Abstract
Information and communication technology is rapidly transforming modern health care systems. Electronic Medical Records (EMRs) systems have replaced traditional forms of storing, processing, interpreting and exchanging patient health information in many health care organizations. However, an increasing number of concerns are raised about the quality of EMR systems and industry regulators are pondering ways to ensure safer health information technologies. This paper discusses fundamental concepts associated with the safety of EMR systems, describes current approaches to regulating the industry, and discusses limitations of traditional safety engineering methods with respect to their application to EMR systems. We then present a domain-specific adaptation of Leveson’s system-theoretic model STAMP for safety engineering of EMR systems and demonstrate its application with a real-world case study.
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References
Standard Practice for System Safety MIL-STD-882E. U.S. Dept. of Defense (2005)
Classification of medical devices class i or class ii patient management software. Health Canada, File number: 10-111648-902, May 21 (2009)
Ammenwerth, E., Shaw, N.: Bad health informatics can kill–is evaluation the answer. Methods Inf. Med. 44(1), 1–3 (2005)
Berger, R., Kichak, J.: Computerized physician order entry: Helpful or harmful? Journal of the American Medical Informatics Association 11(2), 100–103 (2004)
Birtwhistle, R., Keshavjee, K., Lambert-Lanning, A., Godwin, M., Greiver, M., Manca, D., Lagace, C.: Building a pan-Canadian primary care sentinel surveillance network: initial development and moving forward. JAMIA 22(4), 412 (2009)
Brown, M., Shaw, N., Grimm, N., Muttitt, S., Gebran, J.: Electronic health records and patient safety: What lessons can canada learn from the experience of others? Healthcare Quarterly 11(1), 112–119 (2008)
Botti, M., Bucknall, T.: Medical error and error in health care. In: Encyclopedia of Medical Decision Making. SAGE Publications (2009)
Chang, A., Schyve, P., Croteau, R., O’Leary, D., Loeb, J.: The jcaho patient safety event taxonomy: a standardized terminology and classification schema for near misses and adverse events. Intl. J. for Quality in Health Care 17(2), 95 (2005)
FDA. Federal register, vol. 76(31), February 15, rules and regulations. 880.6310 - Medical Data Device Rule (2011)
Fried, B.M., Zuckerman, J.M.: Fda regulation of medical software. Journal of Health Law 33(1), 129–140 (2000)
Holden, R.: Cognitive performance-altering effects of electronic medical records: an application of the human factors paradigm for patient safety. In: Cognition, Technology & Work, pp. 1–19 (2010)
Horsky, J., Kuperman, G., Patel, V.: Comprehensive analysis of a medication dosing error related to cpoe. JAMIA 12(4), 377 (2005)
Isaac, T., Weissman, J., Davis, R., Massagli, M., Cyrulik, A., Sands, D., Weingart, S.: Overrides of medication alerts in ambulatory care. Archives of Internal Medicine 169(3), 305 (2009)
Karsh, B., Holden, R., Alper, S., Or, C.: A human factors engineering paradigm for patient safety: designing to support the performance of the healthcare professional. Quality and Safety in Health Care 15(suppl. 1), i59 (2006)
Kohn, L., Corrigan, J., Donaldson, M., McKay, T., Pike, K.: To err is human. National Academy Press (2000)
Koppel, R., Kreda, D.: Health care information technology vendors’” hold harmless” clause: implications for patients and clinicians. JAMA 301(12), 1276 (2009)
Koppel, R., Metlay, J., Cohen, A., Abaluck, B., et al.: Role of computerized physician order entry systems in facilitating medication errors. JAMA 293(10), 1197 (2005)
Leonard, M., Graham, S., Bonacum, D.: The human factor: the critical importance of effective teamwork and communication in providing safe care. Quality and Safety in Health Care 13(suppl. 1), i85 (2004)
Leveson, N.: A new accident model for engineering safer systems. Safety Science 42(4), 237–270 (2004)
Leveson, N.: Engineering a Safer World - Systems Thinking Applied to Safety. MIT Press (2011)
Leveson, N.G.: Software safety: why, what, and how. ACM Comput. Surv. 18, 125–163 (1986)
Parker, J., Coiera, E.: Improving clinical communication. JAMIA 7(5), 453 (2000)
Phillips, W., Gong, Y.: Developing a Nomenclature for EMR Errors. In: Jacko, J.A. (ed.) HCI International 2009. LNCS, vol. 5613, pp. 587–596. Springer, Heidelberg (2009)
Poissant, L., Pereira, J., Tamblyn, R., Kawasumi, Y.: The impact of electronic health records on time efficiency of physicians and nurses: a systematic review. JAMIA 12(5), 505–516 (2005)
Reason, J.: Human error: models and management. Bmj 320(7237), 768 (2000)
Runciman, W., Helps, S., Sexton, E., Malpass, A.: A classification for incidents and accidents in the health-care system. J. Qual. in Clin. Practice 18(3), 199 (1998)
Schaub, G.H., Hoppner, J.: Software and medical devices - recommendation nb-med/2.2/rec4. European Co-ordination of Notified Medical Devices (NB-MED)
Shuren, J.: Testimony of jeffrey shuren. director of fda’s center for devices and radiological health information technology (hit) policy committee. adoption/certification workgroup, February 25 (2010
Smith, M.: The electronic patient record and computer safety. In: Proceedings Strategic Alliances between Patient Documentation and Medical Informatics, AMICE 1995, Rotterdam, Netherlands, pp. 325–331 (1995)
Weber-Jahnke, J.H.: A preliminary study of apparent causes and outcomes of reported failures with patient management software. In: 3rd Intl. Workshop on Software Engineering in Health Care (SEHC). ACM Press (2011)
Williams, J., Weber-Jahnke, J.H.: Medical device regulation and patient management software. Health Law Journal 18(1) (2010)
Zhang, J., Patel, V., Johnson, T., Shortliffe, E.: A cognitive taxonomy of medical errors. Journal of Biomedical Informatics 37(3), 193–204 (2004)
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Weber-Jahnke, J.H., Mason-Blakley, F. (2012). On the Safety of Electronic Medical Records. In: Liu, Z., Wassyng, A. (eds) Foundations of Health Informatics Engineering and Systems. FHIES 2011. Lecture Notes in Computer Science, vol 7151. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-32355-3_11
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DOI: https://doi.org/10.1007/978-3-642-32355-3_11
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