ESIP first insights on the Inception Impact Assessment

On 23 December the European Commission opened consultations on a European Health Data Space (EHDS). The evaluation roadmap/inception impact assessment remained open for feedback until 3 FebruaryThis initiative would complement the proposal for a Data Governance Act and promote access to and exchange of health data for primary use (healthcare delivery) and secondary use (research and development, policy-making).

ESIP supports a reinforcement of the legislative and governance framework to promote the exchange of health data for primary use among Member States and to establish an institutionalised infrastructure for secondary use of data.

While supporting a EHDS that provides real added value for healthcare delivery, need-driven R&D and policymaking, ESIP calls fordifferent technological solutions and separate governance frameworks for primary and secondary use of health data.

In order to ensure that sensitive health data are exchanged and used in a responsible way ESIP outlines a number of recommendations touching upon:

  • Harmonised standards for data formats, as well as security standards for the processing of sensitive health data;
  • Conditions for access and use applicable to primary and secondary use of health data. Data available for secondary use should be defined, ownership and users’ rights should be clarified;
  • A code of conduct to ensure ethical use of data and promote common understanding and application of the EU Data Protection Regulation;
  • Fairness-by-design, providing an ecosystem of measures that protect end-users, reflecting the central European value of solidarity;
  • Involvement of public authorities in the establishment of the EHDS, data standards and conditions for use of data.

Read the full ESIP feedback here.

A public consultation on the EHDS is expected in the first semester of 2021 and will be followed by an Impact Assessment in the third quarter.The proposal for a Regulation on a European Health Data Space is expected by the end of this year.