Secondary Use of EHRs Enhancing Clinical Research The Healthcare Perspective

1. Secondary Use of EHRs Enhancing Clinical Research The Healthcare Perspective

2. EHR systems: Future Trends Patient-centered (access keeper?) and longitudinal (life-long) Multi-disciplinary / multi-professional Virtual (interoperable?) More sensitive content (biomedical/genetic data) More structured and coded Intelligent (decision support) The «passive» medical records are changing into «active» objects that remind, suggest or even seek out advice: e.g. - indications and contra-indications - drug interactions - side effects, adverse drug reactions, risks

3. EHR systems: Types « The boundaries between EHR systems are fading away… » Settings: primary care, acute hospital care, tertiary care, … Content: summary records, emergency records, discharge records, … Approach: problem-oriented, care pathway- or clinical pathway-oriented, … Context: prevention, diagnostic, therapeutic (care & cure), monitoring, palliation (or combination), research, … Author: medical record (EMR), nursing record, administrative record, patient personal health record (PHR)

4. EHR systems: Content Issues Authorship versus Ownership Sensitivity of the data (personal data versus anonymous data) Objective versus Subjective data Missing data (what about e.g. clinical trial data not normally part of the patient’s record?)

5. EHRs: Stakeholders and Use-Cases Clinicians: care, etc… (incl. e-Prescription) Researchers: clinical trials, disease management studies, post-marketing surveillance, health economics, etc… Health Authorities: pharmacovigilance, management statistics, utilisation review, etc… Data-brokers (& industry): marketing, promotion, sales, etc… Third Party Payers: billing, reimbursement Academics: education IT-vendors: development (enablers) Regulators: legislation (disablers?) Patients: Personal Health Records (PHRs): the future…?

6. EHR Systems: Quality Issues Integrity « Today, the nature of EHRs is rather unregulated which is in contrast with the case of Clinical Research Systems with rules laid out in regulations and good practice guidelines (GCP, …): the integrity of the EHRs holding the source data should meet more rigorous rules» Source attribution (signature) Time chronology, validity (date and time stamping) Location where (document locator IDs) Access history(traceability) (access rights) (cf. liability issue)

7. EuroRec’s Quality Labelling of EHRs The use of EHRs has been proposed as an answer to the challenges of bridging the gap between the world of healthcare and the one of research. EuroRec acts as a central repository of validated quality criteria and other relevant materials that can be used to harmonise European testing, quality labelling and procurement specification of EHR systems. It willnot impose particular certification modelsor specific criteria on any member country but will foster, the progressive adoption of consistent and comparable approaches to EHR system quality labelling. Work in progress: quality criteria on EHRs as e-sources for e-Clinical Trials

8. Indexing the quality criteria • Multiple indexing of each statement • to maximise the likelihood of finding all relevant statements when searching via the indices • Business Function(50 in 8 subcategories) • Care Setting(18 in 3 subcategories) • Component Type(18 in 4 subcategories)

9. Business Function (1) • A0 EHR data (record) management • A00 EHR data entry ! • A01 EHR data analysis • A02 EHR data content • A03 EHR data structure • A04 EHR data display • A05 EHR data export/import ! • A09 EHR generic data attributes • A1 Clinical functions • A10 Clinical: medication management • A11 Clinical: long-term illness management • A12 Clinical: health needs assessment • A13 Clinical: care planning and care pathways • A14 shared care • A15 Clinical: alerts, reminders and decision support • A16 Clinical: workflow and task management • A17 Clinical: patient screening and preventive care services • A2 Administrative services • A20 Appointments and scheduling • A21 Patient consents, authorizations, directives • A22 Patient demographic services • A23 Certificates and related reporting services • A24 Patient financial and insurance services • A3 Care Supportive services • A30 Supportive care service requests (orders) • A31 Supportive care service reporting (results) • A32 Laboratory services • A33 Imaging services • A34 Diagnostic and therapeutic services (other): ECG/EEG etc. • A35 Pharmacy services • A4 Analysis and reporting • A40 Screening and preventive health • A41 Care setting reports

10. Business Function (2) • A5 Population health • A50 Screening and preventive health • A51 Disease registries • A52 Public health ! • A53 Epidemiology • A6 Health system services • A60 Healthcare organisation management • A61 System maintenance and technical support • A62 Education, training, support • A63 System configuration of the application • A64 Individual configuration of the application • A7 Security: privacy and accountability • A70 Security: authentication • A71 Security: authorisation • A72 Security: access control • A73 Security: confidentiality and consents • A74 Security: version management • A75 Security: de-identification services and processes • A8 Security: technical • A80 Security: backup and integrity validation • A81 Security: data retention, availability and destruction • A82 Security: audit and override monitoring • A83 Security: attestation and non-repudiation

