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A new harmonised Data Access Agreement for Controlled Access Data

The Horizon 2020 funded Coordinating and Support Action EU-STANDS4PM developed a new harmonized Data Access Agreement (hDAA) for Controlled Access Data. This new hDAA aims at (1) the harmonisation of DAAs across on-going collaborative research projects as well as (2) rolling out a standardized DAA for future EU projects. The EU-STANDS4PM hDAA is fully compliant with the new regulation regarding handling of personal data, namely the General Data Protection Regulation (GDPR).

Fundamental Research icon Fundamental Research
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Big Data in health and research holds an immense potential for clinical applications, especially for data-driven computational models in personalized medicine. However, despite the ever-increasing technical and scientific advances in producing data, the generation of new knowledge, especially for medical benefits, is lacking behind its full potential. Concerns about a safe exploitation of data, guaranteeing data privacy and security, resulted in the introduction of ‘controlled’ data access. This requires the completion of a data access agreement (DAA) and approval by a data access committee (DAC) prior to data access. As the legal situations and ethical standards in many collaborative projects differ greatly, each project appoints their own DAC and designs their own DAA. The resulting diversity in administrative, ethical and legal requirements has made it unnecessarily complex and, in some cases, impossible to carry out integrative analysis across such data – an essential prerequisite for Personalized Medicine and Data Science. To overcome these obstacles EU-STANDS4PM has two main objectives: (1) To assess and evaluate national standardization strategies for interoperable health data integration, as well as data-driven computational modelling approaches and (2) to harmonize and develop universal standards and recommendations for computational models applied in personalized medicine approaches. Within this context, one of the basic aims of EU-STANDS4PM has been to harmonize DAAs across on-going projects willing to collaborate with us. In addition, we aimed at rolling out a standardized DAA for future EU projects that is fully compatible with the General Data Protection Regulation (GDPR). Hence, the development of the new harmonized Data Access Agreement (hDAA) for Controlled Access Data aiming at better governance and flexibility. The new EU-STANDS4PM hDAA has been approved by the European Genome Phenome Archive (EGA) and is available as a default template for download under: For more information, please visit the project homepage


Data access, Harmonization, General Data Protection Regulation, Integrative data analysis, EU collaborative research