DATACARE

AI-based healthcare: Data sovereignty and informed consent for clinical research

 

Background

Digitization will significantly change health research and healthcare. In the future, data collected in everyday clinical practice will also be used for research, for example to develop new therapies. The volume of patient health data is growing rapidly. For clinical research, these large volumes of data (big data) are an enormous treasure trove of information and, in combination with artificial intelligence (AI), a great opportunity. At the same time, the EU's General Data Protection Regulation (GDPR) strengthens the sovereignty of every individual. Patients decide for themselves how their personal data is to be used. They must explicitly consent to the use of their data for research purposes.

 

Project description

The consistent implementation of data sovereignty in clinical research will have enormous consequences for the collection and processing of data in practice. The main goal of DATACARE is therefore to develop a concept for data sovereignty and informed consent for clinical research, integrating legal, clinical, economic and technical research expertise, and implementing it in a prototype. To ensure acceptance of the DATACARE results, special attention will be paid to the aspects of user orientation and participation. From the very beginning, the participation of patient representatives, self-help organizations, clinicians, and the pharmaceutical industry will be consistently embedded in the project.

 

Range of services

The joint project is managed by Fraunhofer IMW. In this role, the institute is also responsible for the project's communication activities. In addition, the scientists in the project are analyzing methods and tools for deriving value-oriented pricing models for patient data. These will then be tested as part of the prototype and interaction design process.

 

Client

Federal Ministry of Education and Research (BMBF)

 

Project partner

  • Fraunhofer IAIS
  • Fraunhofer ITMP
  • Goethe University of Frankfurt am Main, Data Protection Research Center and Chair of Public Law, Information Law, Environmental Law and Administrative Science
  • University Hospital Frankfurt Goethe University, Department of Rheumatology
  • Karlsruhe Institute for Technology (KIT), Institute for Anthropomatics and Robotics (IAR), Chair of Interactive Real-Time Systems (IES)

 

Project duration

December 1, 2021 – November 30, 2024

 

Project sheet DATACARE

Project website DaRe: Healthcare data trust

 

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