The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a Special Advisory Bulletin on January 27 addressing how the federal Anti-Kickback Statute (AKS) applies to pharmaceutical...more
2/4/2026
/ Anti-Kickback Statute ,
Department of Health and Human Services (HHS) ,
Direct to Consumer Sales ,
Drug Pricing ,
Executive Orders ,
Health Care Providers ,
Healthcare ,
Healthcare Fraud ,
Kickbacks ,
OIG ,
Pharmaceutical Industry ,
Regulatory Requirements ,
Request For Information ,
Telehealth
FDA Commissioner Marty Makary announced policy shifts that ease the path to market for certain digital health technologies, including AI- and generative AI-enabled clinical decision support software (CDS) and consumer...more
1/12/2026
/ Artificial Intelligence ,
Digital Health ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare ,
Innovative Technology ,
Life Sciences ,
Machine Learning ,
Medical Devices ,
Mobile Health Apps ,
New Guidance ,
Pharmaceutical Industry ,
Regulatory Oversight ,
Software Developers
The U.S. Food and Drug Administration announced a major shift in its approach to real‑world evidence (RWE). In new guidance for certain medical device submissions, FDA will accept RWE without always requiring identifiable,...more
12/17/2025
/ Biologics ,
Clinical Trials ,
Data Privacy ,
Data Protection ,
Food and Drug Administration (FDA) ,
Medical Devices ,
New Guidance ,
Patient Privacy Rights ,
Pharmaceutical Industry ,
Privacy-By-Design ,
Regulatory Requirements
Last week, CMS and the FDA announced coordinated efforts to widen access to technology-enabled care for Medicare beneficiaries with certain chronic conditions. CMS unveiled the Advancing Chronic Care with Effective, Scalable...more
The U.S. Food and Drug Administration’s (FDA) Digital Health Advisory Committee (DHAC) held a public meeting on “Generative Artificial Intelligence-Enabled Digital Mental Health Medical Devices,” with a particular focus on a...more
11/12/2025
/ Artificial Intelligence ,
Bias ,
Clinical Trials ,
Digital Health ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare ,
Life Sciences ,
Medical Devices ,
Mental Health ,
Regulatory Requirements ,
Risk Management
US life sciences venture activity slowed sharply in Q3 2025, with deal flow drifting down to a decade low. The policy backdrop was mixed: Faster review timelines continued to help approvals, yet compliance and supply chain...more
10/20/2025
/ Artificial Intelligence ,
FDA Approval ,
Financing ,
Interest Rates ,
Investment ,
Investors ,
Life Sciences ,
Liquidity ,
Machine Learning ,
New Legislation ,
Regulatory Requirements ,
Supply Chain ,
Venture Capital
FDA’s recent announcement that it is undertaking sweeping reforms and a major enforcement initiative targeting allegedly misleading direct-to-consumer (DTC) prescription drug advertising will have significant implications for...more
9/15/2025
/ Advertising ,
Artificial Intelligence ,
Compliance Monitoring ,
Direct to Consumer Sales ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
New Regulations ,
Pharmaceutical Industry ,
Prescription Drugs ,
Rulemaking Process ,
Social Media
The U.S. Food and Drug Administration (FDA) has unveiled a sweeping transparency initiative that will fundamentally change how innovative drug and biologic developers interface with the Agency and the market. ...more
9/8/2025
/ Abbreviated New Drug Application (ANDA) ,
Biologics ,
Disclosure Requirements ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
New Regulations ,
Pharmaceutical Industry ,
Regulatory Oversight ,
Regulatory Reform ,
Risk Management
Illumina, Inc., a publicly-traded biotechnology company, agreed to a $9.8 million settlement with the U.S. Department of Justice (DOJ) in response to alleged violations of the False Claims Act (FCA). DOJ alleged that Illumina...more
8/26/2025
/ Biotechnology ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Department of Justice (DOJ) ,
Enforcement Actions ,
False Claims Act (FCA) ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
Human Genome Project ,
Medical Devices ,
NIST ,
Qui Tam ,
Regulatory Violations ,
Settlement Agreements ,
Software ,
Vulnerability Assessments
Illinois enacted the Wellness and Oversight for Psychological Resources Act, establishing standards for the use of AI technology in the provision of therapy and psychotherapy services. The Act aims to protect consumers by...more
FDA’s Warning Letter to WHOOP, a manufacturer of cutting-edge, wellness wearable tech, has sent shivers through an industry enjoying exponential growth in the health and wellness space. “Wellness technology”, a result of the...more
This year, U.S. VC funding into the life sciences sector has cooled: Q1 softness was followed by a decade low in VC transactions in Q2. Despite the moderation in dealmaking volume, investors continued to deploy sizable...more
Q1 2025 marked another strong quarter for life sciences VC financing, but the industry faces unique headwinds amid ongoing shake-ups in regulatory leadership and US trade relationships. Key takeaways for Q1 2025 include: •...more
Q4 2024 marked the conclusion of a turnaround year for life sciences venture investment. After two consecutive years of declining activity and macroeconomic uncertainty, the dust has settled, and investment is back on the...more
The DOJ has finalized a set of prohibitions and restrictions on cross-border transfers of certain U.S. data to China and other “Countries of Concern” (for now, Cuba, Iran, North Korea, Russia, and Venezuela), as well as to...more
The FDA has shared its first draft guidance on how sponsors should assess the credibility of artificial intelligence (AI) models to support FDA decisions regarding drug safety, effectiveness or quality. The agency noted an...more
The FDA has shared draft guidance on the design and development of AI-enabled medical devices and marketing submissions for those devices. The Importance of Engaging Early Sponsors of AI-enabled devices should engage with the...more
Republished with Permission
In this Law360 article, partners Thora Johnson, Georgia Ravitz and Amy Joseph explore the notable trends to watch in health tech regulation this coming year. The article observes that the...more
Since the previous quarter’s Life Sciences Snapshot, robust dealmaking activity in Q3 has launched YTD life sciences VC deal activity to near parity with 2023 figures, firmly positioning 2024 as the year to break the two-year...more
Generative AI is converging with every sector – and health care is no exception. With it, companies should keep up with the array of laws and regulations – existing and envisioned – that govern its use. Read on for highlights...more