“Recommendations for a strong health industry in Europe”
This requires the creation of a “European Health Data Space”, which is also envisaged in the Mission Letter 11 to the new EU Commissioner for Health. Central recommendations: ▪
We recommend a strategy for a “Digital Single Market for Health” (DSM-H) in order to eliminate regulatory-induced barriers between the national health markets of the EU member states.
▪
The eHealth strategy of the European Commission should be equipped with a clear enforcement framework with concrete goals and implementation periods with one of its objectives being to accelerate the exchange of health data.
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For the good of patients, the secure use of data for academic and industrial research should be guaranteed. This also requires the creation of a “European Health Data Space”.
2.1.
Increasing data availability
Data availability and data use are the basic preconditions for the research and development of digital medical therapies and products. The health industry should be in a position to make use of personal health data from both outpatient and inpatient care as well as from statutory health insurance schemes in order to acquire new findings about efficient methods of treatment and ensure better care. The health industry therefore recommends that there should already be at national level a legally defined framework for the use of personal health data for research purposes. Digital, data-based health care will only develop when legally watertight opportunities exist to process data for research purposes apart from the original reason why the data was collected. The EU GDPR already makes many special privileges available for scientific research, especially in cases of the further processing of personal data for these objectives. The aim now must be to implement this conception at all levels in order to take full account of the wishes of the regulatory authority. Furthermore, the European Commission and the EU member states should provide a binding definition of when there is no longer any reference to actual persons in health data. A uniform regulation governing anonymising and pseudonymising personal health data for extended purposes is therefore absolutely imperative. Some countries, for example, see pseudonymized data within the framework of clinical trials as anonymized data. In Germany
11
Mission Letter Stella Kyriakides: https://ec.europa.eu/commission/sites/beta-political/files/mission-letter-stellakyriakides_en.pdf
www.bdi.eu
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