Original article published in Healthtech360 on 09/11/2022

The adoption of electronic signature solutions and substitutive storage of information consents in the healthcare sector offer enormous benefits to both citizen-patients and healthcare organisations, avoiding the latter to incur legal risks and heavy penalties

The digitisation of processes is a central element in any business environment, including healthcare, in which it is essential that both clinical and administrative processes take place quickly, efficiently and sustainably.

Paper management, costs and limits

The most common practice today is that of requesting the signing of a pre-printed paper form that contains information about the planned health treatment.

But what are the costs and difficulties of this type of management?

First of all, the costs related to the following activities must be considered:

  • printing of documents
  • retention and logistics of signed documents
  • shipping of documents to the retention sites
  • "physical" space required for the archiving

In case of consent, the retention limit is 4 years from the date of the last registration, while the files must be kept for 10 years from the date of the last registration. Furthermore, it is necessary to take into account the costs associated with the documents thinning of the archive (to be disposed of by destruction) which requires high search times and sharing difficulties and, last but not least, also the possibility of human error, in the case - for example - of use of an outdated consent form and / or of an information note not present.

Paper management legal risks

It goes without saying that the risks generated by the aforementioned type of management are manifold.

First of all, there are the legal risks for failure to exhibit consent or for incomplete consent, therefore, lack of lawfulness (Article 6 GDPR), but also inadequate treatment to the type of data processed (Special data management - Article 9 GDPR) and violations of personal data (data breach - Art. 33 and 34 GDPR) in case of loss of documentation.

All situations - those just analysed - that can lead to heavy penalties.

Dematerialisation advantages in Healthcare

To streamline and make the processes management in any area, including healthcare, one of the key points is the paper dematerialisation or, more precisely, the process of collecting and archiving information consents. This can bring numerous benefits compared to the traditional paper-based management still implemented by many healthcare facilities.

Paper dematerialisation, and the consequent adoption of document management based on the systematic use of electronic formats, offers advantages in terms of cost-benefits and involves significant savings, both in terms of work optimisation and in terms of environmental and economic aspects.

According to CERIS-CNR, as early as 2007, the potential savings deriving from the adoption of the digital document, only in the sectors subject to legislation, had been estimated to oscillate between 168 thousand and 259 thousand tons of paper materials, an amount equivalent, at that time, to 13 -21% of total paper consumption in Italian offices.

Basically, by adopting the digital document, it would have been possible to use only one sheet compared to 5 for paper management.

Dematerialisation in Healthcare : the benefits for hospitals

Analyzing the specific case of a possible paper dematerialization concerning the informative consent forms relating to a hospital, for example, it is possible to note that the implementation of ad hoc solutions of digital signature processes leads to a clear reduction in times management of the practice, to a positive economic and environmental impact and to objective advantages in terms of time saved for each operator. The latter can be reallocated according to the needs of the hospital and carry out more urgent or profitable tasks.

Dematerialisation in Healthcare: benefits also for patients

Digitising the system and documenting workflows means offering a more integrated, digital and faster experience for patients as well. While maintaining a familiar environment, and protecting sensitive information, digital solutions allow, for example, the collection and registration of a patient's record in a single integrated platform, combined with the digital signature of clinical documentation (informed consent, medical history form and so on) in a health institution or even remotely.

The handling of sensitive patients information requires a high level of data protection and an integrated and secure system for their storage.

Digital signatures are the most efficient tools aligned with security standards, as they represent an effective way to have documents approved and signed in digital format, remotely or at the healthcare institution, in full compliance with all legal requirements.

Health data: why digital registration is convenient

With an onboarding and digital registration process, it is possible to access and update personal health data in a safe, fast and practical way, proving your identity online through an omnichannel and integrated experience.

Thanks to the use of appropriate solutions, and with a proper identity verification, therefore, it is possible to support your healthcare institution immediately obtaining a series of concrete advantages:

  • collection of digital patient data in a sampler and faster way, regardless of geographic dispersion and with full legal validity
  • integrated and updated digital archive for the patient information
  • no errors or inaccurancies when filling in patient information thanks to the automated procedure
  • reduction of stress level in patients (less waiting times, fewer queues at the counters, etc..)
  • security of the information contained in the documents, guarantee of maximum confidentiality and absence of fraud and identity theft.

The digital signature in Healthcare: not only security

The benefits that can be obtained by implementing an electronic signature solution are not limited to the "security" field but, as mentioned, involve a series of advantages that affect various business areas.

Digital archiving and storage in accordance with the law guarantee:

  • security
  • personal data protection
  • paper, toner and printer maintenance costs reduction
  • logistics management
  • documents archiving

But the benefits don't stop there. Here are a number of other important benefits:

  • the recovery of a specific document in the event of an emergency (for example, for medico-legal disputes) becomes a simple and fast operation
  • the certain acquisition of the consensus variables allows them to be queried for any statistics or classifications
  • there is complete traceability and integrity of each stage of the process
  • the elimination of paper forms, produced by different departments, but validated by a single entity at local or central level, facilitates the controlled distribution of the same
  • the relationship between operators within the health facility and between doctor and patient improves considerably
  • it is possible to enrich the text of the information note with contents, clarifications and questions to check the level of understanding
  • by dematerialising and digitising operations, there is a reduction in carbon dioxide emissions and the number of trees felled, in line with the objectives and actions of the European Union
  • the reduction of management, logistics and filing times of practices leads to the speeding up of internal processes and greater overall satisfaction of patients and healthcare professionals.


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