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Risk Management Artificial Intelligence Healthcare

Dentons

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

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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

McDermott+

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

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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

Womble Bond Dickinson

AI Therapy

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I have mixed feelings about the AI takeover, but here is a positive. In this field test, the AI therapist was ‘on call’ at all times, so that insomniacs could get therapy in the middle of the night....more

Axinn, Veltrop & Harkrider LLP

Axinn Associates at the Spring Meeting: Considerations on Data Privacy and AI Usage for Healthcare Companies

The February 2024 ransomware attack on Change Healthcare was the largest healthcare data breach in U.S. history. The attack disrupted operations—impacting patient care and provider finances—and potentially exposed the...more

Butler Snow LLP

Junk Science: What Courts are Seeing and How It Affects Us: A Judge’s Eye View

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Trial lawyers, especially defense lawyers in the pharmaceutical and medical device arena, strive to ensure that “junk science” stays out of the courtroom. Unfortunately, that is often wishful thinking. When I spoke with an...more

J.S. Held

2025 J.S. Held Global Risk Report: Managing Cyber Risk

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Cyber incidents such as the 2024 event involving Change Healthcare, which compromised the personal information of over 100 million people, highlight the evolving nature of cyber threats – increasingly becoming risk management...more

MoFo Life Sciences

AI Agent as a Service in Medtech: Key Considerations for Commercial Contracts

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Artificial intelligence (AI) is transforming the medical technology (“medtech”) and healthcare industries through the integration of advanced AI agents. Unlike traditional AI systems that perform discrete, predefined tasks,...more

Troutman Pepper Locke

DOJ Addresses AI in Corporate Compliance Programs — 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 attorneys Michael S....more

Sheppard Mullin Richter & Hampton LLP

Key Considerations Before Negotiating Healthcare AI Vendor Contracts

The integration of artificial intelligence (AI) tools in healthcare is revolutionizing the industry, bringing efficiencies to the practice of medicine and benefits to patients. However, the negotiation of third-party AI tools...more

Quarles & Brady LLP

Warning! ChatGPT Exploit Used by Threat Actors in Cyber Attacks

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Members of the health care and financial industries, along with other industries that hold sensitive data, are warned that a ChatGPT vulnerability is being actively exploited by threat actors to attack security flaws in AI...more

Frost Brown Todd

Proposed HIPAA Security Rule Requires AI Governance

Frost Brown Todd on

In terms of healthcare data breaches, 2024 was the worst year ever, with the records of at least 53% of the U.S. population involved and two of the biggest healthcare data breaches of 2024 ranking in the top 10 of all time. ...more

Baker Botts L.L.P.

AI Legal Watch: March 12, 2025

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Virginia has become the first state in 2025 to pass comprehensive artificial intelligence regulation, with lawmakers approving the "High-Risk Artificial Intelligence Developer and Deployer Act" (HB 2094). The legislation,...more

Sheppard Mullin Richter & Hampton LLP

If You Are Uptight About AI, This May Relax You

While AI has many people uptight, Aescape has developed technology to help you relax – AI robotic massage. Aescape touts that it combines the timeless art of massage with robotics and artificial intelligence to deliver an...more

Baker Botts L.L.P.

Virginia Legislature Passes First AI Bill of 2025--Now Awaits Governor's Approval

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Virginia has become the first state in 2025 to pass comprehensive artificial intelligence regulation, with lawmakers approving the "High-Risk Artificial Intelligence Developer and Deployer Act" (HB 2094). The legislation,...more

McDermott Will & Emery

FDA Reveals AI Development Cheat Sheet in Highly Anticipated Draft Guidances

McDermott Will & Emery on

Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial intelligence (AI): Artificial Intelligence-Enabled Device Software Functions: Lifecycle...more

Husch Blackwell LLP

Virginia Legislature Passes High-Risk AI Developer and Deployer Act

Husch Blackwell LLP on

Keypoint: Virginia becomes the second legislature – after Colorado – to pass an algorithmic discrimination bill – although the bill still needs to get through the state’s Republican governor to become law. On February 20,...more

Troutman Pepper Locke

A Model’s Credibility Is in the Details: FDA Draft Guidance on the Use of AI Models in Drug and Biological Product Development

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In January, the U.S. Food and Drug Administration (FDA) issued its first guidance on the use of artificial intelligence (AI) models in drug development and in regulatory submissions titled, “Considerations for the Use of...more

Troutman Pepper Locke

2025 SCOPE Conference Emphasizes AI and Better Technologies to Improve Patient Outcomes

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The 2025 SCOPE Conference (Summit for Clinical Ops Executives), held last week in Orlando, FL, brought together more than 4,500 industry leaders, innovators, and experts in the clinical operations field. ...more

Polsinelli

Generative Artificial Intelligence Leveraged to Deliver Healthcare - Legal Risks and Issues

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With daily media reports citing to the explosion of interest in Artificial Intelligence (“AI”), AI start-ups have attracted a huge capital influx. During the last fiscal quarter of 2024 ending on December 31st, investors...more

A&O Shearman

Zooming in on AI - #14: Enforcement of the AI Act

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The European Union Artificial Intelligence Act (AI Act) entered into force on 1 August 2024. The AI Act establishes a risk-based approach to AI, prohibiting certain practices that are deemed unacceptable, such as social...more

NAVEX

Exploring California’s AI Laws

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California sets the pace for all sorts of trends in the world – so perhaps compliance officers should take note of two recent advisories the state’s attorney general published on artificial intelligence. They capture a lot...more

Shook, Hardy & Bacon L.L.P.

Capital Forum Provides Roadmap of Likely State Law Enforcement Priorities in 2025 and Beyond

The National Association of Attorneys General (NAAG) is a nonpartisan national forum for America’s state and territory attorneys general to collaboratively address issues important to their work protecting the rule of law and...more

Ropes & Gray LLP

The Biden Administration’s Swan Song on Digital Health: Two FDA Guidances on Artificial Intelligence and FDA’s Defense of its...

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In the waning days of the Biden administration, the FDA released a flood of new guidance documents and other agency actions, including several important items related to digital health. On January 7, FDA published two new...more

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

DLA Piper

Key Takeaways from FDA’s Draft Guidance on Use of AI in Drug and Biological Life Cycle

DLA Piper on

The US Food and Drug Administration (FDA) recently issued its draft guidance, Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products, on January 6, 2025. ...more

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