Clinical Safety
- Imran Majid (Deactivated)
- Chloe Gibson
- Michael France
ID | S25 |
|---|---|
Version | 1.0.3 |
Type | Overarching Standard |
Status | Effective |
Effective Date | Jul 1, 2025 |
Contracting Vehicle(s) |
Introduction
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 it provides 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 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.
Baseline Assurance Standard Requirements
The Baseline Assurance Standard (BAS) provides a quicker risk-based assurance approach for Solutions; balancing safety against efficiency by combining a minimum set of essential Requirements from the DSIC Overarching Standards. Completing the BAS is the first step to achieving full assurance with the Overarching Standards allowing Supplier Solutions to be published on the Buying Catalogue. Upon meeting this Standard, Solutions are required to meet all the remaining Overarching Standards subject to the timelines laid out by the Authority.
All Baseline Assurance Requirements can be found here. Each Solution will be assigned a category of A, B or C that determines the level of assurance applied to that Solution. See the relevant category column to understand the assurance required for each Requirement. For information on Solution Categories see Solution Categories for Assurance in DSIC.
The following table of Requirements are the Requirements in the Baseline Assurance Standard related to Clinical Safety.
Applicable Contracting Vehicle(s) | ID | Requirement | Level | Category A | Category B | Category C |
All | GP-08.4.3.01 | Compliance with Clinical Risk Management: Its Application in the Manufacture of Health IT Systems The Supplier to be compliant with the following Standard in respect of Clinical Safety: The submitted safety documents shall be fit for purpose to enable the deploying organisations to undertake an informed risk assessment in line with the requirements specified in the following Standard:
| MUST | Full Assessment Supporting evidence to include:
On successful completion of the Baseline Assurance Standard, Capability Assessments and assurance of the related Standards, the NHS England Clinical Safety Group (CSG) will issue a Clinical Authority to Release (CATR). | Full Assessment Supporting evidence to include:
On successful completion of the Baseline Assurance Standard, Capability Assessments and assurance of the related Standards, the NHS England Clinical Safety Group (CSG) will issue a Clinical Authority to Release (CATR). | Full Assessment Supporting evidence to include:
On successful completion of the Baseline Assurance Standard, Capability Assessments and assurance of the related Standards, the NHS England Clinical Safety Group (CSG) will issue a Clinical Authority to Release (CATR). |
All | GP-MW-2.1-1 | MHRA Compliance The Supplier shall consider whether their Solution falls under the MD regulation using the relevant UK MDR 2002 guidance and declare whether the Solution is classed as a Medical Device within the CSCR. For information see the MHRA website. Note: This is only for information and completeness purposes and the Clinical Safety Group will not undertake any assessment against compliance with MHRA MD Standards. | MUST | Self-certification with Supporting Evidence Supporting evidence to include:
| Self-certification with Supporting Evidence Supporting evidence to include:
| Self-certification with Supporting Evidence Supporting evidence to include:
|
Further Requirements
Suppliers will not be required to meet any Further Requirements to achieve full compliance with the Clinical Safety Standard.
Roadmap
Items on the Roadmap which impact or relate to this Standard