Clinical Safety

IDS25
Version1.0.0
TypeOverarching Standard
StatusEffective
Effective Date 


Description

Supports the management of clinical risk and Patient safety.

Clinical Safety is a mandatory overarching standard. IT is an integral part of modern healthcare, and the functionality they provide is becoming more and more sophisticated. However, it must be recognised that IT failure, or incorrect use has the potential to cause harm to those Patients that it is intended to benefit. Clinical Safety ensures that effective clinical risk management is carried out by organisations that are responsible for developing and modifying IT solutions, and purchasers are involved in the clinical risk management process.

The term ‘clinical risk’ is used to emphasise that the scope is limited to the management of risks related to Patient safety, as distinct from other types of risk such as financial. Clinical risk management may be conducted within the context of an overall risk management system operated by the supplier and any wider health information governance processes. Wherever practical, existing risk management processes would be adapted, and used, to address the requirements for Clinical Safety.

This is not intended to be an exhaustive list of relevant regulations and standards and it is the responsibility of the supplier to identify and comply with any that are not included here.


Please note

Please note that compliance with the Clinical Safety Standard requires suppliers to have a Clinical Safety Officer (CSO) in place. Any suppliers who don't currently have a CSO in place, will not be awarded compliance with this standard until this has been addressed.

Requirements

Requirement IDRequirement TextLevel

GP-08.4.3.01

Compliance with Clinical Risk Management: Its Application in the Manufacture of Health IT Systems

The supplier shall be required to be compliant with the following Standard in respect of Clinical Safety:

DCB0160: Clinical Risk Management: its Application in the Deployment and Use of Health IT Systems is a complimentary standard applicable to Health Organisations.

MUST
GP-MW-2.1-1

MHRA Compliance

Compliance with MHRA medical device standards where the Solution is considered by the supplier to be a medical device.

See also Medical device stand-alone software including apps (including IVDMDs) and Medical Device Regulation (EU) 2017/745

MUST


Capabilities

Applicable Capabilities

All suppliers Solutions delivering any Capabilities will need to meet this Standard.


Roadmap

Items on the Roadmap which impact or relate to this Standard

Suppliers will not be assessed or assured on these Roadmap Items as part of Onboarding