News & Analysis as of

Machine Learning Healthcare Risk Management

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

Quarles & Brady LLP on

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

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Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial intelligence (AI): Artificial Intelligence-Enabled Device Software Functions: Lifecycle...more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A Model’s Credibility Is in the Details: FDA Draft Guidance on the Use of AI Models in Drug and Biological Product Development

Troutman Pepper Locke on

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

Troutman Pepper Locke on

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

Polsinelli on

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

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

Knobbe Martens

FDA Issues Draft Guidance for the Use of Artificial Intelligence (AI) in Medical Devices and Drug Development

Knobbe Martens on

The Food and Drug Administration (FDA) has recently issued two draft guidance documents aimed at providing recommendations for the use of AI in medical devices and drug and biological product development.These guidance...more

Ankura

Enhancing Cross-Border e-Discovery and Data Breach Investigations with AI

Ankura on

Today’s interconnected world presents significant challenges for managing cross-border e-discovery and data breach investigations. These processes—critical for legal proceedings and cybersecurity—are often complicated by...more

DLA Piper

FDA Issues Artificial Intelligence-Enabled Device Software Functions Draft Guidance

DLA Piper on

The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations on January 7, 2025....more

Sheppard Mullin Richter & Hampton LLP

Texas Considers Comprehensive AI Bill

Texas is joining a growing number of states in considering comprehensive laws regulating use of AI. In particular, the Texas Legislature is scheduled to consider the draft “Texas Responsible AI Governance Act” (the “Act”),...more

Foley & Lardner LLP

The Intersection of Agentic AI and Emerging Legal Frameworks

Foley & Lardner LLP on

The evolution of artificial intelligence (AI) has introduced systems capable of making autonomous decisions, known as agentic AI. While generative AI essentially “creates” – providing content such as text, images, etc. –...more

Health Care Compliance Association (HCCA)

AI is here to stay?

Artificial intelligence or AI—yes, we are talking about it again. The explosion of AI in healthcare will only continue to grow. Statistics show that the total market value of AI in healthcare will expand to over $148 billion...more

EDRM - Electronic Discovery Reference Model

Dario Amodei’s Essay on AI, ‘Machines of Loving Grace,’ Is Like a Breath of Fresh Air

While almost everyone is panicking about a potential robot apocalypse, Dario Amodei, the CEO and co-founder of Anthropic (“Claude”), is explaining how AI might compress 100 years of medical progress into a decade, cure mental...more

Cozen O'Connor

Understanding the Colorado AI Act

Cozen O'Connor on

With the governor’s signature, Colorado has enacted a new consumer protection law focused on artificial intelligence (“AI”) systems. The “Colorado AI Act” will go into effect on February 1, 2026. It will have a minor impact...more

Spilman Thomas & Battle, PLLC

Decoded - Technology Law Insights, V 5, Issue 8, October 2024

Welcome to our eighth 2024 issue of Decoded - our technology law insights e-newsletter. Thank you for reading. EU AI Act Tightens Grip on High-Risk AI Systems: Five Critical Questions for U.S. Companies - Why this is...more

Sheppard Mullin Richter & Hampton LLP

Solving for Physician Burnout: How Organizations Can Deploy AI Solutions to Effectively Support Physician Workloads and Avoid...

This series explores legal issues related to physician burnout and potential solutions. Our first post addressed how healthcare organizations can foster the psychological safety and emotional wellbeing of their physicians....more

McDermott Will & Emery

State Regulators Address Insurers’ Use of AI: 11 States Adopt NAIC Model Bulletin

In December 2023, the National Association of Insurance Commissioners (NAIC) adopted a Model Bulletin on the Use of Artificial Intelligence (AI) Systems by Insurers. The model bulletin reminds insurance carriers that they...more

Mintz - Antitrust Viewpoints

Federal Agencies Take Sweeping Action on AI in Accordance with AI EO — AI: The Washington Report (Part 1 of 2)

President Joe Biden’s October 2023 Executive Order on AI directed agencies to institute a significant number of actions on AI. On April 29, 2024, the White House announced that federal agencies had completed “all of the...more

Troutman Pepper Locke

New FDA Guidance on AI and Medical Products

Troutman Pepper Locke on

n March 15, the U.S. Food and Drug Administration (FDA) published a paper titled “Artificial Intelligence and Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” This paper describes the FDA’s strategy for...more

Health Care Compliance Association (HCCA)

Behavioral health, artificial intelligence, and compliance

Technology’s exponential development and use in healthcare provides potentially significant benefits for behavioral health patients but also raises ethical and compliance concerns. The most recent technological advance...more

ArentFox Schiff

POTUS Issues Expansive Executive Order on AI, Calling for All Hands On Deck

ArentFox Schiff on

On October 30, 2023, President Biden issued an expansive Executive Order (EO) on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence (AI), aiming to establish standards for AI technology to...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

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