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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

The current version of the Innovative Licensing and Access Pathway (ILAP) was first launched by the UK government in January 2021, shortly after the Brexit transition period came to an end. Its aim was to be a new, accelerated route to bring innovative medicines to the UK market, through facilitating a streamlined and efficient collaboration between developers, regulators, the UK Health Technology Assessment (HTA) bodies and the NHS, and facilitating enhanced patient access to medicines.

While ILAP has received an unprecedented number of applicants, with 166 Innovation Passports having been awarded since its launch, there have also been criticisms, including delays in considering applications and limited coordination with the NHS and HTA bodies, which slows the adoption of ILAP products. The Medicines and Healthcare products Regulatory Authority (MHRA) is therefore relaunching a renewed version of the scheme to “refine and refresh” the process.

It is hoped that the improvements will make for a quicker and more effective path for transformative medicines to be adopted into the UK market, reducing time to patient access and making the UK a more desirable market to launch innovative products.Continue Reading The UK Innovative Licensing and Access Pathway (ILAP) to enter a new era

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

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

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 post, IDAP has been designed to accelerate the development of innovative medical devices, with the aim of taking delays and uncertainty out of the route to market. IDAP will provide an integrated support service for medical device developers that will include enhanced opportunities for engagement with the regulatory authorities and a streamlined adoption process.

Companies of all sizes are being invited to apply, both internationally and in the UK, where they intend to launch a device for the UK market. 8 products will be selected during the pilot phase, which is designed to test the main elements of the pathway to inform how best to build the future IDAP.

Applications for the pilot phase are open and will close after 29 October 2023; they can be made via an online application form and associated guidance.Continue Reading UK Government launches Innovative Devices Access Pathway (IDAP)

Post-Brexit, the MHRA has been consulting on the future medical devices regulations, and how to retain the UK’s position as an attractive place to launch devices. As part of this, there have been a number of recent announcements about the medical devices regime in the UK.

  • On 27 April 2023, the MHRA updated its guidance on the implementation of the future medical devices regulations (the UK Regulations) to confirm the intention for the “core aspects” of the UK Regulations to apply from 1 July 2025.
  • The UK government has also introduced legislation that will be finalised before 30 June 2023 to allow valid EU CE marked medical devices to continue to be placed on the market in Great Britain. The extended periods will align with the transitional periods under the new UK Regulations.
  • On 26 May 2023, a proposed new regulatory pathway, the Innovative Devices Access Pathway (IDAP), set for pilot launch later in 2023, was announced, published as part of a suite of announcements that we will cover in a separate post.

Stakeholders will no doubt be pleased to hear of the development to extend the validity of EU CE marking in Great Britain, which allows for more realistic timeframes for manufacturers to obtain a UKCA mark, given the current state of flux of the UK medical device market following Brexit and the COVID-19 pandemic. The proposed IDAP pilot will also be a welcome development, and is another step taken by the MHRA to enhance innovation and stimulate interest in the UK medical devices industry, ahead of the implementation of the new UK medical devices regime in 2025.Continue Reading UK Medical Devices Update: Implementation of the UK Medical Devices Regulations and new Innovative Devices Access Pathway

The UK Government (Department of Health and Social Care, DHSC) and the ABPI have announced today that they have agreed the Heads of Agreement for what will now be called a Voluntary Scheme for Branded Medicines Pricing and Access, expected to become effective from 1st January 2019 following the end of the current 2014 Pharmaceutical Pricing Regulation Scheme (PPRS”).

The details of the new Voluntary Scheme are still being finalised and, if agreed in full, will be published in December, at around the same time as publication of the new Statutory Scheme is expected to take place. Companies will then be asked to decide whether to agree to participate in the Voluntary Scheme or be subject to the Statutory Scheme.

The new Voluntary Scheme, which has been described as “a good deal for patients, the NHS and the UK life science industry” by the Health Secretary, Matt Hancock, provides a guarantee that growth of the NHS branded medicines bill will not exceed 2% per year for the next 5 years, delivering expected savings of around £930 million to the NHS in 2019. In assessing growth sales by Voluntary Scheme members, Statutory Scheme companies and parallel import sales will be taken into account. As under the 2014 PPRS, the new Scheme will require industry to make rebate payments in respect of expenditure by the NHS that exceeds the permitted growth. Other important aspects are said to be:Continue Reading The UK 2019 Voluntary Scheme

On Monday, 3 July 2017, the scientific advice service within the National Institute for health and Care Excellence (NICE) launched its Medtech Early Technology Assessment (META) Tool.

The META Tool is an online service that provides developers of medical devices, diagnostics, digital health interventions, and medical apps with a framework to help them identify potential gaps in the available evidence, and prepare for discussions with investors, health technology assessment organisations (including NICE itself), and payers.Continue Reading NICE introduces META Tool