HTI Data Protection Notice

HTI Data
Hospital Treatment Insights (HTI) is a database in which hospital dispensing data is linked with Hospital Episode Statistics (HES), a NHS database containing details of all admissions, A and E attendances and outpatient appointments at NHS hospitals in England. The linkage is carried out by NHS Digital who receive identifiable data from participating hospitals for this purpose. Specifically, NHS Digital receives the following identifiers from hospitals:

 

Identifier

Used for

Action

NHS number

Linking patients in pharmacy data to HES data

Removed prior to supplying data to IQVIA

Unique hospital identifier Linking patients in pharmacy data to HES data Removed prior to supplying data to IQVIA
Date of birth Verifiying the linkage Changed to year of birth only
Gender Verifiying the linkage Retained
Postcode Determining deprivation score Removed prior to supplying data to IQVIA

 

IQVIA Solutions UK Limited is the data controller of the HTI database but does not receive any direct patient identifiers.

IQVIA Ltd also processes this data as a data processor.

The data in HTI is collected during a patient's time at hospital as part of the Commissioning Data Set (CDS). HES data is submitted to NHS Digital for processing and is returned to healthcare providers as the Secondary Uses Service (SUS) data set and includes information relating to payment for activity undertaken. It allows hospitals to be paid for the care they deliver. The dispensing data is generated within the hospital pharmacy when medicines are issued to patients during inpatient stays or outpatient visits.

This same data can also be processed and used for non-clinical purposes, such as research and planning health services. Since these uses are not to do with direct patient care, they are called 'secondary uses'.

HTI data covers approximately 30% of NHS trusts in England.

Each HTI record contains a range of non-identified information about an individual patient admitted to an NHS hospital, including:

  • clinical information about diagnoses and operations
  • patient information, such as year of birth, gender and ethnicity
  • administrative information, such as dates and methods of admission and discharge
  • prescription medicines issued directly from the hospital pharmacy

We apply a strict statistical disclosure control in accordance with the NHS Digital protocol, to all published HTI data. This suppresses small numbers to protect individuals' privacy and to ensure that patient confidentiality is maintained.

HTI data is collected in accordance with the same applicable data protection law as is applied to HES. See further: https://digital.nhs.uk/about-nhs-digital/our-work/keeping-patient-data-safe/gdpr/gdpr-register/hospital-episode-statistics-gdpr/hospital-episode-statistics-hes-gdpr-information.

 

What information is included in HTI data?
HTI data provides non-identified details about patients’ clinical events which have taken place in hospital. These include:

  • Clinical information: diagnoses, procedures, operations
  • Additional key information about the patient: year of birth, gender, ethnicity
  • Administrative information: waiting times, dates and methods of admission / discharge
  • Maternity information: gestation, method and date of delivery, complications, birth weight, length of stay
  • Adult Critical Care: high dependency and intensive care dates
  • Outpatient attendance: appointment dates, diagnoses, procedures
  • Accident and Emergency: attendance dates, diagnoses
  • Prescription medicines issued from the pharmacy
  • Medical history information.

HTI data does NOT include any direct patient identifiers such as names, addresses, NHS numbers, or full dates of birth.

 

The purpose for which HTI data is processed
The data received by IQVIA is non-identified. The individual patient-level data are accessed by employees of IQVIA and academic researchers from universities. This data may be processed and used for the purpose of medical research strictly to perform protocol driven studies. These studies answer specific research questions, HTI data are not used to populate automated decision making tools. HTI studies must fall within the following medical research disciplines:

Advanced statistical analysis

  • Epidemiology
  • natural history of disease
  • health economics and outcomes research
  • drug exposures

Drug safety monitoring

  • monitoring of adverse events for newly licenced drugs prescribed in secondary care
  • pharmacovigilance

IQVIA processes the HTI data under Article 6(1)(f) of the GDPR on the basis of legitimate interests in supporting medical research and because it is necessary for the above scientific research purposes, subject always to appropriate safeguards. The legal basis for processing personal data relating to patient health is under Article 9(2)(j)of the GDPR - processing is necessary for archiving purposes in the public interest, scientific or historical research purposes or statistical purposes. Technical and organisational measures are in place to ensure only non-identified data is used.

