The end of 2023 featured two significant judgments concerning AI inventions: (i) a highly awaited decision from the Supreme Court in Thaler on the ability of AI systems to be named inventors of patents; and (ii) a decision from the
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With nearly 1,000 attorneys, Arnold & Porter provides sophisticated litigation to the life sciences and financial services industries across the globe. Their lawyers cover more than 30 practice areas including corporate finance, intellectual property, litigation, real estate, tax, and bankruptcy. With over 100 years of history, the firm offers clients forward-looking and client driven services to resolve their legal needs.
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The First Virtual and Digital Health Digest of 2024
Welcome to the first Virtual and Digital Health Digest of 2024!…
Virtual and Digital Health Digest, December 2023
Thank you to all who joined us for our December 13 panel titled the “Race to Regulate.” In case you missed it, unpack this year’s pivotal legal challenges impacting the 2023 — and 2024 — digital legal landscape in our …
European Commission, HMA and EMA Publish First Union List of Critical Medicines
On 12 December 2023, the European Commission, the European Medicines Agency (EMA), and the Heads of Medicines Agencies (HMA) published the first version of the Union list of critical medicines (the list). Along with the list, the EMA published a…
Virtual and Digital Health Digest and webinar
Spurred, in part, by the COVID-19 pandemic and the need for new ways to reach patients at home, 2023 saw a boom in digital technologies and healthcare solutions: one-stop-shop telemedicine platforms, app-based remote patient monitoring, direct-to-consumer online pharmacies, software-based medical…
New EU-level actions addressing shortages
On 24 October 2023, the European Commission published a Communication on “Addressing medicine shortages in the EU” (the Communication). The Communication responds to the European Council’s call in June for urgent measures to ensure production and availability of critical medicines…
UK clinical trials – new notification scheme for lowest-risk clinical trials
EMA relaunches Policy 0070 on publication of clinical data for medicinal products for human use
In September 2023, the European Medicines Agency (EMA) relaunched its Policy 0070 on publication of clinical data for medicinal products for human use (the Policy). The Policy, as discussed in previous posts, is one of the Agency’s flagship public…
New UK International Recognition Framework for Medicines
We set out in a previous post that the UK Medicines and Healthcare products Regulatory Agency (MHRA) intends to introduce a new international recognition procedure (IRP) for medicinal products, whereby decisions taken in certain countries could be recognised by the…
UK Government launches Innovative Devices Access Pathway (IDAP)
On 19 September 2023, the UK Government launched the pilot phase of the Innovative Devices Access Pathway (IDAP), an initiative to help bring innovative technologies to the NHS where there is an unmet medical need. As discussed in a previous…