Medical Device Legal News with Sam Bernstein: Episode 11
In September 2022, former President Biden convened the White House Conference on Hunger, Nutrition, and Health, during which the White House introduced its National Strategy on Nutrition and Health (National Strategy). The...more
For more than a decade, the Food and Drug Administration (FDA) has made diversity in clinical trials a focus, including by issuing guidance, convening public-private workshops, and completing data analyses in an effort to...more
On November 21, 2024, the U.S. EPA released a new draft framework – the Interim Framework for Advancing Consideration of Cumulative Impacts – intended to provide EPA’s employees with guidance for how they should consider...more
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape....more
The Department of Commerce released three final guidance documents incorporating public comments from earlier this spring which provide recommendations for managing AI risk, securing AI software development processes, and...more
Welcome to the April-May edition of Akin Intelligence. This edition is a double header, covering both months as we prepare for the launch of our new AI Hub—a one-stop resource for AI coverage that will launch soon. Starting...more
December 7, 2023, President Biden announced new actions to promote competition in health care and to lower prescription drug costs. Of particular note is a newly unveiled framework for deciding whether the Government may...more
On October 30, 2023, the Biden administration issued its long-awaited artificial intelligence (AI) executive order (EO), which issues directives to over 20 federal agencies, with the deadline for implementation spanning...more
Welcome to this week's issue of AI: The Washington Report, a joint undertaking of Mintz and its government affairs affiliate, ML Strategies. The accelerating advances in artificial intelligence (“AI”) and the practical,...more
Seyfarth Synopsis: Following President Biden’s comprehensive Executive Order on AI, the White House announced the formation of the “US AI Safety Institute” within the Commerce Department’s technology arm, the NIST. The...more
On October 9, 2019, President Trump signed two executive orders: Promoting the Rule of Law Through Improved Agency Guidance (Executive Order 13891) (the “Guidance Executive Order”) and Promoting the Rule of Law Through...more
The White House on October 9th issued two executive documents that are relevant to federal environmental enforcement: Executive Order on Promoting the Rule of Law Through Transparency and Fairness and Civil Administrative...more
On June 1, 2017, the state of New York’s Department of Economic Development (the department) issued draft forms and guidance to capture employee salary information from New York state contractors and subcontractors pursuant...more
The FDA’s recently issued draft guidance on “Postmarket Management of Cybersecurity in Medical Devices” seeks to address some of the increasing concerns that medical device providers, regulators, and consumers have about...more
On August 26, 2015, the Section of Public Contract Law of the American Bar Association (“ABA”) submitted public comments to the General Services Administration (“GSA”) and the U.S. Department of Labor (“DOL”) on their...more
On May 27, 2015, the Defense Department, General Services Administration and National Aeronautics and Space Administration announced the Federal Acquisition Regulatory Council’s proposed rule to implement Executive Order...more
President Obama’s Executive Order 13673, called the Fair Pay and Safe Workplaces Order, uses the prospect of gaining or losing an edge in winning government contracts to provide a powerful incentive for employers to comply...more