The medical informed consent in Spain is regulated by Law 41/2002 and Law 14/2007, on biomedical research and there are many types of consents, affecting many areas and processes of an hospital. These documents usually have multiple pages, and, due to the important number of consents that are generated every day, are a key to start the paperless strategy in this area. It typically requires at least two signatures: the patient’s one, who then signed the document freely once he’s properly informed, and medical staff’s one (doctor, anesthetist …).
Well, in viafima, we propose automate this whole process by electronic signature software.
While the medical staff signature could be easily executed with electronic signatures with digital certificates, this is more complicated in the case of the patient, as it can not be assumed that he has a digital certificate, or even know how to use it. Also, we need to count on the additional complexity of the certificate holder, as the signing of informed consent is usually done at the medical center, which almost overrides the use of software certificates, which must be installed on the computer that would perform the signature, hence, in the case of wanting to perform the informed consent signing with a client certificate, this should be done in hardware support (throught a cryptographic card).
In practice, this usually involves the use by patients of the digitalized signature, biometric capture of the the user’s handwritten signature that is inserted into the electronic document, storing a series of legal evidence in order to safeguard the legal coverage of the signed document.
For medical staff, it can be used both the electronic signature with certificates (which also allows, for example, make a batch signing of all-of-the-day informed consents in a single operation) and the digitalized signature of various documents.
Our solutions and specifically in this case, our solution for electronic informed consent in medical centers, allows to isolate the apps of the complexity of using digital signatures in third applications. In addition, our solution Viafirma Platform allows the integration for introducing both electronic signature and digitized signature with full security and biometric data capture. In the case of the digitized signature, supports both capture of biometric data in Pads like Topaz (integrated with desktop computers or Tablet PCs), as Apple iPad and Android tablets, which ensure the necessary capacity to capture sufficient resolution to store a precise points cloud associated with the signature.
In summary, here you are with a good solution to finish the amount of paper that some clinics have only for the traditional informed consents.