When Ursula Von Der Leyen took office as President of the European Commission in 2019, she shared a vision for a European society “powered by digital solutions that put people first, open up new opportunities for businesses, and boost the development of trustworthy technology”[1]. For healthcare, this was translated into policy actions like the Commission Decision on the Digital Decade to ensure that 100% of European citizens have access to Electronic Health Records (EHRs), as well as fostering greater use of Artificial Intelligence (AI) and big data to drive more efficient and resilient healthcare systems.
While European institutions and Member States have embraced the objectives of the Digital Decade, both through EU legislative proposals and national action, many challenges remain and will be high on the policy agenda in 2024. The finalisation and entry into force of key legislation, including the European Health Data Space (EHDS) Regulation[2], Artificial Intelligence (AI) Act[3], and Cyber Resilience Act[4], as well as the execution of several joint actions and research initiatives which aim to support the objectives of these pieces of legislation at the national level, will set the tone for the year ahead.
Fuelled by new EU legislation, we are expecting to see the healthcare sector prepare to accelerate the use of health data, harness the power of AI and step up to the challenge of increased cybersecurity threats—all whilst recognising the needs of ageing populations where staff shortages will have to be addressed through increased use of digital health solutions. With a potentially changing political landscape, FTI Consulting explores key questions as they become more important than ever before – beginning with one that is top of mind for experts across the European Union: ‘Is the healthcare sector ready to rise to the challenges and opportunities of the Digital Decade?’
Will AI be the champion of faster, safer and more accessible healthcare?
With a political agreement reached in December, co-legislators have only just finalised the technical details of this mammoth piece of legislation early this year. The AI Act will impact all sectors; in healthcare, it is envisioned to drive transformation throughout the healthcare cycle, ranging from improving hospital management processes and clinical workflows to streamlining the design of and targeted recruitment for clinical trials. AI systems will assist healthcare professionals in delivering diagnoses and meeting unmet medical needs with tremendous accuracy and personalisation. In the pharmaceutical sector, AI will change approaches to pharmacovigilance, and the increased use of Large Language Models (LLMs) alongside other digital tools will be put to use for further development in drug discovery and development as set out in the European Medicines Agency’s (EMA) AI Work Plan 2023-2028[5]. Alongside innovations and opportunities, this will bring challenges relating to the implementation of the AI Act and its interplay with other EU-level legislation. This will include specific concerns like those in the area of medical devices, where the AI Act classifies certain medical devices using AI as ‘high-risk AI systems’, requiring manufacturers to comply with stricter obligations, including an AI conformity assessment procedure.
Will better availability of health data drive change in healthcare?
AI demands vast amounts of data to develop appropriate large language models and algorithms. Several EU-level initiatives aim to support access to data, including the EHDS Regulation and the Data Analysis and Real-World Interrogation Network (DARWIN EU)[6] by the EMA.
The EHDS aims to digitise the provision of care and facilitate the exchange of publicly and privately held health data amongst businesses, governments, and regulators, and it is expected to be finalised by April 2024. This legislation will create numerous new obligations and opportunities for healthcare professionals, electronic health record manufacturers, pharmaceutical and medical device companies, and patients. That said, 2024 will only be the beginning of a long process to build the needed infrastructure to make the EHDS framework implementable and operational across the EU. Many questions remain about its functionality, impact, and overlap with other legislation—including the AI Act. Therefore, we expect 2024 to be a critical year for legislators and experts to address concerns and work with policymakers to co-create a framework that meets the needs of all stakeholders.
How will the healthcare sector prepare for the threat of cyber-attacks and build new resilience?
The need for more vigilant cyber security grows as healthcare systems move towards more use of cloud-based solutions, implanted and wearable devices, and the increased integration of digital therapeutics and app-based tools to support patients in self-care. Some Member States, like France, have already introduced measures to restrict the storage of health data to a territory of a state part of the European Economic Area (EEA), and sectoral legislation such as the EHDS may introduce additional requirements for storing health data within the EU. At EU level, new cybersecurity requirements are being laid out, which may limit the ability of companies to use cloud providers whose legal parent organisations are established outside the EU. This is also a trend beyond the EU, as the US reconsiders its national position on data flows—this revision would be a withdrawal of its support for unrestricted data flows at the World Trade Organization (WTO) in 2023 on the basis of national security and privacy concerns. The creation of stricter safety protocols around the storage of health data will have a domino effect not only on cloud providers but also on manufacturers of digital solutions relying on these providers, on health systems that procure these solutions and, ultimately, healthcare professionals and patients.
We have highlighted just three major questions and hinted at several others—noting that inevitably, more will come. With the Belgian Presidency of the Council of the EU focusing on ‘A Europe that cares, prepares, and protects’[7][8], 2024 promises an opportunity for all healthcare players to drive this vision forward. With so much going on, stakeholders must remain engaged.
Follow along as we continue to explore these issues, and stay tuned for more insights to come.
Authors: Petra Wilson (Senior Advisor), Angela Velkova (Senior Director), Gianluca Violante (Consultant), Adam Day (Senior Consultant), Cristina Mura (Consultant) from our Healthcare and Life Sciences team in Brussels.
[1] https://reform-support.ec.europa.eu/what-we-do/digital-transition_en
[2] https://health.ec.europa.eu/ehealth-digital-health-and-care/european-health-data-space_en
[3] https://digital-strategy.ec.europa.eu/en/policies/regulatory-framework-ai
[4] https://digital-strategy.ec.europa.eu/en/library/cyber-resilience-act
[5] https://www.ema.europa.eu/en/news/artificial-intelligence-workplan-guide-use-ai-medicines-regulation
[6] https://www.ema.europa.eu/en/about-us/how-we-work/big-data/data-analysis-and-real-world-interrogation-network-darwin-eu
[7] https://www.health.belgium.be/sites/default/files/uploads/fields/fpshealth_theme_file/08012024_brochure_en.pdf
