Next-Generation Capabilities in Trusted Research Environments: Interview Study.

Background: A Trusted Research Environment (TRE; also known as a Safe Haven) is an environment supported by trained staff and agreed processes (principles and standards), providing access to data for research while protecting patient confidentiality. Accessing sensitive data without compromising the...

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Published in:Journal of Medical Internet Research Vol. 24; no. 9
Main Authors: Kavianpour, Sanaz, Sutherland, James, Mansouri-Benssassi, Esma, Coull, Natalie, Jefferson, Emily
Format: research Journal Article
Published: JMIR Publications Inc. Sep2022
Online Access:View this record in EBSCOhost
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      jtl: Journal of Medical Internet Research
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      dt: Sep2022
      vid: 24
      iid: 9
      pid: 21567
      pub: JMIR Publications Inc.
      place: Toronto, Ontario
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        10.2196/33720
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        atl: Next-Generation Capabilities in Trusted Research Environments: Interview Study.
      aug:
        au:
          Kavianpour, Sanaz
          Sutherland, James
          Mansouri-Benssassi, Esma
          Coull, Natalie
          Jefferson, Emily
        affil: 1 School of Design and Informatics, Abertay University, Dundee, United Kingdom
      sug:
        subj:
          Artificial Intelligence
          Data Security
          Privacy and Confidentiality
          Qualitative Studies
          Human
      ab: Background: A Trusted Research Environment (TRE; also known as a Safe Haven) is an environment supported by trained staff and agreed processes (principles and standards), providing access to data for research while protecting patient confidentiality. Accessing sensitive data without compromising the privacy and security of the data is a complex process.Objective: This paper presents the security measures, administrative procedures, and technical approaches adopted by TREs.Methods: We contacted 73 TRE operators, 22 (30%) of whom, in the United Kingdom and internationally, agreed to be interviewed remotely under a nondisclosure agreement and to complete a questionnaire about their TRE.Results: We observed many similar processes and standards that TREs follow to adhere to the Seven Safes principles. The security processes and TRE capabilities for supporting observational studies using classical statistical methods were mature, and the requirements were well understood. However, we identified limitations in the security measures and capabilities of TREs to support "next-generation" requirements such as wide ranges of data types, ability to develop artificial intelligence algorithms and software within the environment, handling of big data, and timely import and export of data.Conclusions: We found a lack of software or other automation tools to support the community and limited knowledge of how to meet the next-generation requirements from the research community. Disclosure control for exporting artificial intelligence algorithms and software was found to be particularly challenging, and there is a clear need for additional controls to support this capability within TREs.
      pubtype: Academic Journal
      doctype:
        research
        Journal Article
      ougenre: Article
    language: English
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