Linked health data for pharmacovigilance in children

Perceived legal and ethical issues for stakeholders and data guardians

Yvonne Marina Hopf, Christine M Bond, Jill J Francis, John Haughney, Peter J Helms

Research output: Contribution to journalArticle

3 Citations (Scopus)
4 Downloads (Pure)

Abstract

Objective
The inclusion of the Community Health Index (CHI) in the recording of National Health Service (NHS) contacts in Scotland facilitates national linkage of data such as prescribing and healthcare utilization. This linkage could be the basis for identification of adverse drug reactions. The aim of this paper is to report the views of healthcare professionals on data sharing, ownership, and the legal and other applicable frameworks relevant to linkage of routinely collected paediatric healthcare data.
Design
Qualitative study using semi-structured face-to-face interviews addressing the study aims.
Participants
Purposive sample of professional stakeholders (n=25) including experts on ethics, data protection, pharmacovigilance, data linkage, legal issues, and prescribing. Interviews were audio-recorded, transcribed and thematically analysed using a framework approach.
Results
Participants identified existing data sharing systems in the UK. Access to healthcare data should be approved by the data owners. The definition of data ownership and associated legal responsibilities for linked healthcare data were seen as important to ensure accountability for the use of linked data. Yet data owners were seen as facilitators of the proposed data linkage. Twelve frameworks (legal, regulatory and governance) applicable to the linkage of healthcare data were identified.
Conclusion
A large number of potentially relevant legal and regulatory frameworks were identified. Ownership of the linked data was seen as an extension of responsibility for, or guardianship of, the source data sets. The consensus emerging from the present study was that clarity is required on the definition of data sharing, data ownership, and responsibilities of data owners.
Original languageEnglish
Article numbere003875
JournalBMJ Open
Volume4
Issue number2
DOIs
Publication statusPublished - 12 Feb 2014

Fingerprint

Pharmacovigilance
Ethics
Ownership
Information Storage and Retrieval
Delivery of Health Care
Information Dissemination
Health
Interviews
Computer Security
Social Responsibility
National Health Programs
Scotland
Drug-Related Side Effects and Adverse Reactions
Information Systems
Consensus
Pediatrics

Keywords

  • pharmacovigilance
  • prescribing
  • data sharing
  • data ownership
  • data linkage

Cite this

Linked health data for pharmacovigilance in children : Perceived legal and ethical issues for stakeholders and data guardians. / Hopf, Yvonne Marina; Bond, Christine M; Francis, Jill J; Haughney, John; Helms, Peter J.

In: BMJ Open, Vol. 4, No. 2, e003875 , 12.02.2014.

Research output: Contribution to journalArticle

@article{e2c1f50866bd4b108a50a1f4b3e4ecce,
title = "Linked health data for pharmacovigilance in children: Perceived legal and ethical issues for stakeholders and data guardians",
abstract = "Objective The inclusion of the Community Health Index (CHI) in the recording of National Health Service (NHS) contacts in Scotland facilitates national linkage of data such as prescribing and healthcare utilization. This linkage could be the basis for identification of adverse drug reactions. The aim of this paper is to report the views of healthcare professionals on data sharing, ownership, and the legal and other applicable frameworks relevant to linkage of routinely collected paediatric healthcare data. Design Qualitative study using semi-structured face-to-face interviews addressing the study aims. Participants Purposive sample of professional stakeholders (n=25) including experts on ethics, data protection, pharmacovigilance, data linkage, legal issues, and prescribing. Interviews were audio-recorded, transcribed and thematically analysed using a framework approach. Results Participants identified existing data sharing systems in the UK. Access to healthcare data should be approved by the data owners. The definition of data ownership and associated legal responsibilities for linked healthcare data were seen as important to ensure accountability for the use of linked data. Yet data owners were seen as facilitators of the proposed data linkage. Twelve frameworks (legal, regulatory and governance) applicable to the linkage of healthcare data were identified. Conclusion A large number of potentially relevant legal and regulatory frameworks were identified. Ownership of the linked data was seen as an extension of responsibility for, or guardianship of, the source data sets. The consensus emerging from the present study was that clarity is required on the definition of data sharing, data ownership, and responsibilities of data owners.",
keywords = "pharmacovigilance, prescribing, data sharing, data ownership, data linkage",
author = "Hopf, {Yvonne Marina} and Bond, {Christine M} and Francis, {Jill J} and John Haughney and Helms, {Peter J}",
year = "2014",
month = "2",
day = "12",
doi = "10.1136/bmjopen-2013-003875",
language = "English",
volume = "4",
journal = "BMJ Open",
issn = "2044-6055",
publisher = "BMJ Publishing Group",
number = "2",

