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Artificial Intelligence Healthcare Regulatory Requirements

Epstein Becker & Green

HealthBench: Advancing the Standard for Evaluating AI in Health Care

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The Evolution of Health Care AI Benchmarking - Artificial Intelligence (AI) foundation models have demonstrated impressive performance on medical knowledge tests in recent years, with developers proudly announcing their...more

Sheppard Mullin Richter & Hampton LLP

The One Big Beautiful Bill Act’s Proposed Moratorium on State AI Legislation: What Healthcare Organizations Should Know

Congress is weighing a sweeping proposal that could significantly reshape how artificial intelligence (AI) is regulated across the United States. At the end of May, the United States House of Representatives passed, by a vote...more

White & Case LLP

AI Watch: Global regulatory tracker - Hong Kong

White & Case LLP on

Hong Kong lacks comprehensive AI legislative framework but is developing sector-specific guidelines and regulations, and investing in AI. Laws/Regulations directly regulating AI (the "AI Regulations") At present, Hong...more

Arnall Golden Gregory LLP

FDA in the “Computer Age” — AI Adoption Accelerates as Staffing Shrinks

Neil Young once sang of adapting to a world ruled by data and digital minds in “Computer Age.” Today, that vision feels increasingly real as the Food and Drug Administration turns to artificial intelligence (“AI”) in the face...more

Smart & Biggar

CDA update: new five-year strategic plan and position statement on using AI in health technology assessments

Smart & Biggar on

On April 15, 2025, Canada’s Drug Agency (CDA) released its new five-year strategic plan, Insight to Impact 2025-2030. Formerly the Canadian Agency for Drugs and Technologies in Health (CADTH), this is the CDA’s first...more

McDermott Will & Emery

McDermott HealthEx 2025: McKinsey Key Takeaways

McDermott Will & Emery on

McDermott HealthEx convened more than 1,300 of the most influential leaders in healthcare and life sciences. The event emphasized creativity, transformation, and growth, with sessions dedicated to innovation, AI-powered...more

Loeb & Loeb LLP

FDA Unleashes AI to Review Product Applications

Loeb & Loeb LLP on

The U.S. Food and Drug Administration (FDA) has been ahead of the curve for a number of years on emerging issues and opportunities for the agency and regulated industry arising from the advent and evolution of artificial...more

Sheppard Mullin Richter & Hampton LLP

Guarding Against the Unknown: M&A Due Diligence of AI Companies in Data-Sensitive Sectors

M&A in the AI sector is redefining deal risk, especially when sensitive data is involved. As AI companies power breakthroughs in biotech, healthcare, defense, and critical infrastructure, the stakes for companies acquiring...more

White & Case LLP

AI’s Expanded Role in the Life Sciences Regulatory Review Process: Key Developments in U.S. and EU

White & Case LLP on

Overview - - The U.S. Food and Drug Administration (FDA) announced that it aims to increase the agency’s use of artificial intelligence (AI) across its centers to accelerate scientific reviews by June 30, 2025. - The...more

Troutman Pepper Locke

Evolving AI Legislation: Federal Policies, Task Forces, and Proposed Laws — The Good Bot Podcast

Troutman Pepper Locke on

Join Troutman Pepper Locke Partner Brett Mason for a podcast series analyzing the intersection of artificial intelligence (AI), health care, and the law. In this episode of The Good Bot, Brett Mason and Emma Trivax delve...more

A&O Shearman

The future of the robotics metaverse in the healthcare sector

A&O Shearman on

On 26 February 2025, the European Economic and Social Committee (EESC) adopted an opinion addressing the integration of robotics and the metaverse in healthcare. This forward-looking document outlines the opportunities and...more

McDermott Will & Emery

Colorado Fails to Amend Groundbreaking AI Law: What Happened and What’s Next

McDermott Will & Emery on

On May 5, 2025, the Colorado Senate rejected an attempt by state lawmakers to amend Colorado’s landmark artificial intelligence (AI) law, known as Senate Bill (SB) 205. Colorado State Senator Robert Rodriguez and State...more

