News & Analysis as of

Final Rules Artificial Intelligence Department of Health and Human Services (HHS)

Baker Donelson

OCR Issues "Dear Colleagues" Letter Regarding AI in Medicine

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On May 6, 2024, OCR published the final rule interpreting and implementing Section 1557 at 45 C.F.R. § 92 (the Final Rule). The Final Rule regulates the use of patient care decision support tools, including AI algorithms for...more

McDermott Will & Emery

Section 1557 Patient Care Decision Support Tools, Anti-Discrimination Compliance: 12 Things to Consider

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In April 2024, the US Department of Health and Human Services (HHS) issued a final rule reinterpreting Section 1557 of the Affordable Care Act, which prohibits discrimination on the basis of race, color, national origin, sex,...more

Dechert LLP

Dechert Cyber Bits - Issue 68

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DOJ Final Rule: New US Restrictions on Nearly All Foreign Access to Personal Data - The National Security Division of the United States Department of Justice has issued a sweeping final rule that would prevent access to...more

Holland & Knight LLP

Holland & Knight Health Dose: December 17, 2024

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

BakerHostetler

What’s Hot in Healthcare: Digital Health Regulatory Update

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As the summer winds down, regulatory updates related to digital health services certainly do not appear to be showing any signs of cooling off. It has been a busy summer, and below we have summarized several key updates for...more

Holland & Knight LLP

Holland & Knight Health Dose: September 10, 2024

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....more

Proskauer - Health Care Law Brief

OIG Reports that Clinical Trials Lack Diverse Subjects: What Role Can Artificial Intelligence Play?

As the largest public funder of biomedical research in the world, the National Institutes of Health (“NIH”) annually funds over $38 billion in extramural research, including about $6 billion for clinical trials. On May 28,...more

Lippes Mathias LLP

HHS Issues Final Rule to Expand Discrimination Prohibition in Health Care Services

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The U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) and the Centers for Medicare & Medicaid Services (“CMS”) issued a final rule on May 6, 2024 (the “Final Rule”) under Section 1557 of the...more

Seyfarth Shaw LLP

HHS Issues New Affordable Care Act Section 1557 Nondiscrimination Regulations

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Seyfarth Synopsis: New regulations effective August 6, 2024 restore and expand scope of civil rights protections under Section 1557 of the Affordable Care Act....more

Mintz - Health Care Viewpoints

OCR, CMS Issue New ACA Section 1557 Final Rule Prohibiting Discrimination Related to Use of Artificial Intelligence in Health Care

Preventing discrimination and bias in connection with the use of artificial intelligence (AI) in health care are among the principal current focuses of U.S. Department of Health and Human Services (HHS) and were included in...more

McDermott Will & Emery

Special Report: Understanding ONC’s Health AI Transparency and Risk Management Regulatory Framework

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The Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) final rule, issued by the US Department of Health and Human Services (HHS) Office of...more

Holland & Knight LLP

Holland & Knight Health Dose: March 5, 2024

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Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. ...more

American Conference Institute (ACI)

[Event] 15th Annual Advanced Forum on Managed Care Disputes and Litigation - May 2nd - 3rd, Chicago, IL

ACI’s Advanced Forum on Managed Care Disputes and Litigation offers an unparalleled learning experience, specifically designed for the MCO legal community. Attend and develop winning legal strategies and business best...more

Fenwick & West LLP

New Federal Requirements for AI and IT System Implementation in Healthcare

Fenwick & West LLP on

On October 30, 2023, the Biden administration issued Executive Order 14110 on the Safe, Secure and Trustworthy Development and Use of Artificial Intelligence (the “Executive Order”). As detailed in our previously published...more

Mintz - Health Care Viewpoints

HHS, ONC HTI-1 Final Rule Introduces New Transparency Requirements for Artificial Intelligence in Certified Health IT

The Department of Health and Human Services (HHS) was tasked with coordinating efforts to regulate artificial intelligence (AI) in health care under the November 2023 Executive Order on the Safe, Secure, and Trustworthy...more

BakerHostetler

Federal Government Addresses AI Transparency and Safety in Healthcare

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On Oct. 30, President Biden signed an executive order calling for a coordinated government approach to establish new safeguards for AI safety and security in healthcare. In response to the executive order, on Dec. 14 the...more

McDermott+

McDermottPlus Check-Up: November 3, 2023

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CONGRESS - House Ways & Means Chair Smith, House Energy & Commerce Chair Rodgers and Senate Finance Ranking Member Crapo Call for Withdrawal of Nurse Staffing Mandate. Rep. Smith (R-MO), Rep. Rodgers (R-WA) and Sen. Crapo...more

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