SUPA! Survivorship Passport für Kinder nach Krebstherapie [email protected] Professor of Pediatrics Head of the Clinical Trials Unit S2IRP-CCRI St. Anna Kinderkrebsforschung e.V. CHILDREN'S CANCER RESEARCH INSTITUTE [email protected] Predictive Healthcare Information Systems Digital Health Information Systems Center for Health and Bioresources AIT Austrian Institute of Technology GmbH

Jahrestagung 2017 15. 3. 2017 Mayer am Pfarrplatz, Wien

Inhalt    

Hintergrund  Pädiatrische Onkologie - Seltene Erkrankungen Der Survivorship Passport (SUPA) Konzept für die Umsetzung in Österreich Zusammenfassung & Schlussfolgerung

Rare Disease Childhood Cancer    

Rare Disease Definition: Prävalenz < 1 in 2000 www.eurordis.org Childhood ( < 15 years) Cancer Incidence in Europe: 1 in 6250 Kaatsch et al. Cancer Treat Rev. 2010, 36(4):277-85. Epidemiology of childhood cancer. In Austria: ~ 185 cases per year (Statistik Austria)

Soft Tissue Sarcoma 7% Other (VRT) 8% Neuroblastoma 8%

Wilms Tumour 6% Bone Tumours 5% Retinoblastoma 3% Liver Tumours 1%

Leukaemia 30% Brain Tumours 19%

Lymphoma 13%

Deutsches Kinderkrebsregister Mainz / 2000 Neuerkrankungen pro Jahr

ENCCA European Network for Cancer research in Children and Adolescents

 FP7 Network of Excellence  2011-2015  Koordinator: St. Anna Kinderkrebsforschung (Prof. Ruth Ladenstein)  AIT: ICT WP Lead: „Establishing the Virtual Institute“  www.encca.eu

The research leading to these results has received funding from the European Union’s Seventh Framework Programme (FP7 2007-2013) under the project ENCCA grant agreement no. 261743. 4

Already available Tools from ENCCA



Survivorship Passport



EUPID – European Patient IDentity Management Service 

https://eupid.eu

R. Ladenstein, M. Schrappe, K. Pritchard-Jones, Z. Dobai, S. Essiaf, P. Kearns, et al., "ENCCA - EUROPEAN ACTIVITIES AND ACHIEVEMENTS WITH POTENTIAL INTEREST OUTSIDE OF EUROPE," Pediatric Blood & Cancer, vol. 62, pp. S202-S202, Nov 2015. 5

• given to the patient after therapy • containing cancer history and therapy information • advice and guidance on patientspecific long-term follow-up • Available in all EU languages • Developed in cooperation with PanCareSurFup • Paper and electronic based European Network for Cancer research in Children and Adolescents

6 European Network for Cancer research in Children and Adolescents

Survivorship Passport - a Lifelong Cancer-Related Patient-Centered Repository Lifelong data preservation The long-term Cancer History

Cancer and 1st end of treatment

FollowFollowups ups Follow-up

Cancer relapse and 2° end of treatment

FollowFollowups ups Follow-up

Secondary Cancer or other diseases

….

Survivorship Passport Platform

Survivorship Passport 1st version

Survivorship Passport 2nd version

Survivorship Passport 3rd version

How to make the Survivorship Passport „fly“? 

Aim – better healthcare for children with cancer  Continuity of Care  Better management of long-term effects  Enhance „Late Effects“ research



In Austria by leveraging the existing eHealth infrastructure  ELGA (Elektronische Gesundheitsakte)

8

Aktueller Stand Ergebnis der Arbeitsgruppe Mitglieder der Konzeptarbeitsgruppe 



„Konzept zur Umsetzung des Survivorship Passport (SUPA) unter Einbezug von ELGA in Österreich“ wurde Ende 2016 dem BMGF übergeben

                

19.03.2017

Ladenstein, Prof. Dr. Ruth, MD, MBA, cPM (St. Anna Kinderkrebsforschung) Arrouas, MR Dr. Magdalena (BMGF, Abteilung III/2) Geissler, Univ.-Prof. Dr. Dietmar (Humanomed Zentrum Althofen) Hackl, Dr. Monika (Statistik Austria) Kienesberger, Anita (Österr. Kinder-Krebs-Hilfe) Lax, Univ.-Prof. Dr. Sigurd (LKH Graz West, Pathologie) Lukas, Univ.-Prof. Dr. Peter (Univ.-Klinik f. Strahlentherapie-Radioonkologie der Med. Univ. Innsbruck Plank Veronika (BMGF, Abteilung III/2) Pregartbauer, DI Manfred (BMGF, Abt.I/B/9 Informationsmanagement) Prenner, Mag. Engelbert (BMGF, Abt. I/B/10 Gesundheitstelematik) Sabutsch, Mag. Dr. Stefan (ELGA GmbH.) Sadjadi, Natascha, MSc (Österr. Kinder-Krebs-Hilfe) Sauermann, FH-Prof. DI Dr. Stefan (FH Technikum Wien) Scharinger, Ing. Robert, BSc, MSc (BMGF, Abt.I/B/9 Informationsmanagement) Schneider, Mag. Carina (Österr. Kinder-Krebs-Hilfe) Schreier, Univ.-Doz. DI Dr. Günter (AIT Austrian Institute of Technology GmbH) Weninger, Dr. Christian (BMGF, Abt.I/B/9 InformationsmanagementUse Cases) 9

ELGA Law 

Elektronische Gesundheitsakte Gesetz – ELGA-Gesetz

 



Grundsätze der Datenverwendung § 14. (1) Die durch ELGA verfügbar gemachten ELGA-Gesundheitsdaten dürfen personenbezogen ausschließlich  1. zu Gesundheitszwecken gemäß § 9 Z 12 DSG 2000 [...] oder  2. zur Wahrnehmung der Teilnehmer/innen/rechte gemäß § 16 [...] verwendet werden.



 a (direct) link to research is not forseen.



