Today, when the digitization of documents and digital transformation become essential for a large number of sectors, the digitization of informed consent for health care institutions, such as hospitals, is necessary.

In some countries, as in Spain for example, consent must be given in writing in certain cases, which requires the patient’s personal signature as proof of consent.

This need for a handwritten signature puts us in front of two options: the digitization of documents or the use of digital solutions such as the electronic signature to sign informed consent.

The digitization of a paper document often results in a change of format, which usually results in a loss of information and thus a loss of evidentiary capacity and is therefore not recommended. However, when using electronic signature solutions, this format change would not occur, since the document is in electronic form right from the start and it isn’t changed throughout its life cycle.

In the following post, we’ll analyze the good use of digital signatures for informed consent from a legal point of view. We’ll point out the advantages of electronically signing such sensitive documents and we’ll see in detail how to choose a secure and suitable signature system for these cases.

Is it adequate to use electronic signatures for obtaining informed consents?

In the UK, informed consent is defined in Regulation 11 of The Health and Social Care Act 2008:
“Regulation 11. Need for consent.

1. Care and treatment of service users must only be provided with the consent of the relevant person.
Although the law allows the patient’s consent to be obtained verbally, the usual practice of doctors and clinics nevertheless is to choose the written form in order to be able to provide evidence
in the event of a legal dispute.

Even though many still opt for the paper-based system, the question arises as to whether the digital signature is valid for signing informed consent. The current eIDAS regulation makes a clear statement in this regard:

“An electronic signature shall not be denied legal effect and admissibility as evidence in legal proceedings solely on the grounds that it is in an electronic form or that it does not meet the requirements for qualified electronic signatures. A qualified electronic signature shall have the equivalent legal effect of a handwritten signature.”

Therefore, electronic signatures are valid for the signature of informed consent.

What are the advantages of using the digital signature for informed consent?

  • It makes it easier for patients to understand the information and improves their relationship with the health professional.
  • Streamlines processes since no printing is required and the user only needs to sign on one device.
  • Reduces the cost of printing and archiving physical documents as well as mailing and furthermore reduces time previously needed to carry out those tasks.
  • Besides the economic benefits, digital signatures also have a positive impact on the environment through saving paper, reducing printer use, etc.
  • Reduces the possibility of errors such as the loss of information (paper).

Although all electronic signatures are in principle valid for signing informed consent, certain types of electronic signatures are legally more valid and also have better usability– two essential elements for signing sensitive documents. It is therefore necessary when choosing the right signature method, to evaluate usability and security of the solution in question.

Why is VIDsigner the optimal electronic signature for signing informed consent and other sensitive documents?

  1. It guarantees that the patient can see what he is signing (WYSIWYS): an essential requirement for signing informed consent and a feature that is not available on signature pads since the document cannot be visualized by the user in these devices.
  2. Legal security: Being a service and not a product it’s legally more secure. In addition, it’s compliant with the most demanding requirements.
  3. Legal responsibility: At VIDsigner, we assume full responsibility for the legal risks associated with our service and have legal experts for public key infrastructure (PKI) and electronic signatures.
  4. Integration with other software: Our electronic signature has more than 500 customers in healthcare and 60 integrations via REST API.
  5. Flexible solution: VIDsigner adapts to any scenario, and offers different signature methods that can be combined with each other to seamlessly adapt to the needs of teams and individuals.
  6. Internationally recognized: VIDsigner’s signature service has been awarded as one of the Top 10 Patient Engagement Solution Providers in Europe.

The VIDsigner electronic signature service responds to the needs of the health sector in terms of obtaining the patient’s informed consent and its ratification by the doctor, as the signatures created with VIDsigner have maximum legal validity. The service also allows the use of two signature methods in the same document: it can register the patient’s advanced electronic signature by capturing handwritten signature (BIO signature), and the Centralized signature based on the doctor’s qualified certificate. All of this, without transferring the technological complexity of electronic signatures to the patient and ensuring full user-friendliness.

There is no digital transformation without dematerialisation of informed consent, but the most important thing is that it offers maximum legal security

As explained above, the use of an electronic signature service to sign informed consent and sensitive documents is not only legally valid but also simplifies and streamlines the process by ensuring that the patient is familiar with what he signs and comfortable with how he signs it.

However, not all electronic signatures are the same and, as noted earlier, there are different types of electronic signatures legally more valid and suitable for different scenarios of use. Therefore, when choosing an electronic signature system, it’s important to choose the method which combines more usability and legal security for obtaining informed consent and other confidential documents.

If you are looking for a digital signature solution for your business or service, contact us for more information and we’ll recommend the signature method that best suits your needs.

Validated ID Team