Information System Hazard Analysis: A Method for Identifying Technology-induced Latent Errors for Safety

Area of Science:

• Health Informatics
• Software Engineering
• Patient Safety

Background:

• Health information and communication technologies (ICT) are critical systems where technology-induced adverse events are frequently reported.
• Despite ongoing concerns, recent data indicate a lack of significant safety improvements in health ICT systems.
• The prevailing industry approach remains reactive ('break & patch'), with limited use of proactive, systematic hazard analysis for 'safe by design' engineering.

Purpose of the Study:

• To address the persistent safety issues in health ICT.
• To introduce and describe a proactive hazard analysis method for engineering safer health ICT systems.
• To promote the adoption of 'safe by design' principles in health technology development.

Main Methods:

• Application of the Information System Hazard Analysis (ISHA) method.
• ISHA adapts and integrates hazard analysis techniques from other safety-critical domains.
• Customization of these techniques specifically for the complexities of ICT systems.

Main Results:

• Demonstration of the ISHA methodology for proactive hazard identification in health ICT.
• Provides a structured approach to systematically analyze potential hazards in health information systems.
• Highlights the feasibility of applying advanced hazard analysis to improve ICT safety.

Conclusions:

• The reactive 'break & patch' model is insufficient for ensuring health ICT safety.
• Proactive methods like ISHA are essential for developing 'safe by design' health ICT.
• Implementing ISHA can lead to more robust and safer health information systems, reducing adverse events.