Healthcare software

Medical software is any software item or system used within a medical context, such as:

Medical software has been in use since at least since the 1960s, a time when the first computerized information-handling system in the hospital sphere was being considered by Lockheed. 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. 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. 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. 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.

The global IEC 62304 standard on the software life cycle processes of medical device software states it's 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. 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."

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).

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