The new Law on electronic or digital Prescriptions was enacted
By Abril Neiman y Josefina Piñeiro.
On February 23, the National Executive Power (N.E.P.) regulated Law 27,553 on Electronic or Digital Prescriptions (hereinafter, “Law”)[1] establishing certain definitions and guidelines of interest. The purpose of the Law is to enable the prescription and sale of medicines, or other prescriptions, to be written and signed electronically or digitally, as well as to allow the use of tele-assistance platforms in healthcare.
Due to the fact that digital prescriptions may allow the access to sensitive data, in order to guarantee the normal operation and strict compliance with Law 25,326 on Personal Data Protection, the Law establishes the following guidelines:
- Existing electronic systems should be adapted and their implementation regulated for the use of electronic or digital prescriptions. The same applies to tele-care platforms.
- The N.E.P. will have the obligation to establish an agency in charge of regulating and controlling this aspect.
- This agency will be responsible for the supervision of the aforementioned systems and to guarantee the custody and access control of the virtual professional database, in addition to ensuring the normal operation and compliance with the Personal Data Protection Law.
- It should be ensured that access to health data is carried out considering the privacy, integrity and confidentiality of the user -i.e., the patient-.
- All the necessary measures should be taken to create mechanisms that comply with the regulations and protect patient privacy, not only by those responsible for health information systems, but also by those authorities responsible for e-commerce, consumer protection, crimes against public health, and cybersecurity.
It is worth mentioning that the Law, in its article 5°, modifies Law 17,132 on Rules for the practice of medicine, dentistry and their collaboration activities[2], so as to provide for the possibility of prescribing handwritten, electronic or digital prescriptions. Electronic prescriptions must adapt their technical and legal requirements and digital prescriptions must adapt to Law 25.506 on Digital Signature[3].
The regulation establishes some requirements for the validity of these prescriptions such as the need for the univocal identification of the patient, as well as of the professional; to set the validity for prescriptions (30 days for medicines and 60 days for other prescriptions); the digital or electronic prescription must be integral and unalterable, being able to be used only once and must comply with the standards established in the current regulations on security, availability, inviolability and protection of personal data.
As a last requirement, the regulation introduces the concept of “interoperability”, which is “the ability of systems to exchange, use and apply information”. With this in mind, the exchange and use of information will be done through the NATIONAL HEALTH INTEROPERABILITY NETWORK[4] using syntactic and semantic standards.
Finally, it is important to mention that the regulation makes the Ministry of Health and the agencies of each jurisdiction responsible for the relevant regulation, and establishes certain criteria to be met by the platforms when using electronic prescriptions or tele-assistance.
For further information please contact: aneiman@ojambf.com and/or jpineiro@ojambf.com.
[1] Law 27,553 on electronic or digital prescriptions, published in the Official Gazette on August 11, 2020.
[2] Law 17,132 on Rules for the Practice of Medicine, Dentistry and Collaborative Activity thereof, published in the Official Gazette on January 31, 1967.
[3] Law 25,506 on Digital Signature, published in the Official Gazette on December 14, 2001.
[4] Created by Resolution of the then Secretary of Government for Health N°115 on January 24, 2019.
