Agenda Item 10(b) 17/11/2014 Rotavirus Evaluation Data Sharing Agreement Between xx CCG and University of Liverpool. Agreement Commenced: Date of signature Agreement expires: 31/05/2017 Unique Reference: 0012 Information Sharing Agreement 0012: Rotavirus Evaluation Sharing Agreement v1.1 Page 0 Business Intelligence Team Rotavirus Vaccine Evaluation Project: Version: Rotavvirus Vaccine Evaluation 1.1 Summary and Benefits of the Project This document outlines the requirements for an information sharing agreement between General Practice, xx CCG and University of Liverpool. The aim of this data sharing project is to enable the sharing of data to inform the evaluation of rotavirus vaccine which was introduced in July 2013. The aim of this evaluation is to: Understand if there any benefits to be gained through vaccinating children against rotavirus Quantify any benefits or disbenefits identified. This document contains the file specification for the fields required from primary care together with a Sharing Agreement detailing how the information will be transmitted, stored and used by both XX CCG and University of Liverpool. Appendix A shows a diagram of the data flow, the governance principles and who has access at each point. Change History Version Date Author Details 1.0 1.1 08/10/2014 17/11/2014 LB LB Document created Expiry date amended, dates of extraction added, extraction field and University of Liverpool details confirmed. Extraction method Signed up GP Practices will allow the extraction of patient level data via EMIS Web to be used only for the purposes within this Information Sharing Agreement (ISA). Extract Frequency Three data extractions will be performed. The first will occur in December 2014, the second extract will occur in August 15. The third and final extract will be performed during August 2016. Extract Parameters The extract parameters are below 1 Business Intelligence Team Search population: Currently registered patients (Excluding dummy patients) Search Date: Day of extraction Date range: Where Indicated - Last 7 years initially Each subsequent extract covers data for previous 12-months. Fields for extraction: Registration status Post Code* Date of Birth* Gender Diarrhoea Time since last diarrhoea episode Diarrhoea symptom NOS Enteritis due to rotavirus Infectious diarrhoea Diarrhoea and vomiting Diarrhoea of presumed infectious origin Viral Gastroenteritis Infectious gastroenteritis Infantile viral gastroenteritis Gastroenteritis - presumed infectious origin Gastrointestinal symptoms NOS 3.6 Rotavirus vaccination (Code & Date) 19F2 19F5 19FZ A0762 A082 19G A083 07y0 A0803 A07y1 A0812 19Z All instances & dates All instances & dates All instances & dates All instances & dates All instances & dates All instances & dates All instances & dates All instances & dates All instances & dates All instances & dates All instances & dates All instances & dates and data management Patient level data extracted from EMIS Web Patient identifable items transformed to non-identifiable form prior to sharing Data extract sent via NHSnet Data analysed for the study The data extraction from EMIS web will be stored temporarily on the CCG secure network for the purposes of transmission to the University of Liverpool. The patient identifiable items within the dataset (DOB and postcode) will be transformed prior to data sharing. This means that postcode will be converted to Lower Super Output Area (LSOA) and date of birth will be converted to age in months. The data will be transmitted to University of Liverpool in the form of batches of CSV files via the CCG Patient Identifiable Data (PID) NHS net account (liverpool.pid@nhs.net). This is an acceptable form of data transmission of patient identifiable data. The information will then be deleted from the CCG network. For security features of this process please see Governance and Security section below. To understand Data Management process - see below. 2 Business Intelligence Team Governance and Security Data Governance It is essential that all processing and use of personal data is in line with the Data Protection Act. In order to protect the rights of individuals there is a statutory duty placed on those who decide ‘how’ and ‘why’ such data is processed – the ‘data controller’. The data controller for this extraction is the GP Practice as they are the statutory body. Therefore all proposed use of the data must be in agreement with GP practices. This essentially means that ALL decisions regarding the use of the data rest with the GP Practice. The data processors cannot utilise or disclose this information to a third party e.g., Department of Health, without your express permission, unless covered by the terms of this agreement. The information will only be used in accordance with the specific purpose that it is provided for and will be at all times treated as confidential and handled in a secure manner. The shared information will not be used for any of the following: Advertising, Marketing & Public Relations Trading/sharing in personal information Future Research not covered by the parameters of this sharing agreement Legal basis for Information Sharing The information shared will not contain patient identifiable data items. The Health and Social Care Act 2012 also allows sharing of information for the purpose of advancing the health and wellbeing of the people in the area, to encourage persons who arrange for the provision of any health or social care services in that area to work in an integrated manner. Security of the servers/data warehouse Data will be extracted and warehoused on a secure server hosted and administered by University of Liverpool. The following security features are in place to ensure the data is