By the Order of 21 July 1994, in which files are regulated with personal data managed by the Ministry of Health and Consumer, compliance with the provisions laid down in the second provision, 2 of the Organic Law 5/1992, of October 29, regulating the automated processing of personal data.

Article 20.1 of the Organic Law 15/1999 of 13 December on the Protection of Personal Data, provides that the creation, modification or deletion of the files of the Public Administrations may be made only by means of general provision published in the Official Journal of the State or the official journal concerned.

By this order it is necessary to amend the Order of 21 July 1994, in order to complete the relationship of files with personal data managed by the Ministry of Health, Social Services and Equality, creating a new file, called "National Health System Electronic Recipe (RESNS)".

In the processing of this order, the Spanish Data Protection Agency has issued a mandatory report.

In its virtue, I have:

Article 1. Creating files.

The contents of Annex 2 "Administrative Character Ficheros" of the Order of 21 July 1994, for which files are regulated with personal data managed by the Ministry of Health, Social Services, is extended. e Equality, with the creation of a new file called "Electronic Recipe of the National Health System (RESNS)", whose data are listed in the annex of this order.

Article 2. Enrollment in the General Data Protection Register.

The Directorate-General for Public Health, Quality and Innovation, through the Health Information and Innovation Directorate-General of the Ministry of Health, Social Services and Equality, will give the creation of this file to the Spanish Data Protection Agency, for the completion of the necessary procedures for its registration in the corresponding General Register of Data Protection.

Article 3. Responsible for the file.

The Directorate-General for Public Health, Quality and Innovation, will adopt, under the top management of the Ministry of Health, Social Services and Equality, the necessary management and organizational measures, ensuring, in all the case, the confidentiality, security and integrity of the data, as well as the drivers to make effective the guarantees, obligations and rights recognized in the Organic Law 15/1999, of December 13, of Protection of Personal Data, in its implementing regulation adopted by Royal Decree 1720/2007 of 21 December 2007, and development standards.

Personal data recorded in the file listed in the Annex shall only be used for the purposes expressly provided for and by duly authorized personnel.

Article 4. Data cession.

The data contained in these files may only be transferred in the cases expressly provided for by law.

Single end disposition. Entry into force.

This order shall enter into force on the day following that of its publication in the "Official State Gazette".

Madrid, June 13, 2014. -Minister of Health, Social Services and Equality, Ana Mato Adrover.

ANNEX

General Directorate of Public Health, Quality and Innovation

Filename: "National Health System Electronic Recipe (RESNS)"

Purpose and intended uses: The purpose of the file is to be able to audit the exchanges that occur in the interoperability framework of the electronic recipe. It will also be used to perform statistical analysis and obtain indicators of pharmaceutical consumption by level of contribution, age and sex of the consumer, specialty of the prescriber and autonomous community of prescription, dispensation or origin of the patient.

Data Source: Healthcare system users to whom a prescription or dispensing of a drug or healthcare product is performed.

Provenance and procedure for collecting personal data: By electronic messaging sent by healthcare providers collecting personal data and the treatment prescribed or dispensed.

Basic file structure: Database.

Personal data included in the file: Patient data (contribution code, ID number or NIE, first and last name, sex, date of birth and SNS code or code assigned on your European health card or temporary replacement certificate or passport number), code of the pharmacy office where the medication is withdrawn through electronic prescription, autonomous community or country where the prescription is made, autonomous community or country where performs the dispensation, autonomous community or country issuing the health card or provisional certificate replacement, date of issue of the electronic prescription, date of dispensing of the electronic prescription, duration of the treatment, data of the prescriber (specialty), data of the center where the prescription is made (code REGCES), data of the treatment (code, description, number of packages, price, patient contribution and type of contingency).

The entire process and databases will be subject to the safety criteria and measures set out in Organic Law 15/1999, of December 13, in its Implementing Regulation approved by Royal Decree 1720/2007, of December 21, and other development standards.

Data and/or data transfers that are provided to third countries: No disposals are foreseen.

Services or Units to which the right of access, rectification, cancellation and opposition may be exercised: Subdirectorate General of Health Information and Innovation. Directorate-General for Public Health, Quality and Innovation. Ministry of Health, Social Services and Equality. Paseo del Prado, 18-20. 28071 Madrid.

Security measures with level indication: High.

Treatment system: Automated.