Can Food Really Be Medicine? Transforming Health Care One Bite at a Time – Diagnosing Health Care Video Podcast
Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®
Podcast - Hot Topics in FDA Regulation: GLP-1s, LDTs, AI and More
Prescribing GLP-1 Medications: Be Aware of Legal Limitations
AGG Talks: Cross-Border Business Podcast - Episode 22: What Global Companies Need to Know About Navigating FDA Regulations and U.S. Market Entry
AI and Pharmacovigilance Under the FDA's New Emerging Drug Safety Technology Program – The Good Bot Podcast
GLP-1 Drugs and Cultivated Meat: What’s the Impact on the Food and Agriculture Industry?
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 202: Life Sciences Startups and Industry Developments with Gil Price, Life Sciences Leader
The Future of Laboratory Testing Just Got a Little Clearer: FDA's Final Rule on LDTs – Diagnosing Health Care
Video: Food for Thought and Thoughts on Food: Innovating USDA Science with Sanah Baig, Deputy Under Secretary for Research, Education, and Economics
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Litigating Nutrition: Class Action Battles Over Dietary Supplements – Speaking of Litigation Video Podcast
Changes in FDA, Cannabis Policies and AI Developments
Ad Law Tool Kit Show – Episode 2 – Marketing FDA-Regulated Products
Medical Device Legal News with Sam Bernstein: Episode 18
Medical Device Legal News with Sam Bernstein: Episode 17
A Look Into the FDA and USDA Regulatory Regimes
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 167: Dr. Ehsan Samei & Dr. Susan Halabi, Triangle CERSI
Recent activity among lawmakers and federal agencies signal that the government may be poised to undertake meaningful legislative and administrative efforts to harness the potential of digital health innovation and to expand...more
In the wake of the 2024 U.S. elections, stakeholders in the life sciences and health care industry are intensely focused on the policy implications for global financial markets, investment strategies, and M&A opportunities....more
Healthcare in the United States is undergoing significant changes, particularly in the areas of reimbursement and coverage of telehealth, substance use disorders (SUDs), and mental health services. The proposed 2025 Physician...more
The Centers for Medicare & Medicaid Services (CMS) have released significant updates affecting Medicare payments for 2025. The changes, outlined in two final rules, will impact both physicians and hospitals, eliciting strong...more
The U.S. Department of Health and Human Services Office of Inspector General (HHS OIG) recently issued Advisory Opinion No. 24-04, which primarily addressed a Refund Program offered by a U.S. pharmaceutical company affiliate....more
The Centers for Medicare & Medicaid Services (CMS) released a Final Notice for Transitional Coverage for Emerging Technologies (TCET), effective August 12, 2024, to provide “transparent, predictable, and expedited national...more
Obtaining Medicare coverage and reimbursement for medical devices is notoriously more difficult than for drugs or biologics, and any progress on expanding coverage pathways has been agonizingly slow for industry stakeholders....more
Pharma’s favorite summer pastime is back again: reviewing the Centers for Medicare & Medicaid Services (CMS) release of the 2025 proposed Hospital Outpatient Prospective Payment System (HOPPS) and Physician Fee Schedule (PFS)...more
On June 28, the US Supreme Court overturned the Chevron doctrine — the legal principle that the judiciary should defer to a federal agency’s reasonable interpretation of an ambiguous statute. Chevron reflected the view...more
Wilson Sonsini’s 31st Annual Medical Device & Digital Health Conference will address topics of critical importance to medical device and digital health companies, including early and late-stage venture financing, partnering...more
Earlier this year, we reported on the expected U.S. Food and Drug Administration (FDA) ruling concerning Laboratory Developed Tests (LDTs). The FDA has consistently shown a commitment to regulating LDTs. On May 6, 2024, the...more
Schmidt v. Schmidt, Kirifides & Rassias, Pa. C. (WCAB); No: 1039 C.D. 2021; filed Nov. 14, 2023; Judge Covey - In this case, the claimant, an attorney, sustained a work injury on April 14, 2017, while loading files into a...more
The U.S. Food and Drug Administration (FDA), in collaboration other agencies, recently published draft guidance (Guidance) on effectively presenting key information regarding informed consent in FDA-regulated clinical...more
Illumina Agrees to Unwind Acquisition of Grail Following Fifth Circuit Decision. On December 15, 2023, the Fifth Circuit vacated the FTC’s order that Illumina unwind its acquisition of Grail—a developer of a multi-cancer...more
In recent years, the Centers for Medicare & Medicaid Services (CMS) has expanded payment for remote monitoring services in an effort to pay for non-face-to-face services that improve care coordination for Medicare...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for July 2023. We discuss several criminal and civil enforcement actions that involve violations of the False Claims Act...more
Nearly nine years to the day the Food and Drug Administration (FDA) issued a draft “information sheet” on informed consent, the agency published a 66-page final guidance document on the topic—marking the first time since 1998...more
Sophisticated clinical software systems employed in specific health care services have graduated from being interfaces, operating systems, and subordinate tools that support physical medical devices and have matured to the...more
Editor’s Note: We are excited to announce that this article is the first of a series addressing Software as a Medical Device and the issues that plague digital health companies, investors, clinicians and other organizations...more
On May 2, 2023, the U.S. Food and Drug Administration (FDA) released Draft Guidance regarding the implementation of Decentralized Clinical Trials (DCTs) for drugs, biological products, and devices. DCTs are clinical trials...more
Advanced Bionics Corporation—a manufacturer and distributor of cochlear implants—entered settlements with six AGs to resolve allegations that the company violated federal and state False Claims Acts by submitting fraudulent...more
+Dx Forum 2023 is the premier gathering for the laboratory diagnostics community. Join us for insightful discussion about the latest regulatory and reimbursement developments....more
DOJ Indicts 47 Individuals in Largest COVID-19 Fraud Scheme To Date - On September 20, 2022, the US Department of Justice (“DOJ”) announced federal criminal charges against 47 defendants from the nonprofit, Feeding Our...more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector. This week's topics include ...more
As of January 15, 2022, fully-insured and self-insured group health plans are required to reimburse participants for the cost of purchasing over-the-counter (“OTC”) COVID-19 tests, even if such tests are purchased without the...more