1. The National Data Guardian review & Government response
Published February 2018 (Review April 2018)

2. Important Note
This is one of a series of Information Packs that have been put together to provide information on the National Data Opt-out. For the latest information on the programme, including key information for organisations to help them be ready for 25 May 2018, please refer to packs D onwards.

3. Overview
Better use of information and data has the potential to transform health and care for everyone.
People want to know that their privacy and rights are safeguarded, understand how and when information about them is shared, and, be able to make an informed choice about whether to share their data or not.
It was in this context that the Secretary of State for Health commissioned a review on data security and data sharing in the health and social care system by Dame Fiona Caldicott, the National Data Guardian for Health and Care (NDG).
This independent review of data security, consent and opt-outs was published July 2016, followed by a public consultation that ran until September 2016.
Government response published on 12 July 2017.
The work takes place in the context of the drive to develop a digitised health and care system that offers patients more control and choice over the care they receive, improves their experience, provides them with better outcomes and delivers a more efficient health and care system.

4. NDG Review and Government’s response
National Data Guardian Review – Key Points & Recommendations
You are protected by the law
Information is essential for high quality care
Information is essential for other beneficial purposes
You have the right to opt out of your personal confidential information being used for these other purposes beyond your direct care:
Providing local services and running the NHS and social care
Supporting research and improving treatment and care
This opt-out will be respected by all organisations that use health and care information
Explicit consent will continue
The opt-out will not apply to anonymised information
Arrangements will continue to cover exceptional circumstances
The Government response to the National Data Guardian Review supports the recommendations

5. “A patient should be able to state their preference once (online or in person), confident in the knowledge that this will be applied across the health and social care system”
National Data Guardian, July 2016
A key message from the review is that the patient must have a simple option available to set or change their opt-out preference that can then be accessed and applied when appropriate by all health and social care organisations that intend to share the patients identifiable health and care information for purposes beyond the individual’s care and treatment.

6. What was said - during the review and consultation
I need a simple explanation and clear choices
Professionals want clarity about their responsibilities
I don’t understand what you do with my data
Majority of purposes beyond direct care do not require personal confidential data
Expectation that information shared for direct care
Case for data sharing needs to be made to public
The review conducted a series of evidence sessions and interviews with key organisations and stakeholders, including patient representative groups, GPs and other clinicians, commissioners and providers of health and social care services, researchers and the Information Commissioner’s Office. Once published the review went out to consultation between 6 July 2016 to 7 September 2016.
In order to promote participation, approximately 500 professional and public stakeholders were directly engaged and signposted to the consultation exercise that followed the publishing of the review. There were 638 responses to the consultation and these came from a broad range of organisations and individuals, including:
Members of the Public, Clinical Commissioning Groups, General Practice Local Authorities, Arm’s Length Bodies, Public Health Organisations, Social Care Provider, Commissioning Support Units, Government Departments, Special Interest Groups, Professional Organisations/Associations, Hospital Trusts/Foundation Trusts and Research Bodies.
In addition to the consultation, three events were held in London, Southampton and Leeds to engage with a wide range of people and explore the NDG review’s findings in more depth. At each event, there was a session for professionals and a session for members of the public. The events were attended by a total of 178 people comprising 111 professionals and 67 members of the public.

7. Implementation Timetable
Area
Opt-out preparations
Opt-out service testing
Setting opt outs
Applying opt-outs
New Data Protection Legislation (GDPR)
Communications strategy
Previously
Jan – Mar 2018
Apr – Jun 2018
Jul 2018 – Mar 2019
Apr 2019 – 2020
Awareness raising
Readying organisations for implementation
Build opt-out service
Test opt-out service
25/05/18 Opt-outs can start being set from this date
25/05/18 Opt-outs upheld by NHS Digital
Upholding of opt-outs phased in for all other health and care organisations
25/05/18 New data protection legislation comes into effect
Develop strategy
Develop materials
Communication materials available
Members of the public will be able to start setting national data opt-outs from March 2018 (as part of ‘private beta’ testing), but the public launch of the service will be 25th May 2018, to align with new data protection legislation (GDPR).
Patients who had previously registered a ‘Type 2’ opt-out will be notified that this will be migrated to a National Data Opt-out, in line with the public launch in May 2018.
Members of the public will be able to start setting national data opt-outs from 25 May 2018.
The Department of Health will work with NHS England and NHS Digital to support all health and social care organisations to uphold the national data opt-out by 2020.
The national data opt-out will be referenced within communications on data use and sharing rather than the communications being focused on the national data opt-out alone.
A separate piece of work has been commissioned to develop a wider benefits of data sharing communications strategy.

8. More information National Data Guardian review
Government response
Your Data, Better Security, Better Choice, Better Care
National Data Opt-out Programme web pages & to join our mailing list
Understanding Patient Data - Wellcome Trust
To be kept informed of further developments about the national data opt-out including news of any events taking place and any new or updated materials being made available please subscribe to our mailing list via the contact form on our web pages.