On August 6, 2024, the Food and Drug Administration (FDA) partnered with the Clinical Trials Transformation Initiative (CTTI) to hold a joint, public workshop titled, “Artificial Intelligence (AI) in Drug & Biological Product...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
On June 27, 2023, the United States Supreme Court decided Mallory v. Norfolk Southern Railway Co., 2023 WL 4187749, 600 U.S. ___ (June 27, 2023), a decision that likely will reinvigorate forum-shopping efforts by plaintiffs...more
We continue to track litigation and legislations involving proposed or enacted bans or limitations on natural gas appliances. As anticipated, this area continues to evolve, and we are finding increased litigation regarding...more
On May 23, 2023, the European Commission formally published the new General Product Safety Regulation, which reforms a variety of product safety regulations for manufacturers doing business in the European Union (EU) and its...more
Citing the effects of carbon emissions on climate change and the potential for health risks, efforts to electrify America’s natural gas infrastructure are underway in various markets. Natural gas comprises primarily methane....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
/ Artificial Intelligence ,
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.
...more
On April 14, 2022, the Environmental Protection Agency (EPA) released draft conclusions in a report updating its analysis regarding formaldehyde exposure, suggesting that long-term exposures to small amounts of formaldehyde...more
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
A new study regarding phthalates has garnered media attention this month, but readers should recognize the study’s limitations. Some media coverage of this study blurs the important distinction between “association” and...more
Jury selection in California is undergoing significant change. In August 2020, the California legislature passed AB 3070, which was signed by Governor Gavin Newsome on September 30. Beginning in 2022, objections to peremptory...more
12/3/2020
/ Bias ,
Defense Strategies ,
Governor Newsom ,
Judges ,
Jury Selection ,
Jury Trial ,
Litigation Strategies ,
Peremptory Challenges ,
State and Local Government ,
Trial Practice Guidance ,
Trial Preparation
The Maryland Court of Appeals has retired the inflexible Frye-Reed standard and adopted the framework of Daubert for evaluating the admissibility of expert testimony. In Rochkind v. Stevenson (August 28, 2020), Maryland...more