As artificial intelligence and robotic surgery become widespread in medicine, the classical "physician responsibility" model is being challenged. The actions of multiple actors (physician, hospital, manufacturer, software provider) combine into a single medical outcome.
Sharing Responsibility
- Physician: Competency to use the device, parameter setting, control.
- Hospital: Device maintenance, calibration, training, spare personnel.
- Manufacturer: Device design, manufacturing defect, user manual.
- Software provider: Algorithm quality, updates, training data.
Medical Device Error — TKHK and TBK
- Law No. 4703 on the Preparation and Implementation of Technical Legislation Regarding Products.
- Law on Consumer Protection No. 6502 (defective goods).
- TBK art.519-540 producer's responsibility.
- Liability insurance requirement (Ministry of Health).
AI Error Types
- Misdiagnosis: Faulty premise of AI.
- "Black box" problem: Failure to explain AI decision
- Biased data: Reflection of race/gender inequality in the training set.
- Currentness: Application of the old algorithm to the new case.
Physician's Responsibility - Assistant Tool
The AI/robot is the physician's assistant tool; The final decision belongs to the doctor. The Supreme Court continues this approach:
- The physician should not blindly accept the AI recommendation.
- In case of device malfunction, the physician must have manual intervention competence.
- The "AI misled" defense does not remove the physician's obligation to supervise.
Supreme Court 13th HD — Expected Approach
The Supreme Court 13th HD will also apply the classical malpractice criteria to AI/robotic surgery files: informed consent (notification that the device will be used), compliance with medical standards, search for fault. In cases where AI error is alleged, the victim must prove that the error is at an "unacceptable level".
Informed Consent — Expanded Content
- Device/AI to be used.
- What the device/AI can do and its limits.
- Existence of manual alternative methods.
- Possible additional risks arising from the device.
Practical Tips
AI/robotic surgery malpractice files will become common in the future. Health and IT law lawyer should work together.