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Hospital Medical Equipment Data Security Governance: A Grounded Theory Informed Data Lifecycle and Governance Matrix
Yang Lu1, Fengyi Yang2, Hanxu Wu1
1Department of Medical Engineering, The First Affiliated Hospital of Soochow University.
This study introduces a novel Medical Equipment Data Security Audit and Tracking Protocol (M-ATSSPD) to enhance hospital data security. The protocol uses grounded theory for reproducible governance and risk mitigation in healthcare settings.
Area of Science:
- Health Informatics
- Information Security
- Qualitative Research Methods
Background:
- Hospital medical equipment generates sensitive data requiring robust security.
- Existing data security protocols may lack comprehensive governance and auditability.
- Need for a structured approach to manage data security across the equipment lifecycle.
Purpose of the Study:
- To develop and describe a reproducible governance protocol for hospital medical equipment data security.
- To operationalize a matrix-based audit and tracking system for medical equipment data.
- To enhance data security, compliance, and incident preparedness in public hospitals.
Main Methods:
- Qualitative evidence collection through semi-structured interviews with 48 stakeholders in 14 tertiary public hospitals.
- Grounded theory analysis (open, axial, selective coding) to identify core categories.
- Development of the Medical Equipment Data Security Audit and Tracking Protocol based on SQ (I SPORT) matrix logic.
Main Results:
- A novel Medical Equipment Data Security Audit and Tracking Protocol (M-ATSSPD) was developed.
- The protocol maps six data lifecycle stages to six governance domains using a scoring system and heat map visualization.
- Defined cell-level ownership and documentation requirements to improve coordination and preparedness.
Conclusions:
- The M-ATSSPD provides a reproducible framework for hospital medical equipment data security.
- The protocol facilitates risk identification, prioritization of corrective actions, and iterative improvement.
- The M-ATSSPD is designed for transferability across public hospital settings, enhancing overall data security posture.
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