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NHS Data Guide

A comprehensive guide to NHS data governance — from Caldicott Principles and data sharing agreements to CIS2 identity management and ICS data flows.

Foundational principles

The eight Caldicott Principles

The Caldicott Principles (updated 2020) form the ethical and governance foundation for NHS data handling. Every NHS organisation must apply these principles to decisions about patient data use.

1

Justify the purpose

Every proposed use or transfer of confidential patient information should be clearly defined and scrutinised to establish whether the purpose is justified.

2

Use only what is needed

Confidential patient information should not be used unless it is absolutely necessary. Anonymised data should be used wherever possible.

3

Use the minimum necessary

Where use of confidential patient information is considered essential, each individual item of information should be justified.

4

Access on a strict need-to-know basis

Only those individuals who need access to confidential patient information should have access to it.

5

Everyone must understand their responsibilities

Action should be taken to ensure that those handling confidential patient information are aware of their responsibilities and obligations.

6

Comply with the law

Every use of confidential patient information must be lawful. UK GDPR, the DPA 2018, and the common law duty of confidentiality all apply.

7

The duty to share can be as important as protecting confidentiality

Health and social care professionals have a duty to share information for direct care purposes. Sharing can be as important as protecting.

8

Inform patients about data use

Patients should be aware of how and why their information is used and what choices they have. This is fundamental to maintaining public trust.

Key areas

NHS data governance topics

Data Sharing Agreements (DSAs)

When NHS organisations share patient data with other organisations (including for research or commissioning), a formal Data Sharing Agreement is required. DSAs must specify the legal basis, data types, retention periods, and security controls.

  • Required for all sharing of identifiable patient data
  • Must be reviewed and renewed periodically
  • Linked to your ROPA as processing activities
  • NHS England template DSAs available for common scenarios

National Data Opt-Out

The National Data Opt-Out allows patients to opt out of their confidential patient information being used for purposes beyond their direct care. Organisations using data under section 251 of the NHS Act must apply opt-outs.

  • Applies to secondary uses of patient data (research, planning)
  • Does not apply to direct care of the patient
  • Opt-out status can be checked via the NHS Spine
  • Annual compliance submissions required for certain data flows

Section 251 Approvals

Section 251 of the NHS Act 2006 allows the Secretary of State to set aside the common law duty of confidentiality for specified purposes. Applications are reviewed by the Confidentiality Advisory Group (CAG).

  • Required where consent is not practical and another basis does not apply
  • CAG reviews applications at NHS England meetings
  • Approved flows must apply the National Data Opt-Out
  • Annual renewal process required

NHS CIS2 & Identity Assurance

NHS Care Identity Service 2 (CIS2) provides the national identity platform for NHS staff. It enables Smartcard and NHS login-based authentication with role-based access to NHS systems.

  • Replaces the legacy NHS Spine smartcard system
  • Supports both smartcard and mobile authenticator
  • Integrates with Azure AD and Microsoft 365
  • Role-based access via national directory (RA01 process)

Incident Reporting to NHS England

Serious data security incidents must be reported to NHS England's Data Security Centre as well as to the ICO. NHS organisations have specific reporting obligations beyond UK GDPR.

  • Serious incidents reported via DSPT incident reporting tool
  • NHS England DSC provides guidance on severity classification
  • ICO notification (72 hours) required for high-risk breaches
  • Lessons-learned process required for serious incidents

Integrated Care System (ICS) Data Sharing

Integrated Care Boards (ICBs) and their partner organisations routinely share patient data for population health management, direct care, and commissioning. Clear governance frameworks are essential.

  • ICS-wide Data Sharing Frameworks recommended
  • Population health management requires careful legal basis analysis
  • Patient engagement on data use is essential for public trust
  • NHSE guidance on ICS data governance available
Governance roles

Key NHS IG roles

Caldicott Guardian

A senior person responsible for protecting the confidentiality of patient information and enabling appropriate information sharing. Usually a senior clinician. Every NHS Trust must have one.

National Data Guardian guidance (2021)

Senior Information Risk Owner (SIRO)

A board-level executive accountable for information risk. Responsible for overseeing the DSPT submission and signing off the organisation's information security posture.

DSPT requirement; Cabinet Office guidance

Data Protection Officer (DPO)

Mandatory under UK GDPR for public authorities (including NHS Trusts). Must be independent, expert in data protection law, and report directly to the highest management level.

UK GDPR Article 37

Information Asset Owner (IAO)

Responsible for individual information assets — understanding what data is held, how it is used, and who has access. Reports risks to the SIRO.

NCSC guidance; HMG Security Policy Framework

Need help with NHS data governance?

Folelse is purpose-built for NHS organisations. From DSPT evidence to Caldicott-compliant ROPA mapping, we have you covered.

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