Next-generation capabilities in trusted research environments: interview study

Sanaz Kavianpour, James Sutherland*, Esma Mansouri-Benssassi, Natalie Coull, Emily Jefferson

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

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Abstract

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.

Original languageEnglish
Article numbere33720
Number of pages14
JournalJournal of Medical Internet Research
Volume24
Issue number9
Early online date20 Sep 2022
DOIs
Publication statusPublished - 20 Sep 2022

Keywords

  • Data safe haven
  • Health data analysis
  • Trusted research environment
  • TRE

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