Legal and Governance Policy

PURPOSE

To provide a central document containing information about laws and policies that relate to HIC Services SOPs, including a legislation register and, in more detail: 

• The GDPR Data Protection Principles 

• The 6 Caldicott Principles 

• Differentiating Audit, Service Evaluation & Research 

SCOPE

This SOP Appendix provides guidance to HIC SOP users as to the key legal and governance policies for the environment in which HIC is operating. 

RESPONSIBILITIES

LEGISLATION REGISTER

POLICY

GDPR Data Principles

Article 5 of the GDPR sets out seven key principles which lie at the heart of the general data protection regime. 

Article 5(1) requires that personal data shall be:   

“(a) Processed lawfully, fairly and in a transparent manner in relation to individuals (‘lawfulness, fairness and transparency’); 

(b) Collected for specified, explicit and legitimate purposes and not further processed in a manner that is incompatible with those purposes; further processing for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes shall not be considered to be incompatible with the initial purposes (‘purpose limitation’); 

(c) Adequate, relevant and limited to what is necessary in relation to the purposes for which they are processed (‘data minimisation’); 

(d) Accurate and, where necessary, kept up to date; every reasonable step must be taken to ensure that personal data that are inaccurate, having regard to the purposes for which they are processed, are erased or rectified without delay (‘accuracy’); 

(e) Kept in a form which permits identification of data subjects for no longer than is necessary for the purposes for which the personal data are processed; personal data may be stored for longer periods insofar as the personal data will be processed solely for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes subject to implementation of the appropriate technical and organisational measures required by the GDPR in order to safeguard the rights and freedoms of individuals (‘storage limitation’); 

(f) Processed in a manner that ensures appropriate security of the personal data, including protection against unauthorised or unlawful processing and against accidental loss, destruction or damage, using appropriate technical or organisational measures (‘integrity and confidentiality’).” 

Caldicott Principles

(The Caldicott Committee (December 1997), Dept of Health) 

HIC Services procedures are also designed to comply with the 6 NHS Caldicott Principles. HIC Services minimises the use of identifiable data - any request for use of identifiable data is referred for specific Caldicott Guardian approval. HIC Services provides a safe environment to implement Caldicott-approved use of data. 

1. Justify the purpose(s): Every proposed use or transfer of patient-identifiable information within or from an organisation should be clearly defined and scrutinised, with continuing uses regularly reviewed by an appropriate guardian. 

2. Don’t use patient-identifiable information unless it is absolutely necessary: Patient-identifiable data items should not be used unless there is no alternative. 

3. Use the minimum necessary patient-identifiable information: Where use of patient-identifiable information is considered to be essential, each individual item of information should be justified with the aim of reducing identifiably. 

4. Access to patient-identifiable information should be on a strict need to know basis: Only those individuals who need access to patient-identifiable information should have access to it, and they should only have access to the information items that they need to see. 

5. Everyone should be aware of their responsibilities: Action should be taken to ensure that those handling patient-identifiable information, (both clinical and non-clinical staff) are made fully aware of their responsibilities and obligations to respect patient confidentiality. 

6. Understand and comply with the law: Every use of patient-identifiable information must be lawful. Someone in each organisation should be responsible for ensuring that the organisation complies with legal requirements.  

 The Information Governance Review, April 2013 (known as Caldicott 2), added a 7th Principle: 

7. The duty to share information can be as important as the duty to protect patient confidentiality:   Health and social care professionals should have the confidence to share information in the best interests of their patients within the framework set out by these principles. They should be supported by the policies of their employers, regulators and professional bodies.   

Differentiating Audit, Service Evaluation & Research

The Health Research Authority (HRA) in its publication ‘Defining Research – guidance from NRES’ provides a guideline as to whether a project is research, which normally requires NHS REC review, or another activity such as audit or service evaluation, which does not. Projects which do require NHS REC review will normally also require NHS R&D permission(s).  This standard also applies to an Approved Project requiring data from HIC Services.  

From ‘Defining Research’. The Health Research Authority (HRA). Ref. 0987 December 2009 (rev. April 2013) 

Differentiating clinical audit, service evaluation, research and usual practice/surveillance work in public health 

*Service development and quality improvement may fall into this category. Source: NHS HRA 

APPLICABLE REFERENCES

• For Definitions see ISMS Glossary

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