Classifying patient safety incidents involving digital health

The systematic analysis of critical incidents is well-established in medical practice. Incidents can trigger root-cause analyses in health services, or provide early warnings of unexpected drug reactions or infectious outbreaks. Our research has extended these methods to incidents associated with digital health (i.e. patient harm due to an IT problem or difficulty in using software).

The goals of this project are to:

• detect IT incidents
• develop a robust classification for IT incidents
• use the classification to track the evolving causes of IT-related harm in Australia
• promulgate the classification internationally.

We have developed a classification for problems associated with IT systems in healthcare that takes a bottom-up approach and was developed by examining “natural categories” of problems described in incidents from a range of health care settings in Australia, the USA and England.

The classification was initially based on incidents reported to a state-wide system in Australia, and then expanded with new categories for software problems using incidents from the US Food and Drug Administration over a 30-month period. It was subsequently validated with 850 incidents reported in the English National Health Service over a 6-year period, and a further 90 incidents reported by Australian GPs over a 19-month period.

The classification was further validated by a 2017 systematic review of problems with health IT which found that no new categories were required to code the IT problems, information errors, and contributing factors identified in the 34 studies included in this review.

Beyond the published literature, this classification was endorsed by the American Nursing Informatics Association in their 2015 position paper on IT safety. It has been used by multiple government agencies and patient safety organisations including the Australian Digital Health Agency; the US Joint Commission; and the Emergency Care Research Institute (ECRI).

We welcome enquiries about our classification and are happy to assist individuals and organisations who wish to use the schema to analyse digital health incidents. A guide to the classification is also available.

Further information

Organisations using the classification. In 2018, the classification was adopted by ISO, the International Organization for Standardization as the basis for a new technical specification to improve reporting about the safety of health software. In 2019, it was adapted for the Australian Safety & Quality Commission's guidance for hospitals nationally. It has also been implemented into the provincial incident monitoring system in British Columbia, Canada - BC Patient Safety & Learning System (BC PSLS).