CRIS (Powered by Akrivia Health)

You can opt out at any time. The National Data Opt-Out (NDOO) service enables people to view or change their NDOO choices. People can decide whether their confidential patient information can be used for research and planning, including CRIS.

People can view or change their NDOO choice at any time by using the online service or by clicking on ‘Your Health’ in the NHS App. Then select ‘Choose if data from your health records is shared for research and planning.’

Further information can also be found at manage your choice | NHS website. 

Here are three video examples from outside our Trust showing how CRIS has supported research: 

Using CRIS for Dementia research:

Using CRIS for Multimorbidity among people with serious mental illness research:

Using CRIS to identify health inequalities — city living and isolation:

How will CRIS affect individual care delivery right now?

The research made possible by CRIS is unlikely to impact directly on care right now. Nevertheless, as demonstrated above, we believe CRIS can make a real and positive difference to future treatments and care.

As shown, anonymous or de-identified data from medical records can be very useful for research. Significant amounts of information are recorded in these records - particularly the free text notes. This information can help organisations better understand how care is being delivered, the causes of disease and the effectiveness of interventions and medications. This de-identified data can help answer all these questions. 

For some research, CRIS can help us find groups of patients that researchers would like to invite to take part in their research.

For example: 

• An NHS Trust wants to speak to patients with schizophrenia who are female and between the ages of 25-45.  
• They can use CRIS to search the anonymous database and find out how many people they have who fit this criteria.  
• If these people have given their consent to be contacted about relevant research projects, a special process can be carried out to allow the researchers to get in contact with these (and only these) individuals. 

Data Security and management of CRIS: 

Q: Do we have control over our Trust’s data?  
A: Yes – our Trust retains control.

Q: Does anyone oversee/monitor CRIS from our Trust?  
A: Yes. A local CRIS administrator will oversee the day to day running of the system. The system captures all actions carried out on CRIS via an audit log. This enables the CRIS administrator and the organisation to know exactly how CRIS users are using the system. Additionally, we will have an oversight committee in place with patient representation. 

Q: Who can access CRIS data?  
A: Researchers employed by our Trust. 

Q: Who manages this access? 
A: We have a strict process in place to control who can access the database. Our CRIS administrator and the oversight committee will manage access. All users will need to register to use CRIS, providing any appropriate evidence of contracts and training completed as defined by us.  

Q: What is de-identified data? 
A: This is data which has had information removed, masked or modified to protect patient privacy. Items such as name, surname, telephone numbers, addresses and NHS numbers will all be removed or masked to minimise any chance a patient could be identified from the data. 

Governance committee???? 

Opting out: 

Q: How and when can patients opt out? 
A: Patients can find out more about opting out at any time via the NDDO website. They can opt out here.  
They can also opt out via the NHS App. Click on ‘Your Health’ and select ‘Choose if data from your health records is shared for research and planning.’  

Question: Can patients change their opt out preferences at any time? 
Answer: Yes they can via the NDDO website. They can opt out here. 

Question: Can a patient’s preference for opting out be updated by staff via Rio (our patient records system)? 
A: No. This cannot be done via RIO. The patient will need to do this via the NDOO service website or NHS App. 

Patient vulnerability and capacity: 

Q: How are decisions managed when a person lacks capacity?  
A: As data controller, our Trust identifies which data sets will be used. 
Staff can direct patients to the NDDO website and refer to the Trust’s NDOO Policy.  
All patient data is anonymised.  
As with any research study, we can only approach the patient once their clinical team have gained their consent for us to contact them. After which there is a robust consenting process.  
There are also robust processes for enrolling people who lack capacity. 

Q: What is the role of staff in supporting or safeguarding patient wishes? 
A: As with every aspect of decision making in healthcare, staff play a vital role in ensuring that patient preferences and rights are respected throughout all stages of care and data use. This includes CRIS.  
Staff:  - Support informed decision-making: by helping patients understand their choices and the implications of consent or opt-out decisions. 
- Safeguard confidentiality: by following data protection and information governance standards to keep patient data secure. 
- Support patient decisions: by ensuring that care and research processes reflect each individual’s expressed wishes. 
- Act when concerns arise: by raising issues through appropriate safeguarding or governance channels if a patient’s wishes are not being upheld. 
- Ensure consistency: by recording and honouring patient preferences across systems such as CRIS and Akrivia Health. 

If you wish to raise a complaint on how we have handled your personal data, please see our ‘what are your rights?’ section on our Trust privacy notice page.

You can make a complaint to us at WHCNHS.InformationGovernance@nhs.net. If you are still unhappy with how we have used your data, you can then complain to the ICO. We are registered with the Information Commissioner's Office (ICO — the UK’s Supervisory Authority). Our registration number is Z2745227.

Make a complaint about how an organisation has used your personal information on the ICO website.