Artigo de revisão
TRUTH DISCLOSURE AND THE DUTY TO INFORM FROM THE PERSPECTIVE OF BRAZILIAN MEDICAL LAW
Como citar: Vilela EGDO, Miziara CSMG, Miziara ID. Revelação da verdade (disclosure) e o dever de informar na perspectiva do direito médico brasileiro. Persp Med Legal Pericia Med. Vol. 10, 2025; 250311.
https://dx.doi.org/10.47005/250311
Recebido em 16/12/2024
Aceito em 15/03/2025
The authors report no conflict of interest.
TRUTH DISCLOSURE AND THE DUTY TO INFORM FROM THE PERSPECTIVE OF BRAZILIAN MEDICAL LAW
Resumo
INTRODUÇÃO: Na relação médico-paciente, o dever de informar é essencial para que os princípios de autonomia e beneficência sejam respeitados. O instituto da revelação da verdade (disclosure) é uma ferramenta que auxilia na transparência dessa relação. OBJETIVO: Descrever a aplicação do disclosure de acordo com o Direito Médico Brasileiro nas instituições de saúde e na relação médico-paciente. Método: Este trabalho baseou-se em uma revisão narrativa de artigos e livros publicados em plataformas digitais e bases de dados, como PubMed e Google Acadêmico. Foram utilizados os seguintes descritores extraídos do DeCS: Disclosure, Dever de Informar, Juridicização da Saúde e Direito da Saúde. RESULTADOS: Embora seja a conduta correta a ser adotada, a comunicação da falha técnica não é uma tarefa fácil ou amplamente aceita pela comunidade médica. Diversas razões justificam a omissão da falha pelo médico, sendo as mais frequentemente citadas o medo de processos judiciais e a vergonha diante do paciente e dos pares. Alguns países possuem legislações que incentivam a comunicação do erro. CONCLUSÃO: O dever de informar é fundamental na relação médico-paciente, e, em se tratando de eventos adversos que exigem comunicação ao paciente ou ao seu responsável, o instituto do disclosure vem se tornando uma ferramenta cada vez mais importante para fortalecer a relação médico-paciente e para o consentimento informado.
Palavras Chave: Responsabilidade pela Informação; Judicialização da Saúde; Direito à Saúde.
Abstract
INTRODUCTION: In the physician-patient relationship, the duty to inform is essential for respecting the principles of autonomy and beneficence. The institution of truth disclosure (disclosure) serves as a tool that promotes transparency in this relationship. OBJECTIVE: To describe the application of disclosure according to Brazilian Medical Law within healthcare institutions and the physician-patient relationship. METHOD: This work is based on a narrative review of articles and books published on digital platforms and in databases, such as PubMed and Google Scholar. The following descriptors from DeCS were used: Disclosure, Duty to Inform, Health Juridification, and Health Law. RESULTS: Although it is the appropriate conduct to adopt, communicating technical errors is not an easy task nor is it widely accepted within the medical community. Several reasons justify the physician’s omission of an error, with the most frequently cited being fear of legal action and shame before the patient and peers. Some countries have legislation that encourages error disclosure. CONCLUSION : The duty to inform is fundamental to the physician-patient relationship, and in cases of adverse events requiring communication to the patient or their responsible party, the institution of disclosure is becoming an increasingly important tool for strengthening the physician-patient relationship and supporting informed consent.
Keywords (MeSH): Responsibility to Inform; Health Judicialization; Right to Health
1.INTRODUCTION
Disclosure, or truth-telling, is the physician’s duty to inform the patient or their legal representative about the occurrence of an adverse event or a failure in the provision of healthcare services. An adverse event is considered to be any harmful or unintended reaction that occurs following the administration of a medication or an unexpected complication during healthcare that results in injury1. When a deviation occurs from the procedure that should have been followed, the term applied is technical or procedural error. Not all adverse events or poor outcomes are due to technical failure, though they frequently lead to legal action. Recently, the Department of Judicial Research of the National Justice Council (CNJ) replaced the terminology « medical error” with material and/or moral damages resulting from healthcare services2,3.
In 2021, the World Health Organization (WHO) adopted a global action plan for patient safety, establishing seven goals for member countries to consider in order to reduce avoidable harm or fatalities, which cannot be mitigated solely by persuading healthcare professionals to adopt more cautious practices. Measures aimed at patient safety seek to identify the risks to safety in healthcare and indicate the adoption of actions to manage risks and minimize harm to patients4.
