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 DevicesQuantum Computing: Action in the EU and Potential Impacts
On December 5, 2023, the Spanish presidency of the Council of the EU issued a declaration to strengthen collaboration with Member States and the European Commission to develop a leading quantum technology ecosystem in Europe.
The declaration acknowledges the revolutionary potential of quantum computing, which uses quantum mechanics principles and quantum bits known as “qubits” to solve complex mathematical problems exponentially faster than classical computers.
The declaration was launched with eight Member State signatories (Denmark, Finland, Germany, Greece, Hungary, Italy, Slovenia, and Sweden), and invites other Member States to sign. By doing so, they agree to recognize the “strategic importance of quantum technologies for the scientific and industrial competitiveness of the EU” and commit to collaborating to make Europe the “’quantum valley’ of the world, the leading region globally for quantum excellence and innovation.”Continue Reading Quantum Computing: Action in the EU and Potential Impacts
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
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FDA Seeks Comments on Agency Actions to Advance Use of AI and Digital Health Technologies in Drug Development
On March 23, 2023, FDA released a Framework for the use of digital health technologies in drug and biological product development (the “DHT Framework”). This DHT Framework is on the heels of a Discussion Paper the Agency released earlier this month on the use of artificial intelligence (AI) in drug
Continue Reading FDA Seeks Comments on Agency Actions to Advance Use of AI and Digital Health Technologies in Drug DevelopmentUK MHRA to recognize foreign regulatory approvals for medicines and medical technologies and promote digital innovation
Last week, Jeremy Hunt, Chancellor of the Exchequer, published his Spring Budget for the UK. It identified life sciences and digital technologies as “high growth sectors,” which the UK Government wishes to prioritize. Among other things, the Budget outlined the Government’s plans to simplify medicines and technology approvals
Continue Reading UK MHRA to recognize foreign regulatory approvals for medicines and medical technologies and promote digital innovation5 Reasons Digital Solutions for Women+ Health Will Grow in 2023
Innovative digital solutions intended to address health issues typically experienced by women have been an area of increased focus. Ranging from reproductive-related mobile applications to AI-enabled breast cancer screening devices, digital solutions for women+ health show promise to serve an enormous market with medical needs that have often failed to
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Change is Coming for Software and AI Medical Devices in the UK
The UK has reaffirmed its commitment to leading the way in regulatory innovation in software as a medical device (“SaMD”) and artificial intelligence as a medical device (“AIaMD”). On 17 October 2022, the UK Medicines & Healthcare products Regulatory Agency (“MHRA”) published its Guidance on “Software and AI as
Continue Reading Change is Coming for Software and AI Medical Devices in the UKFDA Webinar Provides New Insights on Use of Digital Health Technologies in Clinical Trials
Spurred by the realities of the COVID-19 pandemic, FDA has taken a number of regulatory actions to advance the use of digital health technologies (“DHTs”) in clinical trials. DHTs provide sponsors with opportunities to capture a broader array of information from study subjects than is typically available through traditional study
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5 Digital Health Issues to Watch at FDA in 2022
As we kick off 2022, several recent developments from FDA suggest that this year could be pivotal for the Agency’s digital health priorities. From new FDA offices and artificial intelligence guidance, to FDA’s user fee commitments and must-pass legislation in Congress, this post outlines five key issues to watch in
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U.S., UK and Canada Regulators Collaborate to Develop “10 Guiding Principles” for Good Machine Learning Practices (“GMLP”) for Medical Devices
On 27 October 2021, the U.S. Food and Drug Administration (“FDA”), Health Canada, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency (“MHRA”) (together the “Regulators”) jointly published 10 guiding principles to inform the development of Good Machine Learning Practice (“GMLP”) for medical devices that use artificial intelligence and
Continue Reading U.S., UK and Canada Regulators Collaborate to Develop “10 Guiding Principles” for Good Machine Learning Practices (“GMLP”) for Medical Devices