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.
Regulatory Updates
The King’s Speech to Parliament Sets Out Upcoming Legislation. In his speech to the UK Parliament on July 17, 2024, King Charles set out the key legislative and policy agenda as directed by the UK government, which came into office following the national election on July 4, 2024.
The Product Safety and Metrology Bill is listed on this agenda. Although it is unclear exactly what will be included in the bill, it seems that it will have a wide scope and cover “nearly all manufactured products.” As no reference is made to medical devices, it is unlikely that the bill will seek to specifically address such products, but could include powers to amend medical device legislation. Further, it remains to be seen whether the government will align itself with the EU products legislation due to come into force, namely the EU General Product Safety Regulation (Regulation (EU) 2023/988) and the revised EU Product Liability Directive. While it is clear that the UK’s regime needs to be updated to reflect technological progress, it is crucial that industry considers its position carefully in order to provide comments on any forthcoming proposals. You can read more about this on Arnold & Porter’s BioSlice blog.
In addition, the Digital Information and Smart Data Bill is included in the agenda. It is intended to enable scientists to harness the full potential of data in innovative research, for example by ensuring that data subjects are able to provide valid broad consent for wide areas of scientific research.
Despite speculation from commentators, there was no AI bill in the agenda. Instead, the government will “seek to establish the appropriate legislation to place requirements on those working to develop the most powerful artificial intelligence models.” We will continue to monitor the new government’s plans in this area.
German Court Rules on Classification of Telemedicine Software Under the Medical Devices Regulation. A German court of appeal (OLG Hamburg) recently handed down a decision that considered the status of a dermatologic telemedicine app under the Medical Devices Regulation (Regulation (EU) 2017/745) (MDR). The court found that the app was a Class IIa medical device under the MDR, as opposed to its initial Class I classification.
The software at issue in this case was an app that allowed patients to submit pictures of their skin and fill out a questionnaire, which was then forwarded to HCPs for assessment and diagnosis. The app was initially categorized under the MDR as Class I, the lowest risk classification that can be placed on the market following a self-certification by the manufacturer. The claimant, a competitor provider, argued that the software should be a higher risk classification, namely Class IIa. This means that a notified body must be involved in the conformity assessment of the device.
The court agreed with the claimant. It held that the app was a “software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes,” in accordance with rule 11 of Annex VIII of the MDR. It found that “to provide information” included the transfer of information, and the fact that the app was transferring patient information to HCPs constituted provision of information, notwithstanding that the app itself was not making decisions with respect to diagnosis or therapeutic purposes.
This decision has been criticized as it is not in line with guidance from the European Commission and does not focus on the functionality of the software (rather than the decisions taken by those using the software). The court’s risk-averse approach will have implications on how telemedicine providers consider the risk classification of their device.
Publication of the EU AI Act at the Official Journal as Regulation (EU) 2024/1689. On July 12, 2024, the EU regulation laying down the first harmonized rules on AI (referred to as the EU AI Act) was published in the Official Journal, setting in motion the implementation of this new regulatory framework. The EU AI Act entered into force on August 1, 2024, with a staggered implementation of different parts of the regulation. The EU AI Act will apply to AI systems placed on the market or put into service in the EU.
The focus of the EU AI Act is the new regulatory regime for High Risk AI Systems, which applies in addition to any sector-specific regulatory regime, such as the MDR or In Vitro Diagnostic Regulation (Regulation (EU) 2017/746) (IVDR) for medical devices. Like these two regulations, the regulatory framework for High Risk AI Systems set out in the EU AI Act is largely based on the New Legislative Framework approach, meaning many of the concepts will be familiar to medical device manufacturers. However, in many respects, these obligations duplicate, and overlap with, the requirements of the MDR and IVDR. Key areas of overlap include pre-market conformity assessment; CE marking; risk management; obligations on the “provider” who is placing the AI system on the market to establish and maintain a quality management system; and post-market surveillance.
The regulatory framework for High Risk AI Systems will become applicable on August 2, 2027, meaning that from this date, only AI systems that have undergone the necessary conformity assessment procedure can be placed on the market. Certain AI systems are “grandfathered” and not subject to the High Risk AI Systems regulatory regime. However, this only applies to AI systems placed on the market or put into service before August 2, 2026, provided they are not subject to any “significant change” in their design after that date.
You can read more about the impact of the EU AI Act on medical devices in our expert chapter in The International Comparative Legal Guide.
Transition Periods Under the IVDR Extended. The new regulation (Regulation (EU) 2024/1860) introducing changes to the transitional periods for certain in vitro diagnostic devices (IVDs) under the IVDR was published on the Official Journal of the EU on July 9, 2024.
As a reminder, the European Parliament and Council adopted a staggered extension of the IVDR transitional periods back in January 2022. The transitional periods have now been extended once again, in light of the limited capacity of Notified Bodies to undertake conformity assessments and an on-going concern that there will be a shortage of essential high-risk IVDs. Under the new regulation, transitional periods have been extended as late as December 2029 for some products, although the precise date depends on the risk classification of the IVD. You can read more about this on Arnold & Porter’s BioSlice Blog.
ABHI Published Its Report on How HealthTech Can Improve Outcomes Across the Whole Patient Pathway. The UK Association of British HealthTech Industries (ABHI) published its report which explores how HealthTech can improve outcomes across the whole patient pathway. The report considers the challenges faced by the National Health Service (NHS), such as financial strains and worker shortages, and highlights how HealthTech (including digital health technologies) could be used to alleviate and address those challenges. This is in the context of increased focus from the UK government in recent years on the possibilities presented by digital health technologies, including committing £2 billion to implement electronic patient records across all NHS trusts.
The report puts forward the case for how digital health technologies can be used to assist with and increase efficiency in diagnosis, patient safety, surgery, and patient management. It highlights the importance of diagnosing patients as early as possible, using a ratio test for preterm preeclampsia as an example to show that greater accuracy can be achieved alongside a more streamlined process which would also reduce the burden on the NHS. The report calls on the NHS to harness the benefits of HealthTech and to ensure its adoption. It remains to be seen whether the calls will be heard.
IP Updates
UPC Invalidates Dexcom’s CGM Patent in Ongoing Dispute With Abbott in Second Substantive Decision. In the July 2024 digest, we reported on the ongoing global dispute between Abbott and other manufacturers and distributors of continuous glucose monitoring (CGM) devices and technology and summarized decisions relating to the same from the UK Patents Court and The Hague local division of the Unified Patent Court (UPC).
In infringement and invalidity proceedings between Abbott and Dexcom before the Paris local division of the UPC, on July 4, 2024, the Court of First Instance held that Dexcom’s patent EP3435866, which relates to systems and methods of communication between the sensor electronics unit and the display device of an analyte monitoring system (of which CGM systems are an example), was invalid for lack of inventive step. Specifically, the court concluded that the notional skilled person would consider it obvious, on the basis of the prior art put in evidence and common general knowledge, to use Bluetooth to transmit the first portion of data collected by the sensor electronics unit and to use near field communication to transmit the second portion of data in response to a data request command. It is expected that Dexcom will appeal to the Court of Appeal of the UPC.