Artificial Intelligence (AI)

The global biotechnology landscape is evolving at an unprecedented speed, driven by advances in synthetic biology and genome editing, which, coupled with AI, make biotechnology stand at the forefront of innovation.  These developments offer unprecedented opportunities for advancing health and protecting against biological threats, but also make biotechnological misuse faster…

Continue Reading The Proposed EU Biotech Act: New Biosecurity Rules for Artificial Intelligence and Biotechnology Companies

On 29 July 2026, the UK’s Medicines and Healthcare products Regulatory Agency (“MHRA”) (the regulatory authority with responsibility for enforcing UK medical device rules) published new guidance on ambient voice technology-enabled products (“AVTs,” also known as ambient scribing tools) (“AVT Guidance”).  The AVT Guidance is intended to clarify (and essentially…

Continue Reading New UK Guidance Clarifies Medical Device Status of AI Scribes

Bart Van Vooren and Yuliya Gevrenova

The Nagoya Protocol was adopted under the Convention on Biological Diversity (“CBD”) and is built on the idea that the commercial use of materials from nature (“genetic resources”) should translate into fair and equitable benefits for countries providing and protecting nature in their jurisdictions. …

Continue Reading The Numbers Are In: What Financing has the Nagoya Protocol Delivered for Biodiversity After a Decade?

Last week, Germany’s Federal Ministry of Health has adjusted the rules governing Digital Health Applications (DiGA) once more. Key changes include new reporting obligations that require manufacturers to measure and document the success of their digital health apps. This reform adds notable operational pressure, while the reported outcomes will directly…

Continue Reading Germany changes rules for Digital Health Applications (DiGA) – More Reporting, More Transparency, More Work

Artificial Intelligence (“AI”) continues to command attention as today’s prominent technological asset, revolutionizing key markets and sectors. Simultaneously, discussions of another advanced technology known as quantum computing have gained traction. Because both technologies expand the universe of problems that can be tackled by computers, one might wonder, if we have AI, do we also need quantum computing technologies? In this article, we will discuss quantum computing and how it complements AI, including its ability to enhance AI models, and conversely, also explore AI’s ability to strengthen the power of quantum computing.

Continue Reading Harnessing the complementary power of AI and Quantum Computing

On April 30, 2024, the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) outlined its strategic approach (“Approach”) to artificial intelligence (“AI”).  The Approach is a response to the UK Government’s white paper: a pro-innovation approach to AI regulation and subsequent Secretary of State letter of 1 February 2024, and is the culmination of 12 months’ work by the MHRA to ensure the risks of AI are appropriately balanced with the potential transformative impact of AI in healthcare.

AI in Healthcare

AI has the potential to revolutionize the healthcare sector and improve health outcomes at every stage of healthcare provision – from preventative care through to diagnosis and treatment.  AI can help in research and development by strengthening outcomes of clinical trials, as well as being used to improve the clinical care of patients by personalizing care, improving diagnosis and treatment, enhancing the delivery of care and health system efficiency, and supplementing healthcare professionals’ knowledge, skills and competencies. 

Continue Reading MHRA Outlines New Strategic Approach to Artificial Intelligence

On October 19, 2023, the World Health Organization (“WHO”) published a set of regulatory considerations on artificial intelligence (“AI”) for health (press release and full publication).  The publication is not guidance or policy but is intended as a resource for relevant stakeholders in medical devices ecosystems, including manufacturers…

Continue Reading WHO Publishes Regulatory Considerations on AI for Health

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 Lifecycle

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 innovation

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 a Medical Device Change Programme – Roadmap.”  It builds on the Government response to consultation on the future regulation of medical devices in the UK and follows on from the Software and AI as a Medical Device Change Programme, which was published in 2021.  The MHRA has provided deliverables, which map out a course for change to the regulation of this sector.

Continue Reading Change is Coming for Software and AI Medical Devices in the UK