MyHealthMyData (MHMD): Deliverable 3.2 - Ethical Review materials and engagement process definition

The present deliverable is aimed at providing a general evaluation framework for the management of patient consent in MHMD, and its implementation as a smart contract. Such framework will serve as the basis for submitting in due course the needed requests, to MHMD partner hospitals’ Ethics Committees, in view of being authorised to deploy dynamic consent applications within their patient populations. If successful, the outcome of this activity will represent a major result of the project, as it will deliver one of the first ethically compliant (and approved) blockchain architectures specifically conceived for health data management and exchange. The scope of this deliverable has been updated to take into account the changes in task T3.2, as indicated in the recently submitted Amendment, in particular to reflect the new strategy for implementing dynamic consent through smart contracts and leverage the blockchain to make consent management process (from the provision of consent to the ex-post verification of existence of such consent) transparent, semi-automatic and tamper proof.1 The change in strategy was deemed necessary to provide the Ethics Committees not only with the supporting documentation needed for approving a novel mechanism for expressing and managing consent (becoming fully dynamic through smart contracts), but also to encode the conceptual consent framework on which to obtain a comprehensive and robust ethical approval – incorporating the ways in which consent is implemented on the blockchain in code, shared with external parties, and automatically self-enacted and possibly modified by the patient. With this document, an iterative process will be activated, using feedback gathered from Ethics Committees in order to better specify the entire process and corresponding IT architecture. The subsequent phases of the iteration are provided in section 4.4.5 (MHMD approach). Beside presenting the issue of how to translate dynamic consent into smart contracts, this document will also provide a preliminary recognition and analysis of the technological approaches currently followed for smart contracts implementation, thus presenting a general development framework for applying the dynamic consent concept though smart contracts within MHMD.