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 DevicesFood, Drug, and Device
FDA Announces Workshop on AI Used In Drug & Biological Product Development
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 DevelopmentUK Government Outlines New Action to Tackle Biases in Medical Devices
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
Framework for the Future of AI: Senator Cassidy Issues White Paper, Seeks Public Feedback
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 FeedbackEMA Releases Reflection Paper on AI/ML in the Medicinal Product Lifecycle
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 LifecycleFDA Releases Discussion Paper on AI in the Drug and Biological Product Development Process
Last week, the U.S. Food & Drug Administration (“FDA” or the “Agency”) issued a second discussion paper on the use of artificial intelligence (“AI”) and machine learning (“ML”) with respect to drug and biological products, this time focusing on the use of AI/ML in the drug and biologic development process,…
Continue Reading FDA Releases Discussion Paper on AI in the Drug and Biological Product Development Process