IQVIA Medical Research Data Privacy Notice
IQVIA Solutions UK Limited and IQVIA World Publications Ltd (“IQVIA/we/us/our”) are part of the IQVIA Inc. group of companies serving the combined industries of health information technologies and clinical research worldwide. We specialise in the provision of products and services including medical research and analytical solutions to healthcare and life sciences organisations. In the UK, IQVIA has collected and supported the research use of non-identified patient data for over 20 years.
IQVIA™ Medical Research Data is non-identified electronic patient health record data collected from General Practioner (GP) clinical systems via the IQVIA Medical Research Extraction Scheme and The Health Improvement Network, and used for medical research.
Pursuant to data protection legislation, IQVIA is the data controller of the IQVIA™ Medical Research Data.
We are registered in England and Wales as: IQVIA World Publications Ltd, registration number: 01124807; and IQVIA Solutions UK Limited, registration number: 00634325 and our registered office is 210 Pentonville Road, London, N1 9JY.
IQVIA Medical Research Extraction Scheme (MRES)
EMIS Health is a UK GP clinical system provider that has created a bespoke non-identified patient data extract template for IQVIA. IQVIA has set up a research and patient insights programme called the Medical Research Extraction Scheme (MRES) in partnership with EMIS Health to collect the non-identified coded data extracted from the GPsoftware system. IQVIA will use the non-identified patient data for medical and public health research and treatment analysis.
The Health Improvement Network (THIN*)
THIN facilitates the collection of non-identified patient data from UK GP clinical systems. IQVIA has a license agreement to process and use the data collected by THIN for medical research and treatment analysis.
*THIN is a registered trademark of Cegedim SA in the United Kingdom and other countries. Any references made to THIN Data are intended to be descriptive of the data asset licensed by IQVIA.
What information is included in the IQVIA™ Medical Research Data?
The IQVIA™Medical Research Data is non-identified, consisting of data such as:
- Patient details: year of birth, sex, practice registration date, practice de-registration date
- Morbidity data: symptoms, diagnoses with dates, referrals to hospitals
- Prescribed medication: all prescriptions with date issued, drug name, formulation, strength, quantity, dosing instructions
- Immunisations: all in-practice immunisations
- Lab tests and and other health data: smoking status, height, weight, blood pressures, pregnancy, birth, death
The IQVIA™ Medical Research Data does NOT include any direct patient identifiers such as names, addresses, NHS numbers, or full dates of birth, nor any direct identifers of practices participating in this data collection scheme.
The purpose for which the data is processed and used
The IQVIA™ Medical Research Data may be processed and used for the purpose of medical research in the following areas but not limited to:
- Drug safety
- Public health research (including clinical audit)
- Drug Utilisation Studies (DUS)
- Post Authorisation Safety Studies (PASS)
- Outcomes research
- Health economics research
- Resource utilisation
- Treatment analysis and comparison
IQVIA processes the data on the basis of its legitimate interests in supporting medical research and, because it is necessary for the above scientific research purposes, subject always to appropriate safeguards. Technical and organisational measures are in place to ensure only non-identified data is used.
IQVIA collaborates on medical and academic studies in the areas listed above, and uses as well aggregated forms of the data for treatment analysis, to provide insights into patient, disease and prescribing profiles.
The use of IQVIA™ Medical Research Data extracted from the GP software systems for the purpose of medical research and of supplying the data to external researchers for scientifically approved studies under Data Sharing Agreements has been approved by the NHS Health Research Authority (NHS Research Ethics Committee ref 18/LO/0441).
A list of publications relating to studies that have used IQVIA™ Medical Research Data is available on the IQVIA Real-World Insights bibliography: http://www.rwebibliography.com
Who is the IQVIA™ Medical Research Data made available to?
