Project Charter

1. Project Charter Defining EHR Third Party operating model, role and governance. • Problem Statement: The role of a EHR Third Party (EHR TP), to act as a gate keeper for access to EHRs by organizations who did not create the records comes up repeatedly in discussion of use of EHRs for specified medical research. Moving the discussion into a practical pilot stage needs the emergence of some potential EHR TPs. The interest of potential companies wishing to form themselves into EHR TPs needs some clarity regarding the likely remit, role and responsibilities and where they would fit into the overall governance of use of EHRs for specified medical research. • Project Scope: Identification of the rules and governance and behavioural characteristics with which EHR TPs must comply. • Governance: • Knowledge maintenance • Knowledge operationalisation • Identification of the technical infrastructure and data management tools needed for EHR TPs to operate • Roles and Responsibilities • Leader:Louis Schilders & Jean Samuel/ Mats Sundgren • Team Members: See table attached • Exchange point/ commentary resource See table attached • Project Steering Committee: • Ilias Iakovidis • Isabelle de Zegher • Georges De Moor • Jean Samuel • Veli Stroetmann • Mats Sundgren • Petra Wilson • Gudrun Zahlmann Note: this SC covers this and the CRFQ and core dataset projects. • Time Frame (proposal) • Goals • Give clarity to interested parties about what is needed to be a EHR TP and so decide whether to endorse the TP way forward • Encourage businesses/ individuals to step forward to undertake EHR TP roles • Business benefits • A documented definition and business case for Third Party role in the EHR arena that allows organisations and individuals to factor into their business strategy • To allow development of Third Party EHR role in clinical trials beyond the use case and pilots hitherto such that pharma can factor into their business and trial strategy. • Includes buy-in from patient needs

2. Project Charter – cont. Defining EHR Third Party operating model, role and governance. • A formal description of EHR TP role, remit and responsibilities • Mission statement, value proposition and operating model inc : • model contract • Governance • knowledge maintenance • knowledge operation • soft services • Statement of current existing TPs in Europe • Specification of the activities and safeguards needed • Project Deliverables: Approach: Understand current existing TPs in Europe and their different models Consider activities covered in the following bullets • Hold data on architecture of national, local, other, EHR systems: (possible? huge maintenance effort without any guarantee of being up to date?) • Aggregate, copy, de-identify, pseudononymise data service* • De-anonymize for safety events/ signal alerts to Regulators • Operating abroad - appropriate controls and sanctions* • Describe and specify possible uses • Add and possibly tag data from clinical research • Recommend Professional Certification mechanisms for customers re confidentiality , Should TP be certified but not involved in certification? • Recommendations for the governance and accreditation/ inspection of such EHR TPs for review by EU e.g. guideline • Provide environment • Monitor adherence to standards • Feedback to Standards Developing Organisation board of Directors • Support distributed interrogation • Conformance testing of accepted standards, certification of systems. If systems certified by a certification body or authority – TP role? • Version control • Adoption and quality assurance / safe delivery • Commercial: non profit ,making basis • Routinely share with ‘exchange point/ commentary resource’ to ensure alignment with legal and wider governance activities • Measurement

3. Participants lists