Sheppard Mullin Richter & Hampton LLP

Utah Enacts AI Amendments Targeted at Mental Health Chatbots and Generative AI

Utah is one of a handful of states that has been a leader in its regulation of AI. Utah’s Artificial Intelligence Policy Act (“UAIPA”) was enacted in 2024 and requires disclosures relating to consumer interaction with...more

MoFo Life Sciences

Data Privacy at the Crossroads of AI and Life Sciences: U.S. and EU Perspectives

MoFo Life Sciences on

AI is transforming the life sciences industry by accelerating drug discovery and personalizing patient care. But as companies increasingly rely on AI to process genetic, biometric, and other types of health data, they must...more

Bradley Arant Boult Cummings LLP

Colorado’s Artificial Intelligence Act (CAIA) Updates: A Summary of CAIA’s Consumer Protections When Interacting with Artificial...

During the 2024 legislative session, the Colorado General Assembly passed Senate Bill 24-205, which is known as the Colorado Artificial Intelligence Act (CAIA). This law will take effect on February 1, 2026, and requires...more

Jackson Lewis P.C.

Colorado Legislature Fails to Amend Recent Artificial Intelligence Act

Jackson Lewis P.C. on

In 2024, Colorado passed the first comprehensive state-level law in the U.S. regulating the use of artificial intelligence, the Artificial Intelligence Act (the Act). It imposed strict requirements on developers and users of...more

McDermott+

Trump Administration Executive Order Tracker

McDermott+ on

Below is a tracker of healthcare-related executive orders (EOs) issued by the Trump administration, including overviews of each EO and the date each EO was signed. We will regularly update this tracker as additional EOs are...more

White & Case LLP

Life Science Private Equity Risk

White & Case LLP on

Private Equity focused on investment and operations within the Life Science industry faces significant compliance, operational and business risk due to the heavily regulated nature of the investment targets and portfolio...more

McDermott Will & Emery

European Health & Life Sciences Symposium 2025: Key Takeaways

In April 2025, we were proud to host the annual European Health & Life Sciences Symposium at the Shangri-La hotel in Paris. Attended by some 300 delegates from across the industry, participants including investors,...more

MoFo Life Sciences

AI Transparency in Healthcare: Navigating a Changing Regulatory Landscape

MoFo Life Sciences on

Transparency of artificial intelligence (AI) systems in healthcare is quickly becoming a central concern for regulators due to potential impacts on patient safety, healthcare quality, bias mitigation, and public trust. To...more

Gardner Law

AI in Healthcare: Navigating Legal, Ethical, and Regulatory Frontiers

Gardner Law on

On March 22, 2025, Gardner Law, PLLC proudly co-hosted a thought-provoking continuing legal education (CLE) event with the Mitchell Hamline School of Law Health Law Institute, titled “AI in Healthcare: Adapting to...more

Dentons

Ep. 58 – Addressing Potential Discrimination in Patient Care Decision Support Tools

Dentons on

Effective May 1, 2025, the Section 1557 regulations require covered healthcare providers to take reasonable steps by May 1, 2025, to identify and mitigate the risk of discrimination when they use AI and other emergency...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 6, Issue 3, April 2025

Welcome to our third issue of 2025 of Decoded - our technology law insights e-newsletter. We hope you enjoy this issue and thank you for reading. SEC may Reverse Proposed Cryptocurrency Custody Rule and Ohio House...more

McDermott+

An MA Extravaganza: Overview of the Final Rule and Rate Announcement

McDermott+ on

This past week, the Trump administration put its first major stamp on the Medicare Advantage (MA) program. The Centers for Medicare & Medicaid Services (CMS) released two final regulatory documents related to MA: - The...more

Baker Botts L.L.P.

Virginia Governor Vetoes High-Risk AI Regulation Bill

Baker Botts L.L.P. on

In a development for state-level AI policy, Virginia Governor Glenn Youngkin has vetoed the "High-Risk Artificial Intelligence Developer and Deployer Act" (HB 2094). The bill, which narrowly passed both chambers of the...more

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