The Law on Electronic Medical Prescription and Telemedicine No. 27,553 (the “Law”), published today in the Official Gazette, authorizes the digital or electronic prescription of medicines and provides a general regulatory framework for the practice of medicine through digital platforms.
Main points of the Law
The main new features of the Law are:
- The prescription and dispensing of medicines, as well as all other medical prescriptions, can be issued in handwritten, digital or electronic signatures, in electronic or digital medical prescriptions, in all of the national territory.
- Currently, the digital or electronic medical prescription is optional. However, the Law aims to achieve a complete digitalization.
- The Law is applicable to all medicine prescriptions, dentistry and other health professionals.
- The medicines prescribed through digital or electronic prescriptions must be dispensed by any pharmacy, pharmacy service of health institutions and health institutions authorized for the dispensing of medicines in all the national territory.
- The Law allows the use of telemedicine applications or platforms for health treatments in all the national territory. These platforms shall comply with the Data Protection Law (Law No. 25,326) and the Patients’ Rights Law (Law No. 26,529).
- The Law does not provide a comprehensive implementation of the use of telemedicine and grants regulatory powers to the local authorities for its regulation.
- In order to harmonize the current legal regime, the Law amends the current legislation. For example:
- Amends the Medical Practice Law (Law No. 17,132) providing that prescriptions shall not only be handwritten but also electronic or digital and enabling the modality of remote assistance for the practice of medicine, dentistry and collaborative activities.
- Amends the Professional Practice of Psychology Law (Law No. 23,277) allowing the development of this profession through telemedicine applications or platforms enabled and authorized by the enforcement authority.
- Amends the Pharmacies Law (Law No. 17,565) establishing that prescriptions must be kept for at least three years in paper or digital format, and that after that period they may be destroyed or erased, after communication to the health authority. It also provides that pharmacy records may be kept in digital format.
Furthermore, the Law sets forth that the authority of application of the Law will be established by the National Executive Branch who will have to coordinate its actions together with the local authorities. These authorities will aim to achieve total digitalization in prescription and dispensation of medicines and regulate the use of health telemedicine platforms.
These authorities will also be responsible for the supervision of digital or electronic prescription systems and telemedicine systems, which will have to guarantee the custody of the databases of virtual professional assistance, prescription, dispensation and archiving. They will also be responsible for establishing the criteria for authorizing and controlling access to these databases and guaranteeing the normal operation and strict compliance with the Personal Data Protection Law and the Patients’ Rights Law.
In addition, the Law establishes that the systems referred to in the regulation must comply with all current regulations governing the entire drug marketing chain, including the requirements for traceability of medicines and handwritten, electronic or digital signatures. It must also include the issuance of remote assistance, prescription and dispensation records for patients, by computer or printing of such records and the possibility for pharmacists to block a prescription when there is a manifest error, so that the prescriber can review, cancel or adjust as appropriate.
Finally, the Law establishes a period of 120 days for the National Executive Branch to issue the relevant regulations.
This report should not be considered as legal or any other type of advice by Allende & Brea.
