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
Course Details
- smart_display Format
On-Demand
- signal_cellular_alt Difficulty Level
Intermediate
- work Practice Area
Health
- event Date
Thursday, June 13, 2024
- schedule Time
1:00 p.m. ET./10:00 a.m. PT
- timer Program Length
90 minutes
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This 90-minute webinar is eligible in most states for 1.5 CLE credits.
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.
Mr. Ouellette focuses his practice on representing healthcare organizations and is a Certified Information Privacy Professional–US (CIPP–US). He advises clients on a broad spectrum of healthcare regulatory, clinical trial, data privacy, PBM, healthcare technology, and transactional matters. Mr. Ouellette has experience drafting and negotiating healthcare services agreements and with technology transactions as well as counseling clients on state licensure rules, compliance with fraud and abuse laws, privacy and data protection issues, and the Interoperability and Information Blocking Rules under the 21st Century Cures Act.
Ms. Moundas is co-head of the firm's digital health initiative and actively participates in the data, privacy & cybersecurity group. She provides strategic, regulatory, compliance, and transactional advice to healthcare clients, including health systems, hospitals, academic medical centers, long-term care providers, pharmaceutical companies, digital health companies, and investors. As part of her practice, Ms. Moundas also counsels clients on privacy, security and breach matters, and focuses on emerging issues in the digital health space. Prior to joining the firm, she worked for over five years in the U.S. Department of Health and Human Services Office of Inspector General. Ms. Moundas’ work focused on the oversight of certain aspects of federal reimbursement policy, federal fraud and abuse and program integrity initiatives, the Medicare administrative appeals process, as well as national health information technology initiatives.
Mr. Palte advises healthcare providers, healthcare technology companies, health insurance companies, other healthcare organizations, and investors regarding a broad range of transactional and regulatory issues. He has advised regarding interoperability and information blocking requirements and federal ONC Health IT Certification Program requirements, among other matters. In addition, Mr. Palte has assisted private equity firms, healthcare providers, and technology companies with healthcare transactions, including analysis and advice related to fraud and abuse, data privacy and security, interoperability, information blocking, health IT certification, licensure, and corporate practice of medicine issues.
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.
- Introduction
- Final HHS-ONC rule
- AI and other predictive algorithm transparency
- Other Health IT certification program changes
- Updates to information blocking regulations
- Other considerations
- 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?
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