A framework for synthesis of safety justification for digitally enabled healthcare services

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Despotou, George
Ryan, Mark
Arvanitis, Theodoros N
Rae, Andrew J
White, Sean
Kelly, Tim
Jones, Richard W
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Background: Digitally enabled healthcare services combine socio-technical resources to deliver the required outcomes to patients. Unintended operation of these services may result in adverse effects to the patient. Eliminating avoidable harm requires a systematic way of analysing the causal conditions, identifying opportunities for intervention. Operators of such services may be required to justify, and communicate, their safety. For example, the UK Standardisation Committee for Care Information (SCCI) standards 0129 and 0160 require a safety justification for health IT (superseded versions were known as the Information Standards Board (ISB) 0129 & 0160. Initial as well as current standards are maintained by the NHS Digital. Method: A framework was designed, and applied as proof of concept, to an IT-supported clinical emergencies (A&E) service. Evaluation was done qualitatively based on the authors' experience, identifying potential benefits of the approach. Results: The applied framework encapsulates analysis, and structures the generated information, into a skeleton of an evidence-based case for safety. The framework improved management of the safety activities, assigning ownership to stakeholders (e.g. IT developer), also creating a clear and compelling safety justification. Conclusions: Application of the framework significantly contributed to systematising an exploratory approach for analysing the service, in addition to existing methods such as reporting. Its application made the causal chain to harm more diaphanous. Constructing a safety case contributed to: (a) identifying potential assurance gaps, (b) planning production of information and evidence, and (c) communication of the justification by graphical unambiguous means.

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Digital Health

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© The Author(s) 2017. This article is distributed under the terms of the Creative Commons Attribution 3.0 License (http://www.creativecommons.org/licenses/by/3.0/) which permits any use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage).

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Patient safety

Social Sciences

Social Sciences, Biomedical

Biomedical Social Sciences

Health IT safety

safety cases

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Despotou, G; Ryan, M; Arvanitis, TN; Rae, AJ; White, S; Kelly, T; Jones, RW, A framework for synthesis of safety justification for digitally enabled healthcare services, Digital Health, 2017, 3