| Authors: |
Pedro Dias, Rodrigo Antunes, Catarina Nunes-Da-Silva, Soraia Ferreira, Federico Guede-Fernández, Ermanno Pallaoro, Manuel Dias, Ricardo Correia, Salomé Azevedo and Ana Londral |
| Abstract: |
1. Purpose
To design, implement, and validate a GDPR-compliant blockchain-based smart contract architecture for eConsent in digital health research, and to evaluate its technical feasibility and regulatory compliance through a real-world pilot study.
2. Design/Methodology/Approach
A design science research approach was adopted. Requirements were derived from ethical and regulatory frameworks and implemented in the Worthmed-BioGHP integration. Worthmed supports enrolment, communication, and PROM collection via WhatsApp; BioGHP provides the blockchain infrastructure for securely registering consent provision and withdrawal. The smart contract registers consent provision and revocation using pseudonymised identifiers, consent status, and timestamps. Personal data remain off-chain. Pilot validation is planned through a prospective study with 30+ participants.
3. Findings
The demonstrator implements an end-to-end eConsent flow: participants receive a secure WhatsApp link, access a Worthmed-hosted consent form, provide explicit consent, and have their consent status registered on-chain. Revocation via WhatsApp triggers an on-chain status update and suspension of data collection. The implementation demonstrates feasibility, auditability, and GDPR compliance by design through on/off-chain segregation.
4. Research Limitations/Implications
Findings reflect implementation and pre-pilot validation. Usability, acceptance, workload, and feasibility outcomes will be assessed during the pilot. This provides a model for blockchain-backed eConsent in digital health research.
5. Social/Technical Impact
The architecture supports participant-centred consent management, transparent auditability, and practical revocation. It may reduce administrative burden and strengthen trust.
6. Final Comments/Originality/Value
This work presents a functional, GDPR-aligned smart contract demonstrator for eConsent in pilot digital health research, offering an operational framework for future studies. |