A comparative review of patient safety initiatives for national health information technology

International Journal of Medical Informatics

Volumn 82, Issue 5, 2013, Pages

  Magrabi, Farah ^a   Aarts, Jos ^b   Nohr, Christian ^c   Baker, Maureen ^d   Harrison, Stuart ^d   Pelayo, Sylvia ^e   Talmon, Jan ^f   Sittig, Dean F ^g   Coiera, Enrico ^a  

^a UNIVERSITY OF NEW SOUTH WALES   (Australia)

^b ERASMUS UNIVERSITY ROTTERDAM   (Netherlands)

^c AALBORG UNIVERSITY   (Denmark)

^d Department of Health Informatics Directorate ^*  (United Kingdom)

^e University of Lille   (France)

^f MAASTRICHT UNIVERSITY   (Netherlands)

^g UNIVERSITY OF TEXAS   (United States)

Author keywords

Clinical governance; E Health; Health information technology; Internet legislation and jurisprudence; Internet standards; Medical Informatics legislation and jurisprudence; Medical Informatics standards; Oversight; Patient safety; Patient safety legislation and jurisprudence; Regulation; Safety governance; Standards

Indexed keywords

CLINICAL GOVERNANCE; EHEALTH; HEALTH INFORMATION TECHNOLOGIES; MEDICAL INFORMATICS; OVERSIGHT; PATIENT SAFETY; REGULATION;

BIOMEDICAL EQUIPMENT; COMPUTER SOFTWARE; DECISION SUPPORT SYSTEMS; DIAGNOSIS; HEALTH CARE; INFORMATION TECHNOLOGY; PATIENT MONITORING; PUBLIC HEALTH; RISK MANAGEMENT; SAFETY ENGINEERING; STANDARDIZATION; STANDARDS; SYSTEMS ANALYSIS; USER INTERFACES;

INTEROPERABILITY;

ARTICLE; AUSTRALIA; BLOOD BANK; CANADA; CERTIFICATION; COMPUTER INTERFACE; COMPUTER PROGRAM; COMPUTER SECURITY; CONSUMER; DENMARK; HEALTH PRACTITIONER; HUMAN; MEANINGFUL USE CRITERIA; MEDICAL DEVICE; MEDICAL INFORMATICS; MEDICATION THERAPY MANAGEMENT; MONITORING; NETHERLANDS; PATIENT INFORMATION; PATIENT SAFETY; PRACTICE GUIDELINE; PRIORITY JOURNAL; PRIVACY; PUBLIC HEALTH SERVICE; RISK MANAGEMENT; SAFETY; STANDARD; UNITED KINGDOM; UNITED STATES;

CANADA; DENMARK; ENGLAND; HUMANS; INFORMATION MANAGEMENT; MEDICAL ERRORS; MEDICAL INFORMATICS; PATIENT SAFETY; SAFETY MANAGEMENT; UNITED STATES;

EID: 84876976659     PISSN: 13865056     EISSN: 18728243     Source Type: Journal    
DOI: 10.1016/j.ijmedinf.2012.11.014     Document Type: Article

References (65)

