• Skip to main content
  • Skip to secondary menu
  • Skip to primary sidebar
  • Skip to secondary sidebar
  • Skip to footer

  • Opinion
  • Health IT
    • Behavioral Health
    • Care Coordination
    • EMR/EHR
    • Interoperability
    • Patient Engagement
    • Population Health Management
    • Revenue Cycle Management
    • Social Determinants of Health
  • Digital Health
    • AI
    • Blockchain
    • Precision Medicine
    • Telehealth
    • Wearables
  • Life Sciences
  • Investments
  • M&A
  • Value-based Care
    • Accountable Care (ACOs)
    • Medicare Advantage

HHS Finalizes Rule for AI Transparency and Data Interoperability

by Fred Pennic 12/13/2023 Leave a Comment

  • LinkedIn
  • Twitter
  • Facebook
  • Email
  • Print

What You Should Know:

– The U.S. Department of Health and Human Services (HHS) took a major step forward in healthcare data sharing and artificial intelligence (AI) transparency with the finalization of the Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) rule.

– This rule was finalized after months of public feedback, promises to revolutionize how healthcare data is used and accessed in the United States.

Key Highlights of the HTI-1 Rule

This final rule builds upon the proposed rule released in April 2023 and addresses four key areas:

1. Algorithm Transparency

The HTI-1 rule establishes the first-ever nationwide requirements for transparency around artificial intelligence (AI) and other algorithms used in certified health IT. This affects the vast majority of healthcare providers, with ONC-certified health IT supporting over 96% of hospitals and 78% of office-based physicians.

This groundbreaking move aims to promote responsible AI by empowering clinicians with a consistent set of information about the algorithms they use to inform their decisions. This includes details about the algorithms’ fairness, appropriateness, validity, effectiveness, and safety.

2. USCDI Version 3

The rule adopts USCDI Version 3 (v3) as the new baseline standard for data exchange within the ONC Health IT Certification Program. This updated standard focuses on capturing more accurate and complete patient characteristics data, potentially reducing disparities and supporting public health data interoperability. Developers will have the option to move to USCDI v3 earlier than the January 1, 2026, mandatory adoption date.

3. Enhanced Information Blocking

The HTI-1 rule revises certain information blocking definitions and exceptions to facilitate data sharing between healthcare providers and patients. It also introduces a new exception to encourage secure and efficient data exchange under the Trusted Exchange Framework and Common Agreement (TEFCA).

4. New Interoperability Metrics

The rule implements the 21st Century Cures Act’s requirement for certified health IT developers to report specific metrics about how their products are used in healthcare delivery. This will provide valuable insights into the real-world impact of health IT and inform future improvements.

“The HTI-1 final rule is a major win for patients, providers, and the future of healthcare,” said Micky Tripathi, Ph.D., national coordinator for Health Information Technology. He emphasized the importance of continued efforts to build a stronger digital foundation for healthcare and ensure that technology serves to improve patient access, care quality, and well-being for all Americans.

The HTI-1 final rule is posted at HealthIT.gov/HTI-1 and will be submitted to the Office of the Federal Register (OFR) in the coming days

  • LinkedIn
  • Twitter
  • Facebook
  • Email
  • Print

Tagged With: Artificial Intelligence, Health IT Interoperability, patient-generated health data

Tap Native

Get in-depth healthcare technology analysis and commentary delivered straight to your email weekly

Reader Interactions

Primary Sidebar

Subscribe to HIT Consultant

Latest insightful articles delivered straight to your inbox weekly.

Submit a Tip or Pitch

Featured Interview

Reach7 Diabetes Studios Founder Chun Yong on Reimagining Chronic Care with a Concierge Medical Model

Most-Read

Evernorth Health Services Invests $3.5B in Shields Health Solutions

Evernorth Health Services Invests $3.5B in Shields Health Solutions

KLAS Report: Oracle Health Faces Customer Losses and Declining Satisfaction

KLAS Report: Oracle Health Faces Customer Losses and Declining Satisfaction

Tempus AI Acquires Digital Pathology Leader Paige for $81.25M

M&A:Tempus AI Acquires Digital Pathology Leader Paige for $81.25M

Mira Launches Ultra4™, the First At-Home Hormone Monitor with Lab-Quality Insights

Femtech: Mira Launches Ultra4™, the First At-Home Hormone Monitor with Lab-Quality Insights

Preparing for the ‘Big Beautiful Bill’: How Digitization Can Streamline Medicaid Eligibility & Social Care Delivery

Preparing for the ‘Big Beautiful Bill’: How Digitization Can Streamline Medicaid Eligibility & Social Care Delivery

How Healthcare CIOs Can Solve the Unstructured Data Crisis and Reduce Storage Costs

How Healthcare CIOs Can Solve the Unstructured Data Crisis and Reduce Storage Costs

Healthcare C-Suite Acknowledges AI Potential but Lacks Trust

Sage Growth Partners Report: Healthcare C-Suite Acknowledges AI Potential but Lacks Trust

EVERSANA and Waltz Health Merge to Redefine Pharmaceutical Commercialization

EVERSANA and Waltz Health Merge to Redefine Pharmaceutical Commercialization

Advancing Diabetes Care: Combating Burnout and Harnessing Technology

Advancing Diabetes Care: Combating Burnout and Harnessing Technology

White House Event Unveils CMS Health Tech Ecosystem Initiative

White House Event Unveils CMS Health Tech Ecosystem Initiative

Secondary Sidebar

Footer

Company

  • About Us
  • Advertise with Us
  • Reprints and Permissions
  • Submit An Op-Ed
  • Contact
  • Subscribe

Editorial Coverage

  • Opinion
  • Health IT
    • Care Coordination
    • EMR/EHR
    • Interoperability
    • Population Health Management
    • Revenue Cycle Management
  • Digital Health
    • Artificial Intelligence
    • Blockchain Tech
    • Precision Medicine
    • Telehealth
    • Wearables
  • Startups
  • Value-Based Care
    • Accountable Care
    • Medicare Advantage

Connect

Subscribe to HIT Consultant Media

Latest insightful articles delivered straight to your inbox weekly

Copyright © 2025. HIT Consultant Media. All Rights Reserved. Privacy Policy |