mhealth und das Internet der Dinge für die biomedizinisch/klinische Forschung

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1 mhealth und das Internet der Dinge für die biomedizinisch/klinische Forschung Thematic Coordinator Predictive Health Information Systems Digital Safety & Security Department AIT Austrian Institute of Technology GmbH Reininghausstraße 13/1, 8020 Graz März 2016 Konzerthaus Freiburg, Deutschland

2 Inhalt Informations- und Kommunikationstechnologiewellen ehealth, mhealth, Internet of Things, Neue Möglichkeiten zur Datenerfassung Anywhere Anytime Anyone Anything Anwendungsbeispiele Adhärenz-Monitoring Identity Management/Pseudonymisierung Summary & Conclusion 2

3 mhealth History 1967 tricorder* 2007 triband smartphone The universal mhealth toolbox Star Trek, episode #28 The City on the Edge of Forever first broadcast on April 6,

4 Enabling ICTs (Pubmed Query) Internet (ehealth) Mobile Comm. (mhealth) Apps (phealth) Internet of Things (xhealth)

5 ehealth/edc, mhealth/epro, phealth/iot 4 BR, ehealth Healthcare BioMedical Research epro EDC mhealth Apps & IoT 4 Research phealth ICT (Information & Communications Technologies) 5

6 ehealth - Electronic Data Capture (EDC) Erfahrung mit klinische Studien und EDC Schreier G, Messmer J, Rauchegger G, Modre-Osprian R, Ladenstein R. A Web-based platform for interdisciplinary biomedical research. Front Biosci Jan 1;14:

7 mhealth & epro Patient Terminal for Anything & Anyone? Scherr D, Zweiker R, Kollmann A, Kastner P, Schreier G, Fruhwald FM. Mobile phonebased surveillance of cardiac patients at home. J Telemed Telecare 2006;12(5):

8 Interacting with the real world by touching symbols and abstractions By touching things using NFC Keep in Touch Morak, J, Kumpusch H, Hayn D, Modre-Osprian R, Schreier G. Design and evaluation of a telemonitoring concept based on NFC-enabled mobile phones and sensor devices. IEEE TRANSACTIONS ON INFORMATION TECHNOLOGY IN BIOMEDICINE 16 (1):17-23,

9 The Internet of Things (IoT) smart objects with four technological attributes Identification Location Sensing Connectivity enables communication between people and things, and things and things Cyber Physical Systems 9

10 IoT based on Near Field Communication (NFC) Short range (5 cm), low-power, wireless communication technology Bring-in-Touch paradigm Touch contactless smartcard to start software application automatically read data for identification and authentication exchange data with NFC enabled devices read out static data from RFID tag all without prior pairing In 2017, there will be 1.67 billion NFC-enabled handsets in use* *

11 Patients and Doctors keep in touch Heart Failure Patients Doctors Kastner P, MorakJ, Modre R, Kollmann A, Ebner C, Fruhwald FM, Schreier G. Innovative telemonitoring system for cardiology: from science to routine operation. Appl Clin Inf 2010; 1:

12 KIT Telehealth Solutions Herzinsuffizienz Telemonitoring / HerzMobil Gesundheitsdialog Diabetes / DiabMemory Reha-Support nach Herzinfarkt / MyCor Betreubares Wohnen, Smart Homes / modulaar Gesundheitsdialog Bluthochdruck / CardioMemory ca Telemonitoring Tage Erfahrung 12

13 IoT based epro / Telehealth Spirometer Smart Blisters Blutzucker- Messgerät ECG Event Recorder Blutdruck- Messgerät Pedometer Insulinpen ID-Karte Körperwaage Schreier, G. (2014). The Internet of Things for personalized Health. Stud Health Technol Inform 200:

14 phealth Personal Health Records Google Fit Apple HealthKit Microsoft Health, Health Band 14

15 Applications Adherence Monitoring App The Internet of Things The Internet of Pills System for Paediatric Oncology Identity Management / Pseudonymisation epro EDC 15

16 Medication adherence Adherence is "the extent to which a patient acts in accordance with the prescribed interval, and dose of a dosing regimen. Medication non-adherence can affect patient health adversely, negatively impact a patient's relationship with his/her care provider, skew results of clinical therapy trials, and increase health resource consumption. The average adherence rate to chronic medication therapy is approximately 50%. Adherence monitoring should be performed routinely to ensure therapeutic efficacy, avoid unnecessary dose and regimen changes, contain health care costs Dayer L, Heldenbrand S, Anderson P, Gubbins PO, Martin BC Smartphone Medication Adherence Apps - Potential Benefits to Patients and Providers Journal of the American Pharmacists Association. 2013;53(2):

17 Methoden Telehealth App Touch Screen based medication management

18 Medication Management Design and Evaluation of a Multimodal mhealth Based Medication Management System for Patient Self Administration

19 Focus: Medication identification concept Via barcode Via RFID / NFC Schreier G, Schwarz M, Modre-Osprian R, Kastner P, Scherr D, Fruhwald F. Design and evaluation of a multimodal mhealth based medication management system for patient self administration. Conf Proc IEEE Eng Med Biol Soc. 2013;2013:

