1. 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

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

3. 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: /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

4. 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 | JA | 4

5. PARENT JA/P.Doupi

6. PARENT JA/P.Doupi

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

8. 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

9. 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

11. 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

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

13. 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

14. Interoperable registries: Policy requirements
CONDUCIVE RESEARCH INFRASTRUCTURES & eHEALTH STRATEGY

15. 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

16. 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

17. 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

18. 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

19. 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

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