When AI Changes The Deal: Seven AI-related Considerations for Life Sciences M&A Dealmakers
Sally Wagner Partin, Sharon R. Flanagan, and Torrey Cope consider how AI is reshaping drug development, particularly at the stages of target and compound identification, and set out the implications of those changes for valuation, diligence, risk, milestone design, and timing in life sciences transactions.
Is my product a medical device? EU Court judgment clarifies that the test includes objective function and intended purpose, and provides guidance relevant to software and AI-enabled tools
The recent judgment of the Court of Justice of the European Union (CJEU or the Court) in Case C-427/24, Diagramm Halbach clarifies the key principles for determining whether a product falls within the definition of a medical device and will be subject to the EU medical device regime. Crucially, the CJEU held that this analysis includes an assessment of both the manufacturer’s intended purpose of the product and whether the product objectively performs functions for a specific medical purpose listed in Article 2(1) of Regulation (EU) 2017/745, the Medical Devices Regulation (MDR).
UK Looks To Modernize Medicines And Medical Device Regulation In The Era Of AI
A landmark program designed to deepen the regulatory partnership between the UK and the U.S., a regulatory ‘sandbox’ for AI as a medical device, evidence-gathering on AI regulation in healthcare, a consultation on a draft Rare Disease Therapies Regulatory Framework and the launch of the largest package of UK clinical trial reforms in over 20 years – Sidley’s Dr. Chris Boyle and Zina Chatzidimitriadou bring you up to date with developments at the UK Medicines and Healthcare products Regulatory Agency (MHRA) in the first half of 2026.
AI Collaborations – From Strategic License to Strategic Acquisition
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.
For technology and life sciences transactions counsel, this raises a critical question: how can parties structure an initial collaboration to accelerate deployment while preserving long-term strategic optionality?
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.
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 (FDLI) annual conference, the FDA Commissioner at the time, Dr. Martin Makary, announced a new pilot program for “one-day inspections” driven by AI-backed risk analysis for low-risk facilities. Taken together, and against the backdrop of Elsa’s launch less than a year ago, these developments show a continued push from FDA to leverage AI to expedite its operations, including in the enforcement space – a push that could have direct consequences for regulated entities across FDA product categories.
Key Steps Toward Using Artificial Intelligence in Pharmacovigilance – Sidley Insights on the Recent CIOMS Draft Report
The Council for International Organizations of Medical Sciences Working Group XIV (CIOMS) has produced a draft report (the Draft Report) on the use of artificial intelligence (AI) in pharmacovigilance (PV). Torrey Cope, Anna Melin, and Andrew James provide insights on how life sciences companies can take steps to implement key concepts from the Draft Report.
UK Life Sciences Sector Boosted By Raft Of New Policy Measures
A new policy document from the U.K. Government makes the life sciences sector a major focus for changes aimed at facilitating industrial growth. Marie Manley and Dr. Kwabena Tenkorang explain the relevant proposed changes, including reforms to speed up clinical trials, regulatory reforms, the introduction of low-friction procurement and the creation of a Health Data Research Service.
2025 Boston Life Sciences Roundtable
The 5th Annual Boston Life Sciences Roundtable, “Navigating New Frontiers,” brought together legal experts, industry leaders, and innovators for an afternoon of thought-provoking discussion, strategic networking, and forward-looking perspectives on the latest trends and hot topics shaping the industry. Discussions ranged from recent changes at the FDA to strategies on how to de-risk supply chains from recently imposed tariffs to new AI technologies and pathways for products, and creative approaches to funding sources and deal structures amid ongoing regulatory and geopolitical uncertainty, writes Mia Harris.
The Union of AI and Drug Discovery and Development Requires New Thinking for Structuring and Negotiating Strategic Transactions, and a Rigorous Analysis of Applicable Regulatory Considerations
The use of artificial intelligence and machine learning (AI/ML) in drug discovery and development is well established and here to stay. With AI tools developing the potential to impact virtually every stage of the life sciences product life cycle, the FDA continues to refine its framework for the use of AI to support regulatory decision-making. On April 7, the FDA ended its consultation period on two draft guidance documents, one containing recommendations on the use of AI to support FDA regulatory decision-making and another providing a “comprehensive approach” to the management of risk throughout the total product life cycle of AI-enabled devices. We also saw, in January of this year, the U.S. administration issue the Executive Order Removing Barriers to American Leadership in Artificial Intelligence. These developments, and potential developments, need to be carefully taken into account by life sciences companies that are considering transacting with an AI/ML tool provider.
