PARENT Joint Action: bringing EU registries into the spotlight
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The PARENT Joint Action (Cross-border Patient Registries Initiative) was funded through the Second Public Health Programme from May 2012 until November 2015. The main objective of PARENT was to support European Member States in setting-up, developing and governing patient registries in areas of strategic importance such as chronic diseases and medical devices, safety and health technology assessment. Rare diseases became an important focus of this work, and strong synergies were built with various rare disease initiatives, to ensure the applicability of the outputs for the rare disease field.
PARENT sought to promote registries’ comparability and interoperability to facilitate the re-use of data for public health and research purposes, thus maximising the potential of digital patient data in Europe. Coordinated by the National Institute of Public Health of the Republic of Slovenia (NIPH), the partners developed numerous important outputs to support the operation of existing registries, as well as guidance for stakeholders wishing to set-up new registries:
• Methodological Guidelines and Recommendations for Efficient and Rational Governance of Patient Registries: This deliverable provides a comprehensive overview of registry design, operation and utility, with emphasis on the use of information technology. It explains the various types of registries and provides practical, detailed advice on how to set-up and manage patient registries, covering all aspects of the process. The Guidelines define essential quality components of registries (including but not limited to considerations around data quality). There are specific sections dedicated to the concept of interoperability and how to achieve this, on how to enable secondary use of data for public health policy and research, on sharing data across borders, and more. The PARENT Guidelines received the recommendation of the eHealth Network in November 2015.
• Pilot Registry of Registries (http://www.parent-ror.eu/): To improve awareness of existing European registries, PARENT conducted a survey and developed a Registry of Registries (RoR). This resource currently contains over 200 registries and is searchable by, for instance, registry type and purpose. Some rare disease registries are also included in this RoR.
• Wiki tool - internet searchable and editable Guidelines: The aforementioned Methodological Guidelines and Recommendations have been translated into a Wiki-tool to allow registry users to search the Guidelines and -importantly- update and maintain them in future.
• Report on the role of registries and future actions: This report explores the potential for registries to support cross-border healthcare, and identifies challenges and future opportunities in the context of the EU digital data infrastructure. The partners analysed the role assigned to registries in the Cross-Border Healthcare Directive (2011/24/EU) and noted that the only explicit mention occurs in Article 12, in connection with European Reference Networks: since one of the main targets of ERNs is rare diseases, the importance of rare disease registries becomes very clear.
• Report on the sustainability of cross-border collaboration on secondary use of registry data: The consortium explored the use of business models to better understand the trends and options available for achieving sustainability of registries with a cross-border scope, to support re-use of valuable data. The analysis underlined the need to align eHealth and patient registries activities on national and EU-level and demonstrated how the PARENT Framework and tools can be utilized for this purpose.
In summary, PARENT’s major achievement was to bring EU patient registries into the spotlight and to explore their role in the context of implementing the Cross-border Healthcare Directive. Important steps were taken along the road to interoperable cross-border eHealth services. The outputs of PARENT will be incorporated to the ongoing activities of initiatives such as the Joint Action to support the eHealth Network (JAseHN), EUnetHTA JA3, and RD-ACTION.
A full list of deliverables is available here
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