By the Order of 21 July 1994, which regulates the files with personal data managed by the Ministry of Health and Consumer Affairs, compliance with the provisions of the second of the Organic Law 5/1992, of October 29, regulating the 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 Equality, creating two new files, called "Primary Care Clinical Database-BDCAP" and "SIPA Authorised Data".

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 and Consumer Affairs, are extended, with the the creation of two new files, known as the "Primary Care Clinical Database (BDCAP)" and "SIPA Authorised Data Base", the data of which are listed in the Annex to this order.

Article 2. Enrollment in the General Data Protection Register.

The Directorate-General for Public Health, Quality and Innovation, through the General Information and Innovation Subdirectorate of the Ministry of Health, Social Services and Equality, will give notice of the creation of these files to the Spanish Data Protection Agency, for the completion of the necessary procedures for 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 files 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 the 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, 20 January 2014. -Minister for Health, Social Services and Equality, Ana Mato Adrover.

ANNEX

General Directorate of Public Health, Quality and Innovation

1. File: Primary Care Clinical Database (BDCAP).

Filename: "Primary Care Clinical Database (BDCAP)".

Purpose and intended uses: To provide information about the clinical care process recorded in primary care consultations; this is, about the morbidity attended, the interventions performed and certain results achieved in the area of the first level of care. The main objective is the realization of statistics and the obtaining of indicators, such as those related to the analysis of the morbidity attended, the most frequent processes, the quality of care, or the approximation to the efficiency. It will allow the construction of regional, national and international indicators, or other types of aggregations, such as the strata in which basic health zones are grouped, or other criteria of health interest. In addition, it will serve as a reference standard for administrations and as a database for clinical and epidemiological research.

Origin of data: Collective of persons who are intended to obtain personal data or who are obliged to supply data: A random sample of citizens with individual health cards (TSIs), who are users of public health in primary care centres (Health Centres and Local Consultoires), in Spain.

Provenance and procedure for the collection of personal data: Extraction of the expected data of the selected users, based on the records of the electronic medical records. They will be extracted by the Health Services of each Autonomous Community.

Basic file structure: Database.

Personal data included in the file: The file contains a personal identification variable: the personal identification code (CIP) of the Individual Health Card (TSI). This code will preferably be the code of the National Health System (SNS) or, in its absence, the code of the Card of the Autonomous Community in which it is attached at the moment of extracting the data. The only way to identify a particular user from the CIP is to go to another independent, high-level protected database, the National Health System protected population database integrated into the Card database. Individual Health (BDTSI-SNS).

A reason to include the CIP is that of being able to carry out, if necessary, crosses with other databases, such as the BD-TSI of the SNS previously mentioned, in order to be able to obtain assurance data-and other variables of health interest-and assign them to the population contained in the BDCAP. This is intended to carry out population analysis of health inequalities and condition factors of the same, of epidemiological interest (in no case for individual analysis).

Once the originating data and the aforementioned crossings have been loaded, the data shall be transferred to an operating BD where the CIP of the other information object of analysis is dissociated, by means of the prior application of an algorithm that transforms the CIP into anonymous tags.

The CIP will be anonymized by a one-way summary function. Initially the SHA-256 algorithm will be used and, if the advancement of science makes it necessary, it will be replaced in the future by algorithms of greater cryptographic strength.

Therefore, all the manipulations performed on the data for statistical exploitation will be carried out with anonymous data, not being possible, in any case, their association with the CIP of the people nor, therefore, their potential identification, as only once anonymous data will be exploited and the algorithms used for this are irreversible.

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.

Other variables that include the BDCAP of the users of the selected centers in the sample are:

Administrative type: Autonomous Community and Primary Care Equipment to which the user is attached, date of birth, date of death-in case-sex, country of birth, occupation, level of studies.

In addition to the above, this database includes the relationship of the authorized persons in the respective autonomous community for access to the applications. Of these persons the name, professional email and DNI must be in possession of electronic certification.

Of a clinical type: According to the clinical history, the following coded data will be incorporated: Health problems with or have suffered, classification used for coding, starting and closing dates-if applicable- of these problems; diagnostic or therapeutic procedures that have been performed and their date of completion; hospital specialties consulted (inter-consultations) and their date; pharmaceutical prescriptions and their date; figures resulting from the measurement of certain selected parameters and their date; date of the visits performed.

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

The database also implies the existence of a file with the relationship of professionals from the autonomous communities authorized to the load of the annual data mentioned above.

Data transfers and/or data transfers that are provided to third countries: The file will have a public character. The assignment of unit data (microdata) implies the prior dissociation of personal data with irreversible character, so that only anonymous data can be accessed. No data transfers to third countries 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 Level.

Treatment System: Automated.

2. File: Authorized SIAP.

Filename: Authorized SIAP.

Purpose and intended uses: To be discharged in the application enabled by the Ministry of Health, Social Services and Equality, so that those responsible for the authorized autonomous communities can access the Primary Care Information System (SIAP) data and incorporating data from your stand-alone community into it.

Data Source: Designation of the autonomic managers regarding authorized professionals in their autonomous community to enter data into the SIAP load application.

Basic file structure: Database.

Personal data included in the file: The file contains data relating to authorized professionals consisting of first and last names, professional email and DNI.

Data and/or Transfer Crashes: There is no data cession type.

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: Basic level.

Treatment System: Automated.