Informed consent and autonomy in decision-making of the patient[1] is guaranteed under Article 8 ECHR[2] and Article 11 ESC.[3] Article 5 of the Oviedo Convention requires free and informed consent for health interventions, with prior information on purpose, risks, and consequences. Consent can be withdrawn at any time. Special consideration is given to emergency situations, and to individuals unable to consent.[4]

Individuals must be able freely to give or refuse their consent to any intervention, comprising all medical acts including those performed for the purpose of preventive care, diagnosis, treatment, rehabilitation or research. Their consent is considered to be free and informed when it is given on the basis of objective and full information from the responsible health care professional which includes adequately answering to requests for additional information. The provision of information should be detailed enough for the patient to understand the scope, areas and stages of the use of AI tools. The “black box” nature of many AI systems which render probabilistic results makes it difficult to sufficiently understand and weigh up the necessity or usefulness of the intervention. Adequate transparency and oversight requirements for AI systems and their developers as well as education and training of doctors using them might mitigate this. Concerns about the “de-skilling” of health professionals and the de-personalisation of the patient-doctor relationship require attention. [5]

 

[1] Autonomy goes beyond informed consent and engenders a more active role for the patient in shared decision-making, encompassing, for example, the choice to take preventive measures, to ask for a second opinion or to introduce his or her own values, preferences and perspectives in patient-doctor communications, see CDBIO Report p. 13.

[2] Trocellier v. France (dec.), No. 75725/01, 13 April 2023, § 4; Mayboroda v. Ukraine, No. 14709/07, § 52.

[3] Transgender Europe and ILGA Europe v. Czech Republic, Complaint No. 117/2015, 15 May 2018, §81.

[4] Articles 6-8. See also the Explanatory Report to the Oviedo Convention, paragraphs 35-36.

[5] In accordance with Article 4 of the Oviedo Convention, any intervention in the health field must be carried out in accordance with relevant professional obligations and standards. This is interpreted as an obligation of health professionals to pay careful attention to the special needs of each patient. See paragraphs 32 and 33 of the Explanatory Report to the Oviedo Convention.