On January 7, 2025, the Food and Drug Administration (FDA) made available a draft guidance for industry (GFI) titled “Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and...more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Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations; Draft Guidance for Industry and Food and Drug Administration Staff”...more
Recent developments in AI continue to highlight its increasing prevalence and the regulatory challenges it poses. The DOJ has sued RealPage, alleging its AI software enables rent price-fixing, while NIST partnered with OpenAI...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
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
On March 15, the United States Food & Drug Administration published a white paper entitled “Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” FDA announced the paper by sharing a...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
The SEC cracks down on potential conflicts of interest for broker-dealers and investment advisors using predictive data analytics, the “No Robot Bosses Act of 2023” is introduced in the Senate to regulate employers’ use of...more
Our latest briefing dives into new local laws about AI and how it affects both employment and insurance industries, the launch of NIST’s Trustworthy & Responsible Artificial Intelligence Resource Center and the plans for it...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 ,
Causation ,
Class Action ,
Collective Redress ,
Consumer Fraud ,
EU ,
Failure To Warn ,
Federal Industry Standards ,
Food and Drug Administration (FDA) ,
Healthcare ,
Infringement ,
Litigation Funding ,
Medical Devices ,
Personal Jurisdiction ,
Pharmaceutical Industry ,
Popular ,
Prescription Drugs ,
Privacy Laws ,
Regulatory Standards ,
Remedies ,
Settlement ,
State and Local Government ,
Statute of Limitations
Our latest briefing examines the latest signal that the Federal Trade Commission is considering rulemaking, a groundbreaking settlement between the Justice Department and Meta over allegedly discriminatory algorithms,...more
The federal government continues to take significant interest in organizations using artificial intelligence and algorithmic decision-making systems, as evidenced by three recent developments out of Washington, D.C.
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Our latest briefing explores the NAIC’s efforts to address algorithmic bias, the Colorado Division of Insurance’s latest stakeholder session on external consumer data and algorithms, and a private-sector solution for...more