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Clinical Safety Assurance Framework

Clinical Safety Assurance Framework

Clinical Safety Framework

Clinical Safety Assurance Process

The NHS Digital clinical safety framework provides a clinical safety assurance service across the whole of NHS Digital’s work so that NHS IT systems support clinicians in providing better, safer patient care. The approach promotes and ensures that effective clinical risk management is carried out by organisations that are responsible for deploying, developing and modifying health IT systems.

Within the context of the NHS e-Referral Service APIs, the clinical safety approach is driven through the implementation of the Target Operating Model (TOM). The TOM comprises a spreadsheet which as a in-built Clinical Safety worksheet, which can be used to assess whether there may be clinical safety implications of the new interface. Dependant on the clinical setting of your health IT system, the section must be completed or have input from either, a Clinical Safety Officer or suitably trained and experienced clinicians; a Social Care Professional, registered by the General Social Care Council; and, and must be signed off as indicated in the Additional Stakeholder Involvement section.

The assessment will determine the level of clinical safety signoff required and is determined on completing a risk assessment matrix, with five possible outcomes:

  1. None Required
  2. Local Only (Non Clinical)
  3. Local Only (Clinical Safety Related) SCCI0129 / SCCI0160 needs to be applied
  4. NHS Digital Clinical Safety Group Assistance Required
  5. The System falls under the category of a Medical Device and guidance should be sought from the MHRA.

The Clinical Safety team are a multi-disciplinary team made up of Safety Engineers and Clinical Safety Officers. The team are based across our Leeds, London and Exeter offices and can provide guidance related to the implementation of your Clinical Safety Assurance Process steps:

  • Risk Assessment
    An initial assessment of potential risks.
  • Hazard Log
    A list of identified hazards with details of impact and mitigations (Download template).
  • Patient Safety Assessment (PSA)
    A recorded meeting where patient safety is reviewed.
  • Clinical Safety Case Report
    A document bringing together the Risk Assessment, Hazard Log and PSA (Download Template).
  • Target Operating Model
    A self-assessment declaration that the above documentation and processes have taken place and been recorded. A completed TOM must be submitted to NHS Digital and signed off prior to any deployment of software utilising any e-RS APIs. Information on the TOM can be found here.

Further Clinical Safety document templates can be downloaded from the NHS Digital Clinical Safety website.

Further Information:

Note: The information contained within these pages is intended solely as a guide, assuring the clinical safety of any system remains the responsibility of the commissioning party.


All content is available under the Open Government Licence v3.0, except where otherwise stated