KloudStack/healthcare

Assurance

Built for regulated healthcare

Our credentials, and the rules we plan around from the start.

Credentials

  • ISO 27001Information security management
  • ISO 9001Quality management
  • ISO 14001Environmental management systems
  • ICO registeredUK data protection registration
  • UK GDPRPersonal data handled under UK GDPR and the DPA 2018
  • Crown Commercial ServicePublic sector supplier
  • Digital Outcomes 7Crown Commercial Service framework
  • Microsoft PartnerCopilot and Dragon Copilot delivery

Microsoft Partner

Copilot and Dragon Copilot for healthcare

We help health organisations put Microsoft Copilot and Dragon Copilot to work, with the same human checks as everything we build.

Microsoft Copilot
AI assistance for everyday staff and back-office work
Dragon Copilot
AI-assisted clinical documentation for care teams
What we do
Scoping, integration, governance and staff training

UK healthcare requirements

UK requirements a healthcare AI project may need to meet. Credentials we hold are listed separately.
RequirementWhat it governs
UK GDPR / DPA 2018Health data as special category data, including impact assessments
DTACNHS baseline for buying digital health technology
DCB0129 / DCB0160Clinical risk management, for suppliers and deploying organisations
DSPTData security self-assessment for access to NHS patient data
UK MDR 2002 / MHRASoftware with a medical purpose can be a regulated medical device
HL7 FHIR / SNOMED CTStandard health data exchange and clinical terminology

Six questions to ask any AI supplier

Ask us too.

  1. Which sources can the system use, and who approves them?
  2. Where is data processed, and is it used to train a model?
  3. Is this a medical device? Who decided, and on what basis?
  4. Who is the named clinical safety lead on each side?
  5. How is output quality measured after go-live?
  6. Can any answer be traced back to its inputs?

Bring one workflow. We'll scope it.