The negative impacts resulting from healthcare failures on the patient, their family, and healthcare professionals cannot be denied; however, these impacts are part of the learning process, as the response to a failure in care should be more highly regarded than the occurrence of the failure itself5.
The healthcare field, due to its peculiarities, is prone to failures. According to James Reason, there are two critical points involved in “human fallibility”: the individual and system approaches. The first relates to errors made by the person in question, whether due to forgetfulness, lack of attention, or even “moral weakness. The working conditions and safeguards to prevent or mitigate deviations constitute the second point6.
Ethical and legal principles dictate that healthcare professionals must provide adequate and understandable information to patients regarding their health condition, diagnosis, prognosis, treatment options, associated risks and benefits, and other relevant aspects for informed decision-making, always revealing the truth, as this constitutes one of the patient’s rights7. Although Article 34 of the 2018 Code of Medical Ethics does not consider withholding information to be an ethical violation when disclosure may cause harm to the patient, this is a highly subjective and therefore controversial matter8.
Truth disclosure (disclosure) is the communication established between the physician, the patient, and the family in an open, objective, comprehensible, and sincere manner, allowing corrective measures to be taken while respecting the patient’s rights. In this context, although disclosure is the right action to take, it poses significant conflicts for physicians due to the fear of patients’ and families’ reactions and possible legal action, leading to its limited application (66%) by physicians, as shown in a study conducted in Minas Gerais9. In the truth-telling process, it is essential that notification of an adverse event occurs formally, in a supportive environment, and that professionals feel the objective is not punishment but learning, so that similar events do not recur10.
This communication is challenging, as it faces various barriers, ranging from the physician’s discomfort in admitting fault and insecurity about their communication skills, to unclear messages from institutions and insurers, as well as fears of ethical and legal sanctions, among others.
This study aims to highlight the main advances in truth disclosure, examining the barriers faced by professionals and current guidelines on how to proceed, as well as addressing disclosure from the perspective of Brazilian Medical Law, especially regarding civil and ethical responsibility.
- METHOD
This study consisted of a narrative literature review, developed through searches in open-access databases (PubMed, Capes Journals, Google Scholar). No specific time frame was established for the searches, but texts published within the last 10 years were preferentially selected. Materials from official governmental and non-governmental websites, book chapters, and master’s and doctoral dissertations were also included. The keywords used were: Responsibility to Inform, Health Judicialization, and Right to Health. Additional articles, networked references (snowball), and master’s and doctoral theses and dissertations were also included. Texts in English, Portuguese, and Spanish were considered. The selection of articles began with reading the titles, which had to contain at least one of the keywords or refer to the subject under study. Abstracts were then reviewed, and those with relevant content were selected for full reading.
- RESULTS AND DISCUSSION
3.1 Brief Background
In 1984, Dr. Hilfiker published the article Facing Our Mistakes in the New England Journal of Medicine, introducing the concept of “medical error disclosure” for the first time. The author narrates the misdiagnosis of a pregnant patient who exhibited clinical signs suggestive of pregnancy, though four urine tests did not confirm it. The physician assumed it was a missed abortion and proceeded with curettage, even after palpating uterine enlargement compared to his previous examination. During the procedure, he realized his mistake: he had aborted a live fetus, as confirmed by the pathological examination (a live 13-week fetus). The author describes his feelings of sadness and the difficulty of facing the error in a context of moral dilemma, while emphasizing that in medical practice, errors are always possible but remain terrible, confronting physicians with horrific feelings of guilt. He concludes the article by writing, “At some point, we must take our mistakes out of the closet. We need to allow ourselves to recognize our failures and their consequences. We need to find healthy ways to deal with our emotional responses to these errors. Our profession is difficult enough without bearing the burden of perfection11.
Starting in 1984, the topic of disclosure began to be discussed from both ethical and legal perspectives. Studies were conducted demonstrating the value of truth-telling and its legal consequences, highlighting the implications in situations where the truth was or was not disclosed. According to Wei (2007), medicine is grounded in professional norms that “perpetuate fear, guilt, and secrecy12.
