Creation of the National Registry of Digital Health Platforms – Implementation and Contingency Conditions for Electronic and/or Digital Prescriptions – Resolution No. 1959/2024
Healthcare & Life Sciences department report | Creation of the National Registry of Digital Health Platforms – Implementation and Contingency Conditions for Electronic and/or Digital Prescriptions – Resolution No. 1959/2024
Yesterday, 26th june, Resolution No. 1959/2024 (“the Resolution”) was published in the Official Gazette by the Ministry of Health, establishing the National Registry of Digital Health Platforms (“ReNaPDiS”) under the Subsecretaries of Epidemiological Surveillance, Information, and Health Statistics. This registry aims to register digital systems and platforms related to health and will enroll responsible parties according to technical requirements issued.
The National Directorate of Health Information Systems (“DNSIS”), under the aforementioned Subsecretaries, will technically coordinate ReNaPDiS. DNSIS will issue operational guidelines and technical documents that establish recommended operational conditions for platforms and/or systems registered in ReNaPDiS, as well as criteria and standards defined by interoperability tools set by the Ministry of Health.
ReNaPDiS may register, among others, prescription platforms or systems, repositories of digital prescriptions, digital drug dictionaries, and other systems involved in digital health processes. Within ReNaPDiS, the Electronic Prescription Registry is established to enroll platforms and systems using electronic or digital prescriptions. Additionally, the Unique Prescription Identification Key (CUIR) is created to uniquely identify prescriptions, as defined by DNSIS.
In accordance with Decree 70/2023, starting from July 1, 2024, electronic and/or digital prescriptions will be mandatory for all prescriptions. The Resolution establishes implementation conditions, contingency plans, and transitional provisions to be followed during the implementation period of these platforms and systems registered in ReNaPDiS, ensuring patient access to health goods and services.
The lack of technological operational conditions to comply with the comprehensive circuit of electronic and/or digital prescriptions and their dispensing or execution will be considered a contingency condition. In this regard, contingencies will include:
-The implementation period of platforms and/or systems, including those related to electronic and/or digital prescriptions, exceptionally and according to the applicable schedule.
-Technical issues of force majeure that could disrupt the normal operation of systems, as well as the communication channels used to connect them.
In the aforementioned contingency conditions, paper prescriptions with holographic or handwritten signatures, not digitized, will serve as the primary support. Furthermore, during the contingency period, stakeholders involved in receiving, dispensing, and processing prescriptions and orders must have adequate mechanisms to receive and process prescriptions without interfering with access to medications, practices, and coverage conditions.
DNSIS will determine the necessary technical specifications and timelines.
It is important to note that prescriptions issued before July 1, 2024, will remain valid according to current regulations, while those issued thereafter will be valid under transitional conditions established by competent authorities.
The Resolution repeals Resolution 305/23 and clarifies that those who have registered under the terms of that resolution must comply with the provisions of this Resolution.
The Resolution will enter into force on the day following its publication in the Official Gazette, i.e., today.
Ana Andrés
Malvina Acuña