On March 16, 2023 Decree 144/2023 was published in the Official Gazette[1] whereby Act 27,706 was enacted, legislatively formalizing the creation of the Federal Single Program for the Informatization and Digitalization of Medical Records of the Argentine Republic, (Programa Federal Único de Informatización y Digitalización de Historias Clínicas de la República Argentina) in a way that all the information related to the persons’ health will be documented in a single system.
The purpose of this initiative is to guarantee the patients and health care professionals access to an important medical information database for each patient’s medical care from any place of the national territory, observing Chapter IV of Act 26,529 on the Patients’ Rights in their relationship with Health Care Professionals and Institutions and by Act 25,326 on Personal Data Protection and amendments thereof.
The Electronic Medical Record is defined as a mandatory digital document, with a temporal, individualized and complete mark, containing all the medical care acts carried out by health professionals and aides to each patient, ratified by the digital signature of the responsible professional. At all times, each patient, owner of his/her own data, is entitled to know the information therein contained.
The system allows faster services and therefore, the reduction of wait times. Likewise, when practices are standardized in all hospitals, clinical safety is improved during the medical attention process, as well as equity at this stage.
On the other hand, as regards health care professionals, it makes it easier for them the fast access to the whole medical record of patients, from any
point of the network and in real-time, resulting in increased security in the decision-making process and in the prevention of possible mistakes (caused by inaccuracies in the transcription, loss of information, among others). Likewise, it eases cross-consultation by professionals of different health centers.
At present several provinces have already implemented the Electronic Medical Record.[2] However, until the implementation of Act 27,706 said information will be neither incorporated nor interconnected with a national subsystem.
Act 27,706 will generate a progressive process in which all medical records may be interconnected, thus creating the Single System of Electronic Medical Record.
Hence, the Single System for the Registration of Electronic Medical Records acknowledges every health care intervention in charge of health professionals and aides, provided within the national territory, either in public health facilities within the national, provincial o municipal jurisdiction, and of the City of Buenos Aires, and in private and social security institutions.
In this sense, the Act sets forth that the National Government shall bring said system into operation, in coordination with the provinces in Buenos Aires district.
The Unified Electronic Medical Record represents a clear health advantage preventing a patient who uses a sector (either public or private) and then uses another one, from starting with the Medical Record all over again in each health care center.
With Act 27,706, the patient will have complete and accurate clinical information, so that when he/she needs to use another health center, the treating medical doctor will have the background information of the patient’s health condition gathered through previous interactions with him/her.
The enforcement authority (to be appointed by the National Executive Branch in the Regulatory Decree that it shall have to issue within the next 90 days), must determine the technical and operational features of informatization and digitalization of the medical records of the Argentine Republic’s health care system.
Among the enforcement authority’s powers, the following stand out:
– It shall prepare a protocol to upload medical records, as well as the design and implementation of a medical record software coordinating the interjurisdictional implementation, complying with the provisions of Act 27,706 and Acts 26,529 and 25,326 and their amendments and regulations.
– Provide technical and financial assistance to the provincial jurisdictions and the City of Buenos Aires, to comply with the purposes of this Act.
– Install the software free of charge in all the public, national, provincial and municipal hospitals; and, as set forth by regulations, in health care private and social security health care centers;
– Train the health staff.
The patient’s medical data must be clearly gathered and easily understandable, since birth and up to the death of the individual.
The Medical Record must contain the patients’ informed consent, as well as the nursing records, doctors’ and/or professionals’ orders, diet prescriptions, vaccination certificates, medical tests and practices performed, rejected or abandoned.
In case of the patient’s disability or impossibility to understand the information due to his/her physical o psychic condition, the same must be supplied to his/her legal representative or holders of rights, pursuant
to the provisions of Act N° 25,326 on personal data protection and amendments thereof.
The new Act provides that the IT mechanisms for the authentication of persons, agents, health professional and aides intervening in the Single System of Electronic Medical Record must be guaranteed, as well as free access and tracking by the patient.
The registration, updating or modification and consultation of medical information will be carried out under the following strict conditions: security, integrity, authenticity, reliability, accuracy, comprehensibility, conservation, availability, access and traceability of data.
The medical information contained in the Single System for the Registration of Electronic Medical Records shall be confidential, under administrative, civil or criminal liability. The enforcement authority shall appoint the persons responsible for the management and safeguard of medical information.
Personal Data
As regards personal data, Act 27,706 refers to the application of Act 25,326 that sets forth the lawfulness of the personal data processing principles in general, that prove to be applicable to the data related to health.
The data related to health are categorized by Act 25,326, as “sensitive” personal data. Act 27,706 is thus supplemented with Act 25,326, once the health data are voluntarily supplied by its owner, authorizing their processing and creation of files, banks or records storing information directly or indirectly disclosing sensitive data.
In addition to the provisions of Act 25,326, the health data to be recorded in the Electronic Medical Record are regulated by Act 26,529, on the Patients’ Rights in their Relationship with Health Professional and Institutions.
The Health Professional intervening in any stage of the personal data processing is bound by professional secrecy, even after the termination of his/her relationship with the owner of the data file. However, the health professional may be released from the professional secrecy duty as per any courts’ resolutions and when there are well-founded reasons related to public safety, national defense or public health.
It must be highlighted that personal data gathered in the Electronic Medical Record always belong to the patient, and a copy thereof must be delivered upon the simple requirement of its owner[3], and it is expressly provided for that in case of delay or denial the habeas data action will apply.[4]
Since the data included in Medical Records are personal data governed by Act 25,326, the patients/owners thereof shall have the following rights[5]:
– Information: “right to request information from the controlling agency on the existence of files, records, personal databases or databanks, their purposes and the identity of their controllers”; –
– Access: “the data owner, before proving his/her identity, is entitled to apply for and obtain information on his/her personal data included in public or private databanks which purpose is to provide reports”, and the information must be supplied within ten running days following the demand by any reliable means.
– Rectification, updating or suppression of data: “every person is entitled to the rectification, updating and, as applicable, the suppression or obligation of non-disclosure of personal data owned by him/her, which are included in databanks” and the “rectification, updating or suppression of inaccurate or incomplete data contained in public or private records shall be carried out free of charge for the interested party”.
If the information added in the electronic medical record is not supplied within the term set forth in the Act (or the term resulting from the
regulation of Act 27,706), the data owner has the door open to file a habeas data action; as well as to make the relevant reports before the Access to Public Information Agency (Agencia de Acceso a la Información Pública).
[1] https://www.boletinoficial.gob.ar/detalleAviso/primera/282707/20230316 [2] City of Buenos Aires and Provinces: Buenos Aires, San Luis, Córdoba, Santa Fe, Salta, Entre Ríos, among others [3] Act 26.529, section 14. [4] Act 26.529, section 20. [5] Act 25.326, sections 13 to 16.