1. Coiera E., Aarts J., Kulikowski C. The dangerous decade. J. Am. Med. Inform. Assoc. 2012, 19(1):2-5.
2. IOM (Institute of Medicine) Health IT and Patient Safety: Building Safer Systems for Better Care 2012, The National Academies Press, Washington, DC.
3. Ash J.S., Berg M., Coiera E. Some unintended consequences of information technology in health care: the nature of patient care information system-related errors. J. Am. Med. Inform. Assoc. 2004, 11(2):104-112.
4. Magrabi F., Ong M.S., Runciman W., Coiera E. An analysis of computer-related patient safety incidents to inform the development of a classification. J. Am. Med. Inform. Assoc. 2010, 17(6):663-670.
5. Magrabi F., Ong M.S., Runciman W., Coiera E. Patient safety problems associated with healthcare information technology: an analysis of adverse events reported to the US Food and Drug Administration. AMIA Annu. Symp. Proc. 2011, 2011:853-857.
6. Magrabi F., Ong M.S., Runciman W., Coiera E. Using FDA reports to inform a classification for health information technology safety problems. J. Am. Med. Inform. Assoc. 2012, 19(1):45-53.
7. Sittig D.F., Singh H. Defining health information technology-related errors: new developments since to err is human. Adv. Intern. Med. 2011, 171(14):1281-1284.
8. Weiner J.P., Kfuri T., Chan K., Fowles J.B. " e-Iatrogenesis" : the most critical unintended consequence of CPOE and other HIT. J. Am. Med. Inform. Assoc. 2007, 14(3):387-388. discussion 9.
9. Hanuscak T.L., Szeinbach S.L., Seoane-Vazquez E., Reichert B.J., McCluskey C.F. Evaluation of causes and frequency of medication errors during information technology downtime. Am. J. Health Syst. Pharm. 2009, 66(12):1119-1124.
10. Harrison M.I., Koppel R., Bar-Lev S. Unintended consequences of information technologies in health care - an interactive sociotechnical analysis. J. Am. Med. Inform. Assoc. 2007, 14(5):542-549.
11. Perry S.J., Wears R.L., Cook R.I. The role of automation in complex system failures. J. Patient Saf. 2005, 1(1):56-61.
12. Wetterneck T.B., Walker J.M., Blosky M.A., Cartmill R.S., Hoonakker P., Johnson M.A., Norfolk E., Carayon P. Factors contributing to an increase in duplicate medication order errors after CPOE implementation. J. Am. Med. Inform. Assoc. 2011, 18(6):774-782.
13. Software for Dependable Systems: Sufficient Evidence? 2007, The National Academies Press, Washington, DC. D. Jackson, M. Thomas, L.I. Millett (Eds.).
14. Leveson N.G. Engineering a Safer World: Systems Thinking Applied to Safety 2011, Massachusetts Institute of Technology, USA.
15. Coiera E. Interaction design theory. Int. J. Med. Inform. 2003, 69(2-3):205-222.
16. Young F.E. Validation of medical software: present policy of the Food and Drug Administration. Ann. Intern. Med. 1987, 106(4):628-629.
17. Walker J.M., Carayon P., Leveson N., Paulus R.A., Tooker J., Chin H., Bothe A., Stewart W.F. EHR safety: the way forward to safe and effective systems. J. Am. Med. Inform. Assoc. 2008, 15(3):272-277.
18. Singh H., Classen D.C., Sittig D.F. Creating an oversight infrastructure for electronic health record-related patient safety hazards. J. Patient Saf. 2011, 7(4):169-174.
19. Longhurst C.A., Landa H.M. Health information technology and patient safety. BMJ 2012, 344:e1096.
20. European Commission's Directorate for public health and risk assessment, available from: (September 2012). http://ec.europa.eu/health/medical-devices/regulatory-framework/.
21. S.S. Jones, R. Koppel, M.S. Ridgely, T.E. Palen, S. Wu, M.I. Harrison, Guide to Reducing Unintended Consequences of Electronic Health Records (Prepared by RAND Corporation under Contract No. HHSA290200600017I, Task Order #5), AHRQ Publication No. 11-0105-EF, Agency for Healthcare Research and Quality, Rockville, MD, available from: (August 2011). http://www.ucguide.org/.
22. NHS Connecting for Health: Clinical Safety, available from: (December 2011). http://www.connectingforhealth.nhs.uk/systemsandservices/clinsafety.
23. Dansk Patient-Sikkerheds-Database, available from: (September 2012). http://www.dpsd.dk/.
