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Two of the major shortcomings of current practice include the lack of transparency in the safety certification process and the lack of involvement of service providers. We reviewed recent international standardisation activities in this area, and we reviewed regulatory practices in other safety-critical industries. The review showed that the use of safety cases is an accepted practice in UK safety-critical industries, but at present, there is little awareness of this concept in health care. Safety cases have the potential to provide greater transparency and confidence in safety certification and to act as a communication tool between manufacturers, service providers, regulators and patients.<\/jats:p>","DOI":"10.1177\/1460458212462079","type":"journal-article","created":{"date-parts":[[2013,8,27]],"date-time":"2013-08-27T01:44:57Z","timestamp":1377567897000},"page":"165-182","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":20,"title":["Safety cases for medical devices and health information technology: Involving health-care organisations in the assurance of safety"],"prefix":"10.1177","volume":"19","author":[{"given":"Mark A","family":"Sujan","sequence":"first","affiliation":[{"name":"University of Warwick, UK"}]},{"given":"Floor","family":"Koornneef","sequence":"additional","affiliation":[{"name":"TU Delft, Netherlands"}]},{"given":"Nick","family":"Chozos","sequence":"additional","affiliation":[{"name":"Adelard, UK"}]},{"given":"Simone","family":"Pozzi","sequence":"additional","affiliation":[{"name":"Deep Blue Research & Consulting, Italy"}]},{"given":"Tim","family":"Kelly","sequence":"additional","affiliation":[{"name":"University of York, UK"}]}],"member":"179","published-online":{"date-parts":[[2013,8,26]]},"reference":[{"key":"bibr1-1460458212462079","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(12)61047-2"},{"key":"bibr2-1460458212462079","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.d3123"},{"key":"bibr3-1460458212462079","unstructured":"Infusing patients safely: priority issues from the AAMI\/FDA infusion device summit. 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