}

TY - JOUR

T1 - Linked health data for pharmacovigilance in children

T2 - Perceived legal and ethical issues for stakeholders and data guardians

AU - Hopf, Yvonne Marina

AU - Bond, Christine M

AU - Francis, Jill J

AU - Haughney, John

AU - Helms, Peter J

PY - 2014/2/12

Y1 - 2014/2/12

N2 - Objective The inclusion of the Community Health Index (CHI) in the recording of National Health Service (NHS) contacts in Scotland facilitates national linkage of data such as prescribing and healthcare utilization. This linkage could be the basis for identification of adverse drug reactions. The aim of this paper is to report the views of healthcare professionals on data sharing, ownership, and the legal and other applicable frameworks relevant to linkage of routinely collected paediatric healthcare data. Design Qualitative study using semi-structured face-to-face interviews addressing the study aims. Participants Purposive sample of professional stakeholders (n=25) including experts on ethics, data protection, pharmacovigilance, data linkage, legal issues, and prescribing. Interviews were audio-recorded, transcribed and thematically analysed using a framework approach. Results Participants identified existing data sharing systems in the UK. Access to healthcare data should be approved by the data owners. The definition of data ownership and associated legal responsibilities for linked healthcare data were seen as important to ensure accountability for the use of linked data. Yet data owners were seen as facilitators of the proposed data linkage. Twelve frameworks (legal, regulatory and governance) applicable to the linkage of healthcare data were identified. Conclusion A large number of potentially relevant legal and regulatory frameworks were identified. Ownership of the linked data was seen as an extension of responsibility for, or guardianship of, the source data sets. The consensus emerging from the present study was that clarity is required on the definition of data sharing, data ownership, and responsibilities of data owners.

AB - Objective The inclusion of the Community Health Index (CHI) in the recording of National Health Service (NHS) contacts in Scotland facilitates national linkage of data such as prescribing and healthcare utilization. This linkage could be the basis for identification of adverse drug reactions. The aim of this paper is to report the views of healthcare professionals on data sharing, ownership, and the legal and other applicable frameworks relevant to linkage of routinely collected paediatric healthcare data. Design Qualitative study using semi-structured face-to-face interviews addressing the study aims. Participants Purposive sample of professional stakeholders (n=25) including experts on ethics, data protection, pharmacovigilance, data linkage, legal issues, and prescribing. Interviews were audio-recorded, transcribed and thematically analysed using a framework approach. Results Participants identified existing data sharing systems in the UK. Access to healthcare data should be approved by the data owners. The definition of data ownership and associated legal responsibilities for linked healthcare data were seen as important to ensure accountability for the use of linked data. Yet data owners were seen as facilitators of the proposed data linkage. Twelve frameworks (legal, regulatory and governance) applicable to the linkage of healthcare data were identified. Conclusion A large number of potentially relevant legal and regulatory frameworks were identified. Ownership of the linked data was seen as an extension of responsibility for, or guardianship of, the source data sets. The consensus emerging from the present study was that clarity is required on the definition of data sharing, data ownership, and responsibilities of data owners.

KW - pharmacovigilance

KW - prescribing

KW - data sharing

KW - data ownership

KW - data linkage

U2 - 10.1136/bmjopen-2013-003875

DO - 10.1136/bmjopen-2013-003875

M3 - Article

VL - 4

JO - BMJ Open

JF - BMJ Open

SN - 2044-6055

IS - 2

M1 - e003875

ER -