During the pilot data acquisition MES-CoBraD will acquire Real World Data (RWD) in accordance with the protocols established in MES-CoBraD’s Project Manual (PM). The RWD of research participants will be stored in a central database developed. Because of the sensitivity of the project’s envisaged processing activities, the responsibilities and obligations of the consortium must be assessed side by side with the applicable ethical and normative frameworks. These frameworks must be understood as an “essential supporting structure” establishing the conditions and principles for the project ethical and data protection assessment. The deliverable captures the ethical and regulatory framework at the time of writing [M12]. It provides the main findings of T2.1 concerning fundamental rights for data protection as well as social and functional acceptance of the research activities in MES-CoBraD and the development of MES-CoBraD platform. In sum, two main objectives have been pursued: First, provide the normative and ethical framework relevant to the consortium for the performance of its research activities. The ethical and normative frameworks outlined are aimed to help partners assess, anticipate, and mitigate the risks to research participants and their personal data throughout the duration of the whole project. Specific guidance is provided to the partners in order to conduct the research according to the ethical and data protection principles. Second, offer practical insights and guidance for the implementation of the principles of data protection by design and by default for the development of the MES-CoBraD platform for a scenario of exploitation. An updated version of the current deliverable will address any new or outstanding issues that appear as the project progresses. Specific ethical and societal considerations will be further flagged and monitored by partner CEL during the project and while the pilot use cases with human participants take place.