The "Regulation on Obtaining Informed Consent in Electronic Environment," prepared by the Ministry of Health, was published in the Official Gazette dated October 27, 2026. The regulation establishes the procedures and principles regarding the electronic collection of informed consent provided by patients prior to medical interventions.
The regulation, which covers primary, secondary, and tertiary healthcare facilities, provides for the creation, recording, and secure storage of consent forms in an electronic environment.
HOW WILL THE APPROVAL PROCESS WORK?
According to the regulation, patients will be able to access the informed consent form via e-Nabız or through the electronic communication tools of healthcare facilities. The form prepared by healthcare personnel will be accessible via a link sent to the patient's verified mobile phone.
If the patient accepts the medical intervention after reviewing the form, they will provide approval using a one-time SMS password sent to their mobile phone. For transactions made via e-Nabız, the password will be entered into the system by the patient. If the healthcare facility's electronic communication tool is used, the patient will share the password sent to them with the relevant healthcare personnel.
Once the verification process is completed, informed consent will be considered obtained in an electronic environment. For this process, the patient must have a verified mobile phone number.
Patients who do not have a verified phone number in e-Nabız will be able to register their numbers in the system via SMS verification. Mobile phone numbers verified through the electronic systems of healthcare facilities will be valid for 12 months; at the end of this period, re-verification will be required for electronic consent transactions.
Consent forms obtained in an electronic environment will be transferred to the Ministry of Health's central health data system and made accessible to patients via e-Nabız. Records regarding the date, time, SMS verification information, and the healthcare personnel who performed the transaction will also be stored.
Technical measures such as encryption and time stamping will be applied for the security, integrity, and confidentiality of the records. Electronic consent transactions for minor or incapacitated patients will be carried out by their legal representatives within the scope of the Patient Rights Regulation.
In cases where a legal representative is not present, unavailable, or their identity cannot be verified electronically, electronic consent cannot be obtained.
News Source: 12punto
