European Health Data Space and its Impact on EU/SA Collaborative Research

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An informative presentation on the European Health Data Space and its impact on European Union (EU)-South African collaborative research was hosted by UKZN’s College of Health Science’s (CHS) research office under the leadership of Professor Anil Chuturgoon.

Dr Ciara Staunton, who is a senior researcher at the Institute for Biomedicine, Eurac Research (Italy), a consultant to the World Health Organization and a Fellow in the School of Law at UKZN, presented to an audience of lawyers and Medical scientists at the Nelson R. Mandela School of Medicine.

Staunton said the European Health Data Space regulates the protection of the processing of personal data with that protection being a fundamental right which needs to be considered in relation to its function in society.

‘The COVID-19 pandemic demonstrated the benefits of international data sharing and highlighted the imperative of having timely access to electronic health data for health threats preparedness and response as well as for diagnosis and treatment and secondary use of health data. Such timely access would have contributed, through efficient public health surveillance and monitoring, to a more effective management of the pandemic, and ultimately helped to save lives,’ she said.

‘However, this data sharing is not the norm as data sharing needs to navigate complex ethical and legal rules, and in particular, the fragmented application of the General Data Protection Regulation (GDPR). The introduction of the draft regulation for a European Health Data Space (EHDS) in May 2022 seeks to address some of these legal issues and if passed, will create an obligation to share electronic health data for certain secondary purposes.’

The economic and social integration resulting from the functioning of the internal market had led to a substantial increase in cross-border flows of personal data. Further, rapid technological developments with globalisation bringing new challenges. ‘We need to ensure that we balance regulation with innovation and create a market that enables more creativity and innovation,’ she said.

‘The processing of data is managed through primary and secondary use of data. Primary use of data should enable patients to access and control their health data, and to give healthcare professionals access to this data. The secondary use of health data is the use of aggregated health data from population-level sources - such as electronic health records, health insurance claims data and health registry data - to improve personal care planning, medicines development, safety monitoring, research and policymaking.’

Staunton said each member state should have a Health Data Access Body (HDAB) which would hold the data catalogue. One would need to apply to the HDAB for a permit to access the data and this data could only be shared with those mentioned in the application. ‘Apply to one-member country even if you require information from several member states.

‘The new regulation will introduce more data access across EU states but third-world countries will need to improve their own data access regulations and it will introduce more laws and hurdles for countries like South Africa. When applying for a permit to access personal data, one would need to find a legal basis to access the data which may include highly sensitive information such as genomic data, medical registries, biobanks and medical devices. The transfer of data will take place on the basis of the reciprocity principle.

‘The new regulation is set to be passed by the end of the year. Any South African data that goes to the GDPR-Europe to be processed will no longer belong to SA and it will be very difficult getting it back,’ said Staunton.

Said Professor Veron Ramsuran of the CHS, ‘This is a major concern for data that will be generated from South African patients as the data may never get back to them. Researchers need to be mindful when entering into agreements with European entities that will be generating data from African samples.’

Professor of Law at UKZN Professor Donrich Thaldar, who chairs the Health Law and Ethics Research Interest Group, said SA would benefit greatly by adopting the model followed in Nigeria, where countries that accede to the Malabo Convention - the African Union’s convention on data protection - were deemed to provide adequate protection to data, ensuring far less hurdles to cross-border data transfer to such countries. ‘If this solution is adopted widely in Africa, it can create an African free data flow environment, which would stimulate growth, and facilitate better health research.’

Words: MaryAnn Francis

Photograph: Supplied