Patient consent for the secondary use of health data in artificial intelligence (AI) models: A scoping review

Abstract

Background

The secondary use of health data for training Artificial Intelligence (AI) models holds immense potential for advancing medical research and healthcare delivery. However, ensuring patient consent for such utilization is paramount to uphold ethical standards and data privacy. Patient informed consent means patients are fully informed about how their data will be collected, used, and protected, and they voluntarily agree to allow their data to be used for AI models. In addition to formal consent frameworks, establishing a social license is critical to foster public trust and societal acceptance for the secondary use of health data in AI systems. This study examines patient consent practices in this domain.

Method

In this scoping review, we searched Web of Science, PubMed, and Scopus. We included studies in English that addressed the core issues of interest, namely, privacy, security, legal, and ethical issues related to the secondary use of health data in AI models. Articles not addressing the core issues, as well as systematic reviews, meta-analyses, books, letters, conference abstracts, and study protocols were excluded. Two authors independently screened titles, abstracts, and full texts, resolving disagreements with a third author. Data was extracted using a data extraction form.

Results

After screening 774 articles, a total of 38 articles were ultimately included in the review. Across these studies, a total of 178 barriers and 193 facilitators were identified. We consolidated similar codes and extracted 65 barriers and 101 facilitators, which we then categorized into four themes: “Structure,” “People,” “Physical system,” and “Task.” We identified notable emphasis on “Legal and Ethical Challenges” and “Interoperability and Data Governance.” Key barriers included concerns over privacy and security breaches, inadequacies in informed consent processes, and unauthorized data sharing. Critical facilitators included enhancing patient consent procedures, improving data privacy through anonymization, and promoting ethical standards for data usage.

Conclusion

Our study underscores the complexity of patient consent for the secondary use of health data in AI models, highlighting significant barriers and facilitators within legal, ethical, and technological domains. We recommend the development of specific guidelines and actionable strategies for policymakers, practitioners, and researchers to improve informed consent, ensuring privacy, trust, and ethical use of data, thereby facilitating the responsible advancement of AI in healthcare.