The main aim of WP8 is to develop a legal and ethical framework to provide guidance on addressing patient confidentiality and data ownership concerns, and establish sustainable governance for the data infrastructure. The timing of PIONEER will coincide with the coming into force of the General Data Protection Regulation (GDPR) in May 2018, the most significant change in data privacy law in over 20 years. WP8 will closely track how EU members States may derogate from GDPR and how regulatory or professional bodies provide specific guidance on application to patient data and big data. WP8 collaborate with, and provide guidance to other WPs (3, 4 and 5 in particular). WP8 will develop and share best practice as it emerges throughout the term of the lifetime of PIONEER and report regularly on progress. Objectives: Implementation, WP8 will ensure that the policies and processes work in real-world situations by seeking feedback from the other WP participants and end users on the ease of use of such recommended policies and procedures and any issues which arise, for example any rejection by local hospitals or patient groups. In order to achieve implementation policies and processes will be delivered with clear and user-friendly guidance notes to explain the rationale behind particular approaches and to pre-empt and answer queries which may arise. European Organisation for Research and Treatment of Cancer, Pinsent Masons LLP, ASSOCIATION EISBM, Bayer, Astellas Pharma and Orion Corporation.Work package 8: Legal, ethics and governance
WP8 Partners