Digital clinical safety

Alongside cyber resilience and compliance it is critical that we understand the clinical safety benefits and risks of deploying technology into our services. Our expertise in digital clinical safety must keep pace with our ambitions to use digital technologies to positively transform healthcare delivery.

By continuing to invest in this area, we will ensure we have the knowledge and skills within the workforce to critically evaluate digital technologies at key stages including market evaluation, procurement, deployment, acceptance testing, and clinical impact assessment.

Our scale, digital maturity and expertise will enable us to contribute to new standards of clinical safety and use our organisational consumer power to ensure vendors and developers deliver products that meet these standards. Our processes relating to the development, deployment, and use of medical device software and health IT systems are based on risk management best practices including DCB0160, DCB0129 and BS EN ISO 14971, on which we will continue to build.

Our Medical Equipment Systems Committee and its subgroups will continue to help to ensure the safe and effective management of medical equipment systems (including software systems), consistent with legal requirements and industry standards. This includes supporting the implementation of new and evolving medical device regulations within the Board, and monitoring compliance over time.

We will continue to train Clinical Scientists and Clinical eHealth leads to act as Clinical Safety Officers for key systems and to inform Clinical Safety Cases for our internal developments. Our Department of Clinical Physics and Bioengineering will take a lead role in providing Clinical Safety Officer training across Scotland.