Unveiling HTI-1: A New Era for AI Transparency in Healthcare
The Health Data, Technology, and Interoperability (HTI-1) Final Rule is transforming the healthcare landscape. Designed to advance the interoperability, transparency, and ethical use of electronic health information (EHI), this groundbreaking regulation is shaping the future of AI in healthcare.
What Is HTI-1 and Why It Matters
The HTI-1 Final Rule implements provisions of the 21st Century Cures Act and introduces updates to the ONC Health IT Certification Program. The goal? To ensure that AI algorithms integrated into certified health IT systems are transparent, fair, and effective. These systems currently support over 96% of U.S. hospitals and 78% of office-based physicians, making this regulation essential for the healthcare ecosystem.
Key Highlights of HTI-1
1. Algorithm Transparency
For the first time, the HTI-1 rule mandates transparency for AI and predictive algorithms in certified health IT systems. Clinical users will now have access to critical baseline information, empowering them to assess algorithms for:
Fairness
Appropriateness
Validity
Effectiveness
Safety
This transparency ensures responsible AI use and supports informed decision-making in clinical settings.
2. Enhanced Information Blocking Requirements
The regulation revises the definition of information blocking and introduces new exceptions to promote secure, standardized exchange of EHI. These updates align with the Trusted Exchange Framework and Common Agreement (TEFCA), fostering better communication across healthcare organizations.
3. The DIHI Model Facts Label
The Duke Institute for Health Innovation (DIHI) has been a pivotal force in shaping AI transparency. Their Model Facts label, first published in 2020, provides a standardized framework for evaluating AI models. This label has been updated to meet HTI-1 requirements and serves as a template for AI product labels under a Creative Commons Attribution 4.0 license.
What the Future Holds
Starting January 1, 2025, AI products distributed by EHR vendors must disclose 31 source attributes, ensuring compliance with HTI-1 standards. This transparency will help healthcare organizations evaluate AI tools effectively and responsibly integrate them into clinical workflows.
As pioneers in the field, Asher Informatics is actively assisting healthcare delivery organizations and AI vendors in aligning with HTI-1 compliance. Their expertise ensures that these latest changes are implemented seamlessly.
If you are not sharing these source attributes summarized listed here, contact us as we can help.
Why This Matters to You
Whether you're a healthcare provider, AI developer, or patient, the HTI-1 rule represents a critical step toward ethical and effective AI integration. It bolsters trust, improves patient outcomes, and ensures that healthcare technology keeps pace with innovation—all while prioritizing safety and fairness.
Conclusion
The HTI-1 Final Rule is more than just regulation—it's a vision for a transparent, interoperable, and patient-focused healthcare system. We applaud DIHI's efforts to create tools like Model Facts label as we all work towards making the future of AI in healthcare safer, and more collaborative than ever.
For more information, visit the official HTI-1 website or explore the updated Model Facts label template provided by DIHI.