The era of digital health data in Europe – a detailed look at key legislative initiatives

The German Act to Accelerate the Digitalisation of Healthcare – the vision of a digital health landscape

The German Act to Accelerate the Digitalisation of Healthcare (Gesetz zur Beschleunigung der Digitalisierung des Gesundheitswesens, Digital-DigiG) is a draft law published by the German Federal Ministry of Health (Bundesministerium für Gesundheit, BMG) that aims to increase the efficiency of the healthcare system through the extensive integration of digital technologies. The DigiG sets out the following strategic measures:

• Further developing the electronic patient record into a fully-fledged digital health management system with a conversion to an opt-out electronic patient record.
• Integrating the e-prescription app and electronic patient record apps to improve patient data management.
• Expanding digital health apps to improve patient care integration. Planning to extend the entitlement to benefits to medical devices in higher risk classes.
• Focusing even more on cyber security so as to protect sensitive health information by applying the German Federal Cyber Security Authority’s (Bundesamt für Sicherheit in der Informationstechnik, BSI) ‘C5 Cloud Computing Criteria Catalogue’.
• Increasing the number of video consultations and teleconsultations to facilitate the medical consultation process – introducing a benefit entitlement for assisted telemedicine in pharmacies. There are also plans to remove the limit on video consultation hours.
• Including digital solutions for structured treatment programmes (DMP) for diabetes mellitus types I and II.

The German Health Data Usage Act – optimising the way health data is used

The draft law on the improved use of health data – the German Health Data Usage Act (Gesundheitsdatennutzungsgesetz, GDNG) – aims to simplify access to health data in Germany for research and decision-making processes. The following initiatives are being pursued:

• Establishing a national coordination office at the German Federal Institute for Drugs and Medical Products (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) This body will act as an intermediary between the providers and users of health data.
• The planned introduction of an opt-out procedure for providing data to the Research Data Centre should generate comprehensive and representative data from the electronic patient record for research purposes.
• Linking data from the Research Data Centre for Health (Forschungsdatenzentrum für Gesundheit, FDZ Gesundheit) and the cancer registry at individual level.
• Permission for health insurance providers to evaluate data on the individual health and safety of their policyholders. This will enable health insurance providers to address their policyholders individually and to point out specific health risks.
• Granting researchers the right to refuse to testify with regard to health data. This should help to strengthen data protection in the field of health research.

The German Healthcare Strengthening Act – strengthening local healthcare

The German Healthcare Strengthening Act (Gesundheitsversorgungsstärkungsgesetz, GVSG) aims to improve local healthcare and ensure better access to medical services for socially disadvantaged groups. The key points of the law are:

• Health kiosks: Presented back in August 2022, this approach aims to establish health kiosks throughout Germany. These kiosks will provide consultancy and coordination services for health services as well as simple routine medical tasks.
• Primary care centres: These centres will provide regular health services and specialised care for elderly and frail patients, especially to improve care in rural areas.
• Medical care centres: The law should make it easier for municipalities to establish medical care centres, which in turn should lead to improved, decentralised care for the population.
• Health regions: Enabling health insurance providers and municipalities to conclude health region contracts should emphasise regional aspects more strongly and enable municipalities to be better involved in health care provision.
• Transparency: The German National Association of Statutory Health Insurance Funds (GKV-Spitzenverband) will have to issue transparency regulations that relate to service quality, for example with regard to the processing time of health insurance fund applications.

The European Health Data Space – a cross-border exchange of health data

The European Health Data Space (EHDS) is an EU initiative that promotes the exchange of health data across borders. The EHDS pursues the following measures:

• Improving individuals’ control over their own health data.
• Using health data to improve healthcare, research and policy-making.
• Creating a trustworthy framework for sharing data between EU member states.
• Introducing common data standards and interfaces.
• Implementing a common data infrastructure across the EU.
• Developing data sharing protocols to protect privacy.

The Data Act – improving data access and usage

The Data Act is an EU initiative to improve data access and usage for consumers and businesses. The law sets out the following measures:

• Simplifying access and use of data to maximise the benefits of the digital economy.
• Public bodies using corporate data in certain situations.
• Promoting interoperability and standardisation of data to facilitate data exchange.
• Implementing open-data policies.
• Ensuring fair and transparent data trading practices.

The AI Act – regulating artificial intelligence

The AI Act is a major EU legislative initiative that regulates the use of artificial intelligence (AI) and ensures its safety and trustworthiness. Includes the following measures:

• Introducing a risk-based classification structure for AI systems.
• Creating a definition of requirements for high-risk AI systems.
• Creating ‘AI sandboxes’ to promote AI innovation.
• Implementing strict quality controls and safety standards for AI products.
• Facilitating data sharing and collaboration in AI development.
• Establishing AI test centres to validate and certify AI systems.

Conclusion: the future of digital health data

It is wonderful to see the amount of effort being put into optimising how digital health data is handled both in Germany and in Europe. It looks as if these initiatives will significantly improve the quality and the efficiency of health services. But despite all the positive developments, the European initiatives also pose major challenges. Creating a harmonised European Health Data Space means ensuring that data is both used and protected efficiently, and achieving these ambitious goals will need a carefully coordinated approach. There is still certainly a rocky road ahead here, especially with regard to national data health silos.

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