On April 07, 2026, Law No. 15,378/26 was published, establishing the Patient Rights Statute, concerning patients’ rights, principles, and responsibilities. The statute also establishes mechanisms aimed at promoting patient autonomy, dignity, and safety across all stages of healthcare, applicable to public and private healthcare services and professionals.
Law No. 15,378/26 entered into force on the date of its publication, thereby establishing a new legal framework for the protection of patients’ rights.
Who does it apply to?
The Patient Rights Statute applies to healthcare services of any kind, private legal entities that operate health insurance plans, and healthcare professionals.
Its application complements existing legislation, as applicable, including the Health Insurance Plans Law (Law No. 9,656/98), the Consumer Protection Code (Law No. 8,078/90), as well as professional regulations issued by professional councils, such as the Federal Council of Medicine (“CFM”), the Federal Council of Dentistry (“CFO”), the Federal Council of Pharmacy (“CFF”), among others.
What are patients’ rights?
The rights ensured to patients include:
- Self-determination and active participation in decisions regarding their healthcare treatment, including the therapeutic plan.
- Respect for advance directives and access to palliative care, including support for family members.
- Access to medical records without justification, as well as the right to obtain a copy free of charge, request rectifications, and require that such records be kept secure.
- The right to consent to or refuse the disclosure of personal information to unauthorized third parties, including family members, except where disclosure is required by law.
- Care in appropriate facilities, with trained professionals, as well as safe procedures, supplies, and medications, with guaranteed origin, traceability, and safety.
In practice, the statute establishes cross-cutting obligations throughout the patient’s journey, ranging from organizational processes to a humanized approach to care, while respecting patient autonomy. The rights guaranteed to patients must also be interpreted from the perspective of the responsibilities imposed on healthcare services, including the following:
- Quality of care, timely service, and care conditions: the statute ensures patients’ right to quality healthcare provided in a timely manner, in clean and appropriate facilities, and by duly trained and qualified professionals. It also expressly addresses safe transfers between facilities and continuity of care information.
- Patient safety, transparency, and active participation: the law places a central emphasis on patient safety, understood as the provision of a safe healthcare environment, including appropriate procedures and reliable supplies. It also reinforces the patient’s right to ask questions and receive clear information about procedures, supplies, and medications.
- Nondiscrimination, respect for identity and cultural particularities: the statute expressly prohibits any form of discrimination in healthcare and guarantees the patient’s right to be addressed by their preferred name, as well as to have their cultural, religious, and social particularities respected, especially in relation to vulnerable groups.
- Broad, free, and secure access to medical records: the law guarantees patients unrestricted access to their medical records, without the need for justification, as well as the right to obtain copies free of charge, request rectifications, and demand information security.
- Monitoring, institutional transparency, and complaints handling: although aimed primarily at Public Authorities, Section 23 signals an environment of greater monitoring, transparency, and accountability, including periodic disclosure of rights, quality surveys, annual reports, and complaints-handling mechanisms.
What are patients’ responsibilities?
Patients, or persons designated by the patient, must collaborate with healthcare professionals by providing accurate and complete information about their clinical history, illnesses, hospitalizations, and medication use. Patients also have a duty to comply with the rules of the healthcare facility.
What sanctions apply in the event of a breach of patients’ rights?
Violations of patients’ rights provided for in the statute constitute conduct contrary to human rights, under the terms of Law No. 12,986/14, which establishes the National Human Rights Council (“CNDH”).
Within the scope of the CNDH’s authority, sanctions may be imposed on the responsible party holding a position in public administration, including warnings, public censure, and recommendations for removal from office, function, or employment. Additionally, the law recommends that no funds, aid, or subsidies be granted to entities proven to be responsible for such violations.
These sanctions can be applied separately or cumulatively, in proportion to the severity of the conduct, and are autonomous in nature, without prejudice to other criminal, civil, or administrative liabilities provided for under specific legislation.
The indirect impacts of the Patient Rights Statute require healthcare services to adopt a more structured, preventive, and transparent institutional approach, with strengthened internal mechanisms for governance, compliance, and accountability.
In practice, healthcare services must:
- Structure or strengthen internal ombudsman and complaint-handling channels, ensuring proper recordkeeping and timely responses.
- Prepare for audits, quality surveys, and information requests from public authorities.
- Maintain systematic documentation of measures implemented to ensure patient rights, as well as to support reports and inspections.
- Review internal policies to ensure ongoing compliance with legal obligations, thereby reducing regulatory and reputational risks.
Demarest’s Life Sciences and Healthcare team is available to provide any further clarifications that may be necessary.
