On August 11, 2020, the Electronic or Digital Prescriptions Act N.º 27.553 (hereinafter, “LRED”) was passed in Argentina, which is of special importance within the regulatory framework of the Social, Preventive and Mandatory Isolation measures in force in the country. The purpose of this rule is to (i) regulate and allow the dispensing and prescription of medicines, as well as any other prescription, drawn up and signed through electronic or digital signatures; and (ii) enable the use of telecare platforms in health throughout the national territory. Thus, among its most relevant points, the following should be highlighted:
- The telecare platforms shall comply with the Personal Data Protection Act N° 25.326, and the Patients’ Rights Act N° 26.529.
- Medications prescribed under electronic or digital prescriptions must be dispensed at any pharmacy or establishment authorized for this purpose in the country.
- The authority appointed by the national Executive Power, and determined on each jurisdiction, will oversee the implementation and adaptation of the electronic systems for the purposes of the LRED.
- The designated bodies will be responsible for the systems’ audit. Additionally, they shall issue criteria for the authorization of access control to the databases that are created for such purposes and which guarantee compliance with the Personal Data Protection Act Nº 25.326, Patients’ Rights Act N° 26.529, and other applicable regulations.
- The Act N.º 17.132 on the practice of medicine, dentistry and collaboration activity related to these practices, has been modified in order to include the ability to prescribe or certify electronic or digital prescriptions. In relation to this point, it has been established that in case of utilizing digital signature, such signature must be adequate to the requisites of the Digital Signature Act N° 25.506.
- Likewise, the Act N° 17.132 has been modified to enable the telecare modality subject to the protocols and platforms approved by the enforcement authority.
- Pharmacies shall keep records or digital files authorized by the health authority.
- Lastly, the provinces and the Autonomous City of Buenos Aires have been invited to adhere to the LRED.
We remain at your disposal for any questions.
Lerman & Szlak