The informed consent requires the written form in certain circumstances; this also implies the need of obtaining the sign of the patient as proof of consent. This need to include the hand-written sign makes difficult the dematerialization process of this informed consent and, as a consequence, has an effect on the consecution of a complete Electronic Clinic Expedient.
Doing an electronic copy of a document in paper represents a modification of the format, and a modification often represents the loss of information, and, as a consequence, the loss of probatory capacity.
For example, when we digitalize a document in paper, depending of the resolution and the colors, we lose information of the original picture. But there is more information in the paper besides the image itself. For example, if there is a hand-written signature, there is also information of its tracing (parameters such as the pressure, the way the trace is done and others) that may be useful for a hand-writing expert to evaluate its validity.
For this reason, it is relevant, at the moment of deciding which documents may be digitalized and the originals destroyed, evaluating in an adequate way the loss of value of probatory proof, the risk that entails and its administration.
In this ambit we must therefore conclude that, it should not be recommended to digitalize these informed consents, due to the loss of relevant information that may later determine the consent or not of the person interested on matters of special relevance as they could be the medical acts specified in the regulation.
Nevertheless the above-mentioned, exists an alternative to digitalization of informed consents: the use of electronic signatures solutions in which no format change is required later because from the beginning the document is electronic and goes along its life cycle in this same format.
Our service of electronic signature, ViD Signer, is the answer to the need of the sanitary sector in regards of obtaining the informed consent from the patient and his/her ratification for the clinician, because the signatures done with ViD Signer have the maximum legal value and enable the use of one unique document for both; the advanced electronic signature through the capture of the electronic hand-written signature process (called biometrical signature) and the qualified electronic signature through the use of qualified certificates and secure devices to create the signature, such as the DNIe (Identification Document), the IdCat, the Collegiate Card (Firmaprofesional –Professionalsignature- and OMC) or the FNMT card among others. This last feature would enable giving response to any situation in which the signature of more than one person is required: all the advanced signatures, all approved signatures or some advanced and others approved and give value to the digital certificates that are currently in possession of doctors among different Certificate Authorities that are operative in the Sector (Firmaprofesional, OMC, Healthsign, …). From their side, the use of electronic hand-written signatures or biometrical signatures enable to benefit from the advantages of the electronic signature but without transferring to the patient the technological complexity of the current electronic signatures.
Informed consent is defined and regulated in Spain by Article 8 of Law 41/2002:
“Article 8. Informed Consent.
1. Any act of a patient in the sanitary ambit requires the free and voluntary consent of the person affected, once he/she has received the information described in the article 4, and he/she has evaluated the different options of the case.
2. The consent will be verbal and following the general regulation.
However, it will also be presented in the following cases: surgery, diagnostic and therapeutical procedures and, in general, application of procedures that represent risks or evident and foreseeable inconveniences with possible negative repercussion over the health of the patient.
5. The patient can freely refuse in writing his/her consent at any moment.”
In Catalunya applies the Llei 21/2000, in almost identical terms:
“Section 6. Informed consent
1. Any intervention in the health field requires that the person concerned has given free and specific consent has been previously reported, according to the provisions of Article 2.
2. This consent shall be in writing form in cases of surgery, invasive diagnostic procedures and, in general, when performing procedures that involve risks and drawbacks noticeable and predictable, which may affect the patient’s health.
4. At any time the person concerned may freely revoke consent.”
Finally, in Europe, Directive 2001/20/EC makes a definition in the scope of clinical trials extensible by analogy to others treatment in Article 2 thereof:
“(j) ‘informed consent’: decision, which must be written, dated and signed, to take part in a clinical trial, taken freely after being duly informed of its nature, significance, implications and risks and appropriately documented, by any person capable of giving consent or, where the person is not capable of giving consent, by his or her legal representative; if the person concerned is unable to write, oral consent in the presence of at least one witness may be given in exceptional cases, as provided for in national legislation.”