SIOPE and ExPO-r-Net Project welcome forthcoming General Data Protection Regulation stance on health data

The compromise text of the General Data Protection Regulation offers strong but proportionate governance structures for the safe and ethical use of personal health data information in clinical research.

The mission of the European Expert Paediatric Oncology Reference Network for Diagnostics and Treatment (ExPO-r-Net) Project is to reduce current inequalities both in childhood cancer survival and in healthcare capabilities in different European member states.

The activities of ExPO-r-Net centre around two pillars. Firstly it supports the mobility of expertise, be it virtually or physically.

Secondly it promotes developing and sharing information, knowledge and best practice to improve the diagnosis and treatment of rare childhood cancers. ExPO-r-Net will link existing reference centres with tumour boards to provide cross-border advice. It will also ease access to high-quality health care for those children whose cancers demand specialised resources or expertise.


Often such services are not widely available due to low case volumes and lack of local resource. We are developing a Roadmap that will steer health care providers towards clusters with designated specialised expertise. At the same time, we need to develop a new method of structuring compensation for health care costs between member states for this high level, cross-border expert advice.

In addition, ExPO-r-Net will reinforce outcome research by establishing and managing registries covering rare childhood cancers. Long-term follow-up with young cancer survivors, together with health surveillance recommendations based on previous cancer treatment burden are integrated into the ‘survivorship passport’.

This was developed within the ENCCA (European Network for Cancer research in Children and Adolescents) and PanCareSurFup (PanCare Childhood and Adolescent Cancer Survivor Care and Follow-Up Studies) projects and is now at the next level of interoperability.

Using personal data in health research offers the possibility of important, potentially life-saving, discoveries. Building on ExPO-r-Net, such health data is essential to maximise the benefits of our future Paediatric Oncology European Reference Network (PO-ERN).

It will also support the development of research and treatment guidelines for very rare cancers. In addition, data and biomaterials collected in clinical trials, in registries or in biobanks should also be made available for “secondary use”, to further extend these benefits.

SIOPE – the European Society for Paediatric Oncology welcomed the agreement on the EU General Data Protection Regulation. Indeed, the compromise text replaced a previous draft with disproportionate limits on using health data in research that posed a threat to the sector.

One positive aspect of the outcome Data Protection Regulation is the definition of pseudonymisation as “the processing of personal data in such a manner that the personal data can no longer be attributed to a specific data subject without the use of additional information, provided that such additional information is kept separately and is subject to technical and organisational measures to ensure that the personal data are not attributed to an identified or identifiable natural person”.

The new General Data Protection Regulation, expected for final vote by the European Parliament and publication in the Official Journal of the EU by the third quarter of 2016, is set to provide strong but proportionate safeguards and governance structures to ensure that personal health data information is used safely, ethically and securely in research.

Our developments within ExPO-r-Net have just come in time. It is vital to strike an appropriate balance between the use of personal data in research with the individual’s right to privacy. This is why we have designed a specific Information Communication Architecture. This is interoperable with both upcoming national and European wide eHealth infrastructures. It also permits secondary use of datasets for research and education while meeting personal data protection requirements.

The European Unified Patient IDentity management (EUPID) was developed as an effective pseudonymisation concept in the preceding ENCCA project. It is now being implemented within the ExPO-r-NET context. EUPID protect privacy of patients by allowing different pseudonyms in different contexts. At the same time, it allows pseudonyms and related datasets to be linked provided that certain preconditions have been met.

These include involvement of a trusted third party, ethical committees and adequate broad informed consent for research participation from the individuals involved. By introducing effective de- and re-identification methods, EUPID bridges the existing gap between healthcare and research stimulating important medical discoveries in the future.