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).
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2025/05/MN-24012_FCA-Blog-Imagery-Refresh-B_25.jpg606833Dr. Chris Boylehttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngDr. Chris Boyle2026-08-31 03:07:442026-08-27 11:48:25Is 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
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.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Dr. Chris Boylehttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngDr. Chris Boyle2026-08-26 03:06:272026-08-26 10:08:22UK Looks To Modernize Medicines And Medical Device Regulation In The Era Of AI
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.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2025/09/AdobeStock_521493531.png400600Meenakshi Dattahttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngMeenakshi Datta2026-08-24 13:13:532026-08-25 11:23:25CMS’ CY 2027 OPPS and PFS Proposed Rules Include Major Changes to Reimbursement for 340B Hospitals, Data Reporting, and Digital Health
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?
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Joshua T. Hofheimerhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngJoshua T. Hofheimer2026-06-15 09:05:222026-06-12 15:30:24AI Collaborations – From Strategic License to Strategic Acquisition
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.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2026/06/Medical-Devices-12.jpg400599Eva von Mühlenenhttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngEva von Mühlenen2026-06-11 11:07:082026-06-11 11:07:08The EU AI Act’s Machinery Exemption: Does It Extend to Surgical Robotics?
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 to generate an estimated $529B in domestic savings and a 30% decrease in net prices for drugs in the U.S. over the next 10 years.
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.
https://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.png00Raj D. Paihttps://goodlifesci.sidley.com/wp-content/uploads/sites/6/2022/03/sidleyLogo-e1643922598198.pngRaj D. Pai2026-05-20 10:06:332026-05-20 10:06:33FDA’s Elsa at Eleven Months: AI-Powered Operations and One-Day Inspections Signal a New Oversight Paradigm
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).
Dr. Chris Boyle
London
cboyle@sidley.com
Zina Chatzidimitriadou
London
zchatzidimitriadou@sidley.com
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.
Dr. Chris Boyle
London
cboyle@sidley.com
Zina Chatzidimitriadou
London
zchatzidimitriadou@sidley.com
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.
(more…)
Meenakshi Datta
Chicago
mdatta@sidley.com
Trevor L. Wear
Chicago
twear@sidley.com
Catherine Y. Starks
Chicago
cstarks@sidley.com
Elizabeth Hardcastle
San Francisco
ehardcastle@sidley.com
Rina Mady
Chicago
rmady@sidley.com
Kim Schroer
Chicago
kschroer@sidley.com
Taylor Andelman
Washington, D.C.
tandelman@sidley.com
George Maliha
Washington, D.C.
george.maliha@sidley.com
Allie K. Gilchrist
Chicago
alliegilchrist@sidley.com
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?
Joshua T. Hofheimer
Century City, Palo Alto
jhofheimer@sidley.com
Zach Johnston
Dallas
zjohnston@sidley.com
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.
Eva von Mühlenen
Geneva
evonmuehlenen@sidley.com
Anna-Shari Melin
Munich
amelin@sidley.com
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 to generate an estimated $529B in domestic savings and a 30% decrease in net prices for drugs in the U.S. over the next 10 years.
Meenakshi Datta
Chicago
mdatta@sidley.com
Trevor L. Wear
Chicago
twear@sidley.com
Catherine Y. Starks
Chicago
cstarks@sidley.com
Taylor Andelman
Washington, D.C.
tandelman@sidley.com
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.
(more…)
Raj D. Pai
Washington, D.C.
rpai@sidley.com
Jaclyn G. Fonteyne
Washington, D.C.
jaclyn.fonteyne@sidley.com
Andrew James
Washington, D.C.
andrew.james@sidley.com
Julea Lipiz
Washington, D.C.
jlipiz@sidley.com
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