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 April and early May 2025 from the United States, United Kingdom, and European Union.
Cybersecurity is a hot topic in the UK and EU this month. In…
The current EU regulatory landscape for biotechnology is widely viewed as insufficient to be able to exploit the full potential of such technologies. Regulatory hurdles exist at EU and Member State level, and this is thought to have driven investment into other regions.
To help tackle this problem, the introduction of a new EU Biotech…
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 March and early April 2025 from the United States, United Kingdom, and European Union.
The biggest change this month is that as of March 25, 2025, the…
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.…
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…
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…
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…
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…
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…
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…
