Read the untranslated law here: http://www.boe.es/buscar/doc.php?id=BOE-A-2015-10037
The order of 21 July 1994 for regulating files with personal data managed by the Ministry of health and consumption, gave compliance provisions of additional provision second, 2 of the organic law 5/1992 of 29 October, regulation of the automated treatment of the personal data.
Subsequently, the organic law 15/1999, of 13 December, of protection of Personal character data, provided in its article 20.1, creation, modification or deletion of files of public administrations can only be made by general provision published in the «Official Gazette» or in the relevant official journal.
The law 16/2003, 28 may, cohesion and quality of the national health system, provides, in articles 53 and 55, that the Ministry of health, social services and equality will establish a health information system of the national system of health (SNS) which ensure the availability of information and communication among health administrations-reciprocal.
Royal Decree 69/2015, 6 February, regulates the activity registry of specialized health care (SAR-MBDS) attached to the Directorate-General of public health, quality and innovation of the Ministry of health, social services and equality. This record is an evolution of the current minimum basic set of data (MBDS) State, created by the Interterritorial Council of the SNS agreement in 1987, which will be integrated into the history of current registry RAE-MBDS.
By this order is comes to modify the order of 21 of July of 1994 and is creates the file of the «record of activity of care health specialized (RAE-MBDS)» to give compliance to it established in the available additional fifth of the Real Decree 69 / 2015, of 6 of February.
In the processing of this command has issued mandatory report the Spanish Agency of data protection.
By virtue, I have: article 1. Creation of the file.
Expands the contents of the annex 2 «administrative files' of the order of 21 July 1994 by which regulate files with personal data managed by the Ministry of health and consumption, including a new automated file named 'Register of activity of specialized health care (SAR-MBDS)' whose characteristics are detailed in annex I.
Article 2. Deletion of the file.
Suppresses the file of personal data «Basic minimum set of data (MBDS)» contained in annex II.
Article 3. Responsible for the file.
The Directorate-General of public health, quality and innovation will be the administrative body responsible for the file that is created by this order.
Article 4. Management and organization of the file.
The holder of the responsible for the file activity log of specialized health care (SAR-MBDS) shall, under the top address of the holder of the Ministry of health, social services and equality, management and organization that are necessary, measures ensuring, in any case, the confidentiality, security and integrity of the data, as well as the leading to effective warranties, obligations and rights established in the organic law 15/1999 , of 13 December, of protection of data of a Personal nature, in its regulation of development approved by Royal Decree 1720 / 2007, of 21 December, and other standards development.
Them data of character personal registered in the file that is creates by this order only will be used for the purposes expressly planned and by the personal duly authorized.
Article 5. Transfer of data.
The data contained in this file only may be transferred in them alleged expressly provided by the law.
Sole final provision. Entry into force.
This order shall enter into force the day following its publication in the "Official Gazette".
Madrid, 8 September 2015.-the Minister of health, social services and equality, Alfonso Alonso Aranegui.
ANNEX I address General of health public, quality and innovation denomination of the file: «record of activity of attention health specialized (RAE-MBDS)» purpose and uses planned: i. know it demand care and it morbidity attended in them devices of attention specialized, favor the realization of studies of research clinical, epidemiological and of evaluation of services health and of results in health.
II. regional registries provide the information necessary for the evaluation and control of the attention given in the whole of the national health system to its citizens.
III. facilitate the completion of statistics in the health sector at the State level, as well as which arise from commitments with international agencies.
People or groups over which intends to obtain personal data or that they are obliged to provide them: individuals who receive health care under health care modalities of hospitalization, hospitalization at home, hospital medical day, day surgery, outpatient procedure of special complexity and urgency.
Origin and procedure of collection of personal data: the communities autonomous and, where appropriate, health centers will supply data to the body responsible for registration and by electronic means, in such a way enabling its incorporation into the automated.
Transfers of data and/or data transfers expected to third countries: public services responsible for the production of official statistics. Them communities autonomous and them mutual administrative of them regimes special of it security Social of officials will have access to the data of the registration according to it planned in the article 8.3 of the Real Decree 69 / 2015, of 6 of February.
Administrative body responsible for the file: Directorate-General for public health, quality and innovation of the Ministry of health, social services and equality.
Services or units to which it may exercise the right of access, rectification, cancellation and opposition: General Sub-Directorate of health information and innovation, Directorate-General of public health, quality and innovation. Ministry of health, social services and equality, paseo del Prado, 18-20, 28071 Madrid.
Safety with level indication: high.
Basic structure of the file: database.
Personal data included in the file: file contains the data "Code of Personal identification (CIP)" of the Individual health card (TSI), as well as number of medical history.
The CIP are anonimized through a function unidirectional overview. Initially is will employ the algorithm SHA-256 and, if the advance of the science it makes necessary, is replaced in the future by algorithms of greater strength cryptographic.
All manipulations carried out data for statistical exploitation will be made with anonymous data, is not possible, in any case, his association with the CIP or the number of clinical history of persons or, consequently, potential identification, since the data only explode once anonymous and the algorithms used to do this have irreversible character.
All the process of review, load and exploitation of them data as well as them databases, will be subject to them criteria and measures of security established in law organic 15 / 1999, of 13 of December, in its regulation of development approved by Royal Decree 1720 / 2007, of 21 of December, and others rules of development.
Other data that includes the RAE-CMDB are: of type clinical: diagnosis or diagnoses main and secondary; procedures carried out in the Center; procedures performed at other centres; codes of morphology of neoplasms and prior or sudden presence of main and secondary diagnosis (POA indicator).
Administrative data: type code of Personal identification, date of birth; sex; country of birth; postal code of the patient's usual home; municipality of usual residence of the patient; funding regime; date and time of start of care; date and time of the recovery order; type of contact (defined as lent assistance mode); type of visit (defined as medical day hospital care mode); origin (defined as device, health service or entity requesting contact); circumstances of the attention; responsible care service; date and time of completion of the attention; high type; continuity of care device; date and time of intervention; admission to intensive care unit; days of stay in unit of care intensive; Center sanitary; Community autonomous of the central health.
System of treatment: automated.
ANNEX II denomination of the file: «joint minimum basic of data (MBDS)» code of registration in it agency Spanish of protection of data: 1942346895 destination of them data that contains the file: them data of the file existing «joint minimum basic of data (MBDS)» will pass to form part of the structure of the file of new creation called «record of activity of attention health specialized (RAE-MBDS)» that is detailed in the annex I.
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