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)
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
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
At the American Bar Association’s annual Spring Meeting on April 2–4, 2025, an economist and a group of antitrust practitioners, including Axinn partner Leslie Overton, came together to discuss issues of entrenchment on the...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
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
The European Union Artificial Intelligence Act (AI Act) entered into force on 1 August 2024. The AI Act establishes a risk-based approach to AI, prohibiting certain practices that are deemed unacceptable, such as social...more
On 14 January 2025, the European Commission ("Commission") published the findings of its first investigation under the EU's International Procurement Instrument ("IPI"). Findings of the investigation concludes that China...more
New U.S. merger control filing forms to take effect in February 2025 - Following publication in the Federal Register, the new Hart-Scott-Rodino (HSR) premerger notification forms will become effective on February 10, 2025....more
The European Union (EU) is leading the global charge with AI regulations. U.S. companies are not beyond their regulatory reach, however, and should be preparing their AI risk mitigation efforts accordingly....more
The European Commission (EC ) has approved the first Important Project of Common European Interest (IPCEI) in the health sector— IPCEI Med4Cure. Under the IPCEI, six EU member states will provide up to EUR1bn of state aid...more
This newsletter is a summary of the antitrust developments we think are most interesting to your business. David Higbee (Global Head of Antitrust) and Dominic Long (Global Deputy Head of Antitrust) are our editors this month....more
On March 26, 2024, Skadden hosted a discussion on key developments in antitrust enforcement in the pharmaceuticals and life sciences sectors. ...more
The year 2023 ended with a bang in the cartel space, with a federal court of appeals upending what was long believed to be the scope of conduct that should be considered per se under the Sherman Act. The new year, 2024,...more
APRIL – JUNE 2022: KEY THEMES AND TAKEAWAYS - UNITED STATES - • An Overview of Agency Merger Challenges from January 2021 through June 2022 Parties continue to be cautious in litigating challenged transactions. Since...more
In mid-January 2021, the European Data Protection Board (EDPB) announced by press release that it has adopted jointly with the European Data Protection Supervisor (EDPS) written Opinions on the European Commission’s drafts...more
The European Commission (EC) has published details of its proposal to postpone the application date of the Medical Devices Regulation (MDR) for one year. In addition, the EC proposes introducing a new procedure to address...more
Introduction The European Commission has published a factsheet addressed to competent authorities of third countries....more
On 20 November 2018, the European Commission published nine new documents intended to provide guidance to non-EU authorities and economic operators in relation to the Medical Devices Regulation (“MDR”) and In vitro Diagnostic...more
The European Commission is seeking consultation on proposed clarifications for handling duplicate marketing authorisations from stakeholders....more
Earlier this month, privacy and security professionals from around the globe gathered for “Privacy. Security. Risk. 2015”—the second joint conference between the International Association of Privacy Professionals and the...more