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GDPR - General Data Protection Regulation

What is the GDPR?

What is GDPR?The General Data Protection Regulation is a law that covers the use of personal data. It becomes law across the whole of Europe (including the United Kingdom) on 25th May 2018. The GDPR has 11 Chapters, 99 Articles and 173 Recitals.An Article gives the specific requirement in law.A Recital gives the context and background to the related ArticlesThe Chapters group the law into common themes.

What and who does the GDPR cover?

  • Personal data relating to a “natural person” i.e. a living individual (Article 1)
  • Organisations that are based in the European Union (EU) who control or process personal data (Article 3)
  • Organisations processing the personal data of data subjects living in the EU (Article 3)

The GDPR applies to organisations outside of the EU who process EU citizen’s data, and organisations inside the EU who process non-EU citizen’s data.


Data Controller:‘Controller’ means the natural or legal persons, public authority, agency or other body which, alone or jointly with others, determines the purposes and means of the processing of personal data; where the purposes and means of such processing are determined by Union or Member State law, the controller or the specific criteria for its nomination may be provided for by Union or Member State Law (Article 4, Clause 7)

This means that an organisation that decides the ‘How’ and ‘Why” personal data is processed is the Data Controller.

Data Processor: ‘Processor’ means the natural or legal person, public authority, agency or other body which processes the personal data on behalf of the Data Controller (Article 4, Clause 8)

The terms ‘processing’ relates to anything that is done to personal data, including analysing, collecting or storing the personal data.

Personal Data: “Personal Data” means any information relating to an identified or identifiable natural person: An identifiable natural person is one who can be identified, directly or indirectly, in particular by reference to an identifier such as a name, identification number, location data, an online identifier or to one or more factors specific to the physiological, genetic, mental economic, cultural or social identity of that natural person. (Article 4, Clause 1)

The term “personal data’ now specifically includes health, biometric and genetic data.

Data Subject: “Data Subject” is a natural person whose personal data is processed by a controller or processor.

A data subject must be a living person.

Consent: means any freely given, specific, informed and unambiguous indication of the data subjects wishes by which he or she, by a statement or a clear affirmative action, signifies agreement to the processing of personal data relating to him or her. (Article 4, Clause 11)

Consent under the GDPR only relates to the processing of personal data. It does not include consent relating to medical treatment or intervention. Consent is not always required in order to process data. However the rules around what you do with personal data become much stricter when you rely only on consent as the lawful basis for doing the processing.

This includes personal data relating to :

  • Racial or ethnic origin,
  • Political opinions,
  • Religious or philosophical beliefs, or
  • Trade union membership, and the processing of
  • Genetic data,
  • Biometric data for the purpose of uniquely identifying a natural person
  • Data concerning health
  • Data concerning a natural person’s sex life or sexual orientation

The controller and the processor shall designate a data protection officer in any case where :

  1. The processing is carried out by a public authority or body, except for courts acting in their judicial capacity;
  2. The core activities of the controller or the processor consist of processing operations which, by virtue of their nature, their scope and/or their purposes, require regular and systematic monitoring of data subjects on a large scale; or
  3. The core activities of the controller or the processor consist of processing on a large scale of special categories of data pursuant to Article 9 or personal data relating to criminal convictions and offences referred to in Article 10.

Every public authority (including NHS Hospitals, schools, Councils, Police and Fire Services) must appoint a DPO (Article 37). Health care data is included in the special category of data described in Article 9, so those organisations such as GP Practices, which process large volumes of special category data, must also appoint a DPO.

For further enquires please contact DPO Officer

Following its introduction in May 2018 and several subsequent delays, the National Data Opt-Out went live on 31st July 2022. Northampton General Hospital NHS Trust (‘NGH’, ‘the Trust’) are compliant with the National Data Opt-Out.

What is the national data opt-out?

The aim of the data opt-out is to give patients and the public more control over how their information is used. The opt-out provides individuals with the right to request that their data is not used for research and planning purposes. Individuals can choose to stop their confidential patient information being used for research and planning. They can also make a choice for someone else, for example, children under the age of 13.

How are opt-outs recorded?

Opt-out preferences are recorded via the NHS ‘Your Data Matters’ website. NGH are not able to record preferences in relation to the National Data Opt-Out.

Opt-out preferences apply to the health and care system in England. They do not apply to health and care services accessed in Scotland, Wales, or Northern Ireland. Individuals can view their opt-out status using the link above or by phoning the NHS Digital Contact Centre.

The phone number is 0300 303 5678 – Monday to Friday, 9am to 5pm (excluding bank holidays).

How has compliance with the National Data Opt-Out been achieved at NGH?

For teams that use patient information for research and planning purposes, there is now a requirement to check the data opt-out status of patients before using this information.

Where patients have chosen to opt-out, their data will not be used. A National Data Opt-Out policy has been developed and made available to all staff. The National Data Opt-Out predominantly impacts the Trust’s Research and Innovation Teams, Clinical Audit Teams and teams that submit data for audit, research and planning purposes.

How do NGH know when the opt-out applies?

Details about the application of the opt-out preference are available in the National Data Opt-Out policy for the Trust. Some research and audits are granted exemptions which mean that the National Data Opt-Out does not apply to them.

This is managed by the Confidentiality Advisory Group. The Confidentiality Advisory Group (CAG) is an independent body which provides expert advice on the use of confidential patient information. The key purpose of CAG is to protect and promote the interests of patients and the public, while at the same time facilitating appropriate use of confidential patient information for purposes beyond direct patient care.

Registers of approvals can be found on their website, here:

The Health Quality Improvement Partnership (HQIP) also publish a useful directory which includes high-level information about the National Clinical Audit and Patient Outcomes Programme (NCAPOP) and additional projects commissioned by HQIP, plus national quality improvement projects operated by other organisations.

Can individuals opt-out of information being used for care and treatment?

No, The national data opt-out policy does not apply where information is being used or shared for an individual patient's care.

It only applies to use or disclosure of data for purposes beyond individual care such as research and planning. How does NGH know who has opted out?

Information about opt-out preferences is held centrally by NHS Digital. Opt-out preferences for our patients will be extracted from NHS Digital systems by the Trust’s Health Intelligence Team.

This information will be updated daily and will be made available in a report to allow this to be cross checked against other datasets.

Where can I find more information?

There is lots of information available on the NHS websites here:

Information in different languages and formats can be accessed via the NHS website, here:


If you have any further questions, you can contact: Data Security and Protection Team:

  • Deputy Head of Data Security and Protection UHN and Data Protection Officer – Sarah Stell (
  • Caldicott Guardian and Medical Director – Hemant Nemade (
  • Senior Information Risk Officer (SIRO) and Digital Director Dan Howard (




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