Medical software explained

Medical software is any software item or system used within a medical context, such as reducing the paperwork, tracking patient activity[1] [2] [3]

History

Medical software has been in use since at least since the 1960s,[4] a time when the first computerized information-handling system in the hospital sphere was being considered by Lockheed.[5] [6] As computing became more widespread and useful in the late 1970s and into the 1980s, the concept of "medical software" as a data and operations management tool in the medical industry — including in the physician's office — became more prevalent.[7] [8] Medical software became more prominent in medical devices in fields such as nuclear medicine, cardiology, and medical robotics by the early 1990s, prompting additional scrutiny of the "safety-critical" nature of medical software in the research and legislative communities, in part fueled by the Therac-25 radiation therapy device scandal.[9] [10]

The development of the ISO 9000-3 standard as well as the European Medical Devices Directive in 1993 helped bring some harmonization of existing laws with medical devices and their associated software, and the addition of IEC 62304 in 2006 further cemented how medical device software should be developed and tested.[11] The U.S. Food and Drug Administration (FDA) has also offered guidance and driven regulation on medical software, particularly embedded in and used as medical devices.[12] [13] [14] There was an expansion of medical software innovation with the adoption of electronic health records and availability of electronic clinical data. In the United States, substantial resources were allocated starting with the HITECH Act of 2009. [15]

Medical device software

The global IEC 62304 standard on the software life cycle processes of medical device software states it is a "software system that has been developed for the purpose of being incorporated into the medical device being developed or that is intended for use as a medical device in its own right." In the U.S., the FDA states that "any software that meets the legal definition of a [medical] device" is considered medical device software.[16] A similar "software can be a medical device" interpretation was also made by the European Union in 2007 with an update to its European Medical Devices Directive, when "used specifically for diagnostic and/or therapeutic purposes."[17]

Due to the broad scope covered by these terms, manifold classifications can be proposed for various medical software, based for instance on their technical nature (embedded in a device or standalone), on their level of safety (from the most trivial to the most safety-critical ones), or on their primarily function (treatment, education, diagnostics, and/or data management).

Software as a medical device

The dramatic increase in smartphone usage in the twenty-first century triggered the emergence of thousands of stand-alone health- and medical-related software apps, many falling into a gray or borderline area in terms of regulation. [18] While software embedded into a medical device was being addressed, medical software separate from medical hardware — referred to by the International Medical Device Regulators Forum (IMDRF) as "software as a medical device" or "SaMD"[19] — was falling through existing regulatory cracks.

In the U.S., the FDA eventually released new draft guidance in July 2011 on "mobile medical applications," with members of the legal community such as Keith Barritt speculating it should be read to imply "as applicable to all software, since the test for determining whether a mobile application is a regulated mobile 'medical' application is the same test one would use to determine if any software is regulated."[20] Examples of mobile apps potentially covered by the guidance included those that regulate an installed pacemaker or those that analyze images for cancerous lesions, X-rays and MRI, graphic data such as EEG waveforms as well as bedside monitors, urine analyzers, glucometer, stethoscopes, spirometers, BMI calculators, heart rate monitors and body fat calculators.[21]

By the time its final guidance was released in late 2013, however, members of Congress began to be concerned about how the guidance would be used in the future, in particular with what it would mean to the SOFTWARE Act legislation that had recently been introduced.[22] Around the same time, the IMDRF were working on a more global perspective of SaMD with the release of its Key Definitions in December 2013, focused on "[establishing] a common framework for regulators to incorporate converged controls into their regulatory approaches for SaMD." Aside from "not [being] necessary for a hardware medical device to achieve its intended medical purpose," the IMDRF also found that SaMD also could not drive a medical device, though it could be used as a module of or interfaced with one. The group further developed quality management system principles for SaMD in 2015.[23]

International standards

IEC 62304 has become the benchmark standard for the development of medical device software, whether standalone software or otherwise, in both the E.U. and the U.S.[24] Leading industry innovation in software technologies has led key industry leaders and government regulators to recognize the emergence of numerous standalone medical software products that operate as medical devices. This has been reflected in regulatory changes in the E.U. (European Medical Devices Directive) and the U.S. (various FDA guidance documents). Additionally, quality management system requirements for manufacturing a software medical device, as is the case with any medical device, are described in the U.S. Quality Systems Regulation[25] of the FDA and also in ISO 13485:2003.

Software technology manufacturers that operate within the software medical device space conduct mandatory development of their products in accordance with those requirements. Furthermore, though not mandatory, they may elect to obtain certification from a notified body, having implemented such quality system requirements as described within international standards such as ISO 13485:2003.

