Regulation of the Federal Digital Medical Records Program
Written by Josefina Piñeiro
On February 28th, 2023, Act No. 27.706 (hereinafter, the “Act”) creator of the “Federal Single Program of Computerization and Digitization of Medical Records of the Argentine Republic” (hereinafter, the “Program”). On July 31th this year, Executive Order No. 393/2023 (hereinafter, the “Executive Order”). It specifies the most relevant aspects of the aforementioned Law, which we will comment on below.
Section 1 of the Executive Order defines several relevant terms, such as:
- Electronic Clinical History (from now on, “ECH”): set of digital and/or electronic documents, which records all actions performed by health professionals and auxiliaries, all the healthcare processes indicated and received by the patient, accepted or rejected and updated health status data, to ensure adequate assistance.
- Single ECH Registration System: network operated by the Enforcement Authority, which interconnects and interoperates the different electronic health record systems, in accordance with the technical communication standards and clinical terminologies to be determined.
- ECH systems: information system containing health-related data, which has sufficient technological autonomy to support its operation and ensure its correct use, and must be registered in the Register of Health Interoperability Domains. This register was created by Resolution of the then Ministry of Health No. 115/19.
Section 2 establishes certain powers of the Ministry of Health as the implementing authority. Among them, it may: a) create the Program; b) establish the technical standards of communication and clinical terms necessary for the interoperability of the systems involved; c) promote the design and inter-jurisdictional implementation of the software “integrated health history”; among others.
It also defines the limits of the interoperability framework, understood as the framework between the systems that are in operation with the systems to be created to the “National Network of Interoperability in Health”, created by the aforementioned Resolution No. 115/19, in order to enable the integration of information systems from all jurisdictions and sectors of the health system, including the public and private subsectors.
In addition, Chapter II of the Executive Order details all issues relating to the Single Electronic Health Record System. It provides that the guardianship and storage of clinical data shall be carried out in accordance with the provisions of Law No. 25.326 -Personal Data Protection Law- and its amendment, and No. 26.529 -Public Health Law- and its amendments. In this respect, we highlight the most relevant obligations.
First, it is required that the registration, updating or modification and consultation of the data contained in the Electronic Health Record Systems shall be carried out under strict conditions of security, integrity, authenticity, reliability, accuracy, intelligibility, preservation, availability, access and traceability, in accordance with the relevant legislation in force. In this regard, information should be available at all times and in all care establishments.
On the other hand, access must be limited both by the fundamental right to privacy of the patient and by the necessary security mechanisms. In fact, the data contained must be protected by the term and conditions provided for in Law No. 26.529, which in its article 10 establishes that public or private care establishments and health professionals have the obligation of depositaries, and that one must govern for the minimum term of ten (10) years of limitation in full discharge of contractual liability. This time limit is calculated from the last action recorded in the clinical record and it has expired, the depositary shall have it in the manner and form determined by the regulations.
In addition, the Enforcement Authority shall establish standards defining access profiles to health record systems. The Program shall coordinate with the competent authorities’ mechanisms necessary for the authentication of persons, agents, professionals and health assistants (such as “RENAPER” and the Superintendence of Health Services, etc.).
It is worth mentioning that the Electronic Clinical Record may be endorsed with a digital and/or electronic signature, under the terms of Digital Signature Act No. 25.506 and its modifications.
