It is essential that attention to clinical safety be given the highest priority throughout the development, purchase, implementation and ongoing use of health software products.

The NHS Information Standards Board (IBS) recommends that all health organisations comply with ISB 0160 (DSCN 18/2009) – Application of Patient Safety Risk Management to the Deployment and Use of Health Software.

In addition, suppliers of health software products must comply with ISB 0129 (DSCN 14/2009) – Application of Patient Safety Risk Management to the Manufacture of Health Software.

eMBED’s clinical assurance service can ensure compliance (and provide advice) around each of these standards.  The services we can provide include:

  • Formal assessments of the detailed requirements that apply to the Health & Social Care Information Centre (HSCIC) Health Software Products, formerly procured through Connecting for Health (CFH) and non CFH Systems required to link to the ‘Spine’
  • All other healthcare IT Systems that have any impact that may affect patient safety (Procured directly from System Suppliers or built in-house)
  • Existing Systems requiring retrospective clinical safety assurance
  • Investigation of incidents that may have a clinical safety aspect to them