How can we leverage ELGA concepts, mechanisms and infrastructures for establishing the SUPA?

10

EU General Data Protection Regulation 

Regulation (EU) 2016/679



Article 4, Definitions  ‘pseudonymisation’ means the processing of personal data in such a manner that the personal data can no longer be attributed to a specific data subject without the use of additional information, provided that such additional information is kept separately and is subject to technical and organisational measures to ensure that the personal data are not attributed to an identified or identifiable natural person;

11

 EUPID Core Requirements

1. Prevent duplicate registration of patients 2. Use different pseudonyms for different contexts 3. Provide a method to link pseudonyms from different contexts under well defined conditions 4. Preserve the possibility for re-identification by a trusted third party

Vorname, Nachname, Geburtsdatum

EUPID Concept

IDAT […]

Context1

1 Context entspricht 1 Einverständniserklärung (z.B. Studie A)

+

Context 2

+

Encryption Hashing

De-Identification

PID1

Gleicher Patient Neuer Context  Neues Pseudonym PSN2

De-Identification

IDATCRYPT […]

IDATHAS H […]

PID2

• Keine Doppel-Registrierung • Re-Identifizierung IDAT IDATCRYPT IDATHAS H MDAT PID PSN EUPID

Identity Data Encrypted Identity Data Hashed Identity Data Medical Data de-identified context-specific Patient Identifier Pseudonym European Unified Patient Identifier

Pseudonymisation

Input (GUI) accessible (Output) inaccessible (internal)

Pseudonym für diesen Context 19.03.2017

Pseudonymisation

Assignment Assignment

PSN1

PSN2 Assignment

Assignment EUPID

EUPID selbst ist für niemanden sichtbar

13

EUPID Schema EUPID Pseudonymisation Service

SQL Database Verification

EUPID App Service (REST)

M. Nitzlnader and G. Schreier, "Patient identity management for secondary use of biomedical research data in a distributed computing environment," Stud Health Technol Inform, vol. 198, pp. 211-8, 2014.

Authorised Service Consumption

Identity Provider Service

EUPID Pseudonymisation Service Clients Authentication

Android Phone

Web Application (Zero Footprint Client)

iPhone

Mobile App (Mobile Client)

Third Party Application

14

Survivorship Passport in Austria Electronic Health Record Domain

Austrian EHR

PO-CCD (CDA)

Patient Domain

Health Care Domain Health Care Provider

EHR Portal a) CDA + IDAT

e1) CDA + IDAT

Survivorship Passport

Health Professional

Survivor

d) SP + IDAT e2) SP + IDAT

Survivorship Passport App

Research Domain b)

IDAT (encrypted & hashed) PSNSP

EUPID Service EHR … Electronic Health Record PO-CCD … Pediatric Oncology Continuity of Care Document CDA … Clinical Document Architecture IDAT … Identification Data SP … Survivorship Passport PSNSP … Pseudonym in Context SP

c)

extracted data + PSNSP SP + PSNSP

Survivorship Passport Service Platform Health Care Professional Survivor Survivorship Passport App

SUPA App Funktionen 



Erstmaliges Genererieren des SUPA (Health Professional)  Laden des Onkologie-Abschlussberichtes (OAB) / Paediatric Oncology Continuity of Care Document (PO-CCD)  Pseudonymisierung unter Verwendung des EUPID Services  Kommunikation mit der SUPA Service Plattform • pseudonymisierten Registrierung • Übertragen der (extrahierten) Daten • Rückübertragen des generierten SUPA  Re-Personalisierung des SUPA Update des SUPA (Survivor)  Generierung einer aktualisierten Version • Sprache • Vorsorgeempfehlungen  aus einem vorher generierten SUPA oder dem PO-CCD als Token.

Schlussfolgerung 

Für Seltene Erkrankungen wie Krebs bei Kindern ist eine enge Zusammenarbeit von Forschung und Versorgung besonders wichtig



Der gewählte Ansatz verbindet drei existierende Elemente



als Ausgangspunkt für  Continuity of Care  Patient Empowerment  Secondary User of EHR data

17

Close the virtuous circle

19.03.2017

Insights

Action

• Guidelines

• Treatment

Information

Data

• Research Question

• Late Effects Registry

18

More on eHealth …    

www.eHealth2017.at , www.eHealthsummit.at 23. - 24. May 2017 Vienna, Conference Center Schloss Schönbrunn Special Topic: “Digital Insight – information-driven Health & Care”

19