US life sciences venture activity in Q4 2025 reflected a market that remains selective. While overall dealmaking continued to slow, capital deployment held up, reinforcing a multi-year shift toward concentration in fewer,...more
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
The use of facial recognition technology in stadiums is becoming increasingly popular and has the potential to improve the visitor experience. Venues can use the technology to shorten queues at entrances and concession...more
11/4/2025
/ AI Act ,
Arenas and Stadiums ,
Biometric Information ,
California Consumer Privacy Act (CCPA) ,
Consent ,
Cybersecurity ,
Data Privacy ,
Enforcement Actions ,
Facial Recognition Technology ,
General Data Protection Regulation (GDPR) ,
Innovative Technology ,
State Privacy Laws
On October 11, 2025, California enacted Assembly Bill No. 489, introducing new regulatory measures to address the use of artificial intelligence (AI) and generative AI (GenAI) in healthcare communications. The legislation...more
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
At a recent “Make HealthTech Great Again” event, the White House and the Centers for Medicare and Medicaid Services (CMS) announced the launch of a digital health technology ecosystem in partnership with private sector...more
Wearable health technology is rapidly transforming the landscape of professional sports. From heart rate monitors and GPS trackers to biometric gloves and brain health sensors, these devices are now commonplace in...more
Interest in genetic data is on the rise, driven by the growth of direct-to-consumer (DTC) genetic testing and its value for AI in drug development and personalized medicine. Historically, gaps in privacy laws have sometimes...more
8/8/2025
/ Bankruptcy Code ,
Data Privacy ,
Department of Justice (DOJ) ,
Genetic Discrimination ,
Genetic Testing ,
GINA ,
Health Insurance Portability and Accountability Act (HIPAA) ,
New Legislation ,
Privacy Laws ,
Regulatory Requirements ,
State Privacy Laws
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
Join Thora Johnson and Jeremy Sherer to learn about: Evaluating compliance through privacy notices Key questions to address, from leadership accountability to employee training...more
Jeremy Sherer and Thora Johnson share insight on: Key due diligence considerations for healthtech companies State and federal regulations aimed at virtual care delivery...more
Thora Johnson and Alexandra Wood discuss: Key federal regulation including HIPAA The patchwork at the state level, including a growing number of state consumer health privacy laws...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
Thora Johnson shares simple guidance on: Data management for privacy compliance Ensuring data security through storage and retention practices...more
On July 1, 2025 the California Attorney General announced the largest CCPA settlement to date, totaling $1.55 million. The settlement, which is awaiting court approval, was the result of an investigation by the California...more
7/9/2025
/ Advertising ,
California Consumer Privacy Act (CCPA) ,
Corporate Counsel ,
Data Collection ,
Data-Sharing ,
Enforcement Actions ,
Opt-Outs ,
Privacy Policy ,
Settlement ,
State Attorneys General ,
Third-Party
The Montana Legislature recently passed an update to the state’s Uniform Health Care Information Act (the Act), which creates standards for privacy and security of health care information maintained by Montana health care...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