D4.10 Update of the Data Management Plan

Abstract

This Deliverable provides an update to the Data Management Plan (DMP) for AIDAVA first published in M6 of the project under Deliverable 4.2[1]. As with the first version, the updated DMP is based on the European Commission Template for Horizon 2020 projects, though with additional features: in anticipation of the AI Act and European Health Data Space regulation enactments, partner i~HD has updated the DMP template to include a deeper consideration of the sustainability requirements for tooling that may be classed as a Medical Device and therefore High Risk AI System.As Outlined in Deliverable 4.8[2] as the Regulatory Blueprint for the project, AIDAVA may be classed as a Medical Device and High Risk AI System. AIDAVA has therefore populated this Data Management Plan in line with recommended EC guidelines and the additional analysis run in D4.8 as well as learnings achieved throughout the last two years through the completion of the G1 evaluations and commencement of the G2 assessments.A DMP is an important component of any data intensive programme because it imposes a need for balance between protection of data, success of the programme and the potential for reuse of data. AIDAVA is unique as a project because the primary data handling is focused on data ingestion and curation as a tool to assist citizens in managing their own health data. This clearly remains the case as the project commences its final year, where additional emphasis must be placed on the management of results data in particular to support the regulatory requirements for the Medical Device Regulation and AI Act. Both acts place an emphasis on record keeping for development and AI algorithm training data, its use and impact on the running of an AI system. A Data Management Plan keyed to sustainability is paramount.The approach to developing the data management plan originally included workshop discussions with partners at the October 2022 Kick Off Meeting in Maastricht and a dedicated data flow workshop held in Tallinn in December 2023. Relevant activity has further included several iterations of development and dry run events both in person and online, including the May 2024 G1 prototype test run with patient participants and ongoing development of the software specifications throughout consortium meetings and working groups, including the AI Requirements Assessment working group described in D4.8.The details gathered were compared with the proposal and obligations on the partners as described in the consortium agreement. They were also compared with the developing Research Protocols for both the Breast Cancer and Cardiovascular Disease (CVD) use cases developed in Task 1.4 and enhanced throughout the project lifetime and development of the G1 and G2 evaluations.The results of the detail gathering are presented as the Data Management Plan in Section 3 of this Deliverable. It concludes with next steps and specification for future sustainability of AIDAVA post project.

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