Persephone Doupi MD, PhD – THL, WP6 Leader PARENT Cross border PAtient REgistries iNiTiative JA Cross-border use of registry data: requirements Workshop on PARENT Guidelines Brussels, May 19th 2015 Persephone Doupi MD, PhD – THL, WP6 Leader WP6 Core team: Arto Vuori, Antti Tuomi-Nikula, Katariina Peltonen, Hanna Liukkunen Senior Advisors: P. Hämäläinen, M. Gissler

Cross-border use of registry data: WHY? PARENT JA/P.Doupi

Data Linkage: Pharmaco-epidemiology studies Selective serotonin reuptake inhibitors during pregnancy and risk of persistent pulmonary hypertension in the newborn: population based cohort study from the five Nordic countries BMJ 2011;344:d8012 doi: 10.1136/bmj.d8012 (Published 12 January 2012) Study population: women and their infants born in Denmark, Finland, Iceland, Norway, or Sweden between 1996 and 2007 Data Sources: medical birth registers, the prescription registers, and the cause of death registers PARENT JA/P.Doupi

Use of real world data in EUnetHTA pilots on Relative Effectiveness 22 July, 2018 Use of real world data in EUnetHTA pilots on Relative Effectiveness Text slide 1 column Slide: Wim Goettsch, National Health Care Institute (ZIN), Diemen, The Netherlands 17th ISPOR Europe 2014 European network for Health Technology Assessment | JA2 2012-2015 | www.eunethta.eu 4

PARENT JA/P.Doupi

PARENT JA/P.Doupi

Cross-border use of registry data: HOW? PARENT JA/P.Doupi

PARENT JA vision: eData trajectory Source of data Patient Registries Secondary use of registry data Hospital Information System/EMR/ LIS/RIS Product Registries HTA Inter/national indicators Services Registries Practice EHR Research Market Access Condition Registries Safety Patient‘s PHR … QoC … 8

What is needed Researchable data: Knowledge of what data is available, where, under which conditions Documentation & harmonization of procedures Data (flow) complient with regulatory and legal obligations Comparative data across registries, databases disease codes unique patient ID data collection, access and sharing procedures PARENT JA/P.Doupi

Challenges Data entry – data collection: Electronic at present around 40% (PARENT survey) Culture of registry holders: low interest in data sharing (PARENT interviews) Linguistic barriers Consent & other legal requirements Governance models, sustainability Beneficiaries – added value PARENT JA/P.Doupi

Cross-border registries collaboration: REQUIREMENTS PARENT JA/P.Doupi

Requirements 1: Political context NATIONAL & REGIONAL LEVEL: eScience data resources and research infrastructures strategy eHealth strategy Are registries featured in this planning? Are registries needs taken into account and catered for? PARENT JA/P.Doupi

Interoperable registries: Policy requirements CONDUCIVE RESEARCH INFRASTRUCTURES & eHEALTH STRATEGY

Requirements 2: Legal Legal instruments for patient registry establishment: explicit consent of the data subject (European Data Protection Working Party WP 29) law KEY: Final content of forthcoming Data Protection Regulation PARENT JA/P.Doupi

Legal aspects: practical steps Consult data protection authorities and/or ethical committees Transparency and accountability Openness on registration practices: Incl. maintaining clear and open descriptions of the registry and its metadata online. PARENT JA/P.Doupi

Requirements 3: Organisational aspects – operations and procedures Straightforward application processes Systems for remote access Organisational culture: data utilization beyond own remits Appropriate resourcing GOAL: Improved access to registry data PARENT JA/P.Doupi

Requirements 4: Semantics Operating in international environment address linguistic barriers implement supportive solutions at data level and at the level of generic information necessary for data sharing (e.g. information on procedures for access to data, application forms etc.) heavily dependent on the adoption and use of accepted coding standards PARENT JA/P.Doupi

Requirement 5: Technical aspects GOAL: guaranteeing shareable data choices made on the level of an individual registry and up to the level of platforms for cross-border sharing of data. adopted solutions must take into account and support regional/national infrastructures and semantic requirements for patient data collected in the process of healthcare services provision. PARENT JA/P.Doupi

Thank you! CONTACT: persephone.doupi@thl.fi parent@nijz.si WEB: www.patientregistries.eu Twitter: @ParentJA