Decree No. 98/2023: Electronic and Digital Prescriptions.
Healthcare & Life Sciences Department Report | Decree No. 98/2023: Electronic and Digital Prescriptions
Dear Sir or Madam,
On February 27th, 2023, the National Executive Branch issued Decree No. 98/2023 (the “Decree”), which regulates Law No. 27,553 on Electronic and Digital Prescriptions (the “Electronic Prescription Law”). The Decree was published in the Official Gazette on February 28th, 2023. The Electronic Prescription Law was enacted in 2020; it established that the prescription and dispensing of medicines and any other prescription, may be written and signed through handwritten, electronic or digital signatures, in electronic or digital formats, throughout the national territory; as well as the use of telehealthcare platforms, in the same area. The aforementioned Law also entrusted the National Executive Branch with its regulation within 120 days. More than two years later, the Electronic Prescription Law was finally regulated by means of the Decree. However, according to the text of the Decree itself, there are several matters on which the Ministry of Health, the enforcement authority of the Electronic Prescription Law, must now issue additional and complementary regulations.
Decree No. 98/2023’s main points
• The “Electronic Prescription” was defined as the digital document prepared and signed by a health professional, with an electronic signature, through a platform that allows electronic prescription.
• The “Digital Prescription” was defined as the digital document, prepared and signed by a health professional, with a digital signature and competence seal, through a digital platform allowing such prescription.
• In order to be valid, electronic or digital prescriptions must comply with the following requirements:
(i) Identification: it shall include a unique and unrepeatable identifier that will allow it to be univocally identified. The format, structure and content of this identification shall be defined by the Ministry of Health, for statistical, transparency and information security purposes.
(ii) Content: The contents of the electronic or digital prescription shall be included in the section intended for such purpose, in order to favor accessibility, equity, and quality of health care.
(iii) Validity: The effective date of the prescription shall be stated, which may be the same or later than the date of preparation of the electronic or digital prescription, in accordance with the provisions of the regulations in force. The prescription shall be valid for 30 days as from the effective date for medicines and 60 days for other studies unless otherwise provided by law.
(iv) Integrity and unalterability: it shall be integral and unalterable. Modifications linked to the processes necessary for patient or health team annotations and/or headings, dispensing and/or consumption may be incorporated.
(v) Security and confidentiality: it must comply with the standards of security, availability, inviolability, and protection of personal data, in accordance with the regulations in force and those established by the Authority of Application.
(vi) Interoperability: it should use syntactic and semantic standards that allow the exchange and use of information for sanitary, statistical, control, and epidemiological purposes, in accordance with the requirements established by the Authority of Application, according to the regulations in force.
• “Tele-assistance” should be understood as the provision of remote health services through the use of information and communication technologies in a synchronous or asynchronous manner, carried out within the national territory, by the health team, for promotion, prevention, diagnosis, treatment and rehabilitation, in accordance with other requirements established by each health authority and the regulations in force.
• The Ministry of Health will be the enforcement authority of the Electronic Prescription Law. As such, it must define the characteristics, contents, standards, and elements that the digital or electronic prescription must comply with in order to be valid, as well as the requirements referred to the platforms through which they are processed, to guarantee their security, integrity and inalterability.
• The “Federal Sanitary License” (the “License”) was created, which will include all the enabling licenses of health professionals registered in the “Federal Network of Health Professionals’ Registries”. The License will determine a “Unique Health Professional Identification Key” that will allow health professionals to be univocally identified, as well as to access the interoperable systems for the implementation of Information and Communication Technologies in the Argentine Health System. The Ministry of Health shall dictate the complementary norms, details, and stages for its implementation.
• Each province may adhere to the use of the License.
• The platforms through which (a) prescriptions are made, (b) electronic or digital prescriptions are validate and/or dispense, or (c) tele-assistance is managed, must, among other obligations established by the Decree (i) be responsible for the processing of data, being obliged to do so in a confidential and secure manner in accordance with the applicable regulatory requirements; (ii) provide mechanisms to safeguard the credentials and accesses of the actors involved to ensure security; (iii) to host the servers of the platforms in a safe place, in accordance with applicable practice and regulatory requirements, establishing safeguards in order to preserve the security, availability, inviolability, unalterability and confidentiality of personal data; (iv) to comply with the provisions of Law No. 25,326 on the Protection of Personal Data and guarantee to the users of the health system, or to those authorized by them, access to their registered data, as well as its updating, in accordance with Law No. 26,529 on “Patients’ Rights, Clinical History and Informed Consent”, in their relationship with Health Professionals and Institutions, generating the mechanisms for the safeguarding or backup of personal data, for the time provided for in the applicable regulations.
• Those who own the platforms through which electronic or digital prescriptions are issued, are subject to the limitations and/or prohibitions set forth in the rules of professional practice of medicine and pharmacy, as well as to the requirements in force regarding the advertising of services.
• The protection of health data includes both the nominalized medical and administrative records and their complementary documents, and their integrity, authenticity, inalterability, durability, availability at all times, and mechanisms for the recovery of the stored health data must be ensured.
• The restrictions and limitations imposed on the use of artificial intelligence must be observed. Such use shall be only to support professional decision-making, always requiring the supervision of health professionals or medical collaborators.
• Within the definition of “legally restricted sale” products (as established in Decree No. 7123/68), the possibility of prescribing them, in addition to handwritten prescriptions, electronic or digital prescriptions were included, always in officialized forms and according to the model approved by the Ministry of Health.
• It was determined that for “prescription-on-file” products, prescribed in electronic or digital prescriptions, the requirements set forth in the Electronic Prescription Law must be complied with. Likewise, electronic or digital prescriptions must be recorded in the registry or digital file enabled for such purpose, once they have been dispensed and signed electronically or digitally by the pharmacist or pharmacist who dispensed them, according to the form and procedure established by the Ministry of Health.
• It was determined that the products of “prescription dispensing” prescribed by means of electronic or digital prescriptions must be electronically or digitally signed by the Technical Directors and/or auxiliary pharmacists, when they contain magistral and official formulas, being responsible for their correct preparation.
• The records and digital files shall be kept up to date and shall be made available and exhibited, in the corresponding cases, to the Health Authority Inspectors, at their request. Likewise, the digital files must be guaranteed to be secure, unalterable, and complete.
• It was determined that the Ministry of Health will determine and update the minimum requirements and contents that the digital files must have.
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