Data Protection implications of the European Health Data Space Regulation

Chair: Dipak Kalra

 

Abstract

This session aims to highlight those measures in the EHDS regulation that are expected to have implications for DPOs:

  • matters that healthcare organisations will need to have robust approaches to inform patients about, collect consent or opt out choices about
  • matters that regional and national health agencies will have to orchestrate through their healthcare providers and to engage with the public about
  • matters that data users such as clinical research will need to take account of

 

The main topics that will be presented and discussed include the enhanced GDPR rights to portability that will grant patients the right to download and share parts of their EHR, choices of data inclusion within EHRs, patient rights to opt out of sharing parts of their EHR between providers and/or cross border (e.g. genetic data) and their rights to opt out of their data being used for particular kinds of secondary use. Whilst these rights will be formalised at Member State level, they will be actioned at all levels through to the patient/citizen. There will be challenges with public education, implementing these new patient choices in an equitable way, potential workload implications on health professionals, DPOs and ICT departments, potential risks with incomplete data being shared for continuity of care and the introduction of new kinds of bias within secondary use data sets.

 

Structure

 

This 90 -minute session will begin with three 15-minute presentations. Speakers to invite:

 

  1. Petra Wilson, Health Connect Partners: legislative and data protection view on the EHDS Regulation, the new patient rights and their anticipated implications for DPOs
    [Confirmed]
  2. Deborah Mascalzoni, Associate Professor in Biomedical Ethics at Uppsala and lead of the ELSI Research Group at Eurac: the ethical implications for patients and the public when the opt outs are introduced
    [Confirmed]
  3. Milana Trucl, Policy Officer at the European Patients’ Forum: engaging the public in understanding and exercising their EHDS rights and choices

This will be followed by a 40-minute panel discussion between them on the challenges that the Regulation will place on different healthcare and research stakeholders, and what practical measures might best enable EHDS success. Time will be included for audience questions and interaction. The session will close with a final summing up of key considerations that policy makers should take on board.