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Life Sciences › Machine Learning › Risk Assessment

McDonnell Boehnen Hulbert & Berghoff LLP

AI News Roundup – Pew poll reveals AI pessimism among American public, AI-assisted treatment found to reduce Parkinson’s symptoms,...

McDonnell Boehnen Hulbert & Berghoff LLP on

To help you stay on top of the latest news, our AI practice group has compiled a roundup of the developments we are following....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Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial intelligence (AI): Artificial Intelligence-Enabled Device Software Functions: Lifecycle...more

Hogan Lovells

New guidance on AI-enabled device software functions clarifies information FDA expects in marketing applications

Hogan Lovells on

On January 7, 2024, the U.S. Food and Drug Administration (FDA) published the draft guidance “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations,” which...more

King & Spalding

FDA Releases Draft Guidance on Submission Recommendations for AI-Enabled Device Software Functions

King & Spalding on

On January 7, 2025, FDA published a draft guidance titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” The draft guidance was long-anticipated; it...more

American Conference Institute (ACI)

How Can Companies Tackle Europe’s AI and Data Protection Rules?

American Conference Institute (ACI) on

Life science companies will have to grapple with unique questions in complying with the European Artificial Intelligence Act, including the scope of the law’s research exemption and the use of AI in personalized medicine and...more

American Conference Institute (ACI)

Operationalizing the EU AI Act: Five Compliance Steps to Take Now

American Conference Institute (ACI) on

Now that the European Union’s Artificial Intelligence (AI) Act has entered into force, the real work begins putting its obligations into practice. This article explores five compliance steps to take now to operationalize the...more

Fenwick & West LLP

Balancing AI-Powered Drug Discovery’s Risk and Reward

Fenwick & West LLP on

AI is shaving years off the drug-discovery process. But it’s not just leaving other research modalities in the dust—the law itself is struggling to keep up, especially when it comes to patenting AI-aided drug discovery....more

Skadden, Arps, Slate, Meagher & Flom LLP

The Informed Board - Winter 2024

Skadden, Arps, Slate, Meagher & Flom LLP on

The oversight obligations of boards continue to expand. Recent enforcement actions and new laws in areas such as cybersecurity, artificial intelligence and supply chains create new challenges for boards, as we explain in this...more

Health Care Compliance Association (HCCA)

Artificial intelligence: Compliance considerations for provider organizations

Health Care Compliance Association (HCCA) on

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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