DIGITALEUROPE Executive Council for Health’s recommendations for EU digital health policy (2024-29)

The digital health industry plays an important role in delivering vital resources and innovations to advance patient-centric healthcare and research on life-saving treatments. These advancements depend greatly on the use of digital technologies and data-driven solutions, such as AI and digital twins. The EU has always demonstrated global leadership in healthcare, but we are at a critical time as European health systems are facing growing challenges. These include an increasing demand for healthcare due to ageing populations, shortages and uneven distribution of health professionals in EU Member States, and limited financial resources. This strategic advisory paper, developed with the executives of our corporate members and national trade associations (DIGITALEUROPE’s Executive Council for Health), calls on the EU to adopt impactful policy measures to lead developments and widespread implementation of revolutionary solutions in digital health, and ensure that in doing so, it remains competitive for the benefit of patients and health systems.

A successful digital transformation in healthcare could ensure that European health systems become more effective, accessible, equitable, resilient and sustainable. As healthcare is a particularly knowledge-intensive sector, the rapidly growing volume of data relating to health and the extraction of valuable insights offer huge opportunities to improve patient care, manage health systems, develop public health policies, and facilitate health R&I. The use of AI and data science methods could enable new medical discoveries, connect patients with targeted treatments, optimise organisational processes and reduce expenditures. Virtual human twins and precision approaches tailored to the needs of individuals could offer significant hope for patients with cancer or rare medical conditions. Data linkages could help to identify commonalities in biological pathways at the population level to unlock efficiencies in preventive, diagnostic and therapeutic approaches. The broader uptake of telehealth and blended (clinical and remote) healthcare solutions, underpinned by the Internet of Health Things, could improve patients’ accessibility to healthcare, support prevention measures and enable the generation of real-world evidence (RWE).

This strategic advisory paper is a call for action for the EU (and Member States) to pursue the following policy goals in digital health in the 2024–29 term:

• Prioritise digital transformation within the European Health Union and healthcare-related policy instruments through:
  • ensuring that digital technologies and data-driven solutions are central to the formulation of all EU health policies;
  • implementation of the European Health Data Space (EHDS) without fragmentation.

• Enhance the use of data and new enabling technologies in health systems and health R&I through:
  • development of EHDS infrastructure and accompanying health data governance arrangements;
  • advancing the adoption of data-driven and digital approaches in healthcare, and strengthening resilience and security in health systems;
  • including the use of AI and data science methods;
  • development of data-driven insights.

• Improve skills and increase trust in digital health through:
  • enhancing health workforce skills and digital health literacy;
  • incentivising multi-stakeholder collaborations and strengthening public–private partnerships.

• All funding and allocated resources should advance digital transformation in healthcare including:
  • adequate resources for the impactful implementation of the EHDS;
  • a dedicated EU digital health funding program;
  • more efficient funding schemes for digital health;
  • harmonisation of value assessment frameworks, public procurement criteria and reimbursement pathways for digital health solutions.

• Guarantee legal clarity and consistency in digital health policy within the EU through:
  • clear, consistent and implementable rules;
  • consistent and harmonised implementation of privacy, data protection and cybersecurity requirements, and ensuring ubiquitous, cross-border and international data flow needs of digital health ecosystems;
  • effective IP protection to incentivise R&I in digital health;
  • recognition of globally-aligned harmonised standards and adoption of other soft law instruments.