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 Official Journal.

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 (SICN) Neonatal Screening Program Information System".

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

In its virtue, I have:

Article 1. Creating a file.

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 and Consumer Affairs, are extended, with the the creation of a new file, called the "National Health System (SICN) Neonatal Screening Program Information System", the data of which are listed in the Annex of this order.

Item 2. Management and Organization of the file.

The head of the Directorate-General for Public Health, Quality and Innovation, the body responsible for this file, will adopt, under the top management of the head of the Ministry of Health, Social Services and Equality, the management and organisation measures necessary, ensuring, in any case, the confidentiality, security and integrity of the data, as well as the conduct of the guarantees, obligations and rights recognised in the Organic Law 15/1999, of 13 December, of Protection of Personal Data, in its Development Regulation approved by Royal Decree 1720/2007 of 21 December and other implementing rules.

Article 3. Use of the data contained in the file.

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 this file 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, 3 February 2015.-The Minister of Health, Social Services and Equality, Alfonso Alonso Aranegui.

ANNEX

General Directorate of Public Health, Quality and Innovation

Denomination of the file: "National Health System Neonatal Screening Program Information System (SICN)".

Purpose and intended uses: To collect and manage data that will allow the measurement of the objectives and indicators of quality of the neonatal screening program for the metabolic diseases of the National Health System, for, at the autonomous and state levels to carry out proper monitoring and evaluation of this programme.

Persons or collectives on which personal data are intended to be obtained: Born born to some of the diseases that are part of the neonatal screening program for metabolic endocrine diseases of the National Health System; newborns diagnosed for some of the diseases that are part of the specific neonatal screening programs of the Autonomous Communities or Cities of Ceuta and Melilla, which have these programs.

Provenance and procedure for the collection of personal data: The data come from the information system of the neonatal screening program of each Autonomous Community or Cities of Ceuta and Melilla. The introduction of data by the Autonomous Communities or Cities of Ceuta and Melilla in the SICN application, developed by the Ministry of Health, Social Services and Equality, may be carried out manually by means of a web form, or by loading, in the application, an XML with all the data.

Basic file structure: Database.

Personal data included in the file: The file contains the data related to the detection, diagnosis and monitoring of the diagnosed cases for some of the diseases, which are part of the program neonatal screening of metabolic diseases of the National Health System and of the diagnosed cases for some of the diseases that are part of the specific neonatal screening programmes of the Autonomous Communities or Cities of Ceuta and Melilla, which have these programmes. These data are: Number of cases diagnosed (by disease); date of birth; sex; date of detection by the laboratory; whether it has been necessary or not to request a second sample from the laboratory for a dubious result on the first shows; definitive diagnosis/disease (disease the child is suffering from); date of initiation of treatment; if at the time of the case location, was admitted or had been consulted for clinical symptoms related to the disease; if the patient was child in follow-up; clinical follow-up unit (hospital and service) where the case is followed); date of death due to the diagnosis made (cribated metabolic endocrine disease); in the case of congenital hypothyroidism, if the child's diagnostic reassessment has been performed at 3 years of age and the definitive diagnosis.

All of this data will be collected on an annual basis.

The database also includes the relationship of professionals, autonomous communities or cities of Ceuta and Melilla, authorized to load the annual data mentioned above.

Transfer of personal data and/or data transfers to third countries: The data are provided by the designated persons of the Autonomous Communities or Cities of Ceuta and Melilla; these persons may access to exploit the data they have contributed.

Responsible for the file: General Directorate of Public Health, Quality and Innovation. Deputy Director General for Health Promotion and Epidemiology. Paseo Prado, 18-20. 28071 Madrid.

Services to which the right of access, rectification, cancellation and opposition may be exercised: Subdirección General de Promoción de la Salud y Epidemiologia-Dirección General de Salud Pública, Equalidad e Innovación, Ministry of Health, Social Services and Equality. Paseo del Prado, 18-20. 28071 Madrid.

Security Measures with Level Indication: High Level.

Treatment system: Automated.