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

Regulatory Updates

Publication of a Roadmap for the Future Regulation of Medical Devices in the UK. On January 9, the Medicines and Healthcare products Regulatory Agency (MHRA) published its roadmap for the future regulation of medical devices, which includes the regulation of new technologies with software and AI components. The new regulations are intended to prioritize patient safety and provide faster access of innovative technologies to patients. They will be delivered through four statutory instruments (SIs), with post-market surveillance (PMS) measures put in place early in 2024 and will be applicable towards the end of 2024, followed by core elements of the new framework in 2025.

The draft PMS SI includes requirements for what a PMS system should include and enhanced obligations on the reporting of serious incidents and periodic review of PMS data. The SIs on the core regulations will be developed over 2024 through several key stakeholder discussions. The core provisions are expected to include new requirements on clinical investigations and claims made about devices, clarification on conformity assessments and approved bodies, and introduce the international recognition framework, as well as much more.

In addition, the roadmap sets out where we can expect new guidance. Over 2024, the MHRA aims to publish guidance on (1) good machine learning practice for medical device development mapping; (2) AI as a Medical Device development and deployment best practice; and (3) data-driven Software as a Medical Device research, development, and governance. Finally, the roadmap states that the AI Airlock regulatory sandbox, for innovators to test their technologies within a safe environment, will launch towards the middle of 2024.

Commission Adopts Measures To Support the Development of AI in Europe.  On January 24, the European Commission (EC) launched a package of measures to support European start-ups and small and medium-size enterprises in the development of artificial intelligence compliant with EU legislation. The package includes:

  • A  proposal for amendments to Regulation (EU) 2021/1173 regarding a European High-Performance Computing (EuroHPC) initiative for start-ups to boost European leadership in trustworthy artificial intelligence (EuroHPC Regulation) to set up AI factories in the EU in order to support the development and adoption of AI solutions
  • Establishing a  European AI Office within the EC to ensure coordination of AI policy at the EU level, support the accelerated development, roll-out and use of trustworthy AI systems and applications, and supervise the implementation and enforcement of the AI Act
  • An  EU AI Start-Up and Innovation Communication, setting up a strategic investment framework in trustworthy AI to foster an innovative EU AI ecosystem. Among the actions it introduces are accelerating the development of Common European data spaces and launching “GenAI4EU,” which aims to support the development of novel use cases and emerging applications in sectors like health or biotech

Commission Proposes Extension to IVDR Transition Periods and Accelerated Launch of Eudamed. On January 23, the European Commission announced proposals to amend the Medical Device Regulations (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Device Regulations (EU) 2017/746 (IVDR), as applicable, to:

  • Extend the transition provisions for certain in vitro diagnostic medical devices (IVDs) under the IVDR
  • Allow for a gradual roll-out of Eudamed so that certain modules will be mandatory beginning in late 2025
  • Include a notification obligation in case of interruption of supply

Under the proposal, the transition period in the IVDR for certain IVDs will be extended to:

  • December 2027 for Class D high individual and public health risk devices (e.g., HIV or hepatitis tests)
  • December 2028 for Class C high individual and/or moderate public health risk devices (e.g., cancer tests)
  • December 2029 for Class B lower risk devices (e.g., sterile devices such as blood collection tubes)

The above extensions apply to IVDs for which a conformity assessment procedure pursuant to the IVDD did not require the involvement of a notified body, but where a conformity assessment procedure pursuant to the IVDR requires the involvement of a notified body. There is also an extension to December 31, 2027 where certificates have been issued by a notified body, including where these have expired, if certain criteria are met.

The proposal will now need to be adopted by the European Parliament and Council before it enters into force. However, as the proposal follows a similar structure to the recent amendments to the MDR, we do not anticipate significant changes during the legislative process. You can read more in our  blog post.

Privacy Updates

ICO Consultation Series on Generative AI and Data Protection. On January 15, the Information Commissioner's Office (ICO) launched a  consultation series on how UK data protection laws should apply to the development and use of generative AI models. While not directly relevant to the life sciences sector, the consultations may be important where AI is used to analyze and generate output from health data. The first chapter has been published and seeks to gather the views of stakeholders on the lawful basis for web-scraping to train generative AI models. The ICO believes that the only available lawful basis for the collection of personal data in the context of training will be legitimate interests. To establish legitimate interests, a developer must demonstrate that (1) the purpose of the processing is legitimate; (2) the processing is necessary for that purpose; and (3) the individual's interests do not override the interest being pursued. The ICO identifies several ways to mitigate potential risks and meet the third element of the test. The deadline to submit views on the first chapter is March 1, 2024, with publication of the further chapters over the coming months. Read our  Advisory for more information.