Some countries have adopted apology laws in an attempt to break down disclosure barriers, understanding it as a way to repair “damaged relationships. Physicians often withhold disclosure of adverse events, primarily out of fear of legal action. These laws have not yet shown positive results in reducing malpractice rates. According to Roos and Newman (2021), most apology laws protect expressions of regret but do not protect the disclosure of errors. Apology laws do not facilitate the type of communication that would improve physician transparency and overall patient satisfaction13.
In a study comparing malpractice lawsuit rates, there was no statistically significant difference between states that enacted apology laws and those that did not, suggesting that error transparency laws do not affect the volume of legal complaints. According to the researchers, the “medical culture should be initiated at the organizational level14.
In 2019, an article was published proposing competency guidelines for the disclosure of adverse incidents. The author highlighted that saying “I’m sorry” only helps if accompanied by non-verbal skills15, aligning with Allan (2010), who demonstrated that a verbal apology could aid in conflict resolution16, and with Ross and Newman (2021), who consider that an apology is therapeutic for both the patient and the physician by reducing anger and facilitating damage repair13. However, an apology will certainly not always prevent the physician from facing ethical and legal repercussions.
- Definitions of Slip, Lapse, and Error
According to James Reason, error is the failure of a sequence of planned actions, whether mental or physical, to achieve the intended outcome, not attributable to chance. Reason differentiates unintended actions as slips (observable) or lapses (not observable), which are execution errors, while errors in planning occur when the action plan itself is incorrect. The Institute of Medicine defines error as a failure in executing an action or a failure in planning17. Medical errors are also defined as avoidable adverse events in healthcare18. Medical errors are classified into two stages: diagnosis and treatment. Errors in diagnosis include missed, delayed, or incorrect diagnoses19. In the treatment stage, incorrect parameters may include patient instructions, wrong doses or medications, incorrect surgical procedures, wrong patient, etc20,21. In both stages, communication failure is a prominent issue22.
- Barriers Faced by Physicians in Truth Disclosure
The possibility of being sued for failure in healthcare provision is one of a physician’s greatest fears. Meanwhile, the patient suffers pain, disability, and financial loss as a consequence of improper medical actions. These reasons, even in the face of the physician’s honest disclosure, do not prevent legal sanctions from being encouraged23.
Truth disclosure to the patient or their family members, while necessary, is a situation that generates fear of lawsuits, shame for failure, lack of preparation for communication, uncertainty about which facts should or should not be revealed, what words to use, the ideal timing for disclosure, lack of feedback, and uncertainty about the reactions of the patient, colleagues, and the workplace institution. The lack of training in disclosure is perhaps the most relevant factor in this dilemma24,25.
Underreporting of technical failures is primarily justified by fear but may also occur due to lack of attention or concern by the physician regarding the error26. Additional factors include a lack of support from the technical team27 and neglect by the organizational system.
Medical errors are often not associated with physician negligence; they may arise from control system failures. By “system,” one refers to a set of elements that interact interdependently to achieve a common objective. Thus, failures may be human or non-human (such as equipment, technology, etc.)17.
According to Moodley et al. (2021), training in communication methods during medical school would facilitate interpersonal relationships between physicians and patients, between physicians and the healthcare team, as well as with legal professionals, ultimately aiding in the transparent communication of the truth28.
- Litigation and the Benefits of Open Communication
Most lawsuits filed against physicians for alleged harm resulting from healthcare provision do not prove the alleged error; however, the emotional conflicts imposed on physicians occur regardless of the lawsuit’s outcome29. Nevertheless, proof of malpractice resulting in patient harm has a negative impact on the patient and their family, the physician, the hospital, the healthcare financial system, and the insurer.
The disclosure of medical error, defined as “communication between the healthcare provider and the patient, family member, or legal representative,” establishes a direct link between the physician’s action and the harm caused to the patient, which may entail compensation or financial restitution as determined by Civil Law23. Physicians are the most frequently sued professionals for technical failure compared to other professions, largely because medical care is inherently risky and often results in bodily harm, the central concern of tort law.
Litigation arises when a patient claims harm due to deviations in medical practice, and the physician defends themselves by citing idiosyncrasies or unpredictable and unavoidable adverse events. The court, being non-expert in medical matters, requires evidence, which is provided through a medical expert report.
