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
Preparing for CMS Staffing Mandates — Assisted Living and the Law Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 215: Bioactives for Human Health with Jan-Willem van Klinken of Brightseed
At the 2025 HCCA Compliance Institute in Las Vegas (https://www.hcca-info.org/conferences/institutes/29th-annual-compliance-institute), Adam Greene, partner at Davis Wright Tremaine LLP will be leading the session “New...more
As we anticipated in our October 17, 2024, blog, both the Government and the Relator have appealed the district court’s decision in U.S. ex rel. Zafirov v. Florida Medical Associates, LLC, et al. (Zafirov), the first case to...more
Wednesday marked “Keeping Georgia Wild Day” at the State Capitol, and while the moniker might elicit a variety of memories from lawmakers and lobbyists of shenanigans under the Gold Dome, the day’s festivities were focused on...more
As Cyberattacks targeting the health care sector have continued to intensify over the past year, including ransomware attacks that have resulted in major data breaches impacting health care organizations, the protection of...more
Business and community leaders from across the state made their annual pilgrimage to Atlanta on Tuesday morning for the Georgia Chamber of Commerce’s Eggs & Issues breakfast at the Georgia World Congress Center. Although the...more
Find this week’s updates on 340B litigation to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets of more than 50 340B cases to provide you with a quick...more
Bradley is launching a multipart blog series on the U.S. Department of Health and Human Services’ (HHS) proposed changes to strengthen cybersecurity protections for electronic protected health information (ePHI) regulated...more
On January 15, the Department of Justice (DOJ) released its annual report on civil fraud recoveries for FY2024 along with a press release highlighting DOJ’s civil enforcement efforts....more
The Office of the U.S. Trade Representative (USTR) issued its "2024 Review of Notorious Markets for Counterfeiting and Piracy" on January 8th, directed to "prominent and illustrative examples of online and physical markets...more
The final guidance describes FDA’s enforcement discretion policy for sharing scientific information on unapproved uses of approved products and suggests a safe harbor for sharing off-label information consistent with the...more
The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations on January 7, 2025....more
Gain firsthand insights from leading in-house experts on the transformative power of AI in the life sciences at ACI's 2nd Annual Life Sciences AI Summit. Discover strategies to navigate the complex legal and regulatory...more
“Through December 20, 2024, 575 security incidents involving unsecured protected health information affecting 500 or more individuals had been reported to Health and Human Services. Through the same date in 2023, 265...more
Hearings on the merits of the Drug Enforcement Agency’s (DEA) proposed cannabis rescheduling, initially set to begin this month, have been cancelled. The preliminary hearing period has been littered with accusations that the...more
On January 6, 2025, the U.S. Food and Drug Administration (“FDA”) and the Office for Human Research Protections (“OHRP”) issued a joint draft guidance on including tissue biopsies in clinical trials that evaluate...more
Medicare Advantage (MA), the private insurance option under Medicare, is one of many policy areas that will garner great attention in 2025 and beyond under the incoming Trump Administration. We recently released our 2025...more
“Illinois doubled private investments in the state, as well as investments in clean energy, and quadrupled the number of retained jobs in 2024, the Illinois Department of Commerce and Economic Opportunity said this week....more
When it comes to ensuring patient safety, healthcare facilities operate under a complex regulatory framework, including oversight from the Centers for Medicare & Medicaid Services (CMS). One of the more intense processes CMS...more
A special needs trust (SNT) and an Achieving a Better Life Experience (ABLE) account each provide a tax-free way for people with disabilities to save money. Both options provide a mechanism for saving money and protecting...more
On January 14, 2025, EPA released for public comment its Draft Sewage Sludge Risk Assessment for Perfluorooctanoic Acid (PFOA) and Perfluorooctane Sulfonic Acid (PFOS). This draft risk assessment evaluates potential human...more
On January 6, 2025, the U.S. Food and Drug Administration (FDA) released draft guidance titled Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products...more
Fiduciaries should be aware of recent developments involving AI, including emerging and recent state law changes, increased state and federal government interest in regulating AI, and the role of AI in ERISA litigation. While...more
During the COVID-19 crisis, newly-created relief allowed first dollar coverage for telehealth services under a high deductible health plan (HDHP) without ruining health savings account (HSA) eligibility. That relief was...more
Throughout the BIT Standards refresh series, we have referenced the 3-phase BIT process: 1. Gather data, 2. Assess risk, 3. Deploy interventions. Standard 16 builds on the third phase by exploring how teams use case...more
The Centers for Medicare & Medicaid Services (CMS) has issued the Calendar Year (CY) 2026 Advance Notice, proposing updates to payment policies for Medicare Advantage (MA) and Medicare Part D Prescription Drug Programs. This...more