EFPIA Calls for Legal Certainty and Harmonization in the EHDS.  On January 31, the European Federation of Pharmaceutical Industries and Associations (EFPIA) called for the European Parliament and the Council to make certain changes in the regulation on the European Health Data Space (EHDS) to truly foster EU competitiveness and innovation and to achieve the harmonization and representativeness of data. See our  January 2024 Digest for more information on the EHDS.

The EHDS regulation is currently under negotiation by the EU legislators, and as we set out in our previous  Digest, in December, the  Council of the European Union and European  Parliament adopted their positions on the text of the regulation. With this call, EFPIA hopes the institutions consider the following when finalizing the text of the regulation:

  • Truly fostering EU competitiveness and innovation: narrowing the scope of secondary data and balancing the protection of incentives to undertake exploratory research, thereby allowing data holders to be involved in all steps of the protection of their intellectual property and to have the final right to refuse data sharing when there is the risk of serious economic damage through the disclosure of trade secrets
  • Harmonization and representativeness of data: limiting the possibility to include an opt-out mechanism to the minimum categories for secondary use (e.g., health-related administrative data, including claims and reimbursement data, human genetic data, or personally generated electronic health data, including medical devices or digital health applications)
  • Creating a global ecosystem for research:  clarifying the requirement of localization for all health data generated in the EU and the related cross-border restrictions

Intellectual Property Updates

Patents for Glucose Monitoring Devices Invalidated by UK High Court.  On January 15, the UK High Court invalidated four patents relating to Continuous Glucose Monitoring (CGM) devices, though the judge noted that the patents would have been infringed if they had been found to be valid. Abbott and Dexcom each held two patents relating to features and options on smartphone user interfaces for their CGM devices. This included a two-stage notification system that does not interrupt a mobile phone user's actions and installation checks to ensure the monitoring app is not affected by the phone's malfunctions.

The High Court Judge (James Mellor) noted the importance of preventing hindsight from infiltrating the problem which the skilled addressee is deemed to be dealing with when they consider the prior art, explaining that a “signal” becomes easy to extract from “noise” when the circumstances which led up to the event are viewed with hindsight. Justice Mellor further explained that if the invention involved a significant departure from the prior art, and if hindsight has to be used to get to the invention, that is determinative of the invention not being obvious.

The dispute between Abbott and Dexcom is far from over with further trials in the UK in November 2024 and January 2025 relating to other Abbott and Dexcom patents, as well as related proceedings in Spain and Germany and hearings before the European Patent Organisation and the Unified Patent Court.

Patentability of AI-Related Inventions To Be Considered by the UK Court of Appeal. In our  December 2023 Digest, we reported on the landmark UK High Court decision in Emotional Perception, which concluded that emulated artificial neural networks (ANNs) did not operate as a computer program and therefore Emotional Perception's patent application could not be rejected on the grounds that the invention relates to a “computer program as such.” This was promptly followed by an update to the UK Intellectual Property Office (UKIPO) Manual of Patent Practice (MPP) to ensure that examiners do not reject ANNs under the “program for a computer” exclusion to patentability. The UKIPO has now filed an appeal on the following grounds:

  • The judge's decision that the computer program exception to patentability had not been engaged was wrong
  • The judge should not have relied on the UKIPO's “concession” that hardware ANN did not operate as a computer program to conclude that software implemented ANN also did not operate as a computer program
  • The judge was wrong to exclude from consideration the mathematical exclusion model
  • The judge was wrong in deciding that the claimed invention involves a substantive technical contribution.

This appeal will be a good opportunity for the Court of Appeal to provide updated guidance on patentability of computer-generated inventions and inventions involving algorithms or mathematical models, and to confirm the extent to which the UK is aligned with the approach at the European Patent Office. Any developer of digital health products utilizing ANNs should be wary of relying on the updated UKIPO MPP guidance on ANNs when filing and prosecuting patents as the change in practice may be short-lived.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.