1. Primary and Secondary Use of EHR systems EC/EFPIA Georges DE MOOR, MD, PhD - 1 - October 11-12, 2007 (Brussels) Secondary Use of EHRs Enhancing Clinical Research The Healthcare Perspective

2. Primary and Secondary Use of EHR systems EC/EFPIA Georges DE MOOR, MD, PhD - 2 - October 11-12, 2007 (Brussels) 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. Primary and Secondary Use of EHR systems EC/EFPIA Georges DE MOOR, MD, PhD - 3 - October 11-12, 2007 (Brussels) EHR systems: Types 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) « The boundaries between EHR systems are fading away… »

4. Primary and Secondary Use of EHR systems EC/EFPIA Georges DE MOOR, MD, PhD - 4 - October 11-12, 2007 (Brussels) 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. Primary and Secondary Use of EHR systems EC/EFPIA Georges DE MOOR, MD, PhD - 5 - October 11-12, 2007 (Brussels) 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. Primary and Secondary Use of EHR systems EC/EFPIA Georges DE MOOR, MD, PhD - 6 - October 11-12, 2007 (Brussels) 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. Primary and Secondary Use of EHR systems EC/EFPIA Georges DE MOOR, MD, PhD - 7 - October 11-12, 2007 (Brussels) 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 will not impose particular certification models or 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. Primary and Secondary Use of EHR systems EC/EFPIA Georges DE MOOR, MD, PhD - 8 - October 11-12, 2007 (Brussels) Indexing the quality criteria Multiple indexing of each statement –to maximise the likelihood of finding all relevant statements when searching via the indices 1.Business Function (50 in 8 subcategories) 2.Care Setting (18 in 3 subcategories) 3.Component Type (18 in 4 subcategories)

9. Primary and Secondary Use of EHR systems EC/EFPIA Georges DE MOOR, MD, PhD - 9 - October 11-12, 2007 (Brussels) 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 Business Function (1)

10. Primary and Secondary Use of EHR systems EC/EFPIA Georges DE MOOR, MD, PhD - 10 - October 11-12, 2007 (Brussels) 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 Business Function (2)

11. Primary and Secondary Use of EHR systems EC/EFPIA Georges DE MOOR, MD, PhD - 11 - October 11-12, 2007 (Brussels) 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. Primary and Secondary Use of EHR systems EC/EFPIA Georges DE MOOR, MD, PhD - 12 - October 11-12, 2007 (Brussels) 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 and Secondary Use of EHR systems EC/EFPIA Georges DE MOOR, MD, PhD - 13 - October 11-12, 2007 (Brussels) 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. Primary and Secondary Use of EHR systems EC/EFPIA Georges DE MOOR, MD, PhD - 14 - October 11-12, 2007 (Brussels) 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. Primary and Secondary Use of EHR systems EC/EFPIA Georges DE MOOR, MD, PhD - 15 - October 11-12, 2007 (Brussels) EHRs: Communication Scenarios / Examples PatientClinician … Clinical Trial Safety and Adverse event Register Decision Support Utilisation Review Marketing Billing t1t1 t2t2 t3t3 t5t5 t6t6 t7t7 pCRF > eCRF Knowledge Mgmt Platform t4t4

16. Primary and Secondary Use of EHR systems EC/EFPIA Georges DE MOOR, MD, PhD - 16 - October 11-12, 2007 (Brussels) EHRs: Communication Scenarios / Examples User / Clinician t1t1 t2t2 eCRF >, EHR Safety and Adverse event Register Decision Support Utilisation Review Marketing Billing t2t2 t3t3 t5t5 t6t6 t7t7 Knowledge Mgmt Platform t4t4 Clinical Trial

17. Primary and Secondary Use of EHR systems EC/EFPIA Georges DE MOOR, MD, PhD - 17 - October 11-12, 2007 (Brussels) EHRs: Communication Scenarios / Examples User / Clinician t1t1 Simultaneous Transaction Clinical Trial Safety and Adverse event Register EHR Decision Support Utilisation Review Marketing Billing t2t2 t4t4 t5t5 t6t6 Knowledge Mgmt Platform t3t3

18. Primary and Secondary Use of EHR systems EC/EFPIA Georges DE MOOR, MD, PhD - 18 - October 11-12, 2007 (Brussels) EHRs: Communication Scenarios / Examples User / Clinician t1t1 “Two-way exchange” Clinical Trial Safety and Adverse event Register EHR Decision Support Utilisation Review Marketing Billing t2t2 t4t4 t5t5 t6t6 t3t3 Knowledge Mgmt Platform

19. Primary and Secondary Use of EHR systems EC/EFPIA Georges DE MOOR, MD, PhD - 19 - October 11-12, 2007 (Brussels) EHRs: Communication Scenarios / Examples User / Clinician Re-use Clinical Trial Safety and Adverse event Register “From push to pull” EHR Decision Support Utilisation Review Marketing Billing t2t2 t4t4 t5t5 t6t6 t3t3 Knowledge Mgmt Platform t1t1 De-identification

20. Primary and Secondary Use of EHR systems EC/EFPIA Georges DE MOOR, MD, PhD - 20 - October 11-12, 2007 (Brussels) EHRs: Communication Scenarios / Examples User / Patient? (self reported data from patients) Re-use PHR (reliability?) Influencing Factors Informed Consent Patient Empowerment, Consumerism, eHomeCare, … Clinical Trial Safety and Adverse event Register Decision Support Utilisation Review Marketing Billing Knowledge Mgmt Platform

21. Primary and Secondary Use of EHR systems EC/EFPIA Georges DE MOOR, MD, PhD - 21 - October 11-12, 2007 (Brussels) 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. Primary and Secondary Use of EHR systems EC/EFPIA Georges DE MOOR, MD, PhD - 22 - October 11-12, 2007 (Brussels) 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. Primary and Secondary Use of EHR systems EC/EFPIA Georges DE MOOR, MD, PhD - 23 - October 11-12, 2007 (Brussels) 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. Primary and Secondary Use of EHR systems EC/EFPIA Georges DE MOOR, MD, PhD - 24 - October 11-12, 2007 (Brussels) 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. Primary and Secondary Use of EHR systems EC/EFPIA Georges DE MOOR, MD, PhD - 25 - October 11-12, 2007 (Brussels) New Exchange Environments: a more Integrative Approach «Better Efficacy & Safety Prediction and Monitoring with such new environments will boast Biomedical R&D base» «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» Infra- and Infostructure (NHIN-like, SPINE-like (communication intensive processes) (patients as key-holders?)

26. Primary and Secondary Use of EHR systems EC/EFPIA Georges DE MOOR, MD, PhD - 26 - October 11-12, 2007 (Brussels) Thank you for your attention! www.eurorec.org georges.demoor@ugent.be All presentations on: www.eurorec.org - EHR workshop