(ISO: Geneva) -- A new International Organization for Standardization technical report is aimed at reducing the number of patients harmed, or even killed, due to the misuse or malfunction of software for health care. In the past, health-related software was primarily applied to relatively noncritical administrative functions and clinical decision support systems. Such software tended to be relatively simple and understandable in their logic and were used as an adjunct to decisions, rather than a major influence on which to rely routinely. So the potential for harm to the patient, as distinct from disruption to the organization, was low.

However, this has substantially changed, 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. They expect such software to be safe for its purpose. These incidents have also had consequences on the reputation of health organizations or led to substantial legal damages.

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