D4.4 Information Governance Framework and Instruments

Deliverable 4.4 describes the Information Governance Framework for AIDAVA. Information Governance relates to regulatory compliance and risk management for information handling. It will also inform technical design and implementation, including security services such as access controls and encryption.Partner i~HD has therefore under Task 4.1 engaged with the Consortium to conduct the requisite information gathering and risk assessments to ensure high assurance around the handling of health information in line with key Information Governance principles. It has used the Data Protection by Design and Default approach provided by GDPR to engage with the Consortium early on to ensure that it defines the data flows to achieve the goals of AIDAVA, assesses the data protection, security and ethical risks of the project and defines the key instruments that will address them.The outcome of this is the Data Protection Impact Assessment template for the Consortium, which in turn has assisted with the production of a Data Management Plan published as D4.1. Both deliverables are based on Data Flow Diagrams initiated during a dedicated workshop held in December 2022 between WP1 and WP4, and further refined through joint meetings held throughout the project. The processes have allowed an agreement on the roles of the partners and on the contractual agreements required to govern AIDAVA with progress made on defining these contracts. The contracts themselves include a set of bilateral Data Sharing Agreements developed on a standard template defined within the consortium, including - whenever applicable - existing legal provisions and specific technical provisions; Data Processing Agreements were assessed as not needed.Task 4.1 has also offered advisory on submissions to Research Ethics Committees - for accessing patient data for annotation purposes and for assessing the prototype - and design choices for the project. The drafting of a Code of Practice is also underway and key challenges are being collated for submission to AIDAVA’s independent Ethics Advisory Board which will meet for the first time in early October.