DOI QR코드

DOI QR Code

A Study on the Software Safety Assessment of Healthcare Systems

  • Olenski, Rafal (Department of IT Convergence and Application Engineering, Pukyong National University) ;
  • Park, Man-Gon (Department of IT Convergence and Application Engineering, Pukyong National University)
  • 투고 : 2015.06.18
  • 심사 : 2015.08.10
  • 발행 : 2015.06.30

초록

The safety-critical software in healthcare systems needs more and more perceptive excess among human observation and computer support. It is a challenging conversion that we are fronting in confirming security in healthcare systems. Held in the center are the patients-the most important receivers of care. Patient injuries and fatalities connected to health information technologies commonly show up in the news, contrasted with tales of how health experts are being provided financial motivation to approve the products that may be generating damage. Those events are unbelievable and terrifying, however they emphasize on a crucial issue and understanding that we have to be more careful for the safety and protection of our patients.

키워드

참고문헌

  1. Committee on Patient Safety and Health Information Technology of the Institute of Medicine, Health IT and Patient Safety: Building Safer Systems for Better Care, National Academies Press, Washington D.C., 2012.
  2. D. Wang, F. B. Bastani, and I. L. Yen, "Automated Aspect-Oriented Decomposition of Process-Control Systems for Ultra-High Dependability Assurance," IEEE Transactions On Software Engineering, Vol. 31, No. 9, pp. 713-732, Sep. 2005. https://doi.org/10.1109/TSE.2005.99
  3. P. V. Bhansali, "Software Safety: Current Status and Future Direction," ACM SIGSOFT Software Engineering Notes, Vol. 30, No. 1, p.3, January 2005. https://doi.org/10.1145/1102107.1102114
  4. R. R. Lutz, "Software Engineering for Safety: a Roadmap," Proceedings of the Conference on the Future of Software Engineering, pp. 213-226, Jun. 2000.
  5. J. C. Knight, "Safety Critical Systems: Challenges and Directions," Proceedings of the 24th International Conference on Software Engineering (ICSE), pp. 547-550, May 2002.
  6. R. H. Taylor and D. Stoianovici, "Medical Robotics in Computer-Integrated Surgery," IEEE Transaction on Robotics and Automation, Vol. 19, No. 5, pp.765-781, Oct. 2003. https://doi.org/10.1109/TRA.2003.817058
  7. R. Rakitin, "Coping with defective software in medical devices," IEEE Computer, Vol. 39, No. 4, pp. 40-45, 2006.
  8. R. Koppel, J. P. Metlay, A. Cohen, B. Abaluck, A. R. Localio, S. E. Kimmel, and B. L. Strom, "Role of computerized physician order entry systems in facilitating medication errors," The Journal of the American Medical Association, Vol. 293, No. 10, pp. 1197-1203, Mar. 2005. https://doi.org/10.1001/jama.293.10.1197
  9. U.S. Department of Health and Human Services Food and Drug Administration, "Infusion Pump Premarket Notification," Total Product Life Cycle, 2010.
  10. I. Habli, A. Al-Humam, T. Kelly, and L. Fahel, Medical and Health Care products Regulatory Agency, Adverse Incident Reports, 2009.
  11. C. Heneghan, M. Thompson, M. Billingsley, "Medical device recalls in the UK and the device regulation process: retrospective review of safety notices and alerts," BMJ Open, Vol. 1, No. 1, pp. 1-6, May 2011.
  12. Health and Social Care Information Centre, "Clinical Risk Management: it's Application in the Manufacture of Health IT Systems," Report-ISB 0129, 2013.
  13. D. Jackson, Software for Dependable Systems: Sufficient Evidence? Washington, DC: National Academies Press, p.23, 2007.
  14. ISO 14971:2007, Medical Devices - Application of Risk Management to Medical Devices, ISO Standard Catalogue, 2010.
  15. C. Hobbs, Build and Validate Safety in Medical Device Software, Medical Electronics Design, Jan. 2012.
  16. IEC 62304:2006, Medical Device Software-Software Lifecycle Processes, ISO Standard Catalogue, 2010.
  17. M. Thomas, "Engineering Judgment," The 9th Australian workshop on Safety critical systems and software, pp. 43-47, Oct. 2004.
  18. J. McDermid, "Software Hazard and Safety Analysis," Formal Techniques in Real Time and Fault Tolerant systems, Lecture Notes in Computer Science, Vol. 2469, pp. 23-34, Oct. 2002.