EU aktivnosti za čezmejno izmenjavo podatkov pacientov Registri bolnikov Skupna Aktivnost PARENT doc. dr. Matic Meglič, MBA Čezmejno ZV v EU, Ljubljana 18/10/2012
Zdravnik, doktorat s področja ezdravja, MBA Prva slovenska kontrolirana klinična študija učinkovitosti storitve ezdravja (edepresija 2008; JMIR 2010) Predstojnik Centra za Zdravstveno Informatiko, IVZ Docent ezdravje (Upr) Koordinator Skupne Aktivnosti PARENT Član Usmerjevalnih odborov: projekt epsos ehealth Governance Initiative, prej Calliope Vabljeni predavatelj na mednarodnih dogodkih (High Level ehealth Conference, EFMI, HealthTech Council ZDA, EU-US ehealth) @matic_meglic www.ehealth.si
EZDRAVJE IN ZDRAVSTVENO ZAVAROVANJE: STIČNA TOČKA? Kaj Evropa skuša doseči z vrsto aktivnosti na področju interoperabilnosti ezdravja? (čl. 14) Zavarovanje: indirektno. Podlage za: Mobilnost pacientov Bolj enoten trg za zdravstvene storitve, IKT, medicinsko opremo, zdravila, ipd. Bolj enoten trg za zdravstveno zavarovanje
14. ČLEN: EZDRAVJE (EHN) 1. Unija podpira in olajšuje sodelovanje in izmenjavo informacij med državami članicami v okviru prostovoljne mreže, ki povezuje nacionalne organe, pristojne za e-zdravje, ki jih imenujejo države članice. 2. Cilji mreže e-zdravje so: (a) doseči trajnostne epsos project gospodarske in družbene koristi evropskih sistemov in storitev ter interoperabilnih aplikacij e-zdravje, z namenom, da se doseže visoka raven zaupanja in varnosti, izboljša stalnost PARENT Joint oskrbe Action ter zagotovi dostop do varnega in visokokakovostnega zdravstvenega varstva; (b) pripraviti smernice za: (i) neizčrpen seznam podatkov, ki se vključijo v povzetke o pacientih in ki se lahko izmenjujejo med zdravstvenimi delavci, da bi tako zagotovili neprekinjenost oskrbe in varnost pacientov preko meja; ter (ii) učinkovite metode, s katerimi se omogoči uporaba zdravstvenih informacij za javno zdravje in raziskave; (c) podpira države članice pri oblikovanju skupnih ukrepov za identifikacijo in ugotavljanje avtentičnosti, na podlagi katerih se olajša prenosljivost podatkov v čezmejnem zdravstvenem varstvu. STORK 2, ehgi, e- SENS?
D e c i s i o n M a k i n g ehealth Network of Member States Art. 14 Directive on Patients Rights (2011) P r o d u c t i o n ehealth Governance Initiative Joint Action and accompanying Thematic Network SemanticHealthNet project ehealth EIF project PARENT Joint Action CALLIOPE Interoperability Roadmap HITCH project epsos project Patient summary / eprescription STORK project ehealth eidentification SmartPersonalHealth project ehr QTN project 5 Modified from: EIF Phase 2, Deloitte
Health Care Cross-border exchange of health data - EU PERSPECTIVE Public Health Research
Health Care Cross-border exchange of health data Research Public Health key European ehealth IOp pilot co-funded by the EC. improving medical treatment abroad by providing the necessary patient data. One of five Large Scale Pilots 2008-2013, 20 MS + 5 other (50 partners)
From Strategies to Services Provides working cross border services that ensure safe, secure and efficient medical treatment for citizens travelling across EU Supports services close to the patient: Patient Summary for EU Citizens eprescribing for EU Citizens eprescription edispensation Builds on existing National ehealth Projects and uses experience and knowledge from all Member States
Support cross-border use of patient registry data for secondary purposes by facilitating (in MS) : Cross-border exchange of health data Health Care Public Health - development and governance of patient registries - Development of comparable and interoperable patient registries - the provision of information on the relative efficacy and effectiveness of health technologies. Research
ISSUES WITH PATIENT REGISTRIES DIFFERENCES in: Content (clinical, population based) Semantics (meaning) Quality, update frequency, completeness LIMITED POTENTIAL to use the data Across registries Across countries UNMET NEEDS: Share, merge Aggregated or anonymized data Individual data Compare, research: Clinical effectiveness Cost efficiency Quality of treatment Vigilance, etc. Across: Member States Clinical fields 10 www.patientregistries.eu
OUTLINE Start: May 2012 Duration: 30 months Budget: 3.4 Mio (60% EC) 11 Associated partners 12+ Collaborating partners 11 www.patientregistries.eu
OBJECTIVES (BRIEF) Current state Coordination mechanism Pilot Registry of Registries Recommendations, guidelines and IT components Sustainability & Support of Cross-border HC Directive 12 www.patientregistries.eu
ASSOCIATED PROJECT GROUP DG SANCO Clinical Content EPIRARE DG SANCO ehealth JA DG SANCO Methodology EUnetHTA EUCERD JA EuReMS EUBIROD EPAAC, ECIS EAR EuraHS EUROCISS and others. PARENT JA EC ehealth projects ehealth Governance Initiative EHR4CR SemanticHealthNet epsos and others. 13 www.patientregistries.eu M Meglič
[DRAFT] INTEREST FIELDS AND SCENARIOS Registry type Question/Purpose Scenario - Clinical field Products (med.dev., drugs) 1 Safety, HTA, pricing, PhVigil Implants Hernia, Arthroplasty Conditions 2 Research (clinical, post Mkt/Cert) Drugs (TBD Diabetes, Cardiovasc., RD 1 Rare Disease Multip.Sclerosis Allergies Services 3 TBD Indicators Cancer, Diabetes NOT: RCT, regulatory PhVigil European Reference Network 14 www.patientregistries.eu
ZA KONEC Že narejeno je potrebno ponovno uporabiti (standardi, definicije, orodja) PARENT in povezava z vidikom zavarovanja preko zagotavljanja bolj kakovostnih podatkov za: HTA, pogojna povračila, določanje cen storitev. Indikatorji kvalitete in razpoložljivosti storitev Veliko dela še pred nami: nejasno, kako se bodo oblikovale Nacionalne Kontaktne Točke (čl. 6), Referenčna Mreža 16 www.patientregistries.eu
G CONTACT: parent@ivz-rs.si matic.meglic@ivz-rs.si WEB: www.patientregistries.eu #: #ParentJA 18 www.patientregistries.eu