Quality and Certification of Electronic Health Records

Summary

Background: Numerous projects, initiatives, and programs are dedicated to the development of Electronic Health Records (EHR) worldwide. Increasingly more of these plans have recently been brought from a scientific environment to real life applications. In this context, quality is a crucial factor with regard to the acceptance and utility of Electronic Health Records. However, the dissemination of the existing quality approaches is often rather limited.

Objectives: The present paper aims at the description and comparison of the current major quality certification approaches to EHRs.

Methods: A literature analysis was carried out in order to identify the relevant publications with regard to EHR quality certification. PubMed, ACM Digital Library, IEEExplore, CiteSeer, and Google (Scholar) were used to collect relevant sources. The documents that were obtained were analyzed using techniques of qualitative content analysis.

Results: The analysis discusses and compares the quality approaches of CCHIT, EuroRec, IHE, openEHR, and EN13606. These approaches differ with regard to their focus, support of service-oriented EHRs, process of (re-)certification and testing, number of systems certified and tested, supporting organizations, and regional relevance.

Discussion: The analyzed approaches show differences with regard to their structure and processes. System vendors can exploit these approaches in order to improve and certify their information systems. Health care organizations can use these approaches to support selection processes or to assess the quality of their own information systems.

Citation: Hoerbst A, Ammenwerth E. Quality and certification of electronic health records – An overview of current approaches from the US and Europe. Appl Clin Inf 2010; 1: 149–164 http://dx.doi.org/10.4338/ACI-2010-02-R-0009

Keywords

Quality - certification - electronic health record - medical records

 

Conflict of Interest

Alexander Hoerbst is the Head of ProRec in Austria, which is a part of EuroRec.

