PUBLICA HEALTH Law 26.529 Patient's Rights in Relation to Health Professionals and Institutions. Sanctioned: October 21st 2009 Cast: November 19th, 2009

The Senate and Chamber of Deputies of the Argentine Nation assembled in Congress, etc. sanction with force of Law:

RIGHTS OF THE PATIENT, HISTORY AND INFORMATION

ARTICLE 1 Scope of application. The exercise of the patient ' s rights, in terms of the autonomy of will, information and clinical documentation, is governed by this law.

Chapter I

RIGHTS OF THE PACIENT IN ITS RELATION TO PROFESSIONALS AND INSTITUTIONS OF HEALTH

ARTICLE 2 Patient's rights. They constitute essential rights in the relationship between the patient and the health professionals, the health insurance agents, and any effectors in question, the following:

(a) Assistance. The patient, primarily children and adolescents, has the right to be assisted by health professionals, without impairment and any distinction, as a result of their ideas, religious beliefs, policies, socio-economic status, race, sex, sexual orientation or any other status. The acting professional may only be exempted from the duty of assistance, when another competent professional has been effectively taken over by the patient;

(b) Decent and respectful treatment. The patient has the right to have the agents of the intervening health system accord him a decent treatment, with respect to his personal and moral convictions, mainly those related to his sociocultural, gender, prudence and privacy, whatever the suffering he presents, and to extend to the family or companions;

(c) Intimacy. Any medical activity - assistance to obtain, classify, use, administer, guard and transmit information and clinical documentation of the patient must observe strict respect for human dignity and the autonomy of the will, as well as due protection of the privacy of the patient and the confidentiality of his sensitive data, without prejudice to the provisions contained in Act No. 25,326;

(d) Confidentiality. The patient has the right to ensure that any person who participates in the preparation or handling of the clinical documentation, or has access to the contents of the clinical documentation, has the right to maintain the proper reservation, except express provision to the contrary emanating from the competent judicial authority or authorization of the patient himself;

(e) Autonomy of Will. The patient has the right to accept or reject certain medical or biological therapies or procedures, with or without the expression of cause, as well as to later revoke his manifestation of will. Children and adolescents have the right to intervene in the terms of Act No. 26.061 for the purpose of decision-making on medical or biological therapies or procedures involving their life or health;

(f) Health information. The patient has the right to receive the necessary health information related to his or her health. The right to health information includes the right not to receive such information.

(g) Medical consultation. The patient has the right to receive written health information in order to obtain a second opinion on the diagnosis, prognosis or treatment related to his or her state of health.

Chapter II

INFORMATION

Article 3 . Definition. For the purposes of this Act, please provide health information which, in a clear, sufficient and adequate way to the patient ' s ability to understand, reports on the patient ' s state of health, studies and treatments that must be carried out and the foreseeable evolution, risks, complications or sequelae of the patient. ARTICLE 4 . Authorization. Health information may only be provided to third parties, with patient authorization.

In the case of inability of the patient or impossibility of understanding the information due to his or her physical or mental state, the patient will be provided to his or her legal representative or, in the absence of the spouse who lives with the patient, or the person who, without being his or her spouse, lives or is in charge of the assistance or care of the patient and family members up to the fourth degree of consanguinity.

Chapter III

INFORMATION

ARTICLE 5o . Definition. Please, by informed consent, the declaration of sufficient will made by the patient, or by its legal representatives, issued after receiving, by the intervening professional, clear, accurate and appropriate information regarding:

(a) Their state of health;

(b) The proposed procedure, with specification of the objectives pursued;

(c) The expected benefits of the procedure;

(d) foreseeable risks, discomfort and adverse effects;

(e) The specification of alternative procedures and their risks, benefits and prejudices in relation to the proposed procedure;

(f) The foreseeable consequences of non-compliance with the proposed procedure or the specified alternatives.

ARTICLE 6 . Obligatoriedad. Any professional performance in the medical-sanitary sphere, whether public or private, requires, on a general basis and within the limits set by regulation, the prior informed consent of the patient.

ARTICLE 7 . Instrumentation. The consent shall be verbal with the following exceptions, in which it shall be written and duly subscribed:

(a) Detention;

(b) Surgical intervention;

(c) Invasive diagnostic and therapeutic procedures;

(d) Procedures involving risks as determined by the regulation of this Act;

(e) Revocation.

ARTICLE 8 . Exhibition for academic purposes. The patient ' s consent or in its absence, the consent of his or her legal representatives, and of the health professional involved in exhibitions for academic purposes, is required prior to the presentation. Article 9 Exceptions to informed consent. The health professional shall be exempt from requiring informed consent in the following cases:

(a) Where there is a serious danger to public health;

(b) When an emergency situation is mediated, with serious danger to the patient ' s health or life, and could not give consent on its own or through its legal representatives.

The exceptions set forth in this article shall be credited in accordance with the provisions of the regulation, which shall be interpreted as restrictive.

ARTICLE 10. . Revocability. The decision of the patient or his or her legal representative, in respect of consenting or rejecting the treatments indicated, may be revoked. The acting professional must comply with such a decision, and make this manifest in the clinical history, adopting for the case all the formalities that are necessary for the purpose of accrediting such a manifestation of will, and that the same was adopted in knowledge of the foreseeable risks involved.

In cases where the patient or his or her legal representative revoke the rejection of the treatments indicated, the acting professional will only comply with such a decision if the patient's health conditions are maintained that at the time they advised such treatment. The well-founded decision of the acting professional will be settled in clinical history.

