Legal implications of AI standard of care integration on patients’ informed consent - lessons from surgery

Sep 29, 2026

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AI integration into clinical practice raises new legal and ethical questions, especially during transitions from conventional surgery technologies to AI-enabled tools that affect diagnostics and decision support. This Perspective analyzes prior legal cases involving informed consent connected to new surgical technologies to clarify how standard-of-care integration can reshape consent adequacy and liability risk. It also contrasts medical-ethics principles of autonomy and meaningful choice with legal standards that assess consent sufficiency for liability, considering challenges from explainability limits and patient trust.

LanguageEnglish

CategoryHealthcare

FormatPDF

Pages5

Reading Time13 min

AccessFree to download

Questions about the impact of AI on informed consent

A legal primer on treatment malpractice and consent malpractice

npj | digital medicine Perspective | Published in partnership with Seoul National University Bundang Hospital | | | | --- | --- | --- | | [https://doi.org/10.1038/s41746-025-02157-1](https://doi.org/10.1038/s41746-025-02157-1) | | | | Legal implications of AI standard of care integration on patients’ informed consent: lessons from surgery
Check for updates | | | | Mindy N. Duffourc1 & Ronan A. Cahill2,3 | | | | AI integration into clinical practice can introduce novel legal and ethical questions, but there are still important parallels with past medical innovations in how they have been phased into clinical practice and impact consent. This Perspective examines prior legal cases that speciﬁcally evaluate consent in connection with use or availability of new surgical technologies to offer valuable insights into how AI integration can impact informed consent during this transition phase. | | | | Artiﬁcial intelligence (AI) has ignited a critical turning point in digital medicine, shifting the focus from digitization for the sake of efﬁciency to digital tools for clinical efﬁcacy1. What is remarkable for AI, aside from the sophistication of the technology itself, is the broad scope of its potential applications and the speed of its expected integration into clinical care2,3. This transition period brings questions about how AI technologies, particularly those that provide diagnostics and clinical decision-support at the point of care, will disrupt both treatment and the patient-doctor relationship4. Doctors5 and patients6 indicate that AI integration into clinical care will impact the consent process, but the degree and quality of this impact remain unclear.
As AI technologies begin to play a role in directing, or at least impacting, patient care, it is important to consider how the process of informed consent can help preserve patient autonomy7. Because legal evaluations of informed consent often arise in the context of surgery8, important lessons about how standard of care integration for new surgical technologies has impacted medio-legal assessment ofinformed consent can provide some insight for clinical practice more generally.
Questions about the impact of AI on informed consent Informed consent has both ethical and legal dimensions. From the standpoint of medical ethics, consent conversations are a critical part of the patient-doctor relationship9. They proactively advance patient autonomyby ensuring that patients have both relevant information and selfdetermination throughout the medical treatment process. As a preliminary matter, informed consent for medical treatment should be distinguished from informed consent for health data processing in connection with AI use and development. In the context of medical treatment, AI has the potential to impact informed consent by introducing new challenges that stem from the complexity inherent in the technology. For example, the algorithmic reasoningprocess throughwhich anAI-driven tool producesan | output may not always be completely (or at all) understandable by humans (i.e., black-box AI). This opacity makes it difﬁcult to explain the technology that underlies an AI’s clinically relevant output, which itself may support or contradict the physician’s diagnosis or treatment recommendation10. Additionally, a lack of understanding about AI technology generally, especially during transition periods, may make patients fearful of safety and privacy risks that might arise from the use of AI in their medical care11. For these reasons, among others, the World Health Organization recommends that the ethical use ofAI in “diagnosis, prognosis and treatment plans should be incorporated into the process for informed and valid consent”12.
On the other hand, overly burdening the consent process might not improve autonomy or the therapeutic relationship, particularly when AI integration does not present material risks13. Mello et al. suggest that too much disclosure about

FAQs

How does AI integration change the informed consent process in clinical care?

AI integration can introduce new consent challenges because AI outputs may be difficult for humans to understand and can create safety and privacy concerns. The impact also depends on whether the AI tool alters treatment decisions in a way patients can meaningfully evaluate.

What ethical principles guide informed consent in the AI transition period?

Informed consent supports patient autonomy within the patient-doctor relationship by providing relevant information and enabling self-determination. The Perspective emphasizes keeping consent discussions focused on empowering autonomy rather than disclosing information for disclosure’s sake.

How do legal standards evaluate informed consent when new technologies are introduced?

Legally, consent is tied to autonomy and self-determination, but courts assess whether the consent process is sufficient for liability purposes. Since there are no cases yet directly about AI medical technologies, the Perspective draws insights from prior cases involving consent for other new surgical techniques.

Sep 29, 2026

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