• References

• 1 Berner E, Moss J. Informatics challenges for the impending patient information explosion. J Am Med Inform Assoc 2005; 12 (Suppl. 06) 614-617.
• 2 Eurostat.. Database Query –Healthcare Expenditures for all healthcare providers, per inhabitant from 2003 to 2006. http://epp.eurostat.ec.europa.eu/portal/page/portal/health/public_health/database
• 3 Burns F. Information for Health: An information strategy for the modern NHS 1998-2005. A national strategy for local implementation. 2006 [cited 2010 10.01.]; Available from: http://www.dh.gov.uk/en/Publicationsandstatistics/Publications/PublicationsPolicyAndGuidance/DH_4002944
• 4 Sittig DF. Personal health records on the internet: a snapshot of the pioneers at the end of the 20th Century. Int J Med Inform 2002; 65 (Suppl. 01) 1-6.
• 5 Detmer D, Bloomrosen M, Raymond B, Tang P. Integrated personal health records: transformative tools for consumer-centric care. BMC Med Inform Decis Mak 2008; 8: 45.
• 6 Waegemann C. Testimony Regarding Personal Health Records. National Committee on Vital and Health Statistics. Chicago, IL, July 24, 2002. 2002 [cited 2010 10.01.]; Available from: http://www.ncvhs.hhs.gov/020724p6.htm
• 7 National IT Strategy 2003-2007 for the Danish Health Care Service, Ministry of the Interior and Health. Editor. 2003, Ministry of the Interior and Health.
• 8 Bernstein K. et al. Modelling and implementing electronic health records in Denmark. Methods of Information in Medicine, 2005; 74 (Suppl. 02) 213-220.
• 9 Hörbst A, Schabetsberger T, Ammenwerth E. Die Elektronische Gesundheitsakte –Interesse und Akzeptanz der Tiroler Bürger in eHealth2008 –Medical Informatics meets eHealth: Tagungsband eHealth2008 & eHealth Benchmarking. 2008. Wien: OCG.;
• 10 ISO 9000, ISO 9000 –Quality management systems.. Fundamentals and vocabulary. 2005 International Organization for Standardization.
• 11 CCHIT.. About the Certification Commission for Health Information Technology. [Website]. 2009 [cited 2010 10.01.]; Available from: http://www.cchit.org/about
• 12 Leavitt M, O’Kane ME. Joint Statement from the National Committee for Quality Assurance and the Certification Commission for Healthcare Information Technology. 2005 [cited 2009 10.12.]; Available from: http://www.ncqa.org/Portals/0/Newsroom/2005/Joint_5_24_05.pdf
• 13 Hörbst A. Grundlagen der Qualitätszertifizierung von Diensten im Rahmen der Elektronischen Gesundheitsakte, in Institute for Health Information Systems. 2008 UMIT –University for Health Sciences, Medical Informatics and Technology: Hall in Tyrol. p. 321.
• 14 CCHIT.. Get involved with the Certification Commission. 2009 [cited 2010 10.01.]; Available from: http://www.cchit.org/participate
• 15 CCHIT.. Certification Handbook: CCHIT Certified 2011 –Comprehensive Certification Program. 2009 [cited 2010 10.01.]; Available from: http://www.cchit.org/sites/all/files/CCHIT%20Certified%202011%20Comprehensive%20Certification%20Handbook%20Oct%2020%202009.pdf
• 16 NCQA.. NCQA to Certify Electronic Health Record (EHR) Systems; Certification Based on Compatibility with Diabetes Program. National Committee for Quality Assurance;. 2005 [cited 2010 10.01.]; Available from: http://www.ncqa.org/tabid/281/Default.aspx
• 17 CCHIT.. Project Laika. Certification Commission for Health Information Technology. 2009 [cited 2010 10.01.]; Available from: http://www.cchit.org/laika
• 18 Public Law 111–5.. American Recovery and Reinvestment Act of 2009. 2009 [cited 2010 10.01.]; Available from: http://www.gpo.gov/fdsys/pkg/PLAW-111publ5/pdf/PLAW-111publ5.pdf
• 19 Office of the National Coordinator for Health Information Technology.. Federal Advisory Committees. 2009 [cited 2010 10.01.]; Available from: http://healthit.hhs.gov/portal/server.pt?open=512&objID=1149&parentname=CommunityPage&parentid=40&mode=2&in_hi_userid=10741&cached=true
• 20 Health IT Policy Committee.. Health IT Policy Council Recommendations to National Coordinator for Defining Meaningful Use. 2009 [cited 2010 10.01.]; Available from: http://healthit.hhs.gov/portal/server.pt/gateway/PTARGS_0_10741_888532_0_0_18/FINAL%20MU%20RECOMMENDATIONS%20TABLE.pdf
• 21 HIT Standards Committee –Joint Working Groups on Quality and Operations.. Meaningful Use Measure Grid - Data Elements Mapped to HITEP Datatypes. 2009 [cited 2010 10.01.]; Available from: http://healthit.hhs.gov/portal/server.pt/gateway/PTARGS_0_11113_880493_0_0_18/MU%20Grid%20Data%20Element%20Standards_08202009.pdf
• 22 HIT Standards Committee.. PRIVACY AND SECURITY STANDARDS APPLICABLE TO ARRA REQUIREMENTS. 2009 [cited 2009 10.12.]; Available from: http://healthit.hhs.gov/portal/server.pt/gateway/PTARGS_0_11113_880497_0_0_18/PRIVACY%20AND%20SECURITY%20STANDARDS%20APPLICABLE%20TO%20ARRA%20REQUIREMENTS.pdf
• 23 CCHIT.. Certification Handbook –Preliminary ARRA 2011 Certification Program. 2009 [cited 2010 10.01.]; Available from: http://www.cchit.org/sites/all/files/Preliminary%20ARRA%202011%20Certification%20Handbook%20Oct%2020%202009.pdf
• 24 EuroRec.. Articles of Association. 2009 01.11. [cited 2010 10.01.]; Available from: http://www.eurorec.org/files/filesPublic/Articles%20of%20Association%20November%202009.pdf
• 25 Devlies J. The EuroRec Seal 2010. 2009 [cited 2010 10.01.]; Available from: http://www.eurorec.org/files/filesPublic/eurorec2009/Seal2010Sarajevo.ppt
• 26 de Moor G. Extending “Certification of Electronic Health Records” at a Pan-European Level. 2009 [cited 2010 10.01.]; Available from: http://www.eurorec.org/files/filesPublic/Prague%2019feb09%20-%20DE%20MOOR%20Certification_alt.zip
• 27 European Commission.. EHR-Q-TN: Thematic Network on Quality and Certification of EHR systems. 2009 [cited 2010 10.01.]; Available from: http://ec.europa.eu/information_society/apps/projects/factsheet/index.cfm?project_ref=238912
