AI and the False Claims Act
Top Healthcare Compliance Priorities for 2025
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 213: AI Transformations in Life Sciences and Beyond with Igor Jablokov of Pyron
Advancements of Artificial Intelligence in Health Care – One Year After White House Executive Order – Diagnosing Health Care
Preventative Medicine: Health Care AI Privacy and Cybersecurity – Part 2 — The Good Bot Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 178: Life Sciences Industry Impact with Bob Coughlin, JLL Director and Former MassBio CEO
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 174: Artificial Intelligence in Healthcare with Jonathan Samples, Partner at 121G
Episode 172: Matthew Roberts and Lauren DeMoss, Maynard Nexsen Health Care Attorneys
Podcast: Telehealth Post-Public Health Emergency – What to Expect in 2024 – Diagnosing Health Care
Health + Tech - Future of Precision Medicine With Dr. Amrie Grammer
Episode 161: David Garrett and Stephen Davis, Maynard Nexsen Immigration Attorneys
Podcast - Digital Health Market Assessment
Quick Takeaways From the 2024 Proposed Hospice Wage Index Rule
Patient Data and Privacy
Changing Telehealth Rules
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 127: Kelli Ferry, Deputy Chief Legal Officer, and Angela Yochem, Chief Transformation and Digital Officer, Novant Health
Telehealth Risk Report: What the Government Found
The End of COVID Waivers and Exceptions: What Now?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 118: Matthew Roberts and Darra Coleman, Health Care Attorneys, Nexsen Pruet
HIPAA Tips With Williams Mullen - Telehealth After the Pandemic
Overview - As demand for GLP-1 drugs continues to skyrocket, federal and state agencies are turning their attention to the GLP-1 market and ramping up efforts to address the perceived risks associated with counterfeit and...more
The $100B+ Weight-Loss Drug Market Is Red Hot—But So Are the Legal, Regulatory, and Compliance Risks. As the GLP-1 revolution reshapes the future of metabolic health, life sciences companies face mounting scrutiny from...more
For the past several years, physicians and compounding pharmacies have stepped in to address critical patient access gaps during U.S. Food and Drug Administration (FDA) shortage declarations for semaglutide (Ozempic, Wegovy)...more
Telehealth companies selling compounded drugs are making modest inroads into the market for popular weight loss drugs that Big Pharma spent decades and billions of dollars to develop and bring to market. The compounded...more
Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health....more
The Food and Drug Administration (“FDA”) has removed semaglutide from its drug shortage list after the agency determined the current supply of the drug can meet present and future demand. On February 21, 2025, the FDA updated...more
Weight loss clinics, telehealth companies, physicians, and pharmacies that have been prescribing or dispensing compounded GLP-1 medications must prepare for significant changes following the Food and Drug Administration’s...more
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
On February 20, 2025, U.S. Senators Dick Durbin (D-IL) and Roger Marshall, M.D. (R-KS) introduced bipartisan legislation, the Protecting Patients from Deceptive Drug Ads Act (the Act), which closes perceived “legal loopholes”...more
Now that the shortage of semaglutide injection products has been resolved, the Food and Drug Administration (FDA) will restrict third parties from compounding the drug. Our FDA/Food, Drug & Device and Health Care Groups have...more
Last week, the US Food and Drug Administration (FDA) announced the end of a years-long shortage of semaglutide injection products — a popular glucagon-like peptide 1 (GLP-1) weight loss and diabetes medication. As a result,...more
On February 21, the FDA announced that the shortage of semaglutide injection products has been resolved. Semaglutide has appeared on the FDA’s Drug Shortage List since 2022 because demand for the drug exceeded the available...more
The Super Bowl is not just the biggest game of the year for football fans, but it is also one of advertising’s biggest nights. Therefore, the FDA lawyers at Polsinelli were not only tuned in to root for the Kansas City Chiefs...more
DTC Telehealth Platforms - Arrangements involving telemedicine and direct-to-consumer (“DTC”) business services are expected to be a source of major regulatory scrutiny. In 2024, such arrangements were the focus of proposed...more
We bring you Vital Signs, a curated, one-stop resource on the most notable digital health law updates from our U.S. and global contributors. In Industry Insights, we present a timely discussion about increasing litigation and...more
Welcome to our sixth issue of The Health Record - our healthcare law insights e-newsletter. In this edition, we take a look at the impact of AI when it comes to diverse health data, the FDA and AI medical devices, Virginia's...more
Welcome to our third issue of The Health Record - our healthcare law insights e-newsletter! We are winding down the summer with our talented group of law students and they have continued to research and write, shadow...more
Attorneys general across the country have joined in litigation related to mifepristone, a drug used for medication abortions. A case currently before the Supreme Court, FDA v. Alliance for Hippocratic Medicine, could affect...more
This Week in Washington: House and Senate pass continuing resolution; House Energy and Commerce Health Subcommittee reports out 21 healthcare bills; Senate Finance Healthcare Subcommittee holds hearing on telehealth...more
In this issue of our newsletter on developments impacting the life sciences industry, we examine topics including how the increased DOJ and FDA focus on cybersecurity issues could lead to new theories of False Claims Act...more
THIS WEEK’S DOSE - Uncharted Territory in the House: The House voted to remove Rep. McCarthy (R-CA) as Speaker of the House, then recessed until at least October 11, when the House is slated to reconvene to elect a new...more
On May 2, 2023, the U.S. Food and Drug Administration (FDA) took additional steps to support the use of decentralized clinical trials (DCTs) by releasing a new draft guidance titled “Decentralized Clinical Trials for Drugs,...more
News Briefs - Inflation Causes Many Patients to Skip Doctors' Appointments - As prices go up generally, patients stay away from their physicians, according to federal analysts. In 2022, 28 percent of adults went without some...more
On May 2nd, the FDA published draft guidance regarding the use of DCTs to support the development of drugs, biological products and devices. In contrast to traditional site-based clinical trials, DCTs are characterized by...more