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
From Innovation to Commercialization: Turning Research Into Tangible Outcomes With John Bamforth
Harnessing Generative AI: Innovations and Best Practices — The Good Bot Podcast
Hospice Insights Podcast - Meet the New Laws, Same as the Old Laws: Overpayment Recoupment Update
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 214: Pharma Manufacturing in North Carolina with Ed Hernandez of Eli Lilly
AI Discrimination and Emerging Best Practices – Part 2 - The Good Bot Podcast
Year-End and Trending Tax Considerations for Health Care Practices
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
The Evolving Landscape of Behavioral Health Transactions: Insights from Industry Professionals
Advancements of Artificial Intelligence in Health Care – One Year After White House Executive Order – Diagnosing Health Care
Happy Holidays and welcome to our year-end issue of Decoded. We hope you enjoyed reading our technology law insights e-newsletter this year. We are already planning for 2025. ...more
Until recently, Massachusetts was the only state that did not maintain a licensing regime for nonresident pharmacies (i.e., out-of-state pharmacies shipping drugs into the state). On December 6, 2024, the Massachusetts Board...more
Wegovy and other GLP-1 medications have become extremely popular over the past few years. Novo Nordisk (which makes both Wegovy and Ozempic) and other drug manufacturers have invested heavily in promoting these drugs as...more
For calendar-year plans, the 2025 plan year is right around the corner. And even for non-calendar-year plans, January 1, 2025, is a key implementation date for certain plan features. This is the ideal time for plan sponsors...more
Access to first-in-class medicinal products that can save and transform lives is crucial for patients in the UK – and the earlier the access, the more significant the impact. Equally vital, however, is that such products are...more
On October 2, the New York State Department of Health (NYSDOH) issued new cybersecurity regulations (Regulations) for all general hospitals in New York state (“hospitals”), creating a new Section 405.46 in Title 10 (Health)...more
In response to an outbreak of the H5N1 strain of bird flu among dairy cows in at least 15 states, the U.S. Department of Agriculture (USDA) issued a new federal order (the Order) requiring dairy farms and other entities...more
Amid continued rapid development of novel software products that present new opportunities in the health care space, FDA has yet to grant marketing authorization to a medical device incorporating artificial intelligence (AI)...more
Last week, the U.S. Food and Drug Administration (FDA) finalized guidance on the types of information that should be included in a Predetermined Change Control Plan (PCCP) as part of a marketing submission for an artificial...more
On December 4, 2024, the U.S. Food and Drug Administration (“FDA”) released its final guidance for industry on predetermined change control plans (“PCCPs”) for devices that utilize artificial intelligence-enabled software...more
Join Troutman Pepper Partner Brett Mason for a podcast series analyzing the intersection of artificial intelligence (AI), health care, and the law. In this installment of The Good Bot, host Brett Mason is joined by Partner...more
Republicans have swept the 2024 elections, returning Donald Trump to the White House as the 47th President and flipping the Senate to a Republican majority. Having narrowly maintained control of the House of Representatives,...more
The Massachusetts Senate proposed an amendment on Monday December 2, 2024, that would delay implementation and enforcement of the 2021 Patients First Act addressing health care cost transparency. Section 31 of the amendment...more
The Centers for Medicare & Medicaid Services (CMS) recently published its final rule to implement the Medicaid Services Investment and Accountability Act of 2019 (MSIAA). The final rule significantly deviates from the...more
Recorded at NC Life Sciences Organization’s Annual Meeting, Heather and Lauren welcome David Robinson, an attorney at Maynard Nexsen, who also serves as the Honorary Consul for Japan in North Carolina and Chairman of the NC...more
In Charles Dickens’ classic “A Christmas Carol,” the final act is brought by the spectral Ghost of Christmas Future who shows the miserly Ebenezer Scrooge the vision of those he mistreated in life celebrating his death after...more
Allermi, a San Francisco-based telehealth company, is redefining personalized allergy care by offering compounded nasal spray products that combine multiple active ingredients at varying dosages and combinations into a single...more
On November 20, 2024, the US Environmental Protection Agency announced its new initiative—The Tackling Emerging Contaminants Initiative (Initiative). This Initiative is funded by a portion of President Biden’s $50 billion...more
On April 22, 2024, the U.S. Department of Health and Human Services, Office for Civil Rights announced its final rule entitled “HIPAA Privacy Rule to Support Reproductive Health Care Privacy” (the “Reproductive Health Care...more
11 Days Left in Lame Duck - Both houses of Congress are in this week as we approach December 20, the deadline by which Congress must pass a continuing resolution (CR) that will fund the government moving forward. ...more
A heart condition can often be a silent but serious threat to a person’s health. Timely diagnosis and treatment are crucial to prevent life-altering or fatal consequences. However, when a healthcare provider fails to diagnose...more
On November 1, the Centers for Medicare & Medicaid Services (CMS) finalized its proposal to extend virtual direct supervision—i.e., the ability to provide direct supervision through real-time, audio-visual technology (rather...more
To implement its November 2023 final rule on ownership transparency for skilled nursing facilities (“SNFs”), the Centers for Medicare and Medicaid Services (“CMS”) has updated its Medicare enrollment application for...more
Several new laws approved by the Illinois General Assembly and signed into law this year by Governor JB Pritzker are aimed at protecting and expanding the rights of employees in the state. The new measures’ effect will also...more
On September 27, 2024, the U.S. Court of Appeals for the Ninth Circuit reversed the district court’s decision in U.S. v. California Stem Cell Treatment Center, Inc. (“California Stem Cell”), holding that a clinic’s stem cell...more