ARTICLE 11. Early directives. An older person may have advance directives on his or her health, and may consent to or reject certain medical, preventive or palliative treatments, and health decisions. The directives should be accepted by the doctor in charge, except for those that involve developing euthanical practices, which will be non-existent.

Chapter IV

OF THE CLINICAL HISTORY

ARTICLE 12. . Definition and scope. For the purposes of this law, be guided by clinical history, the obligatory chronological, foliated and complete document in which it consists of any action performed to the patient by professionals and health assistants. ARTICLE 13. . Computerized clinical history. The contents of the clinical history can be made in magnetic support provided that all the means that ensure the preservation of its integrity, authenticity, inalterability, durability and recoverability of the data contained in the same in time and form are reduced. To this end, the use of restricted accesses with identification keys, non-rescriptible storage media, field modification control or any other suitable technique to ensure their integrity should be adopted.

The regulation establishes the supporting documentation that must be preserved and designated by those responsible who will have the responsibility of it.

ARTICLE 14. . Ownership. The patient is the headline of clinical history. To his simple requirement, a copy of the same, authenticated by the competent authority of the assistance institution, must be provided. Delivery will take place within forty-eight (48) hours of request, except in case of emergency. ARTICLE 15. Seats. Without prejudice to the provisions of the preceding articles and the provisions of the regulation, the medical history must include:

(a) The start date of the preparation;

(b) Identification data of the patient and his family nucleus;

(c) Identification data of the intervening professional and his specialty;

(d) Clear and accurate records of acts performed by intervening professionals and assistants;

(e) Genetic, physiological and pathological background if any;

(f) Any medical act performed or indicated, whether it is a prescription and supply of medicines, treatments, practices, major and complementary studies related to the presumptive diagnosis and in its case of certainty, records of intervention of specialists, diagnosis, prognosis, procedure, evolution and all other activity inherent, especially incomes and high doctors.

Seats corresponding to the provisions of subparagraphs (d), (e) and (f) of this article shall be made on the basis of universal nomenclatures and models adopted and updated by the World Health Organization, which the implementing authority shall establish and update by regulation.

ARTICLE 16. Integrity. They form part of the clinical history, informed consents, medical indication sheets, nursing tables, surgical protocols, dietary prescriptions, studies and practices carried out, rejected or abandoned, should be accompanied in each case, brief summary of the act of aggregation and authorized breakdown with record of date, signature and seal of the acting professional.

ARTICLE 17. Unique. The clinical history has a unique character within each public or private care facility, and it must identify the patient through a "unique setting", which must be communicated to the patient. ARTICLE 18. . Inviolability. Depositaries. Clinical history is inviolable. Public or private care facilities and health professionals, in their capacity as private office holders, are responsible for their custody and custody, assuming the status of depositaries, and must implement the necessary means and resources in order to avoid access to the information contained therein by unauthorized persons. Depositaries are extended and applicable to the contractual provisions set out in Book II, Section III, of Title XV of the Civil Code, "Del deposit", and concordant rules.

The obligation imposed in the preceding paragraph must govern during the minimum time limit of EZ (10) years of compensatory limitation of contractual liability. This period has been computed since the last performance recorded in the clinical history and expired, the depositary will have the same in the manner and manner determined by the regulation.

ARTICLE 19. . Legitimation. Please note that you are legitimized to apply for clinical history:

(a) The patient and his legal representative;

(b) The spouse or person living with the patient in a de facto union, whether or not of different sex according to accreditation that determines the regulation and the forced heirs, if any, with the consent of the patient, unless the patient is unable to give it;

(c) Doctors, and other professionals of the art of healing, when they have express authorization from the patient or his legal representative.

To that end, the depositary must have a copy of the medical record as a backup copy, reviewing the copy all the formalities and guarantees due to the original. Copies certified by the respective health authority of the medical records may also be delivered, where appropriate, with the record of the person conducting the proceedings, including the necessary data, reasons and other considerations.

ARTICLE 20. Negative. Action. Any subject legitimated in the terms of Article 19 of this Law, in the face of the refusal, delay or silence of the person responsible for the care of the clinical history, shall have the exercise of the direct action of "habeas data" in order to ensure the access and obtaining of it. Such action shall be printed in the manner of process that is more appropriate and expeditious in each jurisdiction. In national jurisdiction, this action will be exempt from justice costs. ARTICLE 21. . Sanctions. Without prejudice to the criminal or civil liability that may correspond, the breaches of the emerging obligations of this law by the professionals and those responsible for the care establishments shall constitute a serious fault, being passive in the national jurisdiction of the penalties provided for in Title VIII of Law 17.132 .Legal Law on the Exercise of Medicine, Dentistry and Auxiliary Activities of the same cada and, in the local jurisdictions, shall be subject to similar penalties.

Chapter V

GENERAL PROVISIONS

ARTICLE 22. National and local implementation authority. It is the authority to apply this law in national jurisdiction, the Ministry of Health of the Nation, and in each of the provincial jurisdictions and Autonomous City of Buenos Aires, the highest local health authority.

Invite the provinces and the Autonomous City of Buenos Aires to accede to the present law on the subject of the sanctions regime and the benefit of free access to justice.

ARTICLE 23. Watch. This law is of public order, and shall enter into force from the NOVENTA (90) days of the date of publication. ARTICLE 24. . Regulation. The Executive Power must regulate this law within the NOVTA (90) days from its publication. ARTICLE 25. Contact the Executive.

IN THE SESSION OF THE ARGENTINE CONGRESS, IN GOOD AIRES, TO THE TWENTY DAYS OF THE OCTOBER OF THE YEAR DOS MIL NEW.

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JULY C. C. COBOS. EDUARDO A. FELLNER. . Enrique Hidalgo. . Juan H. Estrada.