Several American states have adopted the “I’m sorry” law, or apology law, which is used in court as a positive factor, emphasizing the benefits of open communication. Consequently, numerous hospital systems have implemented full disclosure policies, reducing the number of lawsuits and legal expenses by more than 50%
In any civil action filed by an alleged victim of an unforeseen outcome of medical care…any and all statements, affirmations, gestures, or conduct expressing apologies, guilt, sympathy, commiseration, condolences, compassion, or a general sense of benevolence made by a healthcare professional or an employee of a healthcare professional to the alleged victim, a relative of the alleged victim, or a representative of the alleged victim, and relating to the discomfort, pain, suffering, injury, or death of the alleged victim as a result of the unforeseen course of medical care shall be inadmissible as evidence of an admission of liability or as evidence of an admission against interest30.
The poor outcome of a treatment can occur without the physician’s action being incorrect, a fact accepted by lawmakers; however, dishonesty is disapproved31.
- Ethical Aspects
The physician’s omission in revealing the truth to the patient undermines trust in medicine and suggests that personal interests are placed above patient well-being, representing an ethical-professional violation31.
The doctor-patient relationship is based on mutual trust. The physician is subject to duties imposed by the Medical Code of Ethics, which states in its first article that the physician’s responsibility is always personal and cannot be presumed, and that the physician is prohibited from causing harm to the patient through negligence, incompetence, or recklessness. Furthermore, within the ethical-professional context, the code prohibits the physician from avoiding their responsibilities in medical actions8.
The American Medical Association (AMA) Code of Ethics establishes that the physician has a duty to inform the patient in the event of significant medical complications, disclosing the facts in detail so that the patient can understand, even if full disclosure may lead to legal accountability30.
To facilitate communication of adverse events to the patient, it is essential to regularly practice communication about diagnosis, treatment plans, results, and complications, creating a channel of trust32. The duty to disclose the truth arises when it is observed that the executed conduct resulted in an adverse event that could potentially alter the patient’s therapy and progression, either immediately or over time. Patients’ rights to receive information about their health or illness are part of human rights, as is the need to be aware of adverse events resulting from treatments received and their consequences. Ethically, the physician must communicate these events in a way that the patient can understand, using language suited to each individual’s comprehension level33.
3.6. Challenges in Truthful Communication and Preparing Physicians – Suggested Models in the Literature
The cultural shift among physicians and patients could represent progress in truthful communication, though many steps still need to be taken in this direction. Initially, the implementation of a facilitating organizational system for reporting, team training, deepening ethical and moral behaviors among physicians, and the understanding that disclosure is not punitive but educational—serving as an example to prevent recurrence—are the main tools to make disclosure a standard practice rather than underreported.
The initial reaction to a technical failure is often to seek a scapegoat; however, the “error,” apparently caused by a single physician, typically results from a “convergence of multiple contributing factors.” Identifying these factors helps prevent future events, especially by improving workplace safety systems where physicians operate. The role of the system as a key player in accidents was analyzed by Charles Perrow in the “Three Mile Island” case and by James Reason, who studied various events in which the system contributed to the outcome17.
A cultural shift among physicians and patients could represent progress in truthful communication, but many steps remain to be taken in this regard. Initially, the implementation of an organizational system that facilitates reporting, team training, a deepening of physicians’ ethical and moral behaviors, and the understanding that disclosure is meant not to be punitive but educational—serving as an example to prevent recurrence—are the main tools to make disclosure a standard practice rather than underreported34.
The development of knowledge, skills, and attitudes toward communication allows physicians to open a transparent communication channel with the patient, taking responsibility and expressing feelings of regret and apology. The physician should inform the patient about the next steps and what will be done to prevent recurrence. The truth should be communicated to the patient, colleagues, and the healthcare organization. The disclosure of a physician’s technical failure should be incorporated into three areas: the physician, the healthcare organization, and the healthcare practice environment35.
.
3.7. Forensic Evaluation of Harm and Truth Disclosure
Gallagher et al. (2018) discussed communication and resolution programs capable of promoting accountability, transparency, and learning after an adverse event. Communication and Resolution Programs (CRP) aim to reduce future adverse events by providing appropriate responses in situations where outcomes have been unsatisfactory. These programs are part of patient safety initiatives. The authors concluded that greater adherence to these programs would reduce liability-related costs, though other benefits still require further assessment in new studies36, as well as in paragraph 4 of article 14 of the Consumer Protection Code37, thus justifying the need for medical expertise.
