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Centro de Direito Biomédico

PTDC/IVC-JUR/3545/2012 - Strengthened legal protection of the confidentiality of event notifications

Investigador reponsável / Lead Investigator : 

Prof. Doutor Guilherme de Oliveira

Instituição proponente / Candidate Institution: 

Centro de Direito Biomédico

1. The most developed countries are working to install a system for the reporting of adverse events in the context of the improvement of health care quality; Portugal must keep up with them.However, in most countries – Portugal being one of them – there is no legal framework that allows such a notification system to work. In fact, under the current conditions, if a medical liability case is brought before a civil or criminal court, both the patient and the judge may promote the joinder to the process of the content of eventual notifications, so that this content can be used to assist the trial and eventually support the conviction of the doctor. It is easy to predict that after the content of a notification is used in a court case, health professionals will most likely fail to do voluntary notifications again.For the system to benefit from the collaboration of professionals, it is necessary that the notifications made for the purposes of quality assurance are not used within medical liability lawsuits; notifications must benefit from a reinforced legal protection.(In parenthesis, the research team knows that the potential anonymity of notifications does not solve the problem at hand. This investigation is justified precisely because the team knows that anonymity is not sufficient.)

2. But the reinforced legal protection essential to the confidentiality of notifications is contradicted by several fundamental rules of the current legal system, and can not come into force before the legal system is modified.In fact, the Portuguese Constitution grants all citizens the right to initiate legal proceedings, and this right must be exercised through a "fair trial" (art. 20., no. 1 and no. 4), using all evidence, controlling the evidence produced by the other party, presenting the evidence intended to prove the claimed facts (Canotilho; Moreira, annotated Constitution, ..., p. 415-6).Also the Code of Civil Procedure imposes to "all individuals (...) the duty to make their own contribution to the discovery of truth, answering to whatever is asked to them, (...) providing whatever is demanded from them..." (art. 519., no. 1). And even if professional privilege is claimed (no. 3, point c)), it may be ruled out; the court may ultimately require the disclosure of the information contained in the notification of the incident.Moreover, the Code of Criminal Procedure requires employees (such as doctors within the NHS) to denounce facts that constitute crimes (art. 242.), as is the case of some of the facts reported. On the other hand, anyone (such as the doctor) presenting itself as a witness is required to "answer truthfully to the questions submitted to it" (art. 132.), otherwise incurring in the crime of false testimony (art. 360. of the Penal Code). And even if the doctor invokes professional privilege, confidentiality may be ruled out by the court. Furthermore, the forced disclosure of the facts reported may ultimately lead to disciplinary proceedings against the doctor – initiated by the Medical Association, the Inspectorate General of Health or the Directorate of the health unit that employs the doctor – along with the appropriate penalties.Finally, after being forced to reveal the eventually negligent error reported, the doctor’s work environment may be harmed. The doctor’s behavior may fall under the concept of "just cause for dismissal" (art. 396. of the Labour Code) that will justify a "dismissal for cause attributable to the worker" (art. 411. and ff.).In conclusion: one thing is the design of a computerized system for the anonymous notification of adverse incidents and its technical administration; a different reality is the creation of new legal requirements, that ensure an effective confidentiality of the content of notifications, so that this content can not be used in legal proceedings; only then health professionals will collaborate. The fact is that these legal conditions are not present in the existing legislation in Portugal.3. Evidently, this Project does not intend to handle the analysis of the notifications that are going to arise when the system is running. The Project aims to study and propose the necessary legal changes aiming to ensure the reinforced confidentiality of notifications, in order to promote the peace of mind of the notifiers and their collaboration in the system.But this reinforcement of the confidentiality of reports, in the public interest of the continuous improvement of health care, means a violent restriction of the right of patients and courts to access all relevant information.Therefore, it is necessary to find the just and difficult balance between various legal and social interests constitutionally protected, and then propose new legal regimes under the laws of civil, criminal, disciplinary and labour procedural laws.