Further reading

See also

Notes and References

  1. Book: https://books.google.com/books?id=P3VeLRVMdQ8C&pg=PT275 . Medical Instrument Design and Development: From Requirements to Market Placements . Chapter 6: Medical Software . Becchetti, C. . Neri, A. . John Wiley & Sons Ltd . Chichester, U.K. . 2013 . 359–418 . 9781119952404.
  2. Book: https://books.google.com/books?id=LYxH-zUSOTgC&pg=PA27 . Medical Device Software Verification, Validation, and Compliance . Chapter 3: The FDA Software Validation Regulations and Why You Should Validate Software Anyway . Vogel, D.A. . Artech House . Boston, MA . 2011 . 27–36 . 9781596934238.
  3. Book: https://books.google.com/books?id=5I25BQAAQBAJ&pg=PA69 . Distributed Computing and Internet Technology: 9th International Conference, ICDCIT 2013, Bhubaneswar, India, February 5-8, 2013, Proceedings . Medical Software - Issues and Best Practices . Jetley, R. . Sudarsan, S. . R., Sampath . Ramaswamy, S. . Springer . Hyderabad, India . 2013 . 69–91 . 9783642360718.
  4. Web site: Radar and Electronics . Radar and Electronics Association . March 1963 . 26 April 2016.
  5. Book: Lockheed Hospital Information System . Lockheed Aircraft Corporation . 1965 . 82.
  6. Book: Demonstration and evaluation of a total hospital information system . Gall, John E. . Norwood, Donald D. . El Camino Hospital . U.S. Dept. of Health, Education, and Welfare, Public Health Service, Health Resources Administration, National Center for Health Services Research . NCHSR research summary series . 1977 . 38.
  7. Book: Computers for the Physician's Office . Zimmerman, J. . Rector, A. . Research Studies Press . Forest Grove, OR . 305 . 1978 . 0893550078.
  8. Book: Computers in Healthcare, Volume 6 . Consultants Perspective on Medical Office Computerization . Freedman, E. . Hecht, E. . Whiteside, D. . Cardiff Publishing Company . Englewood . 1985.
  9. Quality assurance of medical software . Journal of Medical Engineering & Technology . Cosgriff, P.S. . 18 . 1 . 1–10 . 1994 . 10.3109/03091909409030782 . 8006924.
  10. Web site: A Formal Methods-based verification approach to medical device software analysis . Jones, P. . Jetley, R. . Abraham, J. . Embedded . UBM . 9 February 2010 . 26 April 2016.
  11. Web site: Medical device software – Software life cycle processes . International Standard IEC 62304, First Edition 2006-05 . International Electrotechnical Commission . International Electrotechnical Commission . 2006 . 26 April 2016.
  12. Web site: Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices . Office of Device Evaluation, Center for Devices and Radiological Health . U.S. Food and Drug Administration . 9 September 1999 . 26 April 2016.
  13. Web site: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices . Center for Devices . Radiological Health . U.S. Food and Drug Administration . 11 May 2005 . 26 April 2016.
  14. Web site: Doctors near me.
  15. Web site: HITECH Act of 2009.
  16. Web site: CDRH Regulated Software: An Introduction . Murray Jr., J.F. . U.S. Food and Drug Administration . March 2010 . 26 April 2016.
  17. Web site: Directive 2007/47/ED of the European Parliament and of the Council . PDF . Official Journal of the European Union . European Union . 5 September 2007 . 26 April 2016.
  18. Web site: Technology in healthcare: how software improves medical practice? . Labs Explorer . 5 May 2020.
  19. Web site: Software as a Medical Device (SaMD): Key Definitions . Spanou, D. . International Medical Device Regulators Forum . 9 . 9 December 2013 . 26 April 2016.
  20. New FDA Draft Guidance Sheds Light On Regulation of 'Mobile Medical Apps' and Other Software . Medical Devices Law & Industry Report . 5 . 16 . 1–3 . August 2011 . 26 April 2016 . https://web.archive.org/web/20131127030705/http://www.fr.com/files/Uploads/Documents/Barritt%2C%20Keith.%20BNA%20Medical%20Devices%20Law%20%26%20Industry%20Report.%20New%20FDA%20Draft%20Guidance.%2008-10-11.pdf . 27 November 2013 . dead .
  21. The regulation of mobile medical applications . Lab on a Chip . Yetisen, A.K. . Martinez-Hurtado, J.L. . Vasconcellos, F.C. . Simsekler, M.C.E. . Akram, M.S. . Lowe, C.R. . 14 . 5 . 833–840 . 2014 . 10.1039/C3LC51235E . 24425070.
  22. Web site: Congress, FDA at odds over software as a medical device . Slabodkin, G. . Fierce Mobile Healthcare . Questex, LLC . 20 November 2013.
  23. Web site: IMDRF Proposes QMS Principles for Software as a Medical Device . Mezher, M. . Regulatory Focus . Regulatory Affairs Professionals Society . 8 April 2015 . 26 April 2016.
  24. Book: https://books.google.com/books?id=u3zMCQAAQBAJ&pg=PA19 . Software Process Improvement and Capability Determination . Software Process Improvement and Roadmapping – A Roadmap for Implementing IEC 62304 in Organizations Developing and Maintaining Medical Device Software . Rust, P. . Flood, D. . McCaffery, F. . Rout, T. . C'Connor, R.V. . Dorling, A. . Springer . Cham, Switzerland . 2015 . 19–32 . 9783319198606 . 10.1007/978-3-319-19860-6_3.
  25. Web site: Quality System (QS) Regulation/Medical Device Good Manufacturing Practices . U.S. Food and Drug Administration . 30 June 2014 . 26 April 2016.

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