Artificial intelligence continues to reshape healthcare delivery, particularly in diagnostics, imaging, and care coordination. For established healthcare platforms seeking to integrate innovative capabilities, effective transactions are not always single-step acquisitions. Phased relationships, beginning with commercial alignment and structured with the potential for full-scale integration, can provide a disciplined path to innovation.
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The EU AI Act’s Machinery Exemption: Does It Extend to Surgical Robotics?
The EU’s latest AI reforms are intended to reduce regulatory duplication for products already subject to extensive sector-specific regulation. For manufacturers of surgical robotics, however, they leave unresolved how AI embedded within increasingly sophisticated surgical systems will be regulated in practice.
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Most-Favored-Nations Drug Pricing Policy: White House Quietly Releases Report Describing Voluntary MFN Deals
On May 6, 2026, the White House Council of Economic Advisors (CEA)[1] discretely released the first report quantifying its view of the projected savings generated by the administration’s Most-Favored-Nation (MFN) drug pricing policy framework, based on existing MFN pricing agreements and expectations for future MFN agreements. According to the report, the MFN framework is expected…
FDA’s Elsa at Eleven Months: AI-Powered Operations and One-Day Inspections Signal a New Oversight Paradigm
Recent United States Food and Drug Administration (FDA) announcements continue to highlight the agency’s increasing development and use of artificial intelligence. Earlier this month, FDA announced the launch of the latest version of Elsa – the internal AI solution it first announced last June. That same day, speaking at the Food and Drug Law Institute…
EU Pharma Package: Compromise Text Published – Best Efforts Required (Part 2)
After a 10-year process, the compromise text of the new EU General Pharmaceutical Legislation (GPL or Pharma Package) has been published and will soon become law. This blog post discusses the 10 most important changes for company pipelines, transition mechanisms, interaction with other laws, and next steps, and concludes that best efforts will be required…
Navigating the European Health Data Space Regulation: An (Uneasy) Marriage Between EHDS and GDPR
The European Health Data Space Regulation (EHDS Regulation) took effect on March 26, 2025. Most of its secondary use provisions will apply from March 2029, and implementation at EU and Member State level will have to take place between 2027 and 2035. Health data represents over 30% of the world’s data assets, yet less than…
Delaware Supreme Court Makes Earnouts Less Risky For Buyers Earnout Decision Partially Reversed Because Buyer Did Not Have to Pursue an Alternative Regulatory Pathway
Earnouts are a common feature of life sciences deals, and a 2024 Chancery Court decision had increased the financial risk for buyers agreeing to an earnout. However, the Delaware Supreme Court’s partial reversal of Johnson & Johnson v. Fortis Advisors LLC has addressed this issue by limiting the application of the implied covenant of good…
EU Pharma Package: Sharp New Tools With Limited Protections
Last week, concluding a seven-year process, the Council of the European Union and the European Parliament agreed on the EU Pharma Package consisting of a new Pharmaceutical Directive and Pharmaceutical Regulation. The Package introduces pivotal changes to the EU pharmaceutical legislation, most significantly the introduction of new launch and supply obligations with only limited safeguards…
U.S. Drug Pricing Year in Review: Reflections on 2025 and Getting Ready for 2026
Federal drug pricing pressures intensified in 2025 with the second Trump administration. This Update reviews the year’s pivotal shifts and outlines what manufacturers should expect as they prepare for a more complex 2026.
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What the U.S.–UK Drug Pricing Agreement Reveals About How MFN Drug Policy Could Impact the UK and EU
The new U.S.–UK agreement in principle on pharmaceutical pricing offers more than tariff relief and adjusted UK drug pricing and reimbursement measures – it provides an early window into how U.S. Most Favored Nation (MFN) policies may interact with UK and EU policy to shape drug pricing, launch strategies, and investment across Europe. Sidley’s transatlantic…