False Claims Act Insights - An FCA Perspective on Artificial Intelligence in the Healthcare Industry
The State of Healthcare Enforcement
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 247: Reimagining Cell Therapy for Solid Tumors with Ming-Wei Chen and Fangheng Zhou of RephImmune
What’s in Your Operating Agreement? Legal Tips for Healthcare Providers
10 For 10: Top Compliance Stories For the Week Ending, July 26, 2025
Key Discovery Points: Don’t Get Caught with Your Hand in the Production Cookie Jar
Work this Way: An Employment Law Video Podcast | Episode 50: Creating a Competitive Advantage Through Employee Benefits with Connor Shaw of Gallagher
False Claims Act Insights - Will Recent Leadership Changes Lead to FCA Enforcement Policy Changes?
Podcast: Addressing Patient Complaints About Privacy Violations
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 236: Advocating for Accessible Diagnoses with Sydney Severance of Operation Upright
Podcast - Navigating the New Landscape of Private Equity in Healthcare
Taking the Pulse: A Health Care and Life Sciences Video Podcast | Episode 235: Revolutionizing Cancer Care with Eric Perrault of Kiyatec
Evolving AI Legislation: Federal Policies, Task Forces, and Proposed Laws — The Good Bot Podcast
CareYaya: A Revolutionary Approach to Elder Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 234: Life-Saving Collaboration in the Life Sciences Industry with John Crowley, President & CEO of BIO
False Claims Act Insights - Trump DOJ Sharpens Its Focus on Healthcare Fraud
Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®
Breaking Down the Shifting Vaccine Policy Landscape – Diagnosing Health Care Video Podcast
Criminal Health Care Fraud Enforcement: Projections for 2025 and Beyond – Diagnosing Health Care Video Podcast
Healthcare Industry Segment-Specific Compliance Program Guidances (ICPGs)
Given the real and significant potential benefits of AI, companies have to be careful in the rush to implement AI technology. Starting with a clear use case, companies have to weigh the potential benefits of AI technology and...more
Deal activity: Deal count has picked up through the first half of 2025, up 2% compared to the same period last year but still down 7% from H2 2024. With geopolitical tensions, investors and analysts alike are forecasting...more
Can human beings cure all diseases in our lifetime? For centuries, humanity has strived to cure diseases. With the advent of Artificial Intelligence (AI), the dream of a disease-free world seems more attainable than ever...more
Artificial intelligence (AI) is already indispensable in the healthcare and life sciences sector. Intelligent medical devices promise nothing less than a revolution in the art of healing. With its legislative projects on AI...more
On 4 July 2025, the EC fined Alchem and its subsidiary EUR 489,000 for their role in a long-running cartel concerning the active pharmaceutical ingredient SNBB, used in the production of Buscopan and its generics. This marks...more
Dealmaking in Europe’s life sciences sector has been relatively muted in recent years, but the first half of 2025 has shown signs of strength as companies respond to the stark realities of an aging population - Earlier this...more
The Federal Circuit recently issued a precedential decision in Shockwave Med., Inc. v. Cardiovascular Sys., Inc. (CSI), affirming-in-part and reversing-in-part the Patent Trial and Appeal Board’s (PTAB) decision, and...more
On July 2, 2025, the European Commission released its communication “Choose Europe for life sciences. A strategy to position the EU as the world’s most attractive place for life sciences by 2030” (the Strategy). ...more
European cybersecurity risk management and reporting obligations have received a substantial facelift. The Directive (EU) 2022/2555 on measures for a high common level of cybersecurity across the EU (“NIS 2”) became effective...more
- On 26 March 2025, the European Health Data Space (EHDS) Regulation entered into force. The regulation establishes a comprehensive framework for health-data sharing and access in the EU, with the dual aim of supporting the...more
The intersection of AI and healthcare is outpacing the development of laws and regulations governing the technology. Even in the early days of AI transformation, this is creating uncertainty for healthcare organizations....more
TELA Bio—which was founded in 2012 and is headquartered in Pennsylvania—is a medical device company that specializes in providing soft-tissue surgical products. According to TELA Bio, its soft-tissue reconstruction solutions...more
On 4 June, the Council of the European Union (Council) adopted its negotiation position on the proposals for a new regulation and directive that make up the so-called ‘pharma package’. The pharma package now moves to the next...more
Great Point Partners (GPP) has announced the acquisition of a majority stake in Eutecma. Eutecma, founded in 2008 and based in Germany, is a developer of temperature-controlled packaging solutions for pharmaceutical cold...more
This regular alert covers key policy and regulatory developments related to EU geopolitical risks, including in particular, economic security, Russia’s war against Ukraine, health threats, and cyber threats. It does not...more
Antitrust scrutiny of healthcare markets is nothing new. The Biden Administration and first Trump Administration focused antitrust enforcement efforts across the healthcare and life sciences industries. The newly installed...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
On 26 February 2025, the European Economic and Social Committee (EESC) adopted an opinion addressing the integration of robotics and the metaverse in healthcare. This forward-looking document outlines the opportunities and...more
Transparency of artificial intelligence (AI) systems in healthcare is quickly becoming a central concern for regulators due to potential impacts on patient safety, healthcare quality, bias mitigation, and public trust. To...more
The EU regulation designed to facilitate secondary use of clinical data for research brings benefits for health research, but also poses challenges for companies....more
The European Union ("EU") Listing Act, approved by the EU Council on October 8, 2024, introduces key changes to the EU Prospectus Regulation, offering greater flexibility to access and issue securities on EU markets for small...more
On March 5, 2025, Regulation (EU) 2025/327 of the European Parliament and of the Council of February 11, 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847 (the Regulation)...more
March 26, 2025, marked a pivotal moment in the EU with the European Health Data Space Regulation, (EU) 2025/327 (“EHDS Regulation”), coming into force. The EHDS represents a transformative initiative by the European Union...more
Our clients are at the forefront of many of the developments covered by the report. That said, I couldn’t help thinking that the report overlooked a law that takes effect in less than six months’ time and which will have...more
COMPETITION - Judgment of the Court of 19 March 2025 in Case T-142/23, Ivo Swenters Vs. European Commission Re: Competition - Agreements, decisions and concerted practices - Abuse of a dominant position - Market for the...more