What is an Informed Consent?

Informed consent is the patient's right to receive understandable, sufficient and appropriate information about a medical treatment or procedure, so that he/she can make a free and voluntary decision about whether or not to undergo the procedure.

Signing of Informed Consent

Informed consent does not always need to be signed, since, according to current legislation, it can be either verbal or written, depending on the nature of the medical procedure and the associated risks.

According to Law 41/2002, as a general rule, informed consent is verbal for low-risk or routine procedures, such as a medical consultation or the administration of a commonly used medication.

Informed consent must be signed (written) for procedures involving greater risks or repercussions for the patient's health. According to Article 8 of this law, this includes:

• Surgical interventions.
• Invasive diagnostic and therapeutic procedures.
• Any procedure involving risks or inconveniencesof notorious and foreseeable negative repercussions on the patient's health.

Written consent guarantees greater legal protection for both the patient and the healthcare personnel, as it provides clear evidence that the patient has been adequately informed and has accepted the procedure.

Electronic Signature of Informed Consents

The electronic signature of informed consents is a tool that speeds up the process of obtaining consent, maintaining legal validity and ensuring the authenticity and security of the patient's consent. This modality offers multiple advantages and adapts to the requirements of current regulations, which allow the digitalization of documents and the use of electronic media in various procedures, including medical consents.

Advantages of electronic signature for informed consents:

1. Time and resource savings: Consents can be managed more quickly and efficiently, eliminating the need for physical signatures and travel.
2. Accessibility: Allows patients to sign from any location and device, facilitating processes such as telemedicine or clinical trials in multiple locations.
3. Increased security and traceability: Electronic signatures ensure that a verifiable digital record of consent is maintained, with timestamps that guarantee authenticity and prevent the possibility of alterations.
4. Legal compliance: Qualified electronic signatures have the same legal validity as a handwritten signature, ensuring compliance with healthcare regulations.
5. Data protection: Electronic signatures facilitate the management of medical documents within a secure digital framework, protecting confidentiality and complying with data protection regulations.

XolidoSign allows you to electronically sign informed consents in a secure, simple and effective way, eliminating paper and saving management costs and time. In addition, you will be able to have templates of all the Informed Consents that your Center has in the platform itself, making their management easier.