Accepted for/Published in: JMIR Research Protocols
Date Submitted: Aug 10, 2025
Date Accepted: Dec 22, 2025
Development of an Ethico-legal Framework for Quality Improvement and Performance Management in Healthcare: Protocol for a Qualitative Study
ABSTRACT
Background:
The growing digitisation of health data has expanded opportunities for professional learning and performance improvement. While providing new means for improving the quality and safety of healthcare these new capabilities for data analysis and performance monitoring come with risks and may exacerbate existing ethico-legal concerns about fairness, accountability, privacy and more.
Objective:
This study aims to develop an ethico-legal framework for the evaluation of professional performance that is cognisant of these concerns and addresses the needs of relevant stakeholders. The study will assess the acceptability, comprehensiveness and potential utility of the framework from the perspective of end-users and subject matter experts.
Methods:
This study will utilise existing evidence about ethico-legal considerations surrounding secondary uses of health data for performance improvement and management to draft the framework. We will conduct two focus groups with end-users (e.g., health professionals, administrators) and subject matter experts (e.g., clinical ethicists, legal practitioners) respectively. These focus groups will ask participants to reflect on the frameworkâs structure and comprehension, intended audience, comprehensiveness and relevance of ethical and legal principles, limitations and the utility and acceptability of the framework as a step-by-step guide. This feedback will be thematically analysed involving open coding and verified by an independent reviewer at the focus groups, followed by constant comparisons of feedback in this study to concepts and interrelationships in data previously collected.
Results:
Recruitment for this study is scheduled for August and September 2025. The final comprehensive analysis of the results is planned for late September to October 2025, after all data has been transcribed and thoroughly reviewed.
Conclusions:
This study seeks to create an actionable tool that is readily translatable to clinical practice in collaboration with end-users and subject matter experts. The proposed methodology is a low-resource solution that could be used to periodically update policies and procedures in accordance with stakeholder expectations and technological developments, while the proposed solution, the framework, could support robust and efficient use of practice analytics in performance management that is consistent with regulatory standards, ethical principles and the changing context of health care. Clinical Trial: Not applicable.
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