Maximizing Financial Growth: Insights on HSAs and Smart Investment Strategies with Shaun Eddy
New Developments in Health Information Policy
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 220: Healthcare Regulation Under the Trump Administration with Bob Coble of Maynard Nexsen
Podcast - Rewriting the Narrative of Private Equity in Healthcare
Hospice Insights Podcast - A Year in Review: Reflections and Hopes for the Future
Key Takeaways From the OIG's New Compliance Guidance for Nursing Facilities — Assisted Living and the Law Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 219: The Evolving Nursing Industry with Terry McDonnell of Duke University Health System
AGG Talks: Healthcare Insights Podcast - Episode 7: National MultiPlan Litigation: A Guide for Healthcare Providers
Podcast — The Growth Rocketship: How BridgeBio’s Hub and Spoke Portfolio Strategy Set the Market for the Future of Biotech — Then, Now, and What’s Next?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 218: Artificial Intelligence in Drug Development with John Van Hoy of PPD & Thermo Fisher
Podcast — Drug Pricing: How Might the Trump Administration Transform FDA Enforcement Activities?
AI and Pharmacovigilance Under the FDA's New Emerging Drug Safety Technology Program – The Good Bot Podcast
Podcast — Drug Pricing: What’s in the New CMS Medicaid Final Rule?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 217: Japanese Investment in North Carolina’s Life Sciences Industry with David Robinson of Maynard Nexsen
12 Days of Regulatory Insights: Day 3 - State AG Oversight in the Health Care Industry — Regulatory Oversight Podcast
Hospice Insights Podcast - What a Difference No Deference Makes: Courts No Longer Bow to Administrative Agencies
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 216: Patient Advocacy and Healthcare Policy Change with Melissa Horn of the Arthritis Foundation
AGG Talks: Home Health & Hospice Podcast - Episode 7: OIG Report Reveals Gaps in Hospice PRF Compliance: What Providers Need to Know
Health Policy Update: Impact of the 2024 U.S. Elections – Diagnosing Health Care
Updating the Research Compliance Handbook
Welcome to the latest edition of our Healthcare & Life Sciences Market Update, in which we explore the evolving landscape of investment trends, regulatory challenges, and strategic opportunities shaping the global market. ...more
Last Tuesday, Governor Hochul delivered her 2025 State of the State address, laying out her vision for the year ahead. Highlights from the State of the State are below. The Governor will release her Executive Budget soon to...more
On Jan. 15, 2025, the U.S. Food and Drug Administration revoked its authorization for the use of Red Dye No. 3 in food and ingested medications. Red Dye No. 3, chemically known as erythrosine, is a synthetic color additive...more
The U.S. Department of Health and Human Services Office for Civil Rights (OCR) appears to have made cybersecurity its New Year’s resolution. The first few weeks of 2025 have already brought with them proposed amendments to...more
In an unusual criminal prosecution, the Chesapeake Regional Medical Center (CRMC), a hospital in Chesapeake, Virginia, was indicted last week by a federal grand jury in Virginia for conspiring to defraud the United States and...more
Key Points - - It remains to be seen what priorities Robert F. Kennedy Jr. and Marty Makary might set if confirmed as HHS secretary and FDA commissioner, respectively. - The Trump administration will likely focus on drug...more
In Teva Branded Pharmaceutical Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC, the Federal Circuit jumped on the bandwagon of scrutinizing the types of patents that can be listed in the Food & Drug...more
On December 31, 2024, OIG posted Advisory Opinion No. 24-13, a favorable advisory opinion allowing a pharmaceutical manufacturer (the Requestor) to offer free transportation, lodging, and other support to eligible patients...more
On December 28, 2024, Health Canada published a regulatory proposal in the Canada Gazette, Part I, Volume 158, Number 52, introducing amendments to the Food and Drug Regulations, CRC, c 870 and the Medical Devices...more
On December 23, 2024, President Biden signed into law two important pieces of legislation, the Paperwork Burden Reduction Act (Reduction Act) and the Employer Reporting Improvement Act (Reporting Act), that aim to ease the...more
As the world reacted to the shove heard round the world, the General Assembly kept a low profile on Friday. Convening an hour earlier than the Senate, the House gaveled in and out before senators even made it to their desks....more
The Justice Department released its annual False Claims Act statistics on Wednesday, January 15, detailing the number of cases filed, recoveries made, and relators’ shares awarded in fiscal year 2024. The government recovered...more
Beginning in the first quarter of 2025, California healthcare service plans, health insurers, Medi-Cal managed care plans, and PACE organizations must ensure that staff who have direct enrollee contact receive evidence-based...more
On January 16, 2025 the federal Food and Drug Administration (FDA) issued notice requiring manufacturers to reformulate their products removing Red Dye No. 3 by January 15, 2027 for food (21 CFR §74.303) and January 18, 2028...more
On January 15, 2025, the US Drug Enforcement Administration (DEA) released a proposed rule entitled Special Registrations for Telemedicine and Limited State Telemedicine Registrations. This proposed rule would establish three...more
In April 2024, the US Department of Health and Human Services (HHS) issued a final rule reinterpreting Section 1557 of the Affordable Care Act, which prohibits discrimination on the basis of race, color, national origin, sex,...more
The Trump administration’s food regulatory agenda will come into sharper focus once nominees for the U.S. Department of Health and Human Services (HHS) and secretary of agriculture are confirmed....more
On January 6, the Department of Health and Human Services Office for Civil Rights (OCR) published a notice of proposed rulemaking (Proposed Rule) that would strengthen the requirements of the security rule promulgated...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
The U.S. Food and Drug Administration (FDA) is taking a stronger approach toward supporting health goals in 2025 and beyond by setting the tone and releasing a number of regulatory actions aimed at enhancing consumer health...more
Welcome to our second volume and first issue of 2025 of The Health Record - our healthcare law insights e-newsletter. We hope you enjoyed our Volume 1 issues in 2024 and look forward to continuing to provide information about...more
In the latest development in a road to rescheduling cannabis from Schedule I to Schedule III under the Controlled Substances Act (“CSA”), on January 13, 2025, in the Matter of Schedules of Controlled Substances: Proposed...more
On January 6, 2025, the FDA released final guidance for industry entitled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions...more
With each new year comes a new set of accompanying challenges, from tackling the latest innovations to new incarnations of old issues. 2025 will be no exception to this rule, and with its arrival we examine FDA’s activities...more
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
