Clinical assurance process details

We are here to support you to develop clinically safe systems in line with your responsibility to achieve the relevant DCB0129 or DCB0160 clinical safety standards. 

We host a series of meetings to help you develop clinically safe systems:

• initial meeting
• clinical safety process readiness review meeting
• clinical evaluation of readiness for deployment meeting

Before the initial clinical meeting

At least five working days before the initial meeting between the consumer CSO and the GP Connect clinical team, you should confirm the following:

• high-level use case
• the care settings where you intend to deploy the system and, where possible, the deployment-commissioning or end-user organisation
• the CSO of the consumer organisation and the clinical risk management plan (this must take into account DCB0129 and DCB0160) 
• the intended users and the clinical areas in which you intend to deploy - for example, secondary care clinicians
• whether the software triggers and supports automated decision support functionality

Agenda for initial clinical meeting

This meeting covers:

• the intended scope and functionality used for the use case and the context in which it is used
• a demonstration of how you intend to present the data from the GP Connect structured message (where possible with mock-up slides)
• your clinical safety role regarding user requirements and safety standards
• discussion of the most relevant information in the available materials for the use case; review the consumer hazard log, clinical test data, guidance on the test data and GP Connect data models
• if any elements of Access Record: Structured for the use case are not consumed or processed safely, you will be advised in this initial meeting

Before the clinical safety process readiness review meeting

Complete these tasks before the clinical safety process readiness review meeting:

• provide the initial version of your hazard log and draft clinical safety case report (at least 5 working days before the meeting)
• prepare a demo of what the system will look like and how it will function
• begin to prepare the Supplier Conformance Assessment List (SCAL) for Gate 1 taking into account the requirements set out in the SCAL
• carry out clinical risk analysis if any requirements in the SCAL are considered not relevant and reflect this in the hazard log
• revisit any documentation and materials that were signposted at the first meeting

Agenda for clinical safety process readiness review meeting

This meeting covers:

• system demo and review of presentation of data elements in user interface (UI)
• review of all relevant hazards
• review of any concerns around the clinical requirements in SCAL for Gate 1
• review of the draft clinical safety case documents
• planning for further need for clinical inputs during development and the process towards the path for clinical sign-off
• identifying the need for further support and any iterative review and feedback meetings 

Before the clinical evaluation of readiness for deployment meeting

Provide the following documents before the final clinical evaluation meeting:

• updated clinical safety statement and hazard log, including evidence of any implemented controls to mitigate the risks
• if any clinical risks are transferred to the deploying organisation, document them in the clinical safety statement
• any training or onboarding materials for users intended to mitigate identified clinical risks

Agenda for clinical evaluation of readiness for deployment meeting

This meeting covers:

• final demo, demonstrate the changes made to the UI to mitigate any risks identified
• review of clinical safety documentation with consumer CSO
• discuss consumer preparation plans to deploy safely and the clinical risk incident monitoring process (relating to GP Connect message)
• evaluate the hazard log and safety case including evidence of implementation of controls 

Recommendations for further actions

Following the meeting:

• we review consumer safety documents and make final recommendations before Gate 4 for consideration
• where appropriate, before achieving technical conformance, the consumer CSO confirms the approval and acceptance of the clinical safety statement by the authorising body within the deploying organisation