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Rationale, Aims, and ObjectivesMedical device‐integrated electronic medical records (MDI‐EMR) pose significant challenges in ensuring effective usage, data security and patient safety. The complexities of MDI‐EMR necessitate applying various security mechanisms to safeguard against cyber threats. Therefore, we evaluated cyber threats to MDI‐EMR and the effectiveness of applied security controls using a proposed framework from sociotechnical and risk assessment perspectives.MethodWe conducted a qualitative case study evaluation in a general hospital in Saudi Arabia using interviews, observation, and document analysis from the perspectives of major MDI‐EMR stakeholders, including healthcare providers, IT professionals and cybersecurity specialists.ResultsThe results showed the interplay among physical, technical and administrative security controls that maintained a secure posture of MDI‐EMR. The effectiveness of security controls is highly influenced by the staff's cybersecurity awareness and training. The perceived effectiveness of security controls varied among users, with some expressing satisfaction with the ease of use and reliability, while others highlighting challenges such as password complexity and access procedures. Understanding these diverse perspectives is crucial for tailoring security measures to meet the needs of different stakeholders effectively.ConclusionCollaboration among the key stakeholders is crucial for implementing security controls for MDI‐EMR. Balancing security measures with usability concerns is essential, as highlighted by challenges in implementing technical controls. A comprehensive approach encompassing physical, technical and administrative controls, continuous education and awareness initiatives are significant to empower staff in recognising and mitigating cyber threats effectively to safeguard medical data and ensure the integrity of healthcare systems.
Rationale, Aims, and ObjectivesMedical device‐integrated electronic medical records (MDI‐EMR) pose significant challenges in ensuring effective usage, data security and patient safety. The complexities of MDI‐EMR necessitate applying various security mechanisms to safeguard against cyber threats. Therefore, we evaluated cyber threats to MDI‐EMR and the effectiveness of applied security controls using a proposed framework from sociotechnical and risk assessment perspectives.MethodWe conducted a qualitative case study evaluation in a general hospital in Saudi Arabia using interviews, observation, and document analysis from the perspectives of major MDI‐EMR stakeholders, including healthcare providers, IT professionals and cybersecurity specialists.ResultsThe results showed the interplay among physical, technical and administrative security controls that maintained a secure posture of MDI‐EMR. The effectiveness of security controls is highly influenced by the staff's cybersecurity awareness and training. The perceived effectiveness of security controls varied among users, with some expressing satisfaction with the ease of use and reliability, while others highlighting challenges such as password complexity and access procedures. Understanding these diverse perspectives is crucial for tailoring security measures to meet the needs of different stakeholders effectively.ConclusionCollaboration among the key stakeholders is crucial for implementing security controls for MDI‐EMR. Balancing security measures with usability concerns is essential, as highlighted by challenges in implementing technical controls. A comprehensive approach encompassing physical, technical and administrative controls, continuous education and awareness initiatives are significant to empower staff in recognising and mitigating cyber threats effectively to safeguard medical data and ensure the integrity of healthcare systems.
Complex socio-technical health information systems (HIS) issues can create new error risks. Therefore, we evaluated the management of HIS-related errors using the proposed human, organization, process, and technology-fit framework to identify the lessons learned. Qualitative case study methodology through observation, interview, and document analysis was conducted at a 1000-bed Japanese specialist teaching hospital. Effective management of HIS-related errors was attributable to many socio-technical factors including continuous improvement, safety culture, strong management and leadership, effective communication, preventive and corrective mechanisms, an incident reporting system, and closed feedback loops. Enablers of medication errors include system sophistication and process factors like workarounds, variance, clinical workload, slips and mistakes, and miscommunication. The case management effectiveness in handling the HIS-related errors can guide other clinical settings. The potential of HIS to minimize errors can be achieved through continual, systematic, and structured evaluation. The case study validated the applicability of the proposed evaluation framework that can be applied flexibly according to study contexts to inform HIS stakeholders in decision-making. The comprehensive and specific measures of the proposed framework and approach can be a useful guide for evaluating complex HIS-related errors. Leaner and fitter socio-technical components of HIS can yield safer system use.
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