ScanBalt MTÜ
ScanBalt
ScanBalt is an innovation network that brings together academic and industrial research, university hospitals and non-university research institutions, study centres and highly specialised suppliers in the pharmaceutical, biotechnology and medical technology sectors from different European countries and regions.
ID: 537040240933-13
Lobbying Activity
Response to A European Health Data Space
11 Jul 2022
ScanBalt - an international association of research clusters from the Baltic Sea Region and Scandinavia - has been accompanying the digitalisation and digitisation of healthcare and health research in Europe for many years. We would like to comment on this proposal from a cluster perspective and with a special focus on patient-centred care.
The EHDS holds enormous potential if we work together to ensure that the concerns of patients and of research and innovation are sufficiently addressed. In developing digital solutions to support the WHO's goal of creating integrated health systems, patient-centricity is critical. As patients own their own data, altruism and informed decision-making become increasingly important. Accessibility for all citizens and "health digital literacy" are also important.
Sharing data between professionals and across national borders is legitimate and important to improve patient-centred healthcare. As in all categories and as mentioned earlier, patient consent and interoperability are essential for this type of data. As this data is for immediate use, one should provide a stable running infrastructure to ensure that the data is available and interoperable at all times.
In our opinion, a holistic system that integrates the primary and secondary use of data is of utmost interest. The use of this existing health data will rapidly improve the advice given to future patients, reduce healthcare expenditure through greater efficiency and drive the development of new treatments and technologies. While the ageing population is a major challenge for European social systems, these modern measures are our best hope to significantly reduce the ever-increasing healthcare expenditure. This will greatly benefit the trust that needs to be built in the public. In addition, however, it is crucial that citizens retain the right to object to any storage of their health data.
A detailed statement can be found attached.
Read full responseResponse to A European Health Data Space
2 Feb 2021
During the last two decades, much attention has been paid to the digitization and interoperability of health, healthcare, and medical data in EU member states separately and at the EU level in general. Still, achieving the seamless exchange of European citizens' healthcare data throughout the EU is not achieved. Also, the level of digitization and interoperability varies remarkably between the EU member states.
Current efforts to exchange patient data across borders in the EU are based on voluntary cooperation between health authorities through the eHealth Digital Service Infrastructure ("eHDSI")30, supported by the Connecting Europe facility (broadband and ICT). This exchange is currently limited to patient summary records and electronic prescriptions and e.g., does not extend to electronic health records, let alone biological or
genomic data.
Necessary next steps for a European Health Data Space:
• Establishing EU-wide minimum set of health care taxonomies and standards for data quality, data reliability, and cyber-security, permitting technological evolution;
• Establishing EU-wide minimum datasets for health data exchange;
• EU-wide standardization of electronic health records structure.
• Extending harmonization and interoperability efforts to an increasingly diverse range of data relevant to promote research, prevention, and personalized care, such as data related to biological samples stored in EU biobanks, -omics data, behavioural and environmental data, PROMs, PREMs, etc
• Develop and support infrastructure for the patient's own reported data, collected from different sources. That infrastructure should be able to exchange information with the healthcare data infrastructure
In essence, citizens should have access and control to a complete electronic file containing their health data anywhere in the EU. They should retain control over their health data as well as their own collected data according to GDPR. Be able to share them securely with authorised partners (e.g. Health Providers, Data-Cooperatives, regional Health Organisations, Diagnostic-, Biotech-, Medtech and Pharma- Companies, Disease Management Partners) for medical treatment, prevention services, research and solution/product development, or any other purpose they deem appropriate).
To make data usable for research and development across Europe, we need a uniform, data protection-compliant, and cross-border consent systems coordinated with the member states' data protection officers.
The EU needs to agree on the uniform, internationally recognised and tested standards/codes throughout Europe to ensure procedural interoperability (e.g. IHE), syntactic interoperability (e.g. HL7 FHIR) and semantic interoperability (e.g. LOINC, SNOMED CT). Semantic interoperability is particularly relevant for research and development. The standard used influences the quality of data acquisition considerably, and thereby meaningful use of health data.
Public-private-partnerships need to be strengthened (involving new stakeholders in the healthcare sector) in order to facilitate mutual learning and scientific progress. One way to overcome this hinder could be the use of synthetic data that could support an EU Healthdata space for sandboxing, which could be useful for validation before implementing different services and functions in and between the countries.
The need for harmonizing how to anonymize and pseudonymize health data is an important policy question to the EU.
The foundations must be laid for patients and healthy citizens to be able to declare (and also revoke) their consent to Europe-wide data use (research & care) at the lowest possible threshold. This includes educational and promotional efforts.
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