Integrating EHR and EDC systems

Transcription

1 Integrating EHR and EDC systems Dr. Wolfgang Summa Integration of EDC and electronic Health Records (ehr & phr) Exec. VP Europe & Asia/Pacific Dr. Wolfgang Summa OmniComm Europe GmbH22nd Annual Executive VP Europe & Asia/Pacific OmniComm Systems EuroMeeting March 8-10, 2010 Monaco

2 Disclaimer This presentation includes example screenshots of software products owned by Microsoft, Bayer and Google. The presenter is not employed by or affiliated with any of these organizations, the screenshots are for educational purposes only. All trademarks are the property of their respective owners. All views and opinions expressed in the following PowerPoint slides are those of the individual presenter and should not be attributed to CDISC or any of the before mentioned organizations. 2

3 Agenda The Goal: electronic Health Records (EHR) as electronic source for clinical trials Why one way data transfer is not sufficient Technology and standards used Challenges, solutions, first results Taking the next step PHR Historical Review New product offerings for end users How this can dramtically change our world 3

4 Electronic Health Record (EHR) ECG Lab X- ray EMR Demographics Medical History Medication Lab, ECG, X- Ray Clinical Research Database 4

5 One way is not enough For Patient care large amounts of data from multiple sources and data types are collected as part of the individual diagnosis and treatment Clinical Research requires structured data collection following a protocol and CRF First step must be to get the Metadata of the CRF into the EHR system RFD 5

6 RFD Profile A Archive Form Form Filler D Retrieve Form Submit Form B C Form Archiver Form Manager Form Receiver 6

7 Workflow 1. The Research Nurse logs on to the system and begins the care process. The EHR recognizes patient as a subject in Trial 1234, and requests an electronic case report form for trial #1234 s. Authentication EHR Log In to EHR 2. EHR sends the Nurse s Credentials (login ID + Password) 3. The EDC System presents the XML form which appears to be an imbedded form within the EHR Validate & Complete CRF EDC Send / Receive CCD 4. The Form requests the Continuity of Care Document from the EHR which is sent from the EHR 5. RN validates the patient data and enters any remaining data into the CRF and electronically signs the CRF. The CRF is returned to the EDC database. 6. A copy of the CRF (the source document) is archived in the investigator site archive as part of the permanent source record of the trial. (21 CFR, Part 11) Investigator Site Archive

8 Succesful implementation Using RESTful Web services and ODM data standard Participated in the IHE 2010 Connectathon More than 3,500 tests of IHE Integration profiles by >150 systems from 104 vendors and organizations Successfully tested Form Archiver, Manager and Receiver with multiple EDC and EHR systems using RFD 8

9 The case study Cooperation with the Sarah Cannon Cancer Center Currently using two different EHR systems in different hospitals/departments Project team established in 2009 Delay due to resource constraints on the side of the EHR vendors 9

10 Worlds Relative Sizes Patient Care World 10 9 Patients 10 7 Caregivers Clinical Research World 10 6 Patients 10 4 Professionals Regulatory World 10 3 Professionals 10 2 Agencies Clinical Research Regulatory agencies

11 Adoption of EHR Jha et al., N Engl J Med Apr 16;360(16): Epub 2009 Mar 25. Survey of all acute care hospitals that are members of the American Hospital Association Only 1.5% have a comprehensive EHR system (i.e., present in all clinical units). An additional 7.6% have a basic system (at least in one unit) Numbers in Europe are very different from country to country 11

12 Conclusion Technology and Data standards are available to create reliable links between the Clinical Research and the Patient Care world Low level of EHR adoption and relative small business opportunity Current initiatives of the US government will increase the adoption rate in the US However, the same initiatives bind a lot of resources on the EHR side and make it more difficult to cooperate 12

13 The next step PHR First Personal Health Record systems mentioning in MEDLINE already in 1978 Based on paper, PC, Smartphone or WEB > 10 M patients use ephr provided by 3 major healthcare providers (Kaiser Permanente, US Veterans Association, Aetna), source: HIMMS10 Tethered not portable to other systems Mostly used by chronically ill patients at the age of

14 The next step PHR (2) New Consumer Products available in the US (Microsoft Health Vault, Google Health) Both have adopted broad technical standards to facilitate interoperability of PHI (e.g., the HL7 CCD and the ASTM Continuity of Care Record) Automated upload of data from medical devices (glucose meters, blood pressure monitors) Siemens has signed a license deal with MS in January 2010 to offer the service in Germany 14

15 Direct Data Input from Devices (1)

16 Direct Data Input from Devices (2)

17 Uploading to Microsoft HealthVault

18 Patients own their medical records

19 Granting access to treating physicians

20 Google Health

21 Graphic representation

22 MS Health Vault Integration Uses HL7 messages for Laboratory values REST API for EDC integration Questionnaires have to be submitted in a proprietary format to HealthVault Does not support forms, but different data types (blood pressure, Medication, glucose level), which have to be submitted separately to re-create the form in HealthVault Same mechanism for receiving information back

23 PHR and Clinical Trials Remind patients of scheduled visits and procedures between visits Facilitate continous communication between physician and patient beyond the visit schedule Direct Data Colection from Patient s devices (e.g., glucose meter) Patient Reported Outcome (epro) Questionnaires can be uploaded into the PHR system and transfer the results back into the clinical database

24 However, Acceptance by physicians and clinical laboratories Competing systems provided by healthcare providers (e.g., Barmer EK) Data privacy laws in the US and different European Countries esource regulatory aspects (e.g., 21 CFR part 11) 24

25 WIIFM (What s in it for me)? Both commercial providers claim not to use health records for targeted advertising However, some users are sceptical Your search for cra sincaunre yielded 0 results. Since we can see from your medical records that you have dyslexia, perhaps you meant _car insurance_?

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