Developers of Clinical Decision Support Systems (CDSSs) have to date been more concerned with the efficacy of systems than with safety. In future, CDSS developers may be legally required to acknowledge a "duty of care" covering design, development and deployment. Experience in other safety-critical industries has led to a range of quality and safety assurance methods whose adoption may be needed before CDSSs can safely become a trusted part of routine patient care. No single method will be sufficient; a range of techniques will be needed and used selectively. (This paper is a contribution to discussion of quality, safety and legal liability issues in the medical informatics community.)

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