The informed consent for medical treatment and its digitalisation is one of the challenges that the healthcare sector faces within their own digital transformation. All the bureaucratic and documentary aspects relating to managing patients is evolving to eliminate paper from doctor’s surgeries.
With the aim of facilitating this target, we introduce our advanced electronic signature solution for the health industry and specifically, its benefits for managing informed consent.
This post is also available in Spanish.
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Within the healthcare sector, informed consent is one of the documents that makes up the medical record. It can be defined as the patient’s action of freely and voluntarily authorising the doctor to proceed after being informed of the characteristics of an operation.
Therefore, the purpose of this document is to prove that the patient has been clearly informed in advance and they have signed the document consciously. In fact, managing this procedure badly can have very serious consequences for the professional and the health centres, with different degrees of civil and even criminal liability.
With regards the means of obtaining this consent, there is still a paper-culture in health centres, despite Law 41/2002 on the rights and obligations regarding patient medical information and documentation in Spain, which allows for computers to be used to store the medical record. Times are changing, however.
The Ministry of Health, Social Services and Equality for the Spanish government pushed the project Digital Medical Records of the National Health Service (HCDSNS) last year, to guarantee citizens and health professionals electronic access to medical documentation which is more relevant to each patient.
This challenge responds to the needs of health professionals that have to deal with patients when out on call and the strong political will of achieving a digital transformation of the health service due to its multiple advantages, both economic and managerial.
Well, within this digitalisation process of medical records, informed consent is one of the documents that resists leaving the paper format behind due to the requirement of a signature, as we have mentioned.
However, there are tools such as the advanced electronic signature which makes generating valid and legal electronic documents easy, just by signing on the doctor’s and the patient’s tablet, mobile or computer.
The clear advantages, both economic and managerial, that this processing and digital storage of the daily documentation in any clinic has is enabling this change in the administrative processes in this sector.
Also, if we speak more specifically about informed consent and the legal implications that it could involve if the procedure is not respected, it is overtly necessary to rely on technological solutions that cover the doctor in the event of any complaints.
If there is an incident, although the informed consent does not absolve the doctor from medical malpractice, they would have to provide the signed document as proof that they appropriately informed the patient of the potential risks and that they expressly accepted them.
In fact, what is essential about the informed consent document will be that the signature’s authenticity can be proven, using any means in the event that it has to be asserted before the patient or third parties, not its format.
In other words, how the signature is taken down, be it on paper or electronically, is not important, but where necessary an expert calligrapher could check that the document has not been altered and reach a decision about the signature’s authorship.
The informed consent document in any format (paper or electronic)
will be valid as long as the signature’s authenticity can be proven,
using any means in the event that it has to be asserted before
the patient or third parties.
In any case, as we have mentioned, the most important aspect of the informed consent is that there is absolutely no doubt that the patient has read the document and is able to understand it, that it has been signed by them or their representative and that the content has not undergone any changes after being signed.
It is also necessary for it to be preserved with the guarantees of being able to recover it, read it and activate the mechanisms that prove its reliability and authenticity.
All of this can be achieved thanks to the advanced electronic signature that combines biometric data acquisition with the time stamp in order to determine when the document was signed.
Due to its characteristics, it provides security for user electronic transactions and in this instance, to the informed consent procedure. By using it, the author of the signature can be identified in the event of a dispute and it can also guarantee the reliability of the signed content, in other words, that it has not undergone any changes or variations since the time in which it was signed.
The concept of electronic signatures must be understood under the new eIDAS 910/2014 European Parliament Regulation (July 2014) regarding electronic identification and trustworthy services for electronic transactions on the domestic market.
The standard governs and promotes trustworthy independent third-party services in electronic signature processes that are able to generate recognised legal evidence as proof in the event of a trial.
Also, on using the healthcare industry advanced electronic signature to fulfil this obligatory procedure, clinics will avoid risks such as:
- Loss or errors when filing the signed consent forms thanks to them being digitalised.
- Risks of preserving confidentiality and data protection. The signed document will not move from office to office in the clinic until it is finally archived.
- Potential technical difficulties to access and verify the existence of informed consent before applying the treatment or starting the operation.
- Delays until the signed and scanned consent form is available and conveniently stored, generating managerial costs.
Thanks to our advanced electronic signature solution, the healthcare centres and clinics can improve their work flow and increase their performance immediately by avoiding losing documents.
With the signature, they only have to read the consent form on a mobile or tablet with all the information that they need to know about the treatment they are going to receive and sign directly on the screen.
As explained and now more than ever, taking advantage of the improvements that new technologies provide is becoming necessary to improve the quality of healthcare services and this procedure specifically.
By implementing the Signaturit advanced electronic signature system, paper for patient medical records can be eliminated with all the legal and technical guarantees and in a more practical way than with the original handwritten signature.
The time has come to round off the digitalisation process in health centres thanks to our technology with all the necessary guarantees to face a potential complaint by providing the signed informed consent as documentary evidence.
If you want to enjoy the benefits of the advanced electronic signature, do not hesitate to get in contact with us via the following form, or call us directly on +34 93 551 14 80.
This post is also available in Spanish.