Insurance Europe: EC proposal for European Health Data Space welcomed; further work needed to avoid legal uncertainty

4 August 2022 — Daniela GHETU
Insurance Europe has responded to a consultation conducted by the European Commission on its proposal for the establishment of a European Health Data Space (EHDS). The proposal lays out a new governance framework for the primary and secondary use of health data in the EU.

Under the proposal, individuals would have the right to access a minimum set of health data and share it with third parties free of charge (a primary use of health data). Insurance Europe welcomes the initiative, as there is a need for practical solutions that allow individuals to exercise control over their own data.

Furthermore, the proposal lays out a new mechanism for facilitating the re-use of health data in the EU (a secondary use of health data). Insurance Europe welcomes the Commission's efforts to facilitate better exchange and access to different types of electronic health data for re-use. At present, EU member states have made significantly divergent uses of the specification clauses of the General Data Protection Regulation (GDPR). The resulting fragmentation creates significant challenges when conducting cross-border services, as well as for innovation and scientific research involving health-related data.

However, the Commission's proposal requires refinements regarding:

  • Vague definitions and the unclear scope of several provisions within the Commission's text that threaten to prevent its goals from being achieved. In particular, the definition of "primary use of electronic health data" and "data holder" should be clarified to avoid legal uncertainty. These definitions are too broad and may cover a variety of health-related services. If the text does not clearly define who falls under these definitions, it may lead to legal uncertainty as to who has the obligation to make data available for primary or secondary use, which, in turn, might undermine the rights to privacy and data protection of individuals.
  • A specific prohibition in relation to premium setting in insurance, which would impede insurers from accessing re-used health data to underwrite and assess risks more accurately. In fact, greater availability of anonymized health data for insurers could lead to improved and more effective risk monitoring and assessment. This can enable insurers to offer more affordable rates or to offer insurance for risks that were previously uninsurable, due to information gaps that can now be filled due to the increased availability of data. For example, the increasing availability of data together with medical progress has made it possible, under certain conditions, to provide more affordable insurance cover to individuals with HIV.
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