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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 and recommend health apps. The latest is in Denmark, where new guidance has been published on how health apps will be assessed by the Board for Health Apps. The assessment criteria includes evidence of clinical effectiveness, usability, price, and value to society. This guidance is another important step to ensure greater access to health apps across the EU.

It has been a busy year in digital health and the impact to care delivery is only just beginning. We hope you will continue to follow the digest in 2025 as we track what we expect to be an even busier year.   

Wishing you the best for the new year! 
The Arnold & Porter Team Continue Reading Virtual and Digital Health Digest – December 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 recently published the new medical devices post-market surveillance rules, which could be in place by summer 2025. Further, the Medicines and Healthcare products Regulatory Agency’s (MHRA) priorities until spring 2025 are focused on the draft pre-market rules for devices, the in vitro diagnostics (IVD) roadmap, and guidance on AI development and deployment. In the EU, industry should watch the potential upcoming reform of the Medical Devices and In-Vitro Medical Devices Regulations, with increasingly urgent calls for reform from key stakeholders gaining traction with the institutions.Continue Reading Virtual and Digital Health Digest – November 2024

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

On 8 October 2024, the UK government launched the new Regulatory Innovation Office (RIO), which aims to “reduce the burden of red tape” faced by businesses when bringing innovations to market, including artificial intelligence (AI) healthcare technologies and engineering biology products such as vaccines and cultivated meat.

The RIO, established within the Department of Science, Innovation and Technology, will seek to reshape regulatory landscapes by working with existing regulators to accelerate approvals, bring regulations up to date and facilitate inter-regulator collaboration. The creation of the RIO is a key manifesto commitment, as part of the government’s wider mission to kickstart economic growth, aiming to provide regulatory certainty and reduce unnecessary delays.Continue Reading UK government launches new Regulatory Innovation Office to reduce red tape

This digest covers key virtual and digital health regulatory and public policy developments during August and early September 2024 from United Kingdom, and European Union.

There have been some important reimbursement updates this month. In France, the French health regulator has issued a negative opinion on the first digital therapeutic that sought reimbursement through the PECAN pathway. This opinion suggests that while PECAN provides a more streamlined process by not requiring formal clinical trials, the regulator still expects robust data to show that the digital therapeutic is worthy of reimbursement. In the UK, the National Institute for Health and Care Excellence has published a position paper that highlights the risks of using AI for generating and reporting evidence for health technology assessments. It sets out that the use of AI in this context should be limited to situations where the value of doing so can be clearly demonstrated, and sets out guidance for companies on how to present such data and to justify the use of AI. Health technology assessment seems to be an area where AI has more readily been accepted, and industry will welcome guidance on the parameters around such use.Continue Reading Virtual and Digital Health Digest – September 2024

This digest covers key virtual and digital health regulatory and public policy developments during July and early August 2024  from United Kingdom, and European Union.

Following the UK national elections on July 4, 2024, which brought in a new government, the King delivered a speech to Parliament setting out the government’s key legislative and policy agenda. Of particular importance to the life sciences sector are the Product Safety and Metrology Bill and the Digital Information and Smart Data Bill. Although the scope and content of each bill is currently unknown, they could impact medical devices and innovative scientific research. Further, there was no artificial intelligence bill in the agenda, although the government will “seek to establish the appropriate legislation” in the future.Continue Reading Virtual and Digital Health Digest – August 2024

This digest covers key virtual and digital health regulatory and public policy developments during June 2024 from United Kingdom, and European Union.

While it has been a relatively quiet month in the EU given elections in the European Parliament and in the UK (as well as other countries across the EU), agencies across the globe have published important guidance on machine-learning enabled medical devices. This includes the UK Medicines and Healthcare products Regulatory Agency’s (MHRA) guiding principles on transparency, published together with the U.S. Food and Drug Administration (FDA) and Health Canada, and the International Medical Device Regulators Forum (IMDRF) consultation on its guiding principles on good machine learning practice (which itself follows similar guidance from MHRA, FDA, and Health Canada in 2021). This demonstrates the increased importance of international standards in this area and the need for coordination between regulatory authorities to standardize guidance for these products.Continue Reading Virtual and Digital Health Digest – July 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