• 28 Esterle L. EHR-Implement –National policies for EHR implementation in the European area: social and organizational issues. 2009 [cited 2010 10.01.]; Available from: http://www.ehr-implement.eu
• 29 National E-Health Transition Authority (NEHTA).. The National E-Health Transition Authority Strategic Plan (2009-2012). 2009 [cited 2010 10.01.]; Available from: http://www.nehta.gov.au/about-us/strategy
• 30 National E-Health Transition Authority (NEHTA).. Interoperability Framework Version 2.0. 2007 [cited 2010 10.01.]; Available from: http://www.nehta.gov.au/component/docman/doc_details/391-interoperability-framework-v20
• 31 MedCom.. MedCom –in English. 2009 [cited 2010 10.01.]; Available from: http://www.medcom.dk/wm109991
• 32 Health Level 7.. V3 Messaging Standard. 2009 [cited 2010 10.01.]; Available from: http://www.hl7.org/implement/standards/v3messages.cfm
• 33 Health Level 7.. Clinical Document Architecture. 2009 [cited 2010 10.01.]; Available from: http://www.hl7.org/implement/standards/cda.cfm
• 34 National Electrical Manufacturers Association.. DICOM –Strategic Document. 2009 [cited 2010 10.01.]; Available from: http://medical.nema.org/dicom/geninfo/Strategy.pdf
• 35 McDonald C, Huff S, Mercer K, Hernandez J, Vreeman D. Logical Observation Identifiers Names and Codes (LOINC^®) Users’ Guide. 2009 [cited 2010 10.01.]; Available from: http://loinc.org/downloads/files/LOINCManual.pdf
• 36 International Health Terminology Standards Development Organization.. About Snomed CT. 2009 [cited 2010 10.01.]; http://www.ihtsdo.org/snomed-ct/snomed-ct0
• 37 Blobel B. Q-Rec Project –Inventory of Relevant Standards for EHR Systems. 2007 [cited 2010 10.01.]; Available from: http://www.eurorec.org/services/standards/Q-RECEurorec_Overview%20on%20EHR%20Standards%2001.pdf
• 38 National E-Health Transition Authority (NEHTA).. Review of Shared Electronic Health Record Standards. Sydney, Australia: National E-Health Transition Authority;. 2006 [cited 2010 10.01.]; Available from: http://www.nehta.gov.au/component/docman/doc_download/68-review-of-shared-electronic-health-records-standards-v10
• 39 Eichelberg M, Aden T, Riesmeier J, Dogac A, Laleci GB. Electronic Health Records Standards –a Brief Overview. In: Proceedings of the 4th IEEE International Conference on Information and Communications Technology (ICICT 2006). 2006
• 40 Eysenbach G, Powell J, Kuss O, Sa E-R. Empirical studies assessing the quality of health information for consumers on the World Wide Web: a systematic review. Journal of the American Medical Association 2002; 287 (Suppl. 20) 2691-2700.
• 41 Kalra D. Electronic Health Record Standards. IMIA Yearbook of Medical Informatics 2006. Stuttgart: Schattauer GmbH; 2006: 136-144.
• 42 Ludwick D, Doucette J. A Review of General Practice System Certification Programs in Seven Countries and five Canadian Provinces. Healthcare Quarterly 2009; 12 (Suppl. 03) 111-123.
• 43 IHE International.. About IHE 2009 [cited 2010 10.01.]; Available from: http://www.ihe.net/About
• 44 IHE International.. Integrating the Healthcare Enterprise (IHE) International –Principles of Governance. 2007 Available from: http://www.ihe.net/governance/upload/IHE_Governance_Interim_Document_2007_10_05.pdf
• 45 openEHR.. The openEHR Foundation. 2008 [cited 2010 10.01.]; Available from: http://www.openehr.org/about/foundation.html
• 46 Schloeffel P, Beale T, Hayworth G, Heard S, Leslie H. The Relationship between CEN 13606, HL7, and OpenEHR. In: HIC 2006 and HINZ 2006: Proceedings. Westbrook J, Callen J, Margelis G, Warren J. (Editors). Brunswick East, Vic.: Health Informatics Society of Australia; 2006
• 47 Eichelberg M, Aden T, Riesmeier J, Dogac A, Laleci BG. A Survey and Analysis of Electronic Healthcare Record Standards. ACM Computing Surveys 2005; 37 (Suppl. 04) 277-315.
• 48 Bergmann J. openEHR –Die Geschichte eines Baukastensystems für eine gemeinsame Elektronische Gesundheitsakte. Forum der Medizin Dokumentation und Medizin Informatik 2005; 1: 8-15.
• 49 Classen D, Avery A, Bates D. Evaluation and Certification of Computerized Provider Order Entry Systems. Journal of the American Medical Informatics Association. 2007; 14 (Suppl. 01) 48-55.
• 50 Ludwick DA, Doucette J. Adopting Electronic Medical Records in Primary Care: Lessons Learned from Health Information Systems Implementation Experience in Seven Countries. International Journal of Medical Informatics. 2009; 78 (Suppl. 01) 22-31.
• 51 Han Y, Carcillo J, Venkataraman S, Clark R, Watson S, Nguyen T, Bayir H, Orr R. Unexpected increased mortality after implementation of a commercially sold computerized physician order entry system. Pediatrics. 2005; 116: 1506-1512.
• 52 Terlaak A, King AA. The effect of certification with the ISO 9000 Quality Management Standard: A signaling approach. Journal of Economic Behavior & Organization 2006; 60 (Suppl. 04) 579-602.
• 53 Hoerbst A, Schabetsberger T, Hackl W, Ammenwerth E. Requirements Regarding Quality Certification of Electronic Health Records. In: Adlassnig K-P, Blobel B, Mantas J, Masic I, (Eds.) Medical Informatics in a United and Healthy Europe –Proceedings of MIE 2009 –The XXIInd International Congress of the European Federation for Medical Informatics. Studies in Health Technology and Informatics Vol. 150. Amsterdam: IOS Press.;
• 54 Integrating the Healthcare Enterprise (IHE) International.. IHE 2010 North America Connectathon Policies and Guidelines. 2009 Available from: http://www.ihe.net/north_america/upload/NA2010-Connectathon-Policies-and-Guidelines_2009-08-27.pdf.
• 55 Blobel Bernd und Pharow. Peter 2008. Analysis and Evaluation of EHR Approaches. In: Andersen, Stig Kjær und Klein, G. O. und Schulz, S. und Arts, J. und Mazzoleni, M. C., (eds.) eHealth beyond the horizon –get IT there: proceedings of MIE 2008, the XXIst international congress of the European Federation for Medical Informatics. Studies in health technology and informatics, 136. IOS Press; Amsterdam, S.: 359-364.