On January 7, 2025, the Food and Drug Administration (FDA) made available a draft guidance for industry (GFI) titled “Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and...more
On January 7, 2025, FDA published “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff”...more
A week before the EU’s AI Act comes into force on August 1, the White House announced that U.S. agencies have completed all actions required by President Biden’s AI Executive Order to date. Meanwhile, the Republican Party...more
It’s been a busy summer for the National Institute of Standards and Technology (NIST) and the U.S. AI Safety Institute (itself housed within NIST). July 26, 2024, marked the 270th day since President Biden issued his...more
Not to be left out of the international discourse on AI, on May 15, 2024, a bipartisan group of U.S. senators released a long-awaited “roadmap” for AI, detailing areas the Senate considers ripe for legislation and regulation....more
Regulatory, Legislative and Litigation Developments -
Federal Agencies and the White House Issue Six Month Update on AI Activities Outlined in President Biden’s Executive Order on AI. Since President Biden issued his...more
Since President Biden issued his sweeping Executive Order on the Safe, Secure and Trustworthy Development of AI on October 30 of last year (EO), federal agencies have been operating in high gear to meet the deadlines and...more
The American Conference Institute hosted its inaugural Life Sciences AI Summit in New York on February 21 and 22. The two-day conference brought together key stakeholders, including regulatory players such as FDA and the...more
As we ring in the new year, it is time once again to reflect on some of the most significant legal developments for drug and device companies this year. The list below is by no means exhaustive (who could forget the Rule 702...more
12/23/2022
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Attorney's Fees ,
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Collective Redress ,
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Statute of Limitations
Artificial Intelligence (“AI”) is driving innovation across industries and is playing an increasing role in everyday life. AI (and, more broadly, algorithms) is being used in diagnostics, enabled medical devices, device...more
Our latest briefing explores the FTC’s push to address “commercial surveillance” and data security, proposed rulemaking from HHS prohibiting the use of discriminatory clinical algorithms, a move by the CFPB to hold digital...more