The European Data Protection Body (EDPB) has published a study on how personal health data is and/or can be reused for scientific research in the EU under the EU General Data Protection Regulation (GDPR). The study highlights the related practical challenges due to divergent interpretations of the GDPR and national rules across EU Member States.
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Virtual and Digital Health Digest – March 2025
Welcome to the latest installment of Arnold & Porter’s Virtual and Digital Health Digest. This digest covers key virtual and digital health regulatory and public policy developments during February and early March 2025 from the United States, United Kingdom, and European Union.
Artificial intelligence (AI) has been the focus this month, with certain aspects of…
The UK’s MHRA launches consultation on draft guideline on individualised mRNA cancer immunotherapies
By Emma & Adela Williams
On 3 February 2025, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) launched a consultation asking for stakeholders’ views on draft guideline in relation to the regulation of individualised mRNA cancer immunotherapies (Draft Guideline).
The aim of the proposed guideline is to establish a clear and streamlined regulatory pathway to authorisation so that…
Virtual and Digital Health Digest – February 2025
Welcome to the latest installment of Arnold & Porter’s Virtual and Digital Health Digest. This digest covers key virtual and digital health regulatory and public policy developments during January and early February 2025 from the United States, United Kingdom, and European Union.
In this issue, we discuss some useful international guidance documents from the International…
Virtual and Digital Health Digest – January 2025
Welcome to the latest installment of Arnold & Porter’s Virtual and Digital Health Digest. This digest covers key virtual and digital health regulatory and public policy developments during December 2024 and early January 2025 from the United Kingdom, and European Union.
In this issue, we feature the emerging trends in digital health in 2024 that…
Virtual and Digital Health Digest – December 2024
Welcome to the last 2024 installment of Arnold & Porter’s Virtual and Digital Health Digest! This digest covers key virtual and digital health regulatory and public policy developments during November and early December 2024 from the United Kingdom and European Union.
Of note, health authorities in the EU continue to develop methods to assess…
Virtual and Digital Health Digest – November 2024
This digest covers key virtual and digital health regulatory and public policy developments during October and early November 2024 from the United Kingdom and European Union.
Regulatory and legislative reform is on the horizon in both the UK and in the EU, which will impact software and artificial intelligence (AI) medical devices. The UK government…
The Convergence of Life Sciences and Artificial Intelligence: Seizing Opportunities While Managing Risk
A new report commissioned by Arnold & Porter, based on a survey of 100 senior executives and department heads from biopharmaceutical, digital health, diagnostics, and medical device companies, shows that artificial intelligence (AI) adoption is accelerating across the industry as companies implement it to accelerate product discovery and development, optimize manufacturing and the supply chain,…
UK government launches new Industrial Strategy and Advisory Council to boost economic growth
On 14 October 2024, the day of the International Investment Summit, the UK government published its green paper ‘Invest 2035: The UK’s Modern Industrial Strategy’, a ten-year plan designed to promote growth in the UK, with a focus on growth-driving sectors, including the Life Sciences and the Digital and Technologies sectors.
The Industrial Strategy will…
Virtual and Digital Health Digest – October 2024
This digest covers key virtual and digital health regulatory and public policy developments during September and early October 2024 from the United Kingdom and European Union.
Guidance on AI continues to be published. In the EU, the European Medicines Agency (EMA) has published its Reflection Paper on the use of AI throughout the medicines life…