“Recommendations for a strong health industry in Europe”
data protection insists that all pseudonymized data are still personal data or are potentially so. Here there is a need for uniform provisions. The European Court of Auditors also takes the view that there is a need for a clear strategy and implementation framework supported by the EU member states in order to create mechanisms for the Europe-wide exchange of patient data. In the process clear objectives should be set out and performance regularly monitored. Furthermore, conclusions should be drawn from previous pilot projects in the health area.12 Amongst other countries, Estonia and Croatia are considered to be positive examples. These countries implement European regulations in such a way that, for example, clinical-genomic data bases can be created with wide-ranging access rights. The European Commission should continue to advocate the devising of a legal framework for the use of data already available (including within the framework of big data applications) between but also within the EU member states themselves in order to ensure efficient research and the development of innovative therapies. Central recommendations: ▪
The European Commission should commit itself to a legally secure demarcation in anonymising and pseudonymising personal data in order to promote the exchange of data, for example within the framework of healthcare research.
▪
The European Commission should be committed to the devising of a legal framework for the use of already existing data (e.g. for big data analyses) between but also within the member states in order to guarantee efficient research and the development of innovative therapies.
2.2.
Safeguarding the interoperability of IT systems
Apart from long-term planning security (also financially) for innovators, in order to ensure the necessary attractiveness of a location there must also be the preconditions for a networking capability and connectivity of IT systems across sectoral and national borders. Uniform data formats and software interfaces are a basic precondition for interoperable systems. Only by means of a high degree of interoperability can the potential of IT in the health system be exploited in the best possible way in the interests of better health care. At the same time it remains true that industry and further stakeholders affected should jointly define corresponding uniform data formats and software interfaces – this is not the job of the legislative authority.
European Court of Auditors: Special report: “EU actions for cross-border health care” (2019): https://www.eca.europa.eu/Lists/ECADocuments/SR19_07/SR_HEALTH_CARE_DE.pdf 12
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