Food, Drug, and Device

On Tuesday, March 31, FDA published a Request for Information seeking input on the use of digital health technologies (“DHTs”) in clinical investigations for drugs and biological products (the “RFI”).  Building on commitments under PDUFA VII and prior Agency publications – including a March 2023 Discussion Paper and December 2023

Continue Reading FDA Seeks Input on Use of Digital Health Technologies in Clinical Investigations of Drugs & Biologics

With 2026 underway, signs point to another year focused on enhancing health IT and digital health innovation.  From new payment models to deregulatory efforts, these developments show that digital health continues to be increasingly central to the healthcare and life sciences sectors.  Below are five key developments to watch unfold

Continue Reading 5 Developments Digital Health Innovators Should Watch in 2026

On September 30, 2025, the U.S. Food and Drug Administration (FDA) issued a Request for Public Comment seeking input on “practical approaches to measuring and evaluating the performance of AI-enabled medical devices in the real-world,” including strategies for detecting, assessing, and mitigating performance changes over time (the “Request”). 

The Request

Continue Reading FDA Requests Public Comment on Real-World Evaluation of AI-Enabled Medical Devices

The Food and Drug Administration (FDA) has announced that its Digital Health Advisory Committee (DHAC) will meet on November 6, 2025, to discuss and make recommendations on the topic of genAI-enabled digital mental health medical devices.  The DHAC will discuss potential “benefits, risks to health, and risk mitigations” for

Continue Reading FDA to Convene Advisory Committee Meeting on GenAI Mental Health Devices

On May 13, 2025, the Centers for Medicare & Medicaid Services (CMS) and the Department of Health and Human Services’ Office of the Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP/ONC) announced a request for information seeking stakeholder input on the market of digital

Continue Reading CMS & HHS Health IT Office Issue Request for Information on Digital Health Products and Health Technology Infrastructure

On 1 July 2024, Germany has enacted stricter requirements for the processing of health data when using cloud-computing services. The new Section 393 SGB V aims to establish a uniform standard for the use of cloud-computing services in the statutory healthcare system which covers around 90% of the German population. In this blog

Continue Reading Germany enacts stricter requirements for the processing of Health Data using Cloud-Computing – with potential side effects for Medical Research with Pharmaceuticals and Medical Devices

FDA recently announced that it will host a public workshop on August 6, 2024 focused on “Artificial Intelligence (AI) in Drug & Biological Product Development.”  Aimed at bringing drug sponsors and AI experts together, the workshop, hosted in collaboration with the Clinical Trials Transformation Initiative, will feature presentations and a

Continue Reading FDA Announces Workshop on AI Used In Drug & Biological Product Development

On March 11, 2024, the UK Government published its response (“Government Response”) to an independent review on equity in medical devices commissioned by the Department of Health and Social Care (“Review”).  The Government Response is not guidance nor policy rather it is intended to act as an action plan for tackling potential bias in the design and use of medical devices.  The Government Response fully accepts, and in turn makes a series of commitments in response to, the findings of the Review (which is broken down into 18 recommendations, 51 sub-recommendations, and 3 further calls to action).  Importantly, the Government “wholeheartedly agrees…that medical technology should be unbiased and equitable.” 

Bias in the medical device space, and within healthcare more broadly is (quite rightly) a topic of growing importance to governments, regulators and industry alike.  We set out some key points of interest from both the Review and the Government Response below.  We look forward to seeing more developments and guidance in this area going forwards given its significance to patients and the delivery of healthcare.  

Continue Reading UK Government Outlines New Action to Tackle Biases in Medical Devices

On September 6, Senator Bill Cassidy (R-LA), the Ranking Member of the U.S. Senate Health, Education, Labor and Pensions (HELP) Committee, issued a white paper about the oversight and legislative role of Congress related to the deployment of artificial intelligence (AI) in areas under the HELP Committee’s jurisdiction, including health

Continue Reading Framework for the Future of AI: Senator Cassidy Issues White Paper, Seeks Public Feedback

Hot on the heels of recent announcements from the U.S. Food and Drug Administration (see our prior blogs here), the European Medicines Agency (“EMA”) has joined the conversation on the use of Artificial Intelligence (“AI”) and Machine Learning (“ML”) technologies in the medicinal product lifecycle.

AI and ML have

Continue Reading EMA Releases Reflection Paper on AI/ML in the Medicinal Product Lifecycle