Law 16/2003, of 28 May, of cohesion and quality of the National Health System, establishes, in Article 57, that citizens ' access to health care benefits provided by the National Health System shall be provided through the individual health card, as an administrative document certifying certain details of the holder. Similarly, the law provides that, without prejudice to their management in the respective territorial area for each autonomous community, the cards shall include, in a standardised manner, the basic identification data of the cardholder, of the right who assists him in relation to the provision of the pharmaceutical and health service or the entity responsible for health care. The devices that the cards incorporate to store the basic information and the applications that treat it must allow the reading and checking of the data to be technically possible throughout the territory of the State.

On the other hand, and with the objective of being able to identify each citizen in a safe and secure manner, the law entrusts the Ministry of Health and Consumer to generate a unique personal identification code for the System National Health, through the development of a database that collects the basic information of users of the National Health System, in such a way that the health services have a service of exchange of information on the population protected, maintained and updated by the system members themselves.

In order to comply with the legal provisions, it is necessary to address, in the first place, the aspects related to the issuance of the card by the Health Administrations, as a necessary element to access the services in the set of the National Health System.

Similarly, the minimum information that the card needs to provide about citizens must be normalized, through the incorporation of a common basic set of data into all issued health cards.

In order to minimise the costs of transition and to enable the development and technical adaptation of new health cards, the replacement of existing health cards is foreseen as they expire, in addition, a time limit for the preparation of the requirements necessary for the start of replacement.

The royal decree also addresses the regulation of the personal identification code established by Law 16/2003 of 28 May, which will be unique throughout the life of the person. This will facilitate, among other aspects, the search and consultation of the clinical information of each patient, enabling the exchange of such information within the National Health System in the legally permitted and always with the purpose of contributing to the improvement of quality of care.

In the same way, it is necessary to regulate the functioning of the protected population database of the National Health System, which has as a fundamental objective the generation of this code of personal identification with the largest Possible certainty of its unique character.

The database is conceived as a system for the exchange of information on the protected population between the health administrations, in order to maintain the coherence of the assurance data and to be a reliable source for the management of health cohesion policies. It is also necessary to establish security and access to information and data transfer aspects.

Finally, it is necessary to incorporate into this same system all those collectives whose health coverage is publicly financed and which are included in special regimes through administrative mutualism. This will achieve the correct management of the situations and will place all insured persons on an equal footing with respect to the profits provided by the system of exchange of information on the protected population of the National System of Health.

In its virtue, on the proposal of the Minister of Health and Consumer Affairs, in agreement with the Council of State and after deliberation of the Council of Ministers at its meeting on 30 January 2004,

DISPONGO:

Article 1. Object.

This royal decree regulates, in the development of article 57 of Law 16/2003, of May 28, of the cohesion and quality of the National Health System, the issuance and validity of the individual health card, the basic data of Standard form shall include the personal identification code of the National Health System and the protected population database of that system.

Article 2. Issue and validity of the individual health card.

1. The Autonomous Health Administrations and the National Institute of Health Management shall issue an individual health card with computer support to persons residing in their territory who are accredited to the right to assistance. public health.

2. The individual health card issued by any of the competent health authorities will be valid throughout the National Health System, and will allow access to the health centers and services of the system in the terms foreseen by the the legislation in force.

Article 3. Common basic data for the individual health card.

1. In order to have standard data for each person, as a user of the National Health System, regardless of the title of the person accessing the right to health care and the issuing health administration, all Health cards will incorporate a number of common basic data and will be linked to a unique personal identification code for each citizen in the National Health System.

2. Without prejudice to the information that the law authorizes to incorporate to each competent authority, the individual health card shall contain, in a standardised manner and in a visible manner, the following data:

a) Health administration of the card.

b) Last name and name of the cardholder.

c) Personal identification code assigned by the Health Administration issuing the card.

d) Pharmaceutical delivery mode.

e) Legend reporting its validity throughout the National Health System: "This card allows you access to the services of the entire National Health System."

3. The Ministry of Health and Consumer Affairs, in agreement with the Autonomous Communities and other competent public administrations, shall establish the necessary requirements and standards for the devices that the cards incorporate to store the basic information, and the applications that treat them must enable the reading and verification of the data to be technically possible throughout the territory of the State.

Article 4. Personal identification code of the National Health System.

1. The assignment of the personal identification code of the National Health System will be performed at the time of inclusion of the data relating to each citizen in the population data base protected by the National Health System, developed by the Ministry of Health and Consumer Affairs, and will act as a key to linking the different self-identifying codes that each person may have assigned to them throughout their lives.

2. The personal identification code of the National Health System will be unrepeatable and will be unique throughout the life of each person, regardless of the health care administration competent in their health care at any time.

