In this interview by Giorgia Görner Enrile, Dr. Fabrizio De Nicola, former General Director of healthcare organizations and a member of the HEAL Italia board, explores the implications of the Electronic Health Record. This reflection fully aligns with our Foundation’s mission, which is committed to promoting secure, interoperable, and technologically advanced management of clinical data in order to strengthen research and personalized care.
The Electronic Health Record is not merely a container of clinical information, but a digital health document. Every piece of data entered acquires a value that goes beyond the sphere of care and becomes part of a system of accountability. Physicians, therefore, no longer simply record a medical act, but produce content that may also be used in legal contexts. Clinical documentation thus becomes traceable and verifiable, with direct effects on professional responsibility.
“The critical issue today is not technology, but awareness. Many professionals use the Electronic Health Record without fully understanding its legal implications. In the absence of training and clear operational rules, the risk is that physicians may be exposed to responsibilities that go beyond the clinical act itself and concern the management of digital data.” This is highlighted by Fabrizio De Nicola, member of the HEAL Italia board, former General Director of several Sicilian healthcare authorities, and lecturer in training courses on FSE 2.0.
Healthcare Data as Responsibility
Legislative Decree No. 179 of October 18, 2012 introduced the Electronic Health Record (FSE) into the Italian legal system, defining it as “the set of digital health and social-health data and documents generated by present and past clinical events.” This framework has been strengthened over time, culminating in the Ministry of Health Decree of September 7, 2023, which regulates the new model for interoperability, access, and population of the record. Within this system, healthcare data is no longer a simple clinical note, but a structured, traceable, and persistent element. Every entry becomes part of a digital history that can be reconstructed precisely, with direct implications for professional responsibility.
Physicians therefore operate in a context in which the quality, completeness, and timeliness of information take on concrete legal significance. The availability of digital data also affects expectations regarding the consultation and use of information, with possible consequences for the assessment of clinical conduct.
“This transformation is directly intertwined with the rules on healthcare liability set out in Law No. 24 of March 8, 2017, which already assigned clinical documentation a central role in evaluating a professional’s conduct. With the Electronic Health Record, this principle is further reinforced, because digital traceability makes it possible to verify not only what was done, but also when it was done and what information was available at the time. Documentation is no longer merely a record of the medical act. It becomes part of the decision-making process. Even an omission or delay in updating the record may become relevant from the standpoint of liability, especially when it affects continuity of care or patient safety,” explains De Nicola.
“At the same time, the broad availability of information requires truly effective tools for synthesis and updating, such as the Patient Summary, which must be properly populated and used. In emergency and urgent care settings, where decision-making time is extremely limited, having clear, up-to-date, and immediately accessible data becomes crucial in guiding clinical intervention. In the absence of these conditions, information may be fragmented or outdated, with possible repercussions for the quality of decisions. At the same time, what is documented also takes on central importance in terms of protecting both the physician and the patient. This is because it represents a fundamental element in reconstructing the care pathway and in assessing conduct in judicial proceedings,” he adds.
Privacy and Access to Data
The management of the Electronic Health Record 2.0 operates within a system of strict safeguards for the protection of personal data, governed by the General Data Protection Regulation and Legislative Decree No. 196 of June 30, 2003, as amended by Legislative Decree No. 101 of 2018. Healthcare data falls within the special categories of personal data and therefore requires a high level of protection, both technically and organizationally. However, in everyday clinical practice, this regulatory complexity risks translating into additional pressure on healthcare professionals. Physicians access, consult, and populate the record in a context where every action is logged and may be subject to review.
Added to this is the issue of organizational responsibility, which directly involves healthcare organizations, since they are required to ensure systems that are efficient, up to date, and genuinely interoperable.
“From an operational standpoint, healthcare professionals must adopt specific precautions when using the Electronic Health Record. It is essential to critically assess the available information before making clinical decisions, reporting any significant inconsistencies or gaps. Digital data must never replace direct clinical assessment and listening to the patient, which remain central elements of the care process. Documentation must be timely, but above all clear in representing the decision-making pathway, indicating the clinical elements considered and the conditions in which care was provided. It is equally important to use summary tools correctly, such as the Patient Summary, verifying their actual reliability and level of updating,” De Nicola emphasizes.
“In contexts where decision-making time is limited, such as emergency and urgent care, but also in everyday clinical practice, it becomes essential to be able to rely on trustworthy and up-to-date information. At the same time, documentation also takes on central importance in terms of protecting both the physician and the patient, because it makes it possible to reconstruct the care pathway and assess conduct in legal proceedings. As for access, every consultation must always be justified and consistent with the care pathway, avoiding improper use. These are safeguards that represent a concrete form of protection, because they make it possible to demonstrate the correctness of one’s actions and to place clinical decisions in their proper context,” he concludes. The full article is available at Sicilia Medica.