Hawaii FDA Ruling on Abortion Pill Sparks Big Pharma and Investor Jitters
Understand how the Hawaii FDA ruling on mifepristone reshapes abortion pill regulation, REMS compliance, telehealth access, and investor risk exposure.
Category: Healthcare
Medtech regulation shifts reshaping medtech strategy under new FDA rules
Medtech regulation shifts: Learn how to navigate new FDA changes on wearables, CDS, AI tools, and QMS, and realign strategy, risk, and compliance frameworks.
Medical Device labeling revolution reshaping medical device safety
Explore how medical device labeling, UDI, and EU/FDA regulations enhance safety, traceability, and compliance while guiding practical risk and quality management.
Regulation Roadblocks Cloud AI Integration in Real‑World Evidence
Learn how AI integration in real-world evidence demands high-quality data, robust governance, and regulatory compliance to ensure trustworthy, regulator-ready insights.
HIPAA compliance frontiers reshaping generative AI on AWS
HIPAA compliance for generative AI on AWS with PHI: learn BAA, HIPAA‑eligible services, security controls, and governance to securely deploy healthcare AI.
AKS but-for causation showdown reshapes False Claims Act risk
Analysis of how the AKS but-for causation standard and the Nolan decision reshape False Claims Act risk, enforcement strategy, and healthcare compliance duties.
Federal Trade Commission Non-Compete Crackdown Shifts to Targeted Enforcement
Explore the FTC’s shift from a broad non-compete ban to targeted enforcement in 2025, its impact on businesses and workers, and evolving state and federal regulations.
FDA, HIPAA & AI Rules: Oct 4, 2025 Compliance News You Need to Know
Stay ahead with today’s top compliance headlines in Life Sciences and Healthcare. From FDA’s cybersecurity guidance to HIPAA crackdowns and EMA updates — here’s what GRC professionals need to know today, October 4, 2025.
FDA drug promotion rules spotlight compounded meds in Hims & Hers Super Bowl ad controversy
This article unpacks the regulatory framework implicated by the Hims & Hers’ Super Bowl advertisement, explores the implications for the company and the broader pharmaceutical and telehealth industries, and discusses how evolving enforcement trends may shape future drug promotion practices.
FDA Mental Health Chatbot Rules Tighten Amid Rising AI Risks and Hype
The FDA’s announcement, published in the Federal Register, highlights the “novel risks” posed by devices having Mental Health Chatbots and signals a shift toward more stringent oversight to ensure safety and efficacy. This article explores the implications of these regulatory developments, the evolving landscape, and what it means for companies and users alike.