News on the Law on Electronic or Digital Prescriptions

The regulation of Law No. 27,553 on Electronic or Digital Prescriptions, which can be found in Annex I of the Decree No. 98/2023, was approved on February 28, 2023.

the decree does not affect the validity of wet-signature prescriptions –still in force according to applicable regulations–. It incorporates some definitions to section 1:

 

1. Electronic prescription: "A digital document of a sanitary nature, prepared and signed by a healthcare professional, with electronic signature in accordance with the applicable regulations, through which medicines are prescribed to a patient, or any other prescription to be administered, applied or consumed, through a platform that allows electronic prescription.”

 

2. Digital prescription: “A digital document of a sanitary nature, prepared and signed by a healthcare professional, with digital signature and digital competence seal in accordance with the applicable regulations, through which medicines are prescribed to a patient, or any other prescription is indicated, through a digital platform that allows such prescription.”

 

3. Tele-assistance: “Provision of remote healthcare services through information and communication technologies in a synchronous or asynchronous manner, within the national territory, by a healthcare team, for the promotion, prevention, diagnosis, treatment and rehabilitation, in accordance with other requirements established by each health authority and the regulations in force.”

 

The Regulation states the requirements that an electronic or digital prescription must fulfill to be valid:

 

1. Identification: it must include a unique and unrepeatable identifier that allows the prescription to be univocally identified.
2. Validity: it must include the effective date of the prescription, which must be the same date it was written or later, with a validity of 30 or 60 days, as appropriate.
3. Integrity and unalterability: the electronic or digital document must be complete, unalterable, and comply with the standards of security, availability, inviolability, and protection of personal data.
4. Content: it must comply with section 19, subsection 7 of the Law No. 17,132 on the Art of Healing, as amended by section 10 of Law No. 27,680 (i.e., it must include the following information in Spanish: first and middle names, family names, profession, license number, address, telephone number, and e-mail when applicable. It must also include the date and be signed).
5. Security and confidentiality
6. Interoperability: it must be written with syntactic and semantic standards that allow the exchange and use of information for health, statistical, control, and epidemiological purposes. The exchange of information from the different participants must be made through the National Health Interoperability Network (Resolution No. 115/2019).

 

On the other hand, section 4 lists the general requirements that electronic or digital prescriptions and healthcare tele-assistance platforms must comply with:

 

1. They must be responsible for processing personal data, ensuring the security, privacy, purpose, opportunity, veracity, inviolability, and confidentiality of personal data.

2. They must provide mechanisms to safeguard the credentials and accesses of the actors involved.

3.  They must comply with all the requirements in Law No. 25,326 on the Protection of Personal Data –particularly regarding the data owner’s right to access and update the data– and in Law No. 26,529 on the Rights of the Patient.

4.  They must adopt the necessary security measures to ensure the security, availability, and unalterability of personal data.

5.  The owners of the platforms are subject to the limitations and/or prohibitions in the regulations on the professional practice of medicine and pharmacy, as well as to the requirements regarding the advertising of services.

 

The Regulation appoints the National Ministry of Health to promote the progressive implementation of electronic or digital prescriptions and of healthcare tele-assistance platforms, and to regulate the interoperability in Argentina.

 

The Decree No. 98/2023 thus updates the terms of the Law No. 17,132 on the Art of Healing and of the Law No. 17,565 on the Practice of Pharmacy, consolidating the applicable regulations.