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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, improve marketing and sales strategies, and more.

However, as with any disruptive innovation, risks need to be managed. The report also highlights looming governance and compliance needs as companies seek to mitigate the risks associated with AI technologies, particularly in areas like data privacy, cybersecurity, and intellectual property.

The Arnold & Porter report found that AI use is still in its early stages for many in the life sciences industry, with around 75% of respondents beginning implementation less than two years ago. Despite this, 86% of companies currently integrating AI plan to fully deploy these tools within the next two years, reflecting a significant acceleration in AI adoption.Continue Reading The Convergence of Life Sciences and Artificial Intelligence: Seizing Opportunities While Managing Risk

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 cycle. In the UK, the Medicines and Healthcare products Regulatory Agency (MHRA) opened applications for its AI Airlock, a regulatory sandbox for AI as Medical Devices. And over 100 companies have signed up to join the EU AI Pact, a voluntary initiative to encourage companies to comply with the AI Act before the statutory deadlines. These guidance documents and initiatives provide companies with much greater clarity on how the authorities will regulate the use of AI in health care.Continue Reading Virtual and Digital Health Digest – October 2024

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 Year in Review Pocket Book. Continue Reading Virtual and Digital Health Digest, December 2023

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 devices, and artificial intelligence/machine learning to bolster delivery of telehealth services. Then came a robust government response. In the EU and UK, regulatory bodies grappled with the introduction of machine learning, AI, and other software into healthcare services by, for example, new guidance from the EU Medical Device Coordination Group and UK Medicines and Healthcare products Regulatory Agency on software medical devices, the EU’s AI Act and the UK government’s AI White paper, the European Medicines Agency reflection paper on use of AI in the product lifecycle, the EU Data Privacy Framework and the equivalent UK-U.S. data bridge, and the European Health Data Space. 

We call this the “Race to Regulate.” This push-pull dynamic between digital health innovation and government regulation is key to evaluating regulatory risks in today’s shifting legal landscape. This digest seeks to keep up with these changes and provide you with an overview of the key guidelines and developments as the landscape develops. As we come to the end of 2023 and publish our latest Digest, join us on December 13 as we unpack pivotal moments in the 2023 Race to Regulate and discuss what’s next for virtual and digital health. Continue Reading Virtual and Digital Health Digest and webinar