AI in Healthcare: What Healthcare Providers Should Know

Clinical AI systems are not autonomous. They are designed, developed, validated, deployed, and used by human stakeholders. A clinical diagnosis or triage suggestion made by an AI model has several layers before being acted upon.

There is, therefore, an underlying question:

Was the damage caused by the technology itself, by the way it was implemented, or by the way it was used?

The answer determines liability.

1. The Clinician: Primary Duty of Care

In today’s health care setup, health care providers’ decisions, even in those supported by AI, do not exempt them from legal liability.

If a recommendation is offered by an AI and the following conditions are met by the clinician, then:

• Accepts it without appropriate clinical judgment, or
• Neglects obvious signs that go against the result produced by AI,

So, in many instances, the liability may rest with the clinician. AI systems are not considered autonomous decision-makers but rather decision-support systems by courts.

Legally speaking, the doctor’s duty of care for the patient is not relinquished merely because software was used. This is supported by regulatory bodies, including the FDA in the United States, which considers a majority of the clinical use of AI to be assistive, not autonomous.

2. The Hospital or Healthcare Organization

Healthcare providers can be held responsible for damage caused by system-level issues, for instance:

• Lack of adequate training among staff
• Poor incorporation of AI in clinical practices
• Ignoring known limitations of the system or warnings about safety

For instance, if an AI decision-support system is required by a hospital in terms of triage decisions but an accompanying guideline is lacking regarding under what circumstances an override decision by clinicians is warranted, then the hospital could be held jointly liable for any errors that occur.

With the aspect of vicarious liability in place, the hospital can be potentially responsible for negligence committed through its in-house professionals utilizing hospital facilities.

3. AI Vendor or Developer

Under product liability or negligence, AI developers can be made responsible, especially if negligence occurs in relation to:

• Inherently Flawed Algorithm/Design Issues in Models
• Biased or poor quality training data
• Lack of Pre-Deployment Testing
• Lack of disclosure of known limitations or risks

If an AI system is malfunctioning in a manner inconsistent with its approved use, market claims, legal liability could shift toward the vendor. This leaves developers open to legal liability in case their tools end up malfunctioning in a manner inconsistent with their approved use

But vendors tend to mitigate any responsibility for liability by stating that the use of the AI system should be under clinical supervision, since it is advisory only. Whether this will be valid under any legal system is yet to be tested.

4. Regulators & Approval Bodies (Indirect Role)

The regulatory bodies are not responsible for liability pertaining to clinical mistakes, but regulatory standards govern liability.

The World Health Organization, together with various regulatory bodies, is placing a mounting importance on the following:

• Transparency and explainability
• Human-in-loop decision making
• Continuous monitoring of AI performance

Non-compliance with legal standards may enhance the validity of legal action against hospitals or suppliers in the event of injuries.

5. What If the AI Is “Autonomous”?

This is where the law gets murky.

This becomes an issue if an AI system behaves independently without much human interference, such as in cases of fully automated triage decisions or treatment choices. The existing liability mechanism becomes strained in this scenario because the current laws were never meant for software that can independently impact medical choices.

Some jurists have argued for:

• Contingent liability schemes
• Mandatory Insurance for AI MitsuruClause Insurance for AI
• New legal categorizations for autonomous medical technologies

At least, in today’s world, most medical organizations do not put themselves at risk in this manner, as they do, in fact, mandate supervision by medical staff.

6. Factors Judged by the Court for Errors Associated with AI

In applying justice concerning harm caused by artificial intelligence, the courts usually consider:

• Was the AI used for the intended purpose?
• Was the practitioner prudent in medical judgment?
• Was the AI system sufficiently tested and validated?
• Were limitations well defined?
• Was there proper training and governance in the organization?

The absence or presence of AI may not be as crucial to liability but rather its responsible use.

The Emerging Consensus

The general world view is that AI does not replace responsibility. Rather, the responsibility is shared in the AI environment in the following ways:

• Healthcare Organizations: Responsible for the governance & implementation
• Suppliers of AI systems: liable for secure design and honest representation

This shared responsibility model acknowledges that AI is not a value-neutral tool or an autonomous system it is a socio-technical system that is situated within healthcare practice.

Conclusion

Consequently, it is not only technology errors but also system errors. The issue of blame in assigning liability focuses not on pinning down whose mistake occurred but on making all those in the chain, from the technology developer to the medical practitioner, do their share.

Until such time as laws catch up to define the specific role of autonomous biomedical AI, being responsible is a decidedly human task. There is no question about the best course in either safety or legal terms. Being human is the key. Keep the responsibility visible, traceable, and human.