At the end of each digital healthcare solution are real patients and citizens with the potential to be harmed. In the world of innovation, there is often so much excitement around what a system is capable of, that negative consequences are overlooked or underestimated. Potential harm is becoming an even greater concern in light of the wide reach that technology can have, especially with national rollouts and the vast user base associated with mobile phone applications.
The goal of clinical safety in healthcare IT is to reduce current clinical risks and to minimise new risks associated with the digital solution during development, deployment, and use.
A Clinical Safety Case (CSC) involves profiling and analysing every possible clinical risk (and associated hazards) involved with a digital solution, so that they are identified, considered, monitored, and controlled throughout the software lifecycle by its governing programme.
This process includes:
· identification of hazards
· estimation and evaluation of risks
· control of risks
· monitoring the effectiveness of risk-control measures
This process improves the transparency and visibility of clinical impacts, thus enabling us to create a structured argument supported by a body of relevant evidence that provides a compelling, comprehensible and valid case that a system is safe for a given application in a given operating environment. It can also save both time and money across the life of a programme by identifying risks early so that they are designed out or monitored in the first instance. A CSC will evolve throughout the lifecycle of the digital solution from initial conception to decommissioning, so will need to be regularly reviewed and updated.
It has taken disastrous events in other fields, such as the thalidomide tragedy, to force action, and digital healthcare is equally important as these. We have seen how assuming IT is functioning correctly can create scandals by itself, such as with the Horizon IT systems used by the Post Office, which resulted in everything from financial hardships to suicides. According to a study in Lancet Digital Health, “4% [of health IT failures] caused moderate harm, 1% [of health IT failures] caused severe harm, and <1% [of health IT failures] contribute to the death of a patient. 75% of incidents were deemed to be preventable [in a study of over 2500 health IT incidents].” These statistics, when applied to the use of a national product with millions of transactions, have the potential to result in a significant volume of harm.