News & Analysis as of

Artificial Intelligence Health Care Providers Regulatory Oversight

Hogan Lovells

AI wellness or regulated medical device? A lawyer's guide to navigating FDA rules—and what could change next

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As FDA medical device lawyers advising AI and digital health companies, Hogan Lovells lawyers have had a front-row seat to an increasingly common scenario: software platforms and mobile apps that launch with the best of...more

Wilson Sonsini Goodrich & Rosati

Nevada Passes Law Limiting AI Use for Mental and Behavioral Healthcare

On June 5, 2025, Nevada Governor Joe Lombardo signed AB 406, a law regulating the use of artificial intelligence (AI) for mental and behavioral healthcare. AB 406 comes as other states, such as Utah and New York, have taken...more

Troutman Pepper Locke

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

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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

Lathrop GPM

Fighting the Robots: Texas Attorney General Settles “First-of-its-Kind” Investigation of Healthcare AI Company

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In what it describes as a “First-of-its-Kind Healthcare Generative AI Investigation”, the Texas Attorney General (AGO) recently reached a settlement agreement with an artificial intelligence (AI) healthcare technology...more

Holland & Knight LLP

Regulation of AI in Healthcare Utilization Management and Prior Authorization Increases

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Over the past two years, federal and state government agencies have moved to regulate the deployment of artificial intelligence (AI) in the healthcare setting, including in the utilization management (UM) and prior...more

Holland & Knight LLP

The Future for AI Usage in California Healthcare Hinges on Governor's Indication of State Limits

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With the surge of artificial intelligence (AI) development in recent years, state legislatures, including California's, have contemplated how to balance patient safety and quality of care with the need for and expectation of...more

Foley & Lardner LLP

Artificial Intelligence in Health Care: Key Considerations for Oncology

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Artificial intelligence (AI) has the power to revolutionize health care. In oncology, there are now opportunities to apply AI to support diagnostics, predictive analytics, and administrative functions. This hot topic was...more

Health Care Compliance Association (HCCA)

Federation of State Medical Boards weighs in on ethical use of AI in clinical practice

Though responsible and ethical use of artificial intelligence (AI) has been a hot topic for the past few years, there has not yet been significant adoption of laws or regulations aimed specifically at regulating the use of AI...more

Verrill

Massachusetts Attorney General Artificial Intelligence Guidance: What Healthcare Providers and Health IT Developers Need to Know

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With the explosion of Artificial Intelligence (AI) use and application, the Massachusetts Attorney General’s recent release of AI guidelines should serve as a reminder to healthcare providers and health IT developers of the...more

Robinson+Cole Health Law Diagnosis

Forecasting the Integration of AI into Health Care Compliance Programs

Health care entities maintain compliance programs in order to comply with the myriad changing laws and regulations that apply to the health care industry. Although laws and regulations specific to the use of artificial...more

WilmerHale

State Governments Move to Regulate AI in 2024

WilmerHale on

Recently, New York Governor Kathy Hochul proposed sweeping artificial intelligence (AI) regulatory measures intended to protect against untrustworthy and fraudulent uses of AI. Presented as part of her FY 2025 Executive...more

Holland & Knight LLP

Key Value-Based Care Developments to Watch in 2024

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The goal of value-based care (VBC) is to promote better care for individual patients and improved health outcomes for communities at reduced costs. This is an important and admirable purpose as many VBC stakeholders attempt...more

BakerHostetler

Healthcare Industry Team 2023 Year in Review

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As we approach the conclusion of another transformative year, we are excited to present our comprehensive year-end review, shedding light on the trends shaping the healthcare market in 2023. Our team’s keen insights and...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

Arnall Golden Gregory LLP

Healthcare Authority Newsletter - November 2023 #1

News Briefs - Biden Executive Order Aims to Bolster AI Security in Healthcare - The Biden Administration issued what it's calling a "landmark" executive order designed to help channel the significant promise and manage the...more

Holland & Knight LLP

New Artificial Intelligence Executive Order Contains Numerous Healthcare Implications

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President Joe Biden on Oct. 30, 2023, signed a sweeping executive order (EO) and invoked the Defense Production Act to establish the first set of standards for using artificial intelligence (AI) in healthcare and other...more

Health Care Compliance Association (HCCA)

Artificial intelligence: Compliance considerations for provider organizations

Artificial intelligence (AI) is nothing new to the healthcare industry, as many organizations and clinicians have utilized such tools in some capacity for many years. Imaging-related AI to support radiologists is not...more

Hogan Lovells

Evolution of FDA regulation of AI-based technology

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Hogan Lovells partners Kelliann H. Payne and John J. Smith, M.D., J.D. recently joined Richard Frank, MD, PhD, Chief Medical Officer, Siemens Healthineers, and other industry leaders in person and virtually at the Health Care...more

Epstein Becker & Green

[Webinar] Shaping the Future of Artificial Intelligence (AI) Within Life Sciences - September 30th, 9:00 am - 10:15 am ET

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Amy Dow and Brad Thompson, Members of the Firm, speak on “Shaping the Future of Artificial Intelligence (AI) Within Life Sciences,” a virtual program co-hosted by Simmons & Simmons and Epstein Becker Green. On both sides of...more

MoFo Life Sciences

FDA’S Plan For AI/ML-Based Software As Medical Devices: Progress And Concerns

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U.S. Food and Drug Administration (FDA) has acknowledged the prevalence of Artificial Intelligence/Machine Learning (AI/ML)-Based Software as Medical Devices (SaMDs) and has been taking steps towards advancing its regulatory...more

McDermott Will & Emery

Reviewing Key Principles from FDA's Artificial Intelligence White Paper

McDermott Will & Emery on

In April 2019, the US Food and Drug Administration (FDA) issued a white paper, “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device,”...more

Sheppard Mullin Richter & Hampton LLP

Medical Devices - Artificial Intelligence and Reactions to FDA’s Proposed Oversight

In April of this year, the US Food and Drug Administration (FDA) released a discussion paper, Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML) – Based Software as a Medical...more

Akin Gump Strauss Hauer & Feld LLP

FDA’s AI White Paper: To Be or Not to Be, That is the Question

• FDA has released a white paper outlining a potential regulatory framework for software as a medical device (SaMD) that leverages artificial intelligence (AI) or machine learning (ML). • The white paper distinguishes three...more

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