WP8 provides the critical input to issues arise from the project in relation to the areas of data privacy/protection, legal, ethical and other relevant regulations, and ensure compliance. Patient data within IDEA-FAST is only accessible for specific uses and under certain circumstances (e.g. anonymisation, pseudonymisation, informed consent or another legal basis), and the data flow for analyses must be implemented in a data protection-compliant way. We will address these challenges by liaising with the other WPs and building upon experiences in other projects (e.g. BD2H, BD4BO, Trials@Home). In the BD4BO model, Informed Consent Forms were developed which will be used as the basis for data transfers. We will conduct a “Data Protection Impact Assessment” (DPIA) at key intervals to ensure all GDPR data protection issues are properly addressed and threats to the fundamental rights and freedoms of data subjects are averted. The governance of the IDEA-FAST database will be established, ensuring that the FAIR principles of data sharing will be met, facilitating data reuse within the confines of current data protection laws and respecting IPR. Where appropriate, we will involve Data Protection Authorities and Ethical Committees. The ethical principles of liaising with patient organisations and the public at large, the digital medicine (especially the home monitoring of patients) will also be addressed. MLCF will investigate the conditions under which devices can become an integral, autonomy-promoting part of a patient’s daily life. Issues of reuse of sensor data from the platforms of the devices makers for a learning healthcare system will be addressed beyond the scope of IDEA-FAST.


O8.1 Ensure compliance with data protection issues on all aspects of the IDEA-FAST project (e.g. informed consent, patient rights, data security, privacy by design, etc).
O8.2 Develop the governance strategy of the IDEA-FAST Data Management Platform, with a balanced involvement of all stakeholders (researchers, patients, medical professionals) and adherence to the FAIR principles of data reuse.
O8.3 Assure global legal and ethical supervision via an external legal and ethical advisory board and interaction with data protection authorities and national ethics committees
O8.4 Provide guidance and support about patient involvement throughout the IDEA-FAST project (together with other WPs, especially WP2) in the research and draw lessons for the future.
O8.5 Explore the challenges of home monitoring from a practical, ethical, legal and societal perspective and provide recommendations about addressing these, building on lessons from IDEA-FAST.


D8.1: The model informed consent for the FS
D8.2: The model informed consent for the CVS
D8.3: Report on the challenges of sharing of digital device data from legal and IPR perspectives in the context of a learning health care system
D8.4: Report on the governance of the IDEA-FAST platform