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Navigating New HHS-ONC Final Rule: Health Information Sharing and AI Use; Compliance Strategy and Policy Development

AI Transparency, Health IT Certification, Information Blocking Requirements, and More

Recording of a 90-minute CLE video webinar with Q&A

This program is included with the Strafford CLE Pass. Click for more information.
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Conducted on Thursday, June 13, 2024

Recorded event now available

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This CLE webinar will guide counsel through the U.S. Department of Health and Human Services Office of the National Coordinator for Health Information Technology's (HHS-ONC) final rule titled "Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing" (HTI-1 Final Rule) that significantly impacts health information technology (health IT) management, including use of artificial intelligence (AI), health IT certification, and information sharing across the healthcare industry. The panel will discuss possible state/local law interactions and offer best practices for policy and process compliance.


HHS-ONC recently issued the HTI-1 Final Rule with an effective date of Mar. 11, 2024. The HTI-1 Final Rule significantly impacts health IT management, AI transparency, and information sharing across the healthcare industry. Counsel should be aware of the new rule's requirements to ensure that their clients' policies and processes are in compliance with the new rule.

The HTI-1 Final Rule implements the Electronic Health Record reporting provision of the 21st Century Cures Act by establishing new and revised certification criteria for health IT developers, including the requirement to collect data on certain metrics in 2026 and report the metrics in 2027 as part of their participation in the health IT certification program to provide more insight into how certified health IT is used in support of care delivery.

Additionally, the HTI-1 Final Rule establishes the first of its kind transparency requirements for AI and other predictive algorithms that are part of certified health IT to promote the responsible use of AI and make it possible for clinical users to access a consistent baseline set of information about the algorithms they use to support their decision making and to assess such algorithms for fairness, appropriateness, validity, effectiveness, and safety.

The HTI-1 Final Rule also updates information blocking regulations to support information sharing by revising certain definitions that clarify the scope of who may qualify as certified health IT developers, as well as expanding information blocking exceptions codified in federal regulations.

Listen as our expert panel provides an in-depth look at the HTI-1 Final Rule and discusses its impact on the healthcare industry. The panel will also address state/local law considerations and offer best practices for compliance.



  1. Introduction
  2. Final HHS-ONC rule
    1. AI and other predictive algorithm transparency
    2. Other Health IT certification program changes
    3. Updates to information blocking regulations
    4. Other considerations
  3. Best practices for compliance


The panel will review these and other important issues:

  • How does the HTI-1 Final Rule differ from the April 2023 proposed rule?
  • How does the HTI-1 Final Rule impact the use of AI in the healthcare industry?
  • In what ways does the HTI-1 Final Rule clarify who is covered under the Information Blocking Rule? And how does the HTI-1 Final Rule impact healthcare information sharing?
  • What updates to the health IT certification program were made under the HTI-1 Final Rule?


Moundas, Christine
Christine Moundas

Ropes & Gray

Ms. Moundas is co-head of the firm's digital health initiative and actively participates in the data, privacy...  |  Read More

Ouellette, Pat
Pat G. Ouellette

Mintz, Levin, Cohn, Ferris, Glovsky and Popeo

Mr. Ouellette focuses his practice on representing healthcare organizations and is a Certified Information Privacy...  |  Read More

Zvi Palte, Gideon
Gideon Zvi Palte

Ropes & Gray

Mr. Palte advises healthcare providers, healthcare technology companies, health insurance companies, other healthcare...  |  Read More

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