Health Electronic Or Digital Prescriptions

Original Language Title: SALUD RECETAS ELECTRONICAS O DIGITALES

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image start infoleg site The Ministry of Justice and Human Rights
HEALTH

Law 27553

Electronic or digital recipes.

The Senate and Chamber of Deputies of the Argentine Nation, meeting in Congress, etc.

Law:

Article 1-This law is intended to:

(a) Establish that the prescription and dispensing of medicinal products, and any other prescription, may be written and signed through handwritten, electronic or digital signatures, in electronic or digital prescriptions, throughout the national territory;

b) Establish that health care platforms can be used throughout the national territory, in accordance with Law 25.326 of the Protection of Personal Data and the Law 26,529 of the Rights of the Patient.

Any electronic or digital prescription and tele-care platform in health that meet the technical and legal requirements are valid according to the current legislation that is not modified by this law.

Article 2-This law is applicable to any prescription or prescription, dental or other health professionals legally entitled to prescribe, in the respective areas of health care and public health care and private.

Medicinal products prescribed in electronic or digital prescriptions must be dispensed in any pharmacy in the national territory, pharmacy services of health establishments and health sector establishments authorized for this purpose, according to the to the provisions in force. It also applies to any healthcare platform that is used in the country.

Article 3-The authority of application of this law shall be established by the national executive branch, coordinating its action with the competent judicial authorities and the bodies with responsibility in the matter which those authorities determine, who will define by regulatory means the time limits necessary to achieve the total digitalization in prescription and dispensing of medications, any other prescription, and regulate the use of tele-care platforms in health.

The National Institute of Social Services for Retirees and Pensioners must be convened by the implementing authority for the purpose of collaborating in the regulations that are dictated to this effect.

Article 4-For the implementation of this law, existing electronic systems should be developed and/or adapted and their implementation should be regulated to use electronic or digital prescriptions, and healthcare tele-care platforms. which body should be established by the national executive branch in a timely manner and by the bodies that each jurisdiction determines.

These bodies are also responsible for the audit of electronic or digital recipe systems, and for the systems of healthcare tele-care platforms, which must ensure the custody of the databases of electronic or electronic prescriptions. virtual professional assistance, prescription, dispensing and archiving. They are also responsible for establishing the criteria for authorization and control of access to these databases and ensuring the normal functioning and strict compliance with the law 25.326 of Protection of Personal Data, Law 26,529 of Patient rights and other regulations in force in the field.

Article 5-Amend point 7 of Article 19 of Law 17.132, which shall be worded as follows:

7. To prescribe or certify in handwritten, electronic or digital recipes, in which the following information must be entered in the national language: name, surname, profession, number of registration, address, telephone number and e-mail when corresponds. Only technical posts or titles which are recorded in the competent implementing authority and under the conditions which are regulated may be announced. Prescriptions and/or prescriptions must be formulated in a national language, dated and signed in a handwritten, electronic or digital form. If they are electronically written, the signature and other technical and legal requirements must be in accordance with the legislation in force. In case of using the digital signature, the digital signature must conform to the law 25,506, digital signature, adhering to the regime and intermediary a certifying authority.

Article 6-Incorporate Article 2 (a) to Title I of Law 17.132, which shall be worded as follows:

Article 2 (bis): The modality of teleassistance for the exercise of medicine, dentistry and activities of collaboration of the same is enabled, guaranteeing the rights established in the Law 26,529 of the Rights of the Patient. Teleassistance may be developed only for practices authorised for this purpose, in accordance with protocols and platforms approved by the implementing authority.

Article 7-Amend Article 3 of Law 23.277, which shall be worded as follows:

Article 3: The psychologist can exercise his or her autonomous activity individually and/or integrate interdisciplinary teams, in private or in public or private institutions that require their services.

In both cases they can do so at the request of specialists in other disciplines or persons who voluntarily request their professional assistance. They may develop the exercise of these activities through teleassistance platforms previously enabled for this purpose and authorised by the implementing authority, in accordance with protocols and platforms approved by it and guaranteeing the rights set out in Law 26,529 on Patient Rights.

Article 8-Amend Article 9 of Law 17,565, which shall be worded as follows:

Article 9: In pharmacies, the supply of drugs, medicinal products or medicinal products is in accordance with the following forms according to the laws in force or determined by the health authority:

1. Legally restricted expense;

2. Exposed under archived recipe;

3. Compendium under prescription;

4. Free stipend.

The prescriptions for points 1 and 2, in paper or digital format, should be kept for a period not less than three (3) years, after that period may be destroyed or deleted, after communication to the health authority.

Article 9-Amend Article 10 of Law 17,565, which shall be worded as follows:

Article 10: In pharmacies, the following records or digital files enabled by the health authority should be taken:

(a) Recetary;

(b) Comptroller of narcotic drugs;

(c) Comptroller of psychotropics;

(d) Inspections;

(e) Other digital records or records which the competent authority considers relevant. These must be approved by the health authority.

They must be carried in legibly and without leaving any blank spaces, without altering the order of the seats of the prescribed prescriptions and without amendments or scrapes. The health authority may authorise another recipe copier system, provided that the same ensures the unalterability of the seats. In the event that these books are electronically carried, the signature and other technical and legal requirements must be in accordance with the law in force and with the application authority, ensuring the unalterability of the records.

Article 10.-Article 21a shall be incorporated into law 17,818, which shall be worded as follows:

Article 21a: If the prescriptions referred to in this law are written electronically, or if the mandatory records are electronically carried, the signature and other technical and legal requirements must be in line with the legislation in force and to be established by the implementing authority.

Article 11.-Article 18a is incorporated into law 19.303, which shall be worded as follows:

Article 18a: If the prescriptions referred to in this law are written electronically, or if the mandatory records are electronically carried, the signature and other technical and legal requirements must be in line with the special legislation in force and to the establishment of the implementing authority.

Article 12.-All procedures relating to the regulation of the prescription, waiver and circuits for the provision of narcotic and psychotropic drugs (import, export, official forms and prescriptions, books, records or archives compulsory, vouchers and any other documentation inherent in them) should, from this law, be digitised according to the deadlines and criteria set by the competent authority.

Article 13.-The systems referred to in this law should provide for compliance with all existing regulations governing the entire marketing chain of medicinal products, including the requirements for traceability of medicinal products Handwritten, electronic or digital. It is also necessary to provide for the issue of the constancy of tele-care, prescription and dispensing for patients, by computerised or printing of such constancy and the possibility of blocking by the pharmacist where there is manifest error in the prescription, so that the prescriber can review, cancel or reactivate as the case may be.

The implementing authority may carry out the necessary collaboration and coordination agreements with the schools of health professionals and the colleges of pharmacists for the purpose of making the object provided for in this law enforceable.

Article 14.-Invite the provinces and the Autonomous City of Buenos Aires to adhere to this law.

Article 15.-The national executive branch shall regulate this law within one hundred and twenty (120) days of its promulgation.

Article 16.-Commune to the national executive branch.

GIVEN IN THE SESSION HALL OF THE ARGENTINE CONGRESS, IN BUENOS AIRES, AT THE TWENTY-THREE DAYS OF THE MONTH OF JULY OF THE YEAR TWO THOUSAND TWENTY.

REGISTERED UNDER NO 27553

CLAUDIA LEDESMA ABDALLAH DE ZAMORA-SERGIO MASSA-Marcelo Jorge Fuentes-Eduardo Cergnul

ê 11/08/2020 N ° 31753/20 v. 11/08/2020