Patient Rights in relation to professionals and health institutions

Law No 26,529, passed recently by the National Congress, regulates the exercise of patient rights in relation to professionals and health institutions.

1. Essential rights of the patient

The Law states as essential rights of the patient in their relationship with health professionals, the health insurance agents and any clinic, as follows:

a)  Attendance
b)  Treatment with dignity and respect
c)  Intimacy
d)  Confidentiality
e)  Free will
f)  Health Information
g)  Medical Case Conference

2. Health Information

The Law defines Health Information as any information which, in a clear, adequate and according to the capacity of the patient’s comprehension, informs about his or her health, tests and treatments which may be necessary to take as well as the foreseeable development, risks, complications or consequences thereof.

As part of the required confidentiality, the Law provides that health information can only be provided to third parties with patient permission. In cases where the patient is unable or becomes unable to understand the information, the authorization may be provided by his or her legal representative, spouse or partner, person in charge of assistance or care and family to the fourth degree.

3. Informed Consent

The Law defines informed consent as a sufficient statement of will made by the patient or their legal representatives if any, issued upon receipt, by the professionals involved, with clear, accurate and appropriate information with respect to:

a)  his or her health;
b)  the proposed procedure;
c)  expected benefits;
d)  risks, inconvenience and adverse effects expected;
e)  specifications of the alternative procedures and their risks, benefits and disadvantages in relation to the proposed procedure;
f)  likely consequences of failure to perform the proposed procedure or the alternative.

In turn, the Law requires that any performance in the medical health field is preceded by informed consent.

In principle, consent is expressed verbally. However, the following cases require written consent, namely:

a)  hospitalization;
b)  surgical intervention;
c)  invasive diagnostic and therapeutic procedures;
d)  procedures that involve risks as determined by the regulations of this law;
e)  reversal of consent.

As regards the health professional, same is exempt from requiring informed consent when there is serious public health hazard or an emergency situation, with serious danger to health or life of the patient and said patient was unable to give consent on their own account or through their legal representatives.

The Law also provides that the patient or his or her legal representative may reverse the decision to consent or refuse treatment, the professional must abide by that decision and must state said decision expressly in the Clinical History.

4. Medical Records

The Law defines these as a binding document which is chronological, numbered and complete, stating any action carried out by professionals and health auxiliaries on the patient.

This provision empowers health professionals to make sure that the clinical history is backed up on a floppy disk to ensure by all means that it is preserved in its integrity, authenticity, age resistance, durability and recoverability of data. To this end, the Law provides for techniques to be taken to ensure the integrity of medical records.

The history should identify the patient through a "Uniform key" that must be communicated to it.

For its part, the Law gives the patient the ownership of their medical records. Just by requesting them, he or she must be provided with a copy, certified by the competent authority from the institution in question. The delivery of the copy must be made within 48 hours of the patient’s request, except in an emergency.

As well as the patient, the following subjects ("legitimate subjects") are entitled to request the Clinical History:

a) The patient’s legal representative;
b) The spouse or person residing with the patient and his legal heirs, if any, with patient’s permission, unless that person is unable to give it;
c) Doctors and other medical professionals, when they have express permission from the patient or his or her legal representative.

The Law determines that the clinical history is inviolable. In this regard, both public and private health professionals, in their capacity as holders of private clinics are responsible for the care and custody of medical records. As such, they should implement the necessary means and resources to prevent improper access by unauthorized persons. They are applicable to the case the Civil Code rules relating to the deposit.

The requirement governs custody for a minimum period of 10 years, which is counted from the last act recorded in the clinical history.

The depositary must have a copy of the medical file with backup copy nature.

In the event of being denied the medical history, legitimate subjects shall be able to exercise the direct action of “habeas data” to ensure access and obtain from it. Same solution applies to the case of delay or silence in order to grant the copy of the clinical history. The action handled by the process in each jurisdiction is the most suitable and fastest. In federal jurisdiction the action is exempt from legal fees.

5. General Provisions

The Law provides that, notwithstanding any appropriate criminal or civil liability, breaches of the obligations under the present law by professionals and health care facilities responsible constitute serious misconduct. Under the national jurisdiction of the Legal Regime penalties prescribed by the Practice of Medicine, Dentistry and Related Activities are liable, including: 

a) suspension of registration or qualification of the establishment;
b) warning;
c) fine;
d) suspension of the practice of one (1) month to five (5) years (temporary suspension of registration);
e) total or partial closure, temporarily or permanently of the office, clinic, school, hospital, laboratory or any other premises or place where  the persons who committed the offense act.

In local jurisdictions sanctions that correspond to the statutory medical practice that governs each of them will be subject to breaches of a similar tenor.

The Law determines that the enforcement authority in the national jurisdiction is the Federal Ministry of Health, while in the provinces and in Buenos Aires is the highest local health authority.

Finally, this is a public order Law and shall enter into force within 90 days from its publication in the Official Gazette.