20 Medication Monitoring 60 patients utilizing e-blisters Feedback based on real time compliance measurement Brath H, Morak J, Kästenbauer T, Modre-Osprian R, Strohner-Kästenbauer H, Schwarz M, Kort W, Schreier G. Mobile health (mhealth) based medication adherence measurement a pilot trial using electronic blisters in diabetes patients. British Journal of Clinical Pharmacology, 2013, 76 (Suppl. S1):

21 NFC-based eblister AIT design study

22 Medication monitorng systems - state of the art Stegemann S, Baeyens JP, Cerreta F, Chanie E, Loefgren A, Maio M, Schreier G, Thesing-Bleck E. Adherence measurement systems and technology for medications in older patient populations. European Geriatric Medicine 2012, 3:

23 From IoT to IoP (The Internet of Pills)... Each single pill becomes a smart object Identity Location Sensing Communication 23

24 Ingestible Sensor System How the technology works Hafezi H, Robertson TL, Moon GD, Au-Yeung KY, Zdeblick MJ, Savage GM. An ingestible sensor for measuring medication adherence. IEEE Trans Biomed Eng Jan;62(1):

25 Methods Internet of Things (IoT) Enables Communication between People Things Things Things Enabling technologies RFID NFC Bluetooth Wi-Fi 25

26 Identity Management Kontextspezifische Pseudonymisierung 1. Berücksichtigung aktueller Datenschutzbestimmungen 2. Keine Doppel-Registrierung von Patienten (1 EUPID / Patient) 3. Neues Pseudonym für jede Studie grundsätzlich Trennung der Kontexte Für die eigenen Patienten: Übersicht über alle Studien möglich Nach Freigabe: Möglichkeit zur Verlinkung von Studien gegeben 4. Re-Identifikation möglich Für eigene Patienten Über Trusted Third Party (TPP): für alle Patienten eines Contexts 26

27 EUPID Concept Vorname, Nachname, Geburtsdatum IDAT Context 1 Context [ ] 2 1 Context entspricht 1 Einverständniserklärung (z.b. Studie A) De-Identification + Encryption Hashing + De-Identification Gleicher Patient Neuer Context Neues Pseudonym PSN 2 IDAT IDAT CRYPT IDAT HASH 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 Input (GUI) accessible (Output) inaccessible (internal) Pseudonym für diesen Context IDAT CRYPT IDAT HASH PID 1 [ ] [ ] Keine Doppel-Registrierung PID 2 Verknüpfung Re-Identifizierung Pseudonymisation Assignment Pseudonymisation PSN 1 PSN 2 Assignment Assignment EUPID Assignment EUPID selbst ist für niemanden sichtbar 27

28 Web-App PNET 5 Study Pseudonym: 1099D11A The patient has been registered successfully and a new EUPID was generated. No match with already registered patients was found. Ausdrucken und Ablegen Print 28

29 EUPID Mobile User Interface (Android) 29

30 Use Case Toxicity Monitoring in Paediatric Oncology Identity management / pseudonymisation using EUPID Token based authentication of patients (ID card & PIN) Tagging of Biosamples with RFID tags Electronic Patient Reported Outcomes (epro) Electronic Data Capture (OpenClinica) ID card PIN epro EDC system 30

31 Information Flow 31

32 EUPID Mobile 32

33 EUPID Mobile 33

34 EUPID Mobile 34

35 EUPID Mobile 35

36 EUPID Mobile 36

37 EUPID Mobile 37

38 EUPID Mobile 38

39 EUPID Mobile 39

40 EUPID Mobile 40

41 EUPID Mobile 41

42 EUPID Mobile 42

43 EUPID Mobile 43

44 EUPID Mobile 44

45 EUPID Mobile 45

46 EUPID Mobile 46

47 EUPID Mobile 47

48 EUPID Mobile 48

49 EUPID Mobile 49

50 EUPID Mobile 50

51 EUPID Mobile 51

52 MoKi User Interface 52

53 Information Flow 53

54 Apps - Herausforderungen Keine einheitlichen Standards Keine Interoperabilität Plattformübergreifende Entwicklungen sehr aufwendig Eigene Plattformen, den Multiplattformprozess zu managen 54

55 More on this Vienna, Conference Centre Schloss Schönbrunn May 24 25,

56 Schlussfolgerung ehealth, mhealth und das Internet of Things ermöglichen es uns, Patienten in den Mittelpunkt der Datenerfassung zu stellen und den primären Outcome unter natürlichen Bedingungen zu erfassen objektive Größen (z.b. Blutdruck) subjektive Größen (Quality of Life) das Verhalten der Patienten (Adhärenz, Lifestyle) externe Einflussgrößen (Wetter, ) Damit wird es letztlich möglich, den Stellenwert neuer therapeutischer Ansätze (Medizinprodukte/Medikamente) besser zu bewerten. Von Efficacy (can it work under lab conditions) zu Effectiveness (does it work under real-world condition) 56