IQVIA carries out research on behalf of or makes the data available to the following research groups:
- Providers / commissioners of healthcare services: NHS healthcare providers, private secondary care providers, NHS England, Public Health England, and regulatory bodies
- Academics / universities
- Life science industries: pharmaceutical companies, medical device companies, Industry bodies
- Other: patient groups and healthcare related charities
The IQVIA™ Medical Research Data may only be made available to external researchers for protocol-driven studies under specific Data Sharing Agreement (DSA) terms that restrict use of the data.
Study Protocol Review
All study protocols MUST be approved by a recognised scientific review board. All proposed medical research studies using IQVIA™ Medical Research Data are subject to review and approval by the Scientific Review Committee (SRC).
All studies are required to show scientific merit, fulfill the research purpose outlined, and demonstrate potential benefit to health and social care.
IQVIA™ Medical Research Data consists of all available non-identified patient electronic health records. In order for studies using patient data to be scientifically sound, all information relating to a patient’s past medical events should be considered as this will influence their doctor’s decision and affect their current care. Historical data on patient contact with their GP is important because the lead up to diagnosis of many conditions, particularly rare diseases, can be complex and lengthy. In addition, longitudinal data is increasingly important, for example, in studying chronic conditions, when a long history is required so that trends and signals can be detected and early risk prediction tools can be designed. Availability of sufficient data and research can drive health policy changes or adoption of new guidelines for healthcare providers, thus leading to improved outcomes for patients.
IQVIA retains data in accordance with UK Medical Research Council (MRC) guidelines which recommend basic research data and related material be retained for a minimum of 10 years after the study has been completed. This is to support good research practice which requires research studies to be reproducible.
IQVIA has implemented an Information Security Management System (ISMS). IQVIA Solutions UK Ltd is accredited to the ISO 27001 standard and IQVIA World Publications Ltd has an NHS approved Information Governance Toolkit (IGT) assessment.
We have put in place appropriate technical and organisational security measures to ensure a level of security appropriate to the risk and to prevent accidental or unlawful destruction, loss, alteration, unauthorised access to or disclosure of the data. Access to the data is strictly controlled and limited internally to authorised personnel. External use and access is governed by Data Sharing Agreements which are legally binding agreements detailing confidentiality and the terms on which the data is shared, used, stored and accessed. IQVIA stores the IQVIA™ Medical Research Data on secure servers located in the European Economic Area (EEA). If information is required to be transferred outside the EEA to a country that is not subject to an adequacy decision by the EU Commission, data is adequately protected by EU Commission-approved standard contractual clauses or an appropriate Privacy Shield certification.
Consent and patient rights
Data is collected in line with the requirements of applicable data protection law.
Information on the processing of patients´ data will be made available from the GP practices that are contributing data in accordance with applicable legislation, including the ‘EU Regulation 2016/679 on the protection of natural persons with regard to the processing of Personal Data and on the free movement of such data’ (“GDPR”). The GP practices are also responsible for obtaining any necessary patient consents, if required by GDPR, for the processing of their personal data for the anticipated research purposes.
Each GP practice will additionally provide for the exercise of patients´ rights, including access, rectification, objection to processing and erasure, in accordance with GDPR requirements. Patients have the right to opt out of the data collection scheme and this can be done via the patient’s GP practice. Patients are informed by means of posters in their GP practice that their data is collected for scientific research and they can withdraw their consent at any time by notifying the practice. Any patients that have dissented from THIN or IQVIA Medical Research Extraction Scheme are recorded as non-consenting and will no longer be included in the data extracts from that point forward.
Patients have the right to request rectification of their personal data, or restriction of processing of personal data concerning the data subject, or to object to the processing of such personal data, as well as the right to data portability. This can only be done by the patients contacting their GP to exercise these rights.
Changes to this Notice
We may update this notice from time to time. We encourage you to review this notice periodically to stay informed about how we are using and protecting IQVIA™ Medical Research Data. Any changes to this notice take effect immediately after being posted or otherwise provided by us.
Questions and comments regarding this notice should be addressed to Louise Pinder at IQVIA, 210 Pentonville Road, London, N1 9JY or emailed to email@example.com.