In the forensic context, evaluating the alleged “material and/or moral damage” resulting from healthcare services is key to elucidating facts in litigious cases. Many patients and families believe that an unsatisfactory treatment outcome is not due to the natural progression of the disease but rather to a technical error by the physician, which leads to civil and criminal actions. Medical liability, in the civil sphere, depends on proof of culpable conduct by the professional (negligence, recklessness, or lack of skill), as stated in article 1,545 of the Civil Code38.
A physician’s obligation to follow the standard of care applies only when there is a specific duty owed, and they are not required to assist a stranger in danger solely due to having superior knowledge and skill. Thus, the doctor-patient relationship establishes a bond of affirmative legal obligations23, unlike what occurs when providing aid to someone in an emergency outside of the doctor-patient relationship.
Informing the patient or family member of a technical error does not eliminate the professional’s culpability, though it is understood that worse than disclosing the error and facing a lawsuit is not disclosing it and still being sued. Many factors contribute to adverse outcomes, as discussed by J. Reason; therefore, physicians must take careful measures, such as proper record-keeping of the patient’s chart, attention to seemingly trivial complaints, and maintaining open communication about the risks and benefits of certain treatments or procedures. Medical communication involves information about disease prevention, diagnosis, and treatment, including the risks and benefits of both treatment and non-treatment39.
- Final Considerations
The adverse event in medicine, despite all efforts to prevent it, is often unavoidable, and truth disclosure to the patient is an ethical duty of the physician and a right of the patient. Many barriers prevent or hinder this disclosure, especially due to cultural factors and the lack of training during medical school. Physicians are not prepared to communicate the event with confidence and fear legal action, as well as losing credibility with colleagues or managers.
Disclosing the technical error to the patient, while ethically appropriate, does not imply exemption from legal liability, but it is considered the correct conduct to adopt and may be seen by the court as an act of good faith. Medical schools do not prepare students for failures, nor do they exemplify errors and how they could serve as learning experiences to prevent recurrence. The low adherence to this practice is not an exclusively Brazilian phenomenon, being cited in nearly all countries.
To facilitate the communication of adverse events to the patient, it is essential to have a regular practice of communication about diagnosis, treatment plans, results, and complications. This helps build a greater relationship of trust and openness with the patient. Additionally, it is necessary to manage the fears, concerns, and risks associated with this communication, as despite seeming like a common practice, the number of professionals who have had this experience remains low2,32.
Despite numerous publications stating that truth disclosure is the correct conduct for physicians, adherence remains low. A study showed that most interventions aimed to promote the reporting of incidents with more serious consequences, according to international patient safety recommendations, but few interventions focused on supporting healthcare professionals and preserving the institution’s reputation after the adverse event. The United States and the Netherlands, which have programs to replace the punitive culture after errors, highlight the need to break away from the paradigm of error and blame, supporting the introduction of changes that enable learning from mistakes40.
Disclosure plays an important role in the patient safety process. Using protocols appropriately, it is possible to demonstrate to healthcare users and their families how the healthcare entity conducts its activities, generating transparency between the hospital and the client and promoting communication and safety among employees, patients, and families.
It is known that creating a culture of fair accountability encourages legal compliance, not merely seeking culprits for punishment but promoting transparency and cooperation among the parties involved.
In this way, besides bringing improvements to the quality of care, the hospital provides a quality service and ensures patient rights. This study sought to understand how the duty to inform and its application may or may not contribute in disclosure scenarios in doctor-patient relationships, focusing on adverse events that require communication to the patient or responsible party
In conclusion, in recent decades, the number of publications on this topic has increased, highlighting the scientific concern with the ethics of healthcare professionals in disclosing the truth to patients, even amid uncertainties about their reactions. The barriers faced by physicians are significant, the main one being the lack of preparation during medical school regarding appropriate ways to communicate difficult news. The number of lawsuits for alleged medical error has risen in recent decades, though most were dismissed as unfounded, which, however, does not encourage professionals to disclose errors to patients. The preparation of medical graduates for this type of communication should be encouraged in curricula.
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