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HandWiki. Health Software. Encyclopedia. Available online: https://encyclopedia.pub/entry/30455 (accessed on 23 September 2026).
HandWiki. Health Software. Encyclopedia. Available at: https://encyclopedia.pub/entry/30455. Accessed September 23, 2026.
HandWiki. "Health Software" Encyclopedia, https://encyclopedia.pub/entry/30455 (accessed September 23, 2026).
HandWiki. (2022, October 20). Health Software. In Encyclopedia. https://encyclopedia.pub/entry/30455
HandWiki. "Health Software." Encyclopedia. Web. 20 October, 2022.
Health Software
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The content is sourced from: https://handwiki.org/wiki/Software:Health_software

Medical software is any software item or system used within a medical context, such as reducing the paperwork, tracking patient activity. 

  • standalone software used for diagnostic or therapeutic purposes;
  • software embedded in a medical device (often referred to as "medical device software");
  • software that drives a medical device or determines how it is used;
  • software that acts as an accessory to a medical device;
  • software used in the design, production, and testing of a medical device; or
  • software that provides quality control management of a medical device.
medical patient activity software

References

  1. "Radar and Electronics". Radar and Electronics Association. March 1963. https://books.google.com/books?id=3WpVAAAAYAAJ&q=%22medical+software%22&dq=%22medical+software%22. Retrieved 26 April 2016. 
  2. Lockheed Hospital Information System. Lockheed Aircraft Corporation. 1965. pp. 82. https://books.google.com/books?id=8vsFGwAACAAJ. 
  3. Gall, John E.; Norwood, Donald D.; El Camino Hospital (1977). Demonstration and evaluation of a total hospital information system. NCHSR research summary series. U.S. Dept. of Health, Education, and Welfare, Public Health Service, Health Resources Administration, National Center for Health Services Research. pp. 38. https://books.google.com/books?id=6RA7YzUXYg8C. 
  4. Zimmerman, J.; Rector, A. (1978). Computers for the Physician's Office. Forest Grove, OR: Research Studies Press. pp. 305. ISBN 0893550078. https://books.google.com/books?id=8FprAAAAMAAJ. 
  5. Freedman, E.; Hecht, E.; Whiteside, D. (1985). "Consultants Perspective on Medical Office Computerization". Computers in Healthcare, Volume 6. Englewood: Cardiff Publishing Company. https://books.google.com/books?id=xW1LAAAAYAAJ. 
  6. Cosgriff, P.S. (1994). "Quality assurance of medical software". Journal of Medical Engineering & Technology 18 (1): 1–10. doi:10.3109/03091909409030782. PMID 8006924.  https://dx.doi.org/10.3109%2F03091909409030782
  7. "A Formal Methods-based verification approach to medical device software analysis". Embedded. UBM. 9 February 2010. http://www.embedded.com/design/prototyping-and-development/4008888/A-Formal-Methods-based-verification-approach-to-medical-device-software-analysis. Retrieved 26 April 2016. 
  8. Becchetti, C.; Neri, A. (2013). "Chapter 6: Medical Software". Medical Instrument Design and Development: From Requirements to Market Placements. Chichester, U.K.: John Wiley & Sons Ltd. pp. 359–418. ISBN 9781119952404. https://books.google.com/books?id=P3VeLRVMdQ8C&pg=PT275. 
  9. International Electrotechnical Commission (2006). "Medical device software – Software life cycle processes" (PDF). International Standard IEC 62304, First Edition 2006-05. International Electrotechnical Commission. https://webstore.iec.ch/preview/info_iec62304%7Bed1.0%7Den_d.pdf. Retrieved 26 April 2016. 
  10. Vogel, D.A. (2011). "Chapter 3: The FDA Software Validation Regulations and Why You Should Validate Software Anyway". Medical Device Software Verification, Validation, and Compliance. Boston, MA: Artech House. pp. 27–36. ISBN 9781596934238. https://books.google.com/books?id=LYxH-zUSOTgC&pg=PA27. 