3. Such identification code shall facilitate the search for the health information of a patient who may be dispersed in the National Health System, in order to be able to be located and consulted by healthcare professionals, exclusively when it is in the improvement of health care, with full respect to the provisions of the Organic Law 15/1999, of 13 December, of Protection of Personal Data, and in Law 41/2002, of 14 November, basic Regulation of the autonomy of the patient and of rights and obligations in relation to information and documentation clinical, also ensuring the confidentiality and integrity of the information.

Article 5. Protected population database of the National Health System.

1. In order to proceed with the generation of the personal identification code of the National Health System, the Ministry of Health and Consumer Affairs, through the Institute of Health Information, will develop a database that collects the basic information of the users of the National Health System, as well as the historical file of the situations of insurance and of the person's membership, if any, to different health administrations throughout their life.

2. In order to facilitate the management of the protected population, its mobility and access to health services, this base will act as a system for the exchange of information between the health administrations. The information to be collected should make it possible to ensure the consistency of the insurance data, to avoid simultaneous attachment to different health services and to obtain the highest possible return on the data crosses between the official files. required for proper maintenance.

3. The protected population database of the National Health System will be maintained by the health authorities of the individual health card. Such administrations shall be competent for the inclusion of protected persons in their territorial area. Similarly, they will be responsible for the treatment of current and historical data of their protected population.

4. This database shall respect the model of operation and management of the individual health card databases for each health administration.

5. The database will incorporate information from the social security system and administrative mutualism, in order to provide the health administrations with permanently updated data to enable the correct management of the situation. of persons with respect to high, low, coverage of benefits and mobility of patients in the European Union, in accordance with the Community regulations in force in this field.

6. The statistical operating plan of the database will be agreed by the Interterritorial Council of the National Health System, and the information obtained will be made available to the health administrations. In any case, the information to be provided for these purposes shall be previously disassociated.

7. The Ministry of Health and Consumer Affairs shall have the means to ensure the functioning of the database.

Article 6. Security and access.

1. The relationship of health system agents authorised for access to the database and its operational capabilities with this basis shall be agreed upon by the Interterritorial Council of the National Health System.

2. Without prejudice to the powers conferred on the Spanish Data Protection Agency, the Ministry of Health and Consumer Affairs shall determine the technical and organisational measures to be taken in relation to the population database. protected from the National Health System and which are necessary to guarantee both the safety and the availability of the personal data, avoiding its alteration, loss, treatment and, in particular, the unauthorized access to that. In any event, such measures shall comply with the provisions of existing legislation on the protection of personal data.

3. The Ministry of Health and Consumer Affairs, as responsible for the database, will implement the security and access measures in accordance with the provisions of the Organic Law 15/1999, of December 13, of Protection of Personal Data, and in the Royal Decree 263/1996 of 16 February, regulating the use of electronic, computer and telematic techniques by the General Administration of the State.

Article 7. Data cession.

The Interterritorial Council of the National Health System, if it considers necessary the transfer of the data from this base, will seek the assistance of the Spanish Data Protection Agency, in order to be determined the circumstances under which the transfer may be made to third parties. Such transfer shall in any event be subject to the rules in force in respect of the protection of personal data.

Article 8. Groups insured through special schemes.

The public authorities responsible for health coverage by reason of certain collectives shall issue to each of their insured persons a health card, with computer support and with the basic characteristics that are defined in this royal decree, including the assignment of personal identification code of the National Health System, and will be incorporated into the system of exchange of information that the database of protected population of the National System of Health provides.

Single additional disposition. Standardisation of health cards in the European Union.

To the extent that standardisation criteria are established by the European Union to facilitate the movement and improvement of healthcare for patients at Community level, the individual health cards of the National Health System should be adapted to those.

First transient disposition. Replacing existing health cards.

The process of replacing existing cards with those that meet the requirements set out in this royal decree must be initiated within six months of its entry into force. The replacement, once the process is started, will occur as the cards expire, or when for any reason they will be renewed.

Second transient disposition. Incorporation into the protected population database of the National Health System.

It is established a period of six months from the entry into force of this royal decree for the constitution of the protected population database of the National Health System with the incorporation of all the systems of a health card of the health authorities and public administrations referred to in Article 8.

Final disposition first. Competence title.

This royal decree is issued under article 149.1.16.^a and 17.^a of the Spanish Constitution, and in accordance with the provisions of article 57 of Law 16/2003, of 28 May, of cohesion and quality of the system National of Health.

Final disposition second. Regulatory enablement.

The Minister of Health and Consumer Affairs is empowered to carry out, in the field of his competences, the development of the provisions of this royal decree.

Final disposition third. Entry into force.

This royal decree will enter into force on the day following its publication in the "Official State Gazette".

Given in Madrid, 30 January 2004.

JOHN CARLOS R.

The Minister of Health and Consumer Affairs,

ANA MARIA PASTOR JULIAN