Informed consent with electronic signature

In Healthcare, informed consent is used for many diagnostic tests and surgeries. We have all undergone medical tests and surgery in which we were asked to sign a document informing us of the risks and giving our consent. This post explains what informed consent is, where it is regulated when it is used, and the benefits of using electronic signatures.

What is informed consent?

Informed consent is a process whereby medical professionals inform the patient about the treatment to be received, as well as the risks, benefits or alternatives that are available so that the patient can give their consent or not to the treatment

Law 41/2002 of 14 November regulates patients’ autonomy and their rights and obligations about clinical information and documentation.

The regulation of informed consent follows Law 41/2002, of 14 November, the primary law regulating patient autonomy and the rights and obligations regarding clinical information and documentation, which establishes in article 8 that:

  1. Any action in the field of a patient’s health requires the free and voluntary consent of the person concerned after having received the information provided for in Article 4 and assessed the options available in the case.
  2. Consent shall, as a general rule, be verbal.However, it shall be given in writing in the following cases: surgical intervention, invasive diagnostic and therapeutic procedures and, in general, the performance of processes involving known and foreseeable risks or disadvantages to the health of the patient.
  3. The written consent of the patient shall be necessary for each of the actions specified in the previous point of this article, leaving aside the possibility of incorporating annexes and other general data, and shall have sufficient information on the procedure of application and its risks
  4. Every patient or user has the right to be warned about the possibility of using the prognostic, diagnostic and therapeutic procedures applied to him/her in a teaching or research project, which in no case may entail additional risk to his/her health.
  5. The patient may freely revoke his consent in writing at any time.

Therefore, the regulation of informed consent requires that it must be given voluntarily, that the user is provided with information and that he/she understands it. On the other hand, in particular cases, it is required to be written consent and can be signed using an electronic signature.

How does the electronic signature benefit the informed consent process?

For a long time, informed consent was obtained on a hard copy document, but this posed several problems such as the loss or deterioration of the paper, the user’s possibility of denying the authenticity of their signature, etc. But thanks to the benefits of electronic signatures over informed consent, the following advantages are obtained:

  • Accessibility. The document can be easily consulted at any time and from any device.
  • Saving resources. Electronic signatures are cheaper and more eco-friendly as it is unnecessary to print documents or travel to sign.
  • Legal validity. Electronic signatures are legally valid under European Regulation 910/2014, known as eIDAS, which states in Article 25.1 that an electronic signature shall not be denied legal effect and admissibility as evidence in legal proceedings merely because it is an electronic signature or because it does not meet the requirements of a qualified electronic signature.
  • Documentary evidence. During the process of electronically signing of the informed consent, data of the complete process is recorded to strengthen its legal validity: data of the sender and receiver, data of the emails and IPs involved, timestamp, dates of sending, signed document and attachments, etc.
  • Document’s integrity. The electronic signature process guarantees that the signed document has not been altered or tampered with after signing so that it cannot be fraudulently altered.
  • Traceability. Through the electronic signature process of the informed consent, it is known whether the document has been signed and when.
  • Legal validity. Electronic signatures provide legal security, as we have seen, and security in that it is much more difficult, if not impossible, for the document to be lost.
  • Cost savings. The electronic signature of informed consent is cost-saving: it saves fuel as there is no travelling, it saves energy and ink as no printer is used, and it saves physical space as there is no hard copy paper.
  • Documentary evidence. As a result of the legal validity of the electronic signature and the existence of all the electronic evidence mentioned above, an informed consent signed with an electronic signature can be used as legal evidence in a trial.
  • Storage. Informed consent is a fundamental element of patients’ clinical records, which is why they can request a copy of it, and the aforementioned law makes it obligatory to keep the clinical records for a term of at least fifteen years from the time of release from each health care process. Therefore, informed consent should also be stored during this time, and the electronic signature makes it easier.

As you have already observed, informed consent is essential for many diagnostic tests, and the use of electronic signatures can make a significant contribution to speeding up and simplifying procedures.

If you still have doubts about the usefulness of this type of signature, do not hesitate to register and try the electronic signature for free.

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