title: Quality and safety of detailed clinical models.
abstract: This chapter describes quality and safety risks related to the development and use of Detailed Clinical Models (DCM) and mechanisms which may be employed to mitigate such risks. The chapter begins with a brief discussion of DCMs and the role they can play in mitigating patient safety risk. There is then a brief description of the risks which DCMs themselves may introduce, followed by the introduction of a standards-based risk assessment method and the ways this assessment method may be applied to DCMs in particular. A general description is then made of the ISO 9000-based approach to quality management systems (QMS) and, specifically, how such an approach may be applied to DCM development, maintenance, deployment and use. The chapter concludes with a discussion of specific DCM quality and safety challenges and governance approaches which may be employed to help address these.
authors.affiliation: ecGroup Inc., Canada.
authors.forename: Derek
authors.initials: D
authors.lastname: Ritz
mesh_terms: D016494:Computer Security; D003628:Database Management Systems / Q000592:standards*; D057286:Electronic Health Records / Q000592:standards*; D017408:Guidelines as Topic; D063005:Health Information Systems / Q000592:standards*; D038622:Internationality; D008490:Medical Informatics / Q000458:organization & administration* / Q000592:standards*; D017146:Models, Organizational; D020380:Needs Assessment / Q000592:standards; D011785:Quality Assurance, Health Care / Q000458:organization & administration*; D017751:Safety Management