Feeling Disillusioned with AI? You’re Not Alone
Podcast - FTC to Focus on Deceptive AI Claims: Compliance Management Strategies
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 240: Independent Practice In Dermatology with Dr. Darragh and Dr. Shuler of Carolina Dermatology
Episode 373 -- Christian Focacci on Current Developments in AI and Risk Management
Regulatory Rollback: Inside the CFPB’s FCRA Guidance Withdrawal — The Consumer Finance Podcast
Rethinking Records Retention
Work This Way: A Labor & Employment Law Podcast | Episode 48: Opportunities & Risks with Artificial Intelligence in HR with Chingwei Shieh of GE Power
Upping Your Game: Continuous Monitoring with AI
Compliance Needs are Alive and Well: FTC's Recent Enforcement Activity
From Dashboards to Data-Driven Decisions – The Evolving Role of Technology in Legal Marketing & BD
Regulatory Rollback: Inside the CFPB's FCRA Guidance Withdrawal — FCRA Focus Podcast
No Password Required: Reginald “Andre” Andre, CEO of ARK Solvers and Builder of Human + AI-Driven Culture
Everything Compliance: Shout Outs and Rants - Episode 155
Innovation in Compliance: The Critical Importance of Mobile Application Security: Insights from Subho Halder
Sunday Book Review: June 8, 2025, The Books on AI Governance Edition
2 Gurus Talk Compliance: Episode 53 – The AI as a Whistleblower Edition
Compliance into the Weeds: Autonomous AI Whistleblowing Misconduct
Daily Compliance News: June 4, 2025, The Climate Disaster Management Edition
AI on the Job: How to Stay Ahead of Employment and Data Privacy Risks
As we head into BIO 2025 in Boston, our teams are closely watching trends in biotech and how those affect financings, business development, IP protection, risk, and litigation strategy. Here are eight key trends we’re...more
From lab to commercialization: Navigate the evolving risks of life science companies - Life science companies face rapidly evolving risks—from navigating insurance needs during early funding stages to understanding...more
Overview - - The U.S. Food and Drug Administration (FDA) announced that it aims to increase the agency’s use of artificial intelligence (AI) across its centers to accelerate scientific reviews by June 30, 2025. - The...more
In April 2025, we were proud to host the annual European Health & Life Sciences Symposium at the Shangri-La hotel in Paris. Attended by some 300 delegates from across the industry, participants including investors,...more
Artificial intelligence has become one of the most transformative forces in health care, reshaping everything from drug discovery to diagnostics. For pharmaceutical and medical device companies, AI-driven solutions present...more
In January, the U.S. Food and Drug Administration (FDA) issued its first guidance on the use of artificial intelligence (AI) models in drug development and in regulatory submissions titled, “Considerations for the Use of...more
Since 1995, Nature Medicine has been chronicling advances in medical technology and health care. To mark the journal’s 30th anniversary, each month an issue of critical importance for the future of medicine will be...more
DTC Telehealth Platforms - Arrangements involving telemedicine and direct-to-consumer (“DTC”) business services are expected to be a source of major regulatory scrutiny. In 2024, such arrangements were the focus of proposed...more
The US Food and Drug Administration (FDA) recently issued its draft guidance, Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products, on January 6, 2025. ...more
The U.S. Food and Drug Administration (FDA) recently published its long-awaited draft guidance on considerations for the use of artificial intelligence (AI) to support regulatory decision-making for drug and biologics, which...more
Pharma: Launch of Shortages Monitoring Platform, several Changes re Clinical Trial Management in EU Countries; Devices: Resolution on the need to revise the MDR and IVDR published; Compliance: CSRD still not implemented in...more
Gain firsthand insights from leading in-house experts on the transformative power of AI in the life sciences at ACI's 2nd Annual Life Sciences AI Summit. Discover strategies to navigate the complex legal and regulatory...more
We bring you Vital Signs, a curated, one-stop resource on the most notable digital health law updates from our U.S. and global contributors. In Industry Insights, we present a timely discussion about increasing litigation and...more
Report on Research Compliance 21, no. 9 (September, 2024) - Based on their review of public data on ClinicalTrials.gov, a bipartisan quartet of U.S. representatives has asked the Food and Drug Administration (FDA) to...more
Due to an exponential growth in the investment in female health and wellbeing, Forbes and Dealroom reported that 2023 saw 1.14 billion USD raised collectively across 120 deals in ‘FemTech’. ...more
During this session, the panelists discussed how stakeholders in the clinical research market can leverage new technologies to better identify subjects, optimize trial conduct and reduce costs. For example, common use cases...more
In a landmark decision on June 28, 2024, the Supreme Court overturned a 40-year-old legal precedent known as Chevron deference. Established in 1984, Chevron deference mandated that judges defer to federal agencies concerning...more
In the rapidly evolving biotech and life sciences sectors, the importance of trade secrets has grown significantly. Companies are investing heavily in research and development to create cutting-edge treatment therapies....more
The food, drug and medical device industries comprise some of the most closely regulated sectors in the United States. The US Food & Drug Administration (FDA) actively exercises authority by constantly changing legislation...more
Most people have seen the growth in artificial intelligence/ machine learning (AI/ML)-based medical devices being cleared by FDA. ...more
Late last month, the Association of Corporate Counsel (ACC) hosted a panel on artificial intelligence and how it is rapidly transforming the life sciences sector, allowing companies to leverage large datasets to accelerate...more
While economic factors, including the high cost of capital, continue to keep our clients up at night, we also see signs of optimism in 2024. Against this fiscal backdrop, significant recent regulatory changes and those on the...more
We have been writing about software as a medical device (SaMD) for years, tracking the Food and Drug Administration's (FDA) efforts to keep up with the fast-paced development of digital technology, such as launching the...more