Health software

Incidents where malfunctions attributed to health software have harmed or even caused the premature death of patients has severely affected the trust of the general public in the use of information technology in the health sector. Naturally, they expect such software to be safe for its purpose.

The ISO technical report ISO/TR 27809:2007 is aimed at reducing the misuse or malfunction of software for healthcare.

It presents the control measures required to ensure patient safety with respect to health software products. Its scope is intended to cover those health software products which are not, in practice, covered by medical device regulations.

Related standards

  • ISO/TR 27809:2007
    Health informatics -- Measures for ensuring patient safety of health software

Related information

 
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