s proposed rule is a significant step toward the continued evolution of healthcare powered by technology and interoperability. With these changes, we can expect more access to health information and better collaboration among providers to improve patient care. 

HHS continues to engage in ongoing dialogue and collaboration with the industry to balance maintaining a robust regulatory environment and supporting the dynamic needs of healthcare providers and patients. Over the next few years, we can expect a steady flow of rulemaking proposals.  

These changes—and others that are sure to follow—will affect your business and your customers. Stay tuned for future regulatory updates to be sure your platform is compliant.  

Read the proposed rule here. Don’t forget: the public comment period closes June 20, 2023, giving us all a chance to share our thoughts and help shape the final rule. Happy commenting!