Currently submitted to: Journal of Medical Internet Research
Date Submitted: Mar 2, 2026
Open Peer Review Period: Mar 6, 2026 - May 1, 2026
(currently open for review)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Ethical, Legal, and Social Implications of Automated Adverse Drug Reaction Detection: Applying the VALIDATE Framework in a Systematic Review
ABSTRACT
Background:
Automated systems for detecting adverse drug reactions (ADRs) are increasingly common and carry high expectations from policymakers, researchers, healthcare professionals, and patients, yet evidence of their effectiveness and safety remains limited
Objective:
The aim of this systematic review was to identify the ethical, legal, organizational, social, and environmental implications of these systems.
Methods:
We conducted a systematic using the VALIDATE framework, we conducted a three-step approach: (1) defining scope through literature review and stakeholder consultation; (2) systematic review; (3) environmental inquiries.
Results:
Stakeholders prioritized research on feasibility, barriers, facilitators, alarm management, staged implementation, confidentiality, cybersecurity, and bias detection. The systematic review of ten studies revealed that leveraging new data sources and developing privacy-protection technologies is essential for upholding ethical and legal standards. Cybersecurity risks could expose patient information to unauthorized parties, while biases in training datasets can compromise fairness. Integrating ADR detection into clinical workflows and medication management systems can improve resource optimization and reporting rates. Establishing a positive reporting culture, supported by education and training for healthcare teams, is crucial to enhance ADR reporting.
Conclusions:
Careful planning is critical when implementing an early ADR detection system. Incorporating co-design methodologies can help align these automated systems with stakeholder needs and improve medication safety. Clinical Trial: Not requiered
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