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).
CMS’ CY 2027 OPPS and PFS Proposed Rules Include Major Changes to Reimbursement for 340B Hospitals, Data Reporting, and Digital Health
In July 2026, the Centers for Medicare & Medicaid Services (CMS or Agency) published two of their annual proposed rules: the CY 2027 Hospital Outpatient Prospective Payment System and Ambulatory Surgical Center Proposed Rule (OPPS-ASC Proposed Rule) and the CY 2027 Medicare Physician Fee Schedule Proposed Rule (PFS Proposed Rule). These proposals include several significant policy and payment changes, including substantial reductions in reimbursement for 340B-acquired drugs in the hospital outpatient setting and changes to Medicare reimbursement methodologies for Evaluation and Management (E/M) services and digital health services, including remote patient monitoring services and telehealth, among other items. The Agency also proposes several changes to CPT codes, PFS practice expense inputs, and OPPS Ambulatory Payment Classification (APC) assignments and payment rates for established services. Stakeholders should review relevant proposals, including changes to APC assignments and payment rates in the OPPS Addendum, and consider providing input through comments. Comments on the OPPS-ASC Proposed Rule are due August 31, and comments on the PFS Proposed Rule are due September 14.
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.
Navigating the European Health Data Space Regulation: An (Uneasy) Marriage Between EHDS and GDPR (Part 2)
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 3% is utilized for secondary purposes such as research, regulatory, or public health purposes, a persistent “data-to-value” gap. This update examines how the EHDS Regulation seeks to close that gap by introducing a more prescriptive legal framework for access to health data for (certain) secondary use purposes whilst still aligning with requirements under EU privacy law; and what life sciences companies should be doing now to anticipate such secondary use obligations, data access requests, and opportunities.
European Regulator Clarifies Guidance on the Use of AI in the Medicinal Product Lifecycle
The European Medicines Agency (EMA) has published a final reflection paper on the use of AI in the drug lifecycle, which provides important insights into the expectations from the EMA to clinical trial sponsors, as well as marketing authorization (MA) applicants and holders who use AI systems. Josefine Sommer and Zina Chatzidimitriadou explain.
Investor Attitudes to Healthcare AI Technologies
Investors are eyeing up the opportunities to invest in healthcare AI as it pushes the healthcare industry into new and exciting territory. R&D is currently focused on genomic sequencing, mapping, understanding populations and the treatment of rare diseases and hereditary cancer. AI applications are fundamentally altering how such R&D is conducted, as well as changing healthcare services to improve patient experience and outcomes. The advent of AI has dramatically altered the cost of capital, with private equity firms prepared to invest substantial sums into early adopters. These evolving opportunities raise important questions.
