This report constitutes the Deliverable “D8.5 – Ethics, Safety and mHealth Barriers (Regulation, Legislation, etc.) Manual” of the myAirCoach project (Grant Agreement No.: 6436071), and aiming to outline the project’s plan towards addressing issues related to the safety and privacy of asthma patients and the participants of the project trials while ensuring the fulfilment of high ethical standards .The current deliverable is mainly connected with “Task 8.3 Ethical, Safety and mHealth Barriers Issues”. In addition and thought “Task 8.1 Project Management” and “T8.2 Risk management and contingency planning” the outcomes of this deliverable will be applied to all the work done under the myAirCoach project. The deliverable has two main functions. Firstly to identify of privacy, safety and legal issues that are related to the myAirCoach project and especially to the components compromising in novel mHealth nature. Secondly, this document is providing a first version of the project’s strategy towards the resolution of these issues and in order to minimise any related risk that may rise in the course of the project. In this basis, the current deliverable is considered a living document and will be continuously updated during the course of the project in order to address any emerging needs and requirements and cover any additional risks identified. Furthermore, and as the test campaigns and pilots of the project are forming and their procedures are accurately defined this document will be adapted by the responsible partners in order to include requirements specific for the two countries of deployment, namely the United Kingdom and the Netherlands. Finally, and after the finalisation of the myAirCoach system, the current document will be reviewed and extended where needed in order to cover all the aspects of the evaluation process as it is foreseen for WP6 and the commercial exploitation requirements as they will be defined within WP7.
The final and consolidated version of the document will be available by Month 35 as described in the project’s Description of Work.