DIGITAL HEALTH

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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

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

Of interest, artificial intelligence (AI) safety has been in focus over the past month, including with the publication of the Interim International Scientific Report on the Safety of Advanced AI. International collaboration in this area is increasing as world leaders met at the AI Summit in Seoul, and the UK government recently announced a collaboration on AI safety with Canada, supplementing its existing commitment with France. Further, the UK launched the AI safety evaluations platform, which is available to the global community. In the meantime, the EU has established an AI Office to oversee the implementation of the AI Act and the Medicines and Healthcare products Regulatory Agency (MHRA) has published its AI Airlock to address novel challenges in the regulation of artificial intelligence medical devices (AIaMD).Continue Reading Virtual and Digital Health Digest – June 2024

This digest covers key virtual and digital health regulatory and public policy developments during April and early May 2024.

You will note that France has set out new pricing rates for innovative digital therapeutic medical devices under the accelerated market access pathway, known as PECAN. While the pathway was set out in February 2023, the lack of reimbursement rates means up-take has been low. The order of April 22, 2024 introduces the new pricing structure, with the maximum amount of financial compensation set at €780 per year, per patient. This is an important step in ensuring digital therapeutic products can be widely available in France while also ensuring that developers can obtain appropriate reimbursement.Continue Reading Virtual and Digital Health Digest, May 2024

This digest covers key virtual and digital health regulatory and public policy developments during March.

You will note that the EU institutions have been busy during March. On March 12, 2024, the European Parliament (EP) formally adopted the revised Product Liability Directive, which makes several important changes to the existing European Union (EU) product liability regime, including that software and artificial intelligence (AI) technologies will now fall within the scope of a product. On March 13, 2024, the EP formally adopted the Artificial Intelligence Act, meaning the legislative process for the world’s first binding law on AI is nearing its conclusion. Finally, on March 15, 2024, the Council of the European Union and the EP reached a provisional agreement on the European Health Data Space (EHDS), which aims to improve access to health data electronically across the EU. Each of these important legislative provisions should shortly be finalized and will then become law in the EU.Continue Reading Virtual and Digital Health Digest, April 2024

This digest covers key virtual and digital health regulatory and public policy developments during February 2024.

Of note, the UK continues to pursue a “pro innovation” flexible approach to the regulation of AI. As outlined in the UK government’s response to the public consultation, the government will develop a set of core principles for regulating AI, while leaving regulatory authorities, like the Medicines and Healthcare products Regulatory Agency (MHRA), discretion over how the principles apply in their respective sectors. A central governmental function will coordinate regulation across sectors and encourage collaboration. The government’s aim with this approach is to enable the UK to remain flexible to address the changing AI landscape, while being robust enough to address key concerns. This is in sharp contrast to the position in the EU, where the EU AI Act is reaching the conclusion of the legislative process.Continue Reading Virtual and Digital Health Digest, March 2024

A version of this article was first published in Life Sciences IP Review

There is currently no specific legislation in the UK that governs AI, or its use in healthcare. Instead, a number of general-purpose laws apply that have to be adapted to specific AI technologies. As a step towards a more coherent approach, the government recently published its response to its consultation on regulating AI in the UK.  This maintains the government’s “pro-innovation” framework of principles, to be set out in guidance rather than legislation, which will then be implemented by regulatory authorities in their respective sectors, such as by the MHRA for medicines.  The MHRA has already started this process and signalled itself as an early-adopter of the UK government’s approach. The hope is that this will lead to investment in the UK by life science companies as the UK is seen as a first-launch country for innovative technologies.Continue Reading The UK’s pro-innovation approach to AI: What does this mean for life science companies?