24. The Dutch Health Care Inspectorate, available from: (February 2012). http://www.igz.nl/english/.
25. US Office of the National Coordinator for Health IT, available from: (December 2011). http://www.healthit.hhs.gov/portal/server.pt/community/healthit_hhs_gov__home/1204accessed.
26. US Food and Drug Administration: Draft Guidance for Mobile Medical Applications, available from: (January 2012). http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ucm255978.htm.
27. Health Canada, available from: (December 2011). http://www.hc-sc.gc.ca/dhp-mps/md-im/activit/announce-annonce/md_notice_software_im_avis_logicels-eng.php.
28. Canada Health Infoway, available from: (December 2011). http://www.infoway-inforoute.ca/working-with-ehr/solution-providers/certification.
29. NEHTA - National E-Health Transition Authority: (December 2011). http://www.nehta.gov.au/connecting-australia/cca.
30. Australian Commission on Safety and Quality in Health Care Electronic Medication Management Systems - A Guide to Safe Implementation 2012, ACSQHC, Sydney, available from http://www.safetyandquality.gov.au/publications-resources/publications/page/3/ (September 2012). 2nd edition.
31. International Organization for Standardization - Medical Devices - Application of Risk Management to Medical Devices (EN ISO 14971:2007) - Geneva, 2007.
32. International Electrotechnical Commission - Medical Devices - Application of usability engineering to medical devices (IEC 62366:2008) - Geneva, 2007.
33. International Electrotechnical Commission - Medical Devices - Application of risk management for IT-networks incorporating medical devices (IEC 80001:2010) - Geneva, 2010.
34. NHS CfH Common User Interface, available from: (December 2011). http://www.connectingforhealth.nhs.uk/systemsandservices/data/cui.
35. NHS Connecting for Health Safer Implementation - A Guide to Implementation 2010, available from: http://www.connectingforhealth.nhs.uk/systemsandservices/clinsafety/key/.
36. NHS Connecting for Health Safer Design - A Guide to Design 2010, available from: http://www.connectingforhealth.nhs.uk/systemsandservices/clinsafety/key/.
37. NHS Connecting for Health, Health Informatics - Application of Clinical Risk Management to the Manufacture of Health Software (Formerly ISO/TS 29321:2008(E)) - DSCN14/2009.
38. NHS Connecting for Health, Health Informatics - Guidance on the Management of Clinical Risk Relating to the Deployment and Use of Health Software (Formerly ISO/TR 29322:2008(E)), DSCN18/2009.
39. UK Medicines and Healthcare Products Regulatory Agency, available from: (September 2012). http://www.mhra.gov.uk/Howweregulate/Devices/index.htm.
40. NIST Technical Evaluation, Testing, and Validation of the Usability of Electronic Health Records, US National Institute of Standards and Technology (NISTIR 7804), US National Institute of Standards and Technology, 2012, available from: . http://www.nist.gov/manuscript-publication-search.cfm%3Fpub_id=909701.
41. Lowry S.Z., Quinn M.T., Ramaiah M., Brick D., Patterson E.S., Zhang J., Abbott P., Gibbons M.C. A Human Factors Guide to Enhance EHR Usability of Critical User Interactions when Supporting Pediatric Patient Care (NISTIR 7865) 2012, US National Institute of Standards and Technology.
42. General Principles of Software Validation, Final Guidance for Industry and FDA Staff, (11.01.02). http://www.fda.gov/cdrh/comp/guidance/938.html.
43. Draft Guidance for Industry: Blood Establishment Computer System Validation in the User's Facility, (October 2007). http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/ucm072560.htm.
44. Guidance for the Submission of Premarket Notifications for Medical Image Management Devices, (July 2007). http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/.
45. US Certification Commission for Healthcare IT, available from: (September 2012). http://www.cchit.org/cchit-certified.
46. Manufacturer and User Facility Device Experience Database - (MAUDE), available from: (accessed December 2011). http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/ReportingAdverseEvents/ucm127891.htm.
