Why is this project important?
Existing provision of regulations for medical devices are insufficient for the digital age. Considering safer decisions in a digital world, we looked at the safety of algorithms embedded within clinical systems.
As patient-safety specialists, we are also interested in the broader questions around dependability, success factors and understanding unintended consequences of digital tools and the regulatory landscape in which they operate.
What did we do?
We developed and evaluated the safety of computer-aided risk-assessment tools (RATs) that are designed to improve patient safety within primary care. The tools are expected to bring risks to the attention of healthcare staff so that they can address problems early. Importantly, these tools focus on decision support and systems that will enhance the clinician rather than replace them.
Working with Professor Willie Hamilton and Professor Richard Neal at the University of Exeter, we implemented cancer risk assessment tools within the SystmOne system used by many of the UK’s GPs. Throughout the development and implementation, we studied the safety of relevant standards and regulations in the UK and EU.
In our paper, we argued that the complexity of healthcare information systems is not being acknowledged and incorporated in the design of many regulations and standards.
Outputs and Impact
- We have developed a digital implementation of the Prof. Willie Hamilton’s cancer risk assessment tools, called the eRAT.
- We continue to develop Very Smart Cancer RATs that will improve upon the performance and safety-case of the eRAT.
- We have reviewed and published on current and impending regulations and standards for software-as-a-medical-device, from a patient-safety perspective.
- We summarised our recent publication in our Centre blog.