This data is not used for profiling.

 

Who is the data made available to?
IQVIA makes the non-identified, individual patient-level data to its employees and to academic researchers based in universities in the UK. Data containing identifiers is not shared with IQVIA but is sent by the hospital via secure means to NHS Digital only.

IQVIA carries out research on behalf of other research groups also and will share the results of this research in the form of aggregated data tables including: 

  • Providers of healthcare services including but not limited to:
  • Clinical Commissioning Groups
  • Commissioning Support Units (CSUs)
  • Hospital Trusts
  • Private secondary care providers
  • Mental Health trusts
  • Community Provider Trusts
  • Pharmacies
  • NHS England
  • Public Health England
  • Sustainability and Transformation Partnerships (STPs)
  • Health and Wellbeing Boards
  • Universities
  • Life science industry
  • Pharmaceutical companies
  • Medical Device companies
  • Industry bodies – limited to the Association of the British Pharmaceutical Industry (ABPI), Ethical Medicines Industry Group (EMIG) and the Proprietary Associated of Great Britain (PAGB)

The HTI database is not used for commercial purposes such as sales targeting or commercial insurance. Non-identified, individual patient level data are only accessed by researchers physically located in the UK. National data tables not containing any identafiable patient data may be shared with researchers in other locations.

 

HTI Study Protocol Review
For advanced scientific analysis, IQVIA  produce bespoke analysis for external organisations on a project by project basis.  All requests for bespoke analysis are subject to review by an independent scientific advisory committee (ISEAC) who review the proposed study design. If ISEAC approves the study, it is logged on an access control register and the IQVIA  researchers are allowed to access data. The researchers will present the results of their analysis to external organisations in the form of aggregated, small number suppressed tables. These outputs may also take the form of counts, proportions or formulae. HTI data may be accessed by academic researchers for approved protocol research under the same strict conditions applied to IQVIA researchers.

ISEAC is a group of medical and scientific advisors who are independent of IQVIA . For studies based on HTI data the role of this committee is to ensure that any study performed is compliant with the NHS the data sharing agreement and by extension, the Care Act 2014. All ISEAC decisions are binding, and any studies not approved will not be performed unless revised and subsequently approved. ISEAC records of decisions can be made available to NHS Digital under the caveat that they will remain in confidence.

 

Data Retention 
IIQVIA 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.

 

Security
IQVIA has implemented an Information Security Management System. IQVIA Solutions UK Ltd and IQVIA Technology Services Ltd are accredited to the ISO 27001 standard.

IQVIA stores the HTI data records on secure servers located in the UK. We have put in place appropriate security measures to prevent unauthorised access to or disclosure of the HTI data. Access to the data is strictly controlled and limited to authorised IQVIA personnel.

 

Patient rights
There is no obligation on hospitals or patients to provide this data for research. Patients have the right to opt out of their data being included in the HTI database via the NHS. Patients also have the right to request the rectification or restriction of processing of their personal data held by the NHS or to object to the processing of such personal data, as well as the right to data portability. Patients would need to contact the NHS to exercise these rights.  (https://www.nhs.uk/your-nhs-data-matters/)

 

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 HTI data. Any changes to this notice take effect immediately after being posted or otherwise provided by us.

 

Contact details

Questions and comments regarding this notice should be addressed to Amanda Culley at IQVIA, 210 Pentonville Road, London, N1 9JY or emailed to our Data Protection Officer Barbara Bressolles at eu.dpo@iqvia.com. If you have unresolved concerns, you also have the right to complain to the Information Commissioner´s Office website at https://ico.org.uk/.

 

About IQVIA
IQVIA Solutions UK Limited and IQVIA Technology Services Ltd (“IQVIA/we/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.

We are registered in England and Wales as: IQVIA Technology Services Ltd, registration number: 03566800 and IQVIA Solutions UK Limited, registration number: 00634325 and our registered office is 210 Pentonville Road, London, N1 9JY.