Hazard and Risk Analysis of Health Informatics: Fundamental Challenges and New Directions

There is an increasing focus on the importance of the availability and interchange of digital health information within health and care organisations as a means of improving patient care quality and outcomes. In England, this has recently been emphasised through the Government’s vision for a ‘paperless’ Na- tional Health Service (NHS) by 2020. The scope of the technology supporting health informatics is expanding and is used to improve the integration between primary, secondary, community and social care settings. To promote patient-cen- tred care, mobile apps, wearable devices and social media are used to actively involve patients in their own health and well-being management. Despite poten- tial benefits, the new information-intensive capabilities pose a fundamental safety challenge: how should engineers and health and care professionals iden- tify hazards and assess the risks posed by the technology in this large-scale, com- plex and dynamic socio-technical system? In this paper, we deconstruct this chal- lenge and identify concrete safety problems, and opportunities for improvement, by examining current practice in hazard and risk analysis for health informatics. We then introduce the Safety Modelling, Assurance and Reporting Toolset (SMART), which has been developed collaboratively between The University of York and NHS Digital to help address these challenges and support clinicians and engineers to systematically assure the safety of health informatics.