Law No. 27,706: Electronic Health Record.
Healthcare and Life Science Department Report | Law No. 27,706: Electronic Health Record
Dear Sir or Madam,
On February 28th, 2023, the Legislative Body approved Law No. 27,706 (the “Law”), published in the Official Gazette today, which creates the Single Federal Program for the Computerization and Digitalization of Medical Records. The purpose of this Program is to establish a Single System for the Registration of Electronic Medical Records (the “Single System for the Registration of Electronic Medical Records”).
The purpose of the Single System of Electronic Medical Records is to guarantee patients and health professionals access to a single database containing and recording the patient’s clinical data and information and all medical-healthcare interventions, from birth to death, relevant to their health care from anywhere in the national territory, whether they are treated in public or private health system establishments.
The Law clarifies that the Electronic Health Record is a digital, mandatory, time-stamped, individualized, and complete document that contains all the healthcare actions carried out by healthcare professionals and assistants to each patient, with the digital signature of the person in charge.
According to the Law, the Electronic Medical Record includes informed consent, medical and/or professional indication sheets, nursing forms, surgical protocols, dietary prescriptions, vaccination certificates, studies, and practices performed, rejected, or abandoned.
Likewise, it is established that the Single System for the Registration of Electronic Medical Records shall comply with the following characteristics:
(i) The clinical information contained therein must be confidential;
(ii) The clinical information contained therein, its registration, updating or modification, and consultation shall be carried out under strict conditions of security, integrity, authenticity, reliability, accuracy, intelligibility, conservation, availability, access, and traceability;
(iii) The computerized mechanisms for the authentication of the persons who intervene in the Unified System for the Registration of Electronic Medical Records shall be guaranteed;
(iv) Free access and follow-up by the patient shall be guaranteed;
(v) It shall contemplate the recovery of files and the durability of the information;
(vi) It shall be auditable and subject to inspection by the corresponding authorities;
(vii) The information contained therein will constitute authentic documentation and, as such, will be valid and admissible as a means of proof, making it full faith for all purposes, provided that it is authenticated.
It should be noted that the Law places special emphasis on the fact that the patient is the owner of the data and has the right to know the information detailed in the Electronic Health Record at all times. In the event of the patient’s incapacity or impossibility to understand the information due to his/her physical or psychological condition, the same must be provided to his/her legal representative or legal guardians, in accordance with the provisions of Law 25,326 on the protection of personal data and its amendments.
The Law granted a 90-day term for the Executive Power to dictate the application authority and to regulate the application of the Law.
Among the points to be regulated by the application authority are: (i) to determine the technical and operative characteristics of the computerization and digitalization of medical records; (ii) to design and implement medical record software and to prepare a protocol for loading medical records, (iii) to coordinate the operation of the system to be created with the systems in operation in the public and private sectors and in the social security field, (iv) to install the software in all the hospitals and health centers of the country, and (v) to provide technical (training of health personnel) and financial support to the different provinces.
Furthermore, an Interdisciplinary Experts Commission will be created, in which all the subsystems involved will participate, for the purpose of coordinating the implementation of the Law with the provincial authorities and the authorities of the Autonomous City of Buenos Aires.
Please, let us know should you require any further information on this matter.
Sincerely,
Ana Andrés
Julieta Gonzalez