  11. Office of Device Evaluation, Center for Devices and Radiological Health (9 September 1999). "Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices" (PDF). U.S. Food and Drug Administration. https://www.fda.gov/downloads/MedicalDevices/.../ucm073779.pdf. Retrieved 26 April 2016. 
  12. "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". U.S. Food and Drug Administration. 11 May 2005. https://www.fda.gov/RegulatoryInformation/Guidances/ucm089543.htm. Retrieved 26 April 2016. 
  13. Murray Jr., J.F. (March 2010). "CDRH Regulated Software: An Introduction" (PDF). U.S. Food and Drug Administration. https://www.fda.gov/downloads/Training/CDRHLearn/UCM209129.pdf. Retrieved 26 April 2016. 
  14. "Directive 2007/47/ED of the European Parliament and of the Council" (PDF). Official Journal of the European Union. European Union. 5 September 2007. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2007:247:0021:0055:en:PDF. Retrieved 26 April 2016. 
  15. "Technology in healthcare: how software improves medical practice?". https://www.labsexplorer.com/c/technology-in-healthcare-how-software-improves-medical-practice_216. Retrieved 5 May 2020. 
  16. Spanou, D. (9 December 2013). "Software as a Medical Device (SaMD): Key Definitions" (PDF). International Medical Device Regulators Forum. pp. 9. http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-131209-samd-key-definitions-140901.pdf. Retrieved 26 April 2016. 
  17. "New FDA Draft Guidance Sheds Light On Regulation of ‘Mobile Medical Apps’ and Other Software" (PDF). Medical Devices Law & Industry Report 5 (16): 1–3. August 2011. http://www.fr.com/files/Uploads/Documents/Barritt,%20Keith.%20BNA%20Medical%20Devices%20Law%20&%20Industry%20Report.%20New%20FDA%20Draft%20Guidance.%2008-10-11.pdf. Retrieved 26 April 2016. 
  18. Yetisen, A.K.; Martinez-Hurtado, J.L.; Vasconcellos, F.C.; Simsekler, M.C.E.; Akram, M.S.; Lowe, C.R. (2014). "The regulation of mobile medical applications". Lab on a Chip 14 (5): 833–840. doi:10.1039/C3LC51235E. PMID 24425070.  https://dx.doi.org/10.1039%2FC3LC51235E
  19. Slabodkin, G. (20 November 2013). "Congress, FDA at odds over software as a medical device". Fierce Mobile Healthcare. Questex, LLC. http://www.fiercemobilehealthcare.com/story/congress-fda-odds-over-software-medical-device/2013-11-20. 
  20. Mezher, M. (8 April 2015). "IMDRF Proposes QMS Principles for Software as a Medical Device". Regulatory Focus. Regulatory Affairs Professionals Society. http://www.raps.org/Regulatory-Focus/News/2015/04/08/21936/IMDRF-Proposes-QMS-Principles-for-Software-as-a-Medical-Device/. Retrieved 26 April 2016. 
  21. Jetley, R.; Sudarsan, S.; R., Sampath; Ramaswamy, S. (2013). "Medical Software - Issues and Best Practices". Distributed Computing and Internet Technology: 9th International Conference, ICDCIT 2013, Bhubaneswar, India, February 5-8, 2013, Proceedings. Hyderabad, India: Springer. pp. 69–91. ISBN 9783642360718. https://books.google.com/books?id=5I25BQAAQBAJ&pg=PA69. 
  22. Rust, P.; Flood, D.; McCaffery, F. (2015). "Software Process Improvement and Roadmapping – A Roadmap for Implementing IEC 62304 in Organizations Developing and Maintaining Medical Device Software". Software Process Improvement and Capability Determination. Cham, Switzerland: Springer. pp. 19–32. doi:10.1007/978-3-319-19860-6_3. ISBN 9783319198606. https://books.google.com/books?id=u3zMCQAAQBAJ&pg=PA19. 
  23. "Quality System (QS) Regulation/Medical Device Good Manufacturing Practices". U.S. Food and Drug Administration. 30 June 2014. https://www.fda.gov/medicaldevices/deviceregulationandguidance/postmarketrequirements/qualitysystemsregulations/default.htm. Retrieved 26 April 2016. 
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