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
On January 6, the U.S. Food and Drug Administration (“FDA” or the “Agency”) released a draft guidance titled “Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway” (the “Draft...more
During the Biden Administration’s final week, congressional Republicans are moving full steam ahead with Senate confirmation hearings for Trump-nominated officials and with ongoing budget reconciliation discussions....more
On December 30, 2024, both the Massachusetts House of Representatives and the Massachusetts Senate enacted House Bill 5159 (H.5159), and Governor Maura Healey signed it on January 8, 2025. The bill seeks to strengthen...more
The Food and Drug Administration’s (FDA or Agency) final rule on Additional Conditions for Nonprescription Use (ACNU) paves the way for some drugs that are currently available only with a prescription to switch to OTC where a...more
Under the Affordable Care Act’s (ACA) employer shared responsibility provisions, applicable large employers (ALEs) must either offer minimum essential coverage that is “affordable” and that provides “minimum value” to their...more
A few weeks ago, someone at a holiday party asked “Whitt, why doesn’t Budding Trends take on the weighty legal issues of the day and instead resort to cheap pop culture references and puns?” I thought about responding with a...more
Third-party financing services are frequently used by patients to finance out-of-pocket dental expenses. Effective January 1, 2025, dental practices in Illinois are prohibited from facilitating or assisting with patient...more
The Drug Supply Chain Security Act (DSCSA) (section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 USC §360eee – 1) was introduced in response to several drug contamination, counterfeiting, and diversion...more
Just two weeks into the year, 2025 is already shaping up to be a busy year for privacy lawyers, especially those tasked with helping covered entities and business associates comply with the HIPAA Security Rule. As we...more
Teaching hospitals training over their graduate medical education (GME) caps have limited opportunities to receive additional funding from Medicare. ...more
Our FDA/Food, Drug & Device and Health Care teams discuss new guidance from the Food and Drug Administration (FDA) on federal notification requirements for medical device manufacturing shortages during public health...more
As we kick off 2025, it's worth reflecting on the forces that shaped digital health in 2024. From early-stage innovation capturing investor attention to mega funds like a16z and General Catalyst driving dealmaking, the year...more
On January 8, 2025, the governor of Massachusetts signed into law H.5159, An Act enhancing the market review process (the “Act”). Among various other healthcare market oversight enhancements, the Act expands the authority of...more
With President Trump’s 2nd term quickly approaching, Heather and Matthew sit down with Maynard Nexsen attorney Bob Coble to discuss what changes we can expect in healthcare over the next 4 years. As the former Mayor of...more
The U.S. Food and Drug Administration (FDA) published the draft guidance “Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices,” which provides advice for sponsors, investigators, and...more
On November 15, 2024, the Department of Health and Human Services (HHS) and the US Drug Enforcement Agency (DEA) issued a joint regulations further extending the flexibilities that have been in place relating to prescribing...more
U.S. Food and Drug Administration (FDA) Commissioner Robert Califf, M.D., and other senior FDA officials recently published a “Special Communication” in JAMA describing FDA’s concerns with the use of AI in medical product...more
On January 10, 2025, the Supreme Court of the United States granted certiorari in three cases: Becerra v. Braidwood Management, Inc., No. 24-316: This case addresses the constitutionality of the U.S. Preventive Services...more
The Food and Drug Administration (FDA) recently issued a final guidance document, Validation and Verification of Analytical Testing Methods Used for Tobacco Products. This nonbinding guidance provides tobacco product...more
On January 7, the FDA made available draft guidance on the development of drugs and biological products for weight reduction within the Center for Drug Evaluation and Research intended for reduction and long-term maintenance...more
New Leadership for PA General Assembly Committees- The Pennsylvania General Assembly has appointed new chairs for its 52 standing committees, which play a crucial role in discussing, amending, and approving legislation,...more
Consistent with the 2015 Inflation Adjustment Act, which provides for the annual increase in penalties under the Occupational Safety and Health Act by the previous year’s rate of inflation, the maximum OSHA penalties for...more
On January 8, 2025, Massachusetts Governor Maura Healey signed into law “An Act Enhancing the Health Care Market Review Process.” Part of this sweeping healthcare oversight law includes changes to the Determination of Need...more
Drive compliance program success with cutting-edge education and valuable connections! For over two and a half decades, healthcare compliance professionals have gathered at HCCA’s Compliance Institute (CI) to share ideas,...more
In December 2024, New York Governor Kathy Hochul signed into law two bills (A8872A and S2376B; collectively, the “Bills”) that amend New York’s Data Breach Notification Law. The Bills introduce a maximum thirty-day timeframe...more