Receiving a notice of investigation, a summons, or notification of an assessment following an adverse clinical event can raise an immediate question: does a negative outcome for the patient mean that the healthcare professional has committed a crime? The answer is no. In criminal proceedings, it is not enough for injuries or a death to have occurred: it is necessary to establish individual negligent conduct and demonstrate that specific conduct caused the event.
In this guide, I want to clarify what distinguishes a complication from criminal liability, what weight guidelines, medical records, and technical consultations hold, and why the initial stages of investigations require careful attention. We will also examine what changes between a choice error, an execution problem, an organizational shortcoming, and a decision made under urgency with limited information.
Criminal liability does not coincide with an unfavorable clinical outcome
Harm to a patient does not prove fault on its own. To allege negligent injury or negligent manslaughter in a healthcare setting, the prosecution must identify a rule of diligence, prudence, or skill that the individual healthcare professional allegedly violated. It must then link that violation to the event through solid causal reasoning: in simple terms, it must be demonstrated that correct conduct would have prevented or significantly delayed the injurious event.
Negligence can take different forms. Negligence in the strict sense concerns, for example, the unjustified omission of necessary checks or information; imprudence concerns a risky choice that was not adequately justified; lack of skill concerns the incorrect application of professional knowledge or techniques. The distinction directly affects the defense, because the rules concerning guidelines do not operate in the same way for every form of fault.
The actual position of the healthcare professional also matters. Different professionals may intervene along a hospital pathway at different times and with different duties: those who perform triage, those who examine, those who order an exam, those who perform a procedure, those who receive handover notes, and those who have the authority to modify a therapy. It is incorrect to automatically attribute the same allegation to everyone simply because they participated in the care. The proceedings must clarify what information each person possessed, what decisions they could make, and what conduct is alleged against them.
A useful criminal defense therefore starts with a concrete question: what alternative was considered mandatory? It is not sufficient to state, after the event, that it would have been preferable to act differently. It is necessary to verify whether, at the time of the choice, the symptoms, the available tests, the patient's conditions, and the care context truly made different conduct reasonably expected. The judgment cannot turn a negative result into a presumption of error.
Guidelines and best practices: a benchmark, not an automatism
Guidelines must be compared against the specific case. Article 5 of Law no. 24 of 2017 states that healthcare professionals shall comply with the recommendations of guidelines published according to the system provided by law, without prejudice to the specificities of the patient and the clinical situation. You can read the text of the provision in the regulatory reference to Article 5 of Law no. 24 of 2017.
This means that a guideline can provide an important criterion for reconstructing diligent conduct, but it does not replace clinical reasoning. Following a recommendation is not enough if it was not suited to the age, conditions, comorbidities, urgent picture, or peculiarities of the patient. Similarly, a departure does not automatically prove a crime if it is justified, explainable, and consistent with the information available at that time.
When Article 590-sexies of the Criminal Code applies
The rule concerns lack of skill and requires precise conditions. Article 6 of Law no. 24 of 2017 introduced Article 590-sexies of the Criminal Code for cases of death or injury committed in the exercise of the healthcare profession. The text links the exclusion of punishability to lack of skill, compliance with the recommendations of guidelines provided by law or, in their absence, clinical-care best practices, provided that such recommendations are appropriate to the specificities of the case. The legislative text can be consulted in the publication of Law no. 24 of 2017 in the Official Gazette.
Reading the provision requires caution. There is no general criminal shield for the healthcare professional. The Joint Sessions of the Court of Cassation have traced the ground for non-punishability to a narrow scope: the adoption of appropriate guidelines or best practices, the executive phase of the service, and slight lack of skill matter. According to that interpretation, negligent or imprudent conduct, the choice of inappropriate recommendations, and cases of gross lack of skill remain excluded. The framework is illustrated in the criminal review of the Court of Cassation on the decision of the Joint Sessions.
For this reason, the decisive question is not merely whether a guideline existed. It is necessary to understand which version was applicable on the date of the facts, which specific recommendation concerned the contested passage, whether the case fell within its scope, and whether any deviation was motivated by real clinical elements. A generic citation of protocols or scientific publications does not resolve these steps.
Medical records and documents: what they can prove
Documentation reconstructs the care pathway and does not decide the trial on its own. Medical records, medical and nursing logs, reports, prescriptions, tracings, anesthetic charts, triage sheets, handovers, and communications between wards can show what data were available, when they were detected, and what decisions were made. These are central elements when the allegation concerns a diagnostic delay, omitted monitoring, a therapy, an invasive procedure, or a failure to reassess.
The presence of a note does not automatically prove that the choice was correct; the absence of a record does not automatically prove criminal liability. The meaning of the document depends on its content and context. An isolated clinical value may require comparison with previous parameters, the patient's evolution, and other available data. Similarly, a concise handover may take on a different significance if the incoming professional had access to tests, reports, or urgent information.
Informed consent deserves a distinction. Consent does not replace the correctness of care. Documentation of consent can be relevant to the relationship with the patient and the information provided regarding risks, but it does not eliminate a potential technical problem in diagnosis, therapy, or the execution of an act. Conversely, an allegation regarding treatment cannot be resolved simply by looking at the consent form; it is necessary to distinguish the informational aspect from that of clinical causation and professional fault.
