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Investigating standards for the safety of health software

Investigating standards for the safety of health software

There is increasing dependency on healthcare and clinical information systems. Improved integration of these systems means that there are greater opportunities for improved clinical decision support. However, there is little or no regulation of healthcare software. Whilst there are international standards that address some parts of the safety of health software, there is no one definitive source for such guidance. In addition, there is no formal regulation of software and to date software companies and industry are left to self-regulate. As has been experienced recently through the development of the Australian national eHealth initiative, the issue of software safety and its potential impact on clinical and patient safety is only now coming to the fore. This project investigates and analyses national and international standards for the safety of health software.

The researchers have strong links with and representation at the national and international level in the health Informatics Standards Community including ISO, HL& and IHE.


Associate Professor Trish Williams
Medical Software Industry Association (MSIA), Dr Vincent McCauley

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