47. Karsh B.T. Beyond usability: designing effective technology implementation systems to promote patient safety. Qual. Saf. Health Care 2004, 13(5):388-394.
48. Tullis T., Albert A. Measuring the User Experience: Collecting, Analyzing and Presenting Usability Metrics 2008, Elsevier Inc.
49. Chai J.Y. Medical device regulation in the United States and the European Union: a comparative study. Food Drug Law J. [Comp. Study] 2000, 55(1):57-80.
50. Kuyvenhoven J.D., Lahorte P., Persyn K., De Geest E., van Loon P.W., Jacobs F., van Rijk P.P., Lemahieu I., Dierckx R.A. European Medical Device Directive: impact on nuclear medicine. Comput. Med. Imaging Graph. 2001, 25(2):207-212.
51. Guidelines on the Qualification and Classification of Stand Alone Software Used in Healthcare Within the Regulatory Framework of Medical Devices, (February 2012). http://ec.europa.eu/health/medical-devices/documents/guidelines/index_en.htm.
52. Goodman K.W., Berner E.S., Dente M.A., Kaplan B., Koppel R., Rucker D., Sands D.Z., Winkelstein P. Challenges in ethics, safety, best practices, and oversight regarding HIT vendors, their customers, and patients: a report of an AMIA special task force. J. Am. Med. Inform. Assoc. 2011, 18(1):77-81.
53. Miller R.A., Gardner R.M. Summary recommendations for responsible monitoring and regulation of clinical software systems. American Medical Informatics Association, The Computer-based Patient Record Institute, The Medical Library Association, The Association of Academic Health Science Libraries, The American Health Information Management Association, and The American Nurses Association. Ann. Intern. Med. 1997, 127(9):842-845.
54. Pham J.C., Gianci S., Battles J., Beard P., Clarke J.R., Coates H., Donaldson L., Eldridge N., Fletcher M., Goeschel C.A., Heitmiller E., Hensen J., Kelley E., Loeb J., Runciman W., Sheridan S., Wu A.W., Pronovost P.J. Establishing a global learning community for incident-reporting systems. Qual. Saf. Health Care 2010, 19(5):446-451.
55. Agency for Healthcare Research and Quality, Common Formats, US Department of Health and Human Services, Rockville, MD, available from: (September 2012). http://www.pso.ahrq.gov/formats/commonfmt.htm.
56. Walker J.M., Hassol A., Bradshaw B., Rezaee M.E. Health IT Hazard Manager Beta-Test: Final Report (Prepared by Abt Associates and Geisinger Health System, under Contract No. HHSA290200600011i, #14), AHRQ Publication No. 12-0058-EF May 2012, Agency for Health care Research and Quality, Rockville, MD.
57. European Commission DG Enterprise and Industry Directorate F-Consumer Good Unit F3-Cosmetic and Medical Devices: Guidelines on a Medical Device Vigilance System, MEDDEV 2.12-1 rev 6, December 2009.
58. Singh H., Wilson L., Petersen L.A., Sawhney M.K., Reis B., Espadas D., Sittig D.F. Improving follow-up of abnormal cancer screens using electronic health records: trust but verify test result communication. BMC Med. Inform. Decis. Making 2009, 9:49.
59. Medikonda B.S., Panchumarthy S.R. An approach to modeling software safety in safety-critical systems. J. Comp. Sci. 2009, 5(4):311-322.
60. The Use of Computers in Safety-Critical Applications 1998, Health & Safety Executive, Norwich, UK, available from: http://www.hse.gov.uk/nuclear/computers.pdf (19.09.12).
61. Kornecki A.J. Software Development Tools for Safety-Critical, Real-Time Systems Handbook 2007, Federal Aviation Administration, Washington, DC, Contract No.: DOT/FAA/AR-06/35.
62. Storey N. Safety-Critical Computer Systems 1996, Pearson Education Limited, UK.
63. Marshall D., Bruno J., Solid Code: Optimizing the Software Development Life Cycle 2009, O'Reilly Media, Inc.
64. Sittig D.F., Singh H. Electronic health records and national patient-safety goals. N. Engl. J. Med. 2012, 367(19):1854-1860.
65. Sittig D.F., Classen D.C. Safe electronic health record use requires a comprehensive monitoring and evaluation framework. JAMA 2010, 303(5):450-451.