Nathan Brown

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Articles

FDA And Department Of Veteran Affairs Set To Launch Virtual Lab Testing AI Tools, Subject To Trump's Plans

Nov 12, 2024 | mondaq.com | Nathan Brown |Marlee Gallant

FDA and the Department of Veterans Affairs (VA) announced last week that they plan to develop the first intergovernmental health artificial intelligence (AI) lab. This lab would test health-related AI applications for safety and effectiveness in a virtual lab environment. VA Undersecretary for Health Dr. Shereef Elnahal announced the news during the Veterans Health Administration Innovation Experience conference. The VA serves 9 million veterans—the largest health system in the country.
In Effort To Avoid Supply Chain Disruptions, FDA Extends DSCSA Exemptions

Oct 14, 2024 | mondaq.com | Nathan Brown

On October 9, the FDA announced that the agency is providingexemptions from the enhanced drug distribution security requirements of section 582 of the Federal Food, Drug and Cosmetic Act (FD&C Act) for eligible trading partners, which were scheduled to take effect on November 27.
EXPERT INSIGHTS-FDA PUBLISHES DIGITAL HEALTH AND ARTIFICIAL INTELLIGENCE GLOSSARY

Sep 26, 2024 | today.westlaw.com | Marlee Gallant |Nathan Brown

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President Biden's AI EO: Key Takeaways For Health Care & Life Sciences

Nov 14, 2023 | mondaq.com | Marlee Gallant |Jo-Ellyn Sakowitz Klein |Nathan Brown |Anna Marie Abram

President Biden's eagerly-awaited executive order (EO) on artificial intelligence (AI) tasks the Department of Health & Human Services (HHS) with promoting responsible AI innovation, development and use, including addressing the potential risks associated with AI-enabled technologies in health care and use of AI in drug development.
President Biden's AI EO: Key Takeaways for Health Care & Life Sciences

Nov 9, 2023 | lexology.com | Marlee Gallant |Jo-Ellyn Sakowitz Klein |Nathan Brown |Anna Marie Abram

Key PointsPresident Biden’s eagerly-awaited executive order (EO) on artificial intelligence (AI) tasks the Department of Health & Human Services (HHS) with promoting responsible AI innovation, development and use, including addressing the potential risks associated with AI-enabled technologies in health care and use of AI in drug development.
False Claims Act Decisions To Know From Q2 2023

Aug 29, 2023 | mondaq.com | Nathan Brown

In this post, we summarize noteworthy False Claims Act (FCA) decisions from the second quarter of 2023. U.S. Supreme Court Decisions. The second quarter was particularly noteworthy because the Supreme Court decided two cases involving the FCA. Since we previously provided an in-depth analysis of those cases on the blog, we will not reanalyze those decisions here but encourage readers to read our summaries of U.S. ex rel. Schutte v. Supervalu Inc. and U.S. ex rel. Polansky v.
False Claims Act Decisions to Know from Q2 2023

Aug 25, 2023 | lexblog.com | Nathan Brown

In this post, we summarize noteworthy False Claims Act (FCA) decisions from the second quarter of 2023. U.S. Supreme Court Decisions. The second quarter was particularly noteworthy because the Supreme Court decided two cases involving the FCA. Since we previously provided an in-depth analysis of those cases on the blog, we will not reanalyze those decisions here but encourage readers to read our summaries of U.S. ex rel. Schutte v. Supervalu Inc. and U.S. ex rel. Polansky v. Executive Health Resources.