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National Clinical Informatics Service for Scotland (NCISS)

Published on 16 May 2024

About our services

The suite of services offered include expertise in Software as a Medical Device regulations (SaMD), clinical terminologies (including the implementation of SNOMED CT), healthcare analytics (via Primary Care Informatics in addition to population health management approaches), and clinical safety (through adverse event management and conducting standards based clinical safety cases).

The team's experienced Clinical Informaticians are trained in a variety of clinical specialities and offer expert consulting in the fields of clinical data, information, research, innovation, as well as digital health care solutions. These Clinical Informaticians are supported and complimented by the in-depth knowledge of our Clinical Safety Engineers. NCISS also offer training & events for subjects within its domain of expertise. All elements of the team's activities are designed with the end goal of improving patient safety and healthcare delivered to the nation through any digital means.

Our services include:

Clinical safety assessment

  • Clinical Safety Assurance for Digital Solutions
  • Clinical Safety Case (ISO 14971 & 81001-1)
  • Quality Management Approach (ISO 13485)
  • Medical Device Software Lifecycle (IEC 62304)

Clinical governance

  • Adverse event management, clinical expertise, and data analysis
  • Clinical risk management
  • Compliance: Caldicott Guardian and Data Protection

SaMD and regulatory compliance

  • Regulatory compliance advice on software as a medical device (SaMD) and AI (AIaMD)
  • Quality Management System (QMS) auditing, design, remediation, and certification for SaMD (ISO 13485)

Primary care informatics

  • Primary Care Data Intelligence Platform
  • GP Editorial Board
  • Cohort generation, including vaccination programme cohorts.
  • Advice on use of primary care data
  • Support to Digital Health and Care at Scottish Government

Clinical informatics consultancy

  • Advice and input to procurement of digital solutions
  • Clinical Safety Officer (CSO) and Clinical Safety Engineer (CSE) training
  • Clinical informatics input to programmes and projects

Clinical terminologies

  1. Implementation
  2. Expression Constraint Language (ECL)
  3. Virtual Centre of Excellence (VCoE)
  4. Terminology server
  • READ 2

Health and care analytics

  • Population Health Management Approaches
  • Information mapping
  • Clinical decision support (CDS)

Digital and care solution

  • Interoperability and integration
  • Information Standards
  • FHIR, HL7 and OpenEHR
  • Full software lifecycle (IEC 62304)

Contact us

If you need assistance in relation to any of our services or would like to understand how we can assist you, please email