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An Ethically Supported Framework for Determining Patient Notification and Informed Consent Practices When Using
Susannah L Rose1, Devora Shapiro2
1Center for Bioethics and Society, Department of Bioinformatics, Vanderbilt University Medical Center, Vanderbilt University, Nashville, TN.
Hospital leaders need clear guidelines on informing patients about artificial intelligence (AI) in healthcare. This study proposes a framework to determine when notification or informed consent is necessary for AI use, fostering patient trust.
Area of Science:
- Healthcare Technology
- Medical Ethics
- Artificial Intelligence
Background:
- Artificial intelligence (AI) is rapidly integrating into healthcare delivery.
- Lack of standardized ethical guidelines for AI notification risks patient mistrust.
- Hospital leaders require guidance on patient communication regarding AI in care.
Purpose of the Study:
- To provide a framework for hospital leaders to determine when patients should be informed about AI use.
- To establish criteria for categorizing AI technologies based on notification and informed consent requirements.
- To promote ethical and transparent AI implementation in healthcare.
Main Methods:
- Proposed a 5-criteria framework for evaluating AI use-cases: autonomy, departure from standards, patient-facing nature, clinical risk, and administrative burden.
- Utilized case examples to illustrate the application of the proposed framework.
- Categorized AI technologies into: no notification/informed consent, notification only, and formal informed consent.
Main Results:
- The proposed framework offers a structured approach to AI use-case evaluation.
- Identified key factors influencing the level of patient notification and informed consent required.
- Demonstrated how to apply the framework using a healthcare AI case example.
Conclusions:
- The proposed framework can serve as a foundation for developing consensus on AI notification and informed consent standards.
- Ethical and transparent communication about AI in patient care is crucial for building trust.
- Standardized guidelines are needed as AI becomes more prevalent in healthcare.
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