As a doctor I know that any treatment I provide to my patient should not cause harm or increase the risk to my patient. If I carry out procedures I need to ensure I take informed consent, make the patient aware of any of the risks involved and the chance of those risks occurring. This process allows the patient to make an informed decision about going ahead with a procedure. Clinical risk management is the equivalent process but related to the health IT systems that patients interact with. Any interaction a patient has with health IT should not increase their risk of harm. Ensuring this is my responsibility in the work I do as a Clinical Safety Officer.

The NHS provides assurance to Health IT in the form of two Clinical Safety Standards DCB0129 and DCB0160, which sit under the Health and Social Care Act 2012. They ensure the application of a consistent clinical safety management approach so that NHS IT systems support clinicians in providing better, safer patient care. These safety standards are also aligned with the medical device regulations.

The first of the standards, DCB0129, set the requirements for manufacturers of health IT systems; and the second, DCB0160, are the standards for health organisations who are deploying new or modified health IT systems. This allows the process to be embedded into the lifecycle from product development, through implementation, into deployment and throughout the ongoing use of any health IT product. The standards provide structure to the required documentation and ongoing monitoring.

Clinical safety is an important part of governance and an essential component for any digital health SMEs who are planning to integrate into NHS systems. This aspect of risk management is only becoming more important in the current climate with the increasing digital delivery of healthcare and the more sophisticated functionality in health IT systems.

Please get in touch if you would like to discuss the clinical safety or other clinical governance requirements of your organisation: harriet.leyland@doctors.org.uk

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