(ISO: Geneva) -- A new ISO technical report is aimed at reducing the number of patients harmed or killed due to the misuse or malfunction of software for health care. These incidents have affected the reputations of health organizations and led to substantial legal damages.

In the past, health-related software was primarily applied to relatively noncritical administrative functions. Clinical-decision support systems tended to be relatively simple and understandable in their logic and used as a background adjunct to decisions, rather than a major influence. The potential for harm to the patient was low.

This has changed substantially, and the nature of these changes will increase the potential for risks to patients. Incidents where health software has caused harm to, or the premature death of, patients has severely affected the trust of the general public, who expect such software to be safe for its purpose.

ISO/TR 27809:2007—“Health informatics—Measures for insuring patient safety of health software” considers the control measures required to ensure patient safety in respect to health software products and the standards needed to underpin them. Its scope is intended to cover those health software products that are not, in practice, covered by medical-device regulations.

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