secure. Servers have routine, auditable back up procedure to prevent data loss Secure anti-virus software Servers in secure room with key access and log book for access Building has swipe card access for every floor. Computers have time out screens and screen lock functions for users. Users have secure password to network This process is regularly audited by external auditors to ensure fit for purpose Data Management The data extracted will be housed in a secure data warehouse as above. The University of Liverpool data governance practices, which are informed by the Data Protectiion Act (1998), will be rigidly adhered to. Retention period 3 Business Intelligence Team The data will be stored by University of Liverpool for 10 years after the expiry of this data sharing agreement (31/05/2017). No further data will be shared between the University of Liverpool and GP after the expiry of this data sharing agreement (31/05/2017). Subject Access Subject access requests will be dealt with by the data controller in accordance with the provisions of the Data Protection Act 1998. Complaints Complaints will be dealt with in accordance with XX CCG Complaints Policy. Transmission In line with Department of Health recommendations, the use of laptops or other portable media for storing/transferring person identifiable or other sensitive information is not allowed under this agreement unless it is encrypted to standards approved by the DoH. Data will be transmitted via approved secure routes in this case NHS net to NHS net or encrypted email. Information breaches Partners will take steps to avoid any breach (intentional or otherwise) or disclosure to third parties outside the remit of this Agreement. Breaches must be reported through to XX CCG Incident reporting procedures, fully investigated and a report provided to XX CCG. Any Serious Untoward Incidents occurring within the scope of the information shared under this agreement must be reported to the participating organisations within 1 day of the incident occurring. The SUI must be fully investigated. The GP practices reserves the right to be informed at every stage of the investigation. Disciplinary action will be the responsibility of the organisation where the incident has occurred. This agreement will be reviewed in light of any lessons learnt from such incidents. Information will only be accessible to those authorised by this agreement or for whom it is essential to access the information to complete the purpose of the sharing. Confidentiality Partner organisations must have confidentiality clause within staff contracts of employment and or require staff participating in this agreement to sign confidentiality agreements. Staff must have current CRB checks where agreements require the sharing of sensitive data in particular children’s data Where training needs to meet the requirements of this agreement are assessed and identified, each organisation will ensure that the resource is made available to staff. Patient Confidentiality Some patients may still wish to opt out of sharing data in the same way as they may have done for the national spine. Patients’ data will not be shared if the read codes of 93C3 (Refused consent for upload to national shared electronic record) and 93C1 (Refused consent for upload to local shared electronic record). Patients will also be hidden from the extract if a practice marks their records as ‘private’ from within the clinical system. Both methods are acceptable. 4 Business Intelligence Team Dissemination Copies of this agreement will be provided to each of the signatory organisations. A master copy will be held by XX CCG. XX CCG will support any changes or amendments to this agreement. This information sharing agreement will be adopted by the signatory organisations. Key staff will be identified in each organisation to ensure that the protocols in this agreement are adhered to. Information Governance All signatories to this agreement are required to have approved Information Governance Policies in place that state the legal, ethical and professional obligations to protect service user information. Signatories to this agreement must ensure that all staff, contractors or other third parties who are involved in the processing of information covered by this agreement have received appropriate Information Governance training. Monitoring & Review Review of this agreement will be overseen by XX CCG, with reference to the signatory organisations, and in particular if there are changes to the agreed purpose or processes. This document will also be reviewed whenever there are changes to legislation or guidelines that may affect the sharing of the information covered by the agreement. Staff are required to report any adverse incidents that may affect the validity of the statements in this agreement and any breaches of security or confidentiality to Information Intelligence Services at Liverpool CC. Any queries relating to this agreement should be addressed to XX CCG. This agreement will be sent to practices once Practices will be communicated to every two years providing them with an opportunity to opt out. Effective Date This ISA is considered to be effective following signature of all parties and from the date on the signature page of the agreement unless prior authorisation to share has been approved by the Caldicott Guardian. Information Sharing Agreement You agree to share the data specified within this sharing agreement for the purpose specified. XX CCG Signed ………………………… Designation…………………. Date of expiry 31/05/2017 University of Liverpool 5 Business Intelligence Team Signed ………………………… Designation…………………. Date of expiry 31/05/2017 GP Practice Name: Signed ………………………… Designation…………………. Date of expiry 31/05/2017 i 6