JOHN CARLOS I
KING OF SPAIN
To all who will see it and understand it.
Know: That the General Courts have approved and I come to sanction the following law.
EXPLANATION OF REASONS
The importance of patients' rights as a basic axis of clinical-care relations is demonstrated by the interest shown in them by almost all international organizations with competence in the field. Since the end of the Second World War, organizations such as the United Nations, UNESCO and the World Health Organization, or more recently the European Union and the Council of Europe, among many others, have promoted declarations or, in some cases, have enacted legal standards on generic or specific aspects related to this issue. In this regard, it is necessary to mention the importance of the Universal Declaration of Human Rights of 1948, which has been the obligatory reference point for all subsequent constitutional texts, or, in the more strictly health-related area, the Declaration on the Promotion of Patients' Rights in Europe, promoted in 1994 by the Regional Office for Europe of the World Health Organization, in addition to numerous international declarations of greater or lesser scope and influence that have referred to these issues.
Recently, it is worth highlighting the special relevance of the Council of Europe Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine (Convention on Human Rights and Biomedicine), signed on 4 April 1997, which entered into force in the Kingdom of Spain on 1 January 2000. This Convention is a major initiative: in fact, unlike the various international declarations that have preceded it, it is the first international instrument of a legally binding nature for the countries that sign it. Its special value lies in the fact that it establishes a common framework for the protection of human rights and human dignity in the application of biology and medicine. The Convention deals explicitly, in detail and at length, with the need to recognise patients' rights, among which the right to information, informed consent and privacy of information concerning people's health stand out, seeking to achieve the extent of harmonisation of the laws of the various countries in these matters; in this respect, it is absolutely appropriate to take the Convention into account when addressing the challenge of regulating such important issues.
It must be said, however, that the regulation of the right to health protection, set out in Article 43 of the 1978 Constitution, from the point of view of the issues most closely linked to the status of the users of health services as subjects of rights, i.e. the implementation of the rights relating to clinical information and the individual autonomy of patients with regard to their health, has been the subject of basic regulation within the scope of the State, through Law 14/1986, of 25 April, the General Health Act.
On the other hand, this Law, despite the fact that it basically focuses on the establishment and organization of the health system from an organizational point of view, dedicates various provisions to this issue, among which the desire to humanize health services stands out. It thus maintains the utmost respect for the dignity of the person and individual freedom, on the one hand, and, on the other, declares that the health organization must make it possible to guarantee health as an inalienable right of the population through the structure of the National Health System, which must be ensured under conditions of scrupulous respect for personal privacy and the individual freedom of the user, guaