A standardized data access agreement for personalized medicine

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.

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