11. Care Setting • B0 Generic or ubiquitous • B01 Regional healthcare network (specific distribution) • B02 Virtual or telehealth • B03 Personal health • B04 Community and home care • B05 Health, wellness and prevention • B06 Occupational health • B07 Public health ! • B1 Health care enterprises • B10 Long-term care (institution) • B11 General practice • B12 Secondary care (hospital) • B13 Tertiary care centre (specialist hospital) • B14 Domain specific • B15 Profession specific • B2 Secondary uses • B20 Research and knowledge discovery ! • B21 Education • B22 Health service and planning

12. Component Type • C0 EHRS functional component • C1 EHRS infrastructure component • C10 EHRS Interoperability component ! • C11 Security management component • C2 Knowledge resources • C20 Knowledge: terminology • C21 Knowledge: ontology • C22 Knowledge: archetype • C23 Knowledge: template • C24 Knowledge: data set • C25 Knowledge: guideline • C26 Knowledge: algorithm • C3 Directory services • C30 Directory: patients • C31 Directory: personnel • C32 Directory: equipment • C33 Directory: health service directories • C34 Directory: service resources • C35 Third parties • C4 Profiling or authoring tool • C5 Documentation, support etc. • C6 EHR system functional component

13. Primary, Secondary, Tertiary … n-ary Uses Cave: the interpretation may differ as contexts differ! Primary goal Secondary use Unidirectional versus multidirectional exchange: «an ideal and efficient environment requires often a two-way transfer of data» A secondary record may become on its turn a primary source for another use.

14. EHRs: Representation Issues Terms, concepts and codes, … Controlled vocabularies ICD, SNOMED, LOINC, ICPC, … (coding) MeSH, UMLS, … (indexing) MBDS, DRGs, … (data sets) Clinical Archetypes (ontology-based-approach)

15. Clinical Trial Safety and Adverse event Register Marketing Utilisation Review Knowledge Mgmt Platform Decision Support EHRs: Communication Scenarios / Examples … Patient Clinician pCRF > eCRF t1 t2 t7 t6 t3 t4 t5 Billing

16. Clinical Trial Safety and Adverse event Register Marketing Utilisation Review Knowledge Mgmt Platform Decision Support EHRs: Communication Scenarios / Examples User / Clinician eCRF >, EHR t1 t2 t2 t7 t6 t3 t4 t5 Billing

17. Clinical Trial Safety and Adverse event Register Marketing Utilisation Review Knowledge Mgmt Platform Decision Support EHRs: Communication Scenarios / Examples User / Clinician EHR Simultaneous Transaction t1 t6 t5 t2 t3 t4 Billing

18. Clinical Trial Safety and Adverse event Register Marketing Utilisation Review Knowledge Mgmt Platform Decision Support EHRs: Communication Scenarios / Examples User / Clinician EHR “Two-way exchange” t1 t6 t5 t2 t3 t4 Billing

19. Clinical Trial Safety and Adverse event Register Marketing Utilisation Review Knowledge Mgmt Platform Decision Support EHRs: Communication Scenarios / Examples User / Clinician EHR “From push to pull” Re-use de-identification t1 t6 t5 t2 t4 t3 Billing

20. Clinical Trial Safety and Adverse event Register Marketing Utilisation Review Knowledge Mgmt Platform Decision Support EHRs: Communication Scenarios / Examples Influencing Factors Informed Consent Patient Empowerment, Consumerism, eHomeCare, … User / Patient? (self reported data from patients) PHR (reliability?) Re-use Billing

21. EHRs: Barriers to Secondary Uses Interoperability (language, semantics, …) Educational (attitude of physicians and patients) Legal (privacy protection, ownership, …) Ethical (finality-principle, …) Organisational (shift of roles, corporatistic reflexes) …

22. Workshop Stream A : New Interaction Models Focus: • Patient Recruitment (awareness, GRPs and assessing inclusion with eligibility criteria) • Data Capture (efficiency, efficacy, effectiveness and integrative approach) • Safety (prediction, monitoring and assessment)

23. Electronic Data Capture (EDC): Advantages (1) EDC & the Clinician: avoid duplication of effort: enter the data only once (reduce workload) less data transcription errors reduce time and cost enables real-time / interactive feed-back / support more data reliability (more guarantees) higher data quality (research data are more structured) easier to anonymise (on the fly, if needed)

24. Electronic Data Capture (EDC): Advantages (2) EDC & the Investigator: earlier review of safety and efficiency higher reliability of data trail shorter development time reach earlier decisions (e.g. abandonment of ineffective new products)

25. New Exchange Environments: a more Integrative Approach «There are - today - “healthcare centric” and “research centric” ICT-spheres developing independently (and thus diverging). Let us work towards a connected healthcare and research environment as a new paradigm» (communication intensive processes) Infra- and Infostructure (NHIN-like, SPINE-like (patients as key-holders?) «Better Efficacy & Safety Prediction and Monitoring with such new environments will boast Biomedical R&D base»

26. Thank you for your attention! www.eurorec.org georges.demoor@ugent.be All presentations on: www.eurorec.org - EHR workshop