Dissecting liabilities in adversarial surgical robot failures: A national (Danish) and EU law perspective
This academic paper examines liabilities arising from adversarial cyberattacks on surgical robots from both a Danish national and European Union law perspective. It proposes a taxonomy for adversarial and non-adversarial failures in cyber-physical medical systems and evaluates how existing frameworks like the EU Medical Device Regulation and Danish tort and product liability apply. The authors also discuss administrative remedies such as the Danish Patient Compensation system as a streamlined mechanism for patient recovery.
Summary and content fields are drawn from the document text and are pending editorial review.
Who issued it
Who it governs
Researchers, legal scholars, and medical device manufacturers seeking to understand liability frameworks and cybersecurity challenges in surgical robotics.
What the document contains
The paper covers the categorization of security and safety failures in surgical robotics, the application of the European Medical Device Regulation and proposed AI regulations, and an in-depth legal analysis of civil litigation and administrative patient compensation in Denmark.
The text does not provide empirical case law specifically involving adversarial cyberattacks on surgical robots, as no such incidents have been publicly adjudicated in Denmark or Nordic courts.
- Surgical robots function as cyber-physical systems whose network connectivity exposes them to both safety and security failures.
- The EU Medical Device Regulation governs surgical robots and imposes strict risk and quality management obligations on manufacturers, though it lacks literal references to cybersecurity.
- Danish law provides multiple avenues for patient recovery, including product liability lawsuits, traditional tort claims, and the administrative Patient Compensation system.
- Proving the causal link between a sophisticated cyberattack and patient injury in court presents significant evidentiary challenges for claimants.
- Administrative compensation schemes like Denmark's Patient Compensation provide a technology-neutral and effective remedy by focusing strictly on equipment failure rather than underlying causes.
· 1 Introduction · 2 Definitions - 2.1 Surgical Robots - 2.2 Cyberphysical Systems - 2.3 Adversarial failures - 2.4 Adversarial model · 3 Legal Sources · 4 The European Medical Device Regulation - 4.1 Background - 4.2 Guidance on Cybersecurity - 4.3 Manufacturers - 4.4 Regulators - 4.5 Comments on the MDR - 4.6 The Future AI Regulation · 5 Danish law - 5.1 Product liability - 5.2 Patient Compensation Association - 5.3 Reimbursement Outside of Contract - 5.4 Adversarial Considerations · 6 Additional Perspectives · 7 Future Work · 8 Conclusion
How it scores
Each score is backed by a quote verified against the document text. Editorial review has not yet confirmed them.
Accountability
4/5Clear responsibility for AI outcomes
The term sole responsibility refers to the manufacturer’s role as both the creator and controller in Article 10(12), in the sense that any non-compliance by the device has to be relayed to the regulator
4.3 Manufacturers
screening score · 2026-10-23
Fairness
0/5Non-discrimination and equitable treatment
screening score · 2026-10-23
Human Dignity
0/5Respect for the inherent worth of persons
screening score · 2026-10-23
Human Oversight
0/5Humans remain in control of consequential decisions
screening score · 2026-10-23
Privacy
1/5Protection of personal data and private life
inferring the surgical procedure to compromise patient privacy
2.3 Adversarial failures
screening score · 2026-10-23
Transparency
0/5Openness about how AI systems work and are used
screening score · 2026-10-23