Abstract
Digitization is becoming more and more important in the medical sector. Through electronic health records and the growing amount of digital data of patients available, big data research finds an increasing amount of use cases. The rising amount of data and the imposing privacy risks can be overwhelming for patients, so they can have the feeling of being out of control of their data. Several previous studies on digital consent have tried to solve this problem and empower the patient. However, there are no complete solution for the arising questions yet. This paper presents the concept of Sovereign Digital Consent by the combination of a consent privacy impact quantification and a technology for proactive sovereign consent. The privacy impact quantification supports the patient to comprehend the potential risk when sharing the data and considers the personal preferences regarding acceptance for a research project. The proactive dynamic consent implementation provides an implementation for fine granular digital consent, using medical data categorization terminology. This gives patients the ability to control their consent decisions dynamically and is research friendly through the automatic enforcement of the patients’ consent decision. Both technologies are evaluated and implemented in a prototypical application. With the combination of those technologies, a promising step towards patient empowerment through Sovereign Digital Consent can be made.
Highlights
Received: 14 January 2022The use of digital consent seems to be a promising improvement to speed up research projects that use personal health data
We introduce a consent privacy impact quantification (CPIQ), which we see as one key part of Sovereign Digital Consent
This paper presents the concept of Sovereign Digital Consent which is a patientempowering and research-friendly implementation of digital consent
Summary
The use of digital consent seems to be a promising improvement to speed up research projects that use personal health data. The European General Data Protection Regulation (GDPR) considers personal health data as highly sensitive data and sets strict requirements for processing exclusion for them [1]. While the technology itself becomes more and more usable in practice, from a technical point of view, there are still open questions in terms of usability, privacy, and acceptance of digital consent. This is clearly an interdisciplinary topic that requires an ethical and legal point of view
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