When requests for documents, copies, or clarifications emerge, existing documentation must be preserved in its integrity. It is not prudent to intervene subsequently to create notes that appear contemporary to the facts. If formally possible additions or communications required by the facility are made, they must be recognizable by date, author, and function, without confusing what was noted during assistance with subsequent observations.
Criminal investigations and expert technical consultation
The technical phase can have a major impact long before the trial. In investigations for healthcare liability, personal examinations, biological sample analyses, medico-legal assessments, medical record reconstructions, and specialized evaluations may be ordered. Some acts are repeatable; others are not, because the state of persons, things, or places is destined to change or because the sample is consumed in the analysis.
For non-repeatable technical assessments, Article 360 of the Code of Criminal Procedure provides for notice to the person under investigation, the injured party, and the defense counsel, indicating the day, time, and place of the assignment and the right to appoint technical consultants. Appointed defense counsels and consultants may attend, participate, and formulate observations and reservations: the referenced text is available in the institutional reference to Article 360 of the Code of Criminal Procedure.
A defense technical consultation is not a favor report. The defense consultant translates the issues that the proceedings must address into clinical and scientific terms: temporal sequence of symptoms, appropriateness of the therapeutic choice, reliability of the data, compatibility between conduct and event, and alternative explanations of the outcome. Their function is to engage with the question, the available data, and the conclusions of other experts, rather than assert apodictically that there is no error.
The consultant must also possess competence consistent with the concrete problem. A case of anesthesia, sepsis, surgery, obstetrics, radiology, emergency, or oncology may require different knowledge. Medico-legal evaluation is often necessary for the causal link, but it does not replace the contribution of the specialist in the discipline concerned. The composition of the technical support therefore depends on the allegation, not just on the qualification of the investigated person.
Defensive choices change with the allegation and the stage of the proceedings
A notice does not equate to a formal charge or a conviction. It may concern a specific investigative act and indicate a provisional hypothesis that still needs to be verified. The primary need is to understand what fact is alleged, what injury or death is being examined, what conduct is indicated as negligent, and at what moment of assistance the allegation refers.
If the allegation concerns a diagnostic error, the point may be the actual availability of clinical signs and the promptness of the response. If it concerns a procedure, the core may be the surgical indication, the technique, the management of a complication, or subsequent monitoring. If it concerns team activity, the concrete distribution of roles, the handover of information, and the authority of each professional to intervene become central. These are distinct problems and do not receive a standard answer.
It may also be relevant to distinguish personal responsibility from an organizational criticality. Staff shortages, unavailability of instruments, internal procedures, or dysfunctions in handovers between services do not automatically erase the position of the individual, but they can modify the analysis of what was concretely expected. At the same time, reference to an organizational problem is not enough to exclude the allegation if the healthcare professional had the tools and information to intervene differently.
Insurance coverage and civil liability are planes not to be confused with the criminal one. A policy does not eliminate criminal risk. It can regulate defense, guarantees, or financial consequences within the limits of the contract, but it does not decide whether fault exists nor does it replace the technical verification required in the proceedings. Communications to the insurer must comply with the policy conditions, without assuming identical terms for every contract.
To prepare for an initial discussion, it is useful to have the received documents and an essential timeline. Above all, the notified measure, the indication of the scheduled act, the role played in the assistance, and the documents already legitimately available are needed. From there, we can distinguish what is already alleged from what still needs to be ascertained, avoiding hasty explanations or reconstructions based solely on memory.
Frequently asked questions
Does being investigated for medical negligence mean being guilty?
No. Registration or a notice of investigation indicates that checks are being carried out on a crime hypothesis. To arrive at criminal liability, it is necessary to prove individual negligent conduct, the causal link with injuries or death, and the absence of elements that exclude punishability. A received act must be read to understand what fact is actually alleged.
Do guidelines automatically protect me from an accusation?
No, but they can be very relevant. They must be pertinent, appropriate to the patient's specificities, and applicable at the time of the facts. Furthermore, Article 590-sexies concerns lack of skill and does not indiscriminately cover negligence, imprudence, inappropriate choice of recommendations, or every error in healthcare assistance.
Can I appoint a defense technical consultant?
Yes, in the forms provided by the proceedings. In non-repeatable technical assessments ordered by the public prosecutor, Article 360 of the Code of Criminal Procedure recognizes the person under investigation the right to appoint a consultant. The technical professional can participate in the act, formulate observations, and engage with the clinical issues raised by the investigation.
Does an incomplete medical record automatically lead to a conviction?
No. A documentary omission can make it more difficult to reconstruct the care pathway and may assume relevance in the specific case, but it does not replace the proof of criminal fault and the causal link. It is necessary to verify which data is missing, who should have noted it, what other sources can clarify it, and whether the absence truly affects the allegation.
Does the insurance policy also manage criminal proceedings?
It depends on the contractual conditions. The policy may provide for guarantees and communication obligations, but it does not eliminate the need for a criminal defense nor does it decide the existence of fault. It is important to distinguish criminal proceedings, any compensation claims, and the rules of coverage, checking the text of the policy without assuming terms or guarantees not provided.
When it is useful to clarify your position immediately
The first act received may already be important. If you are a doctor or healthcare professional in Milan and an investigation concerns an adverse clinical event, you can contact me to examine the content of the act, identify the technical issues truly in discussion, and evaluate with the staff whether it is necessary to promptly activate specialized expert defense support.