2.2. Guaranteeing the interoperability of IT systems

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.

12 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

Of particular importance are the infrastructural framework conditions for the electronic cross-border exchange of data. The electronic exchange of data between all areas presupposes that the communication procedure is as uniform and transparent as possible. The basis is provided by longstanding and internationally recognized standards and norms which are jointly developed and published in a defined process with the inclusion of all participants. All participants in the health system should jointly describe efficient, intersectoral, interoperable processes and technical specifications on the basis of international norms, for example within the framework of an interoperable electronic patient record.

In no EU member country alone can access to structured data sets be generated in sufficient numbers. In order to combine these data sets across national borders, medicine requires a clear, generally accepted and widespread terminology such as SNOMED CT (Systematized Nomenclature of Medicine). Without such a terminology system there can be no efficient, interoperable communication, no reliable access to and no reliable analysis of all important patient data, neither within the European Union nor throughout the world. This applies to research and care purposes in which both the scientists and the health industry have a special interest. An EUwide mutual understanding on the mandatory use of international standards and of the funding for their use in all EU member states is necessary. The recommendations of the European Commission for the specifications of an Electronic Health Record are an example of this.

At present the European Commission, together with the member states, is constructing an EU-wide voluntary eHealth Digital Service Infrastructure (eHDSI) in order to enable the exchange across national borders of patient health data, in particular of electronic prescriptions and patient records. In order to promote the development of the eHDSI, there should be greater efforts to advance innovative services in various groups of EU member states, with this to be coordinated by a “leading nation”.

Central recommendations:

▪ The interoperability of digital systems in the health sector should be enhanced. This requires an EU-wide common understanding on the mandatory use of international standards and specifications for their implementation.

▪ German industry advocates flexible project groups of interested EU member states for the implementation of innovative services within the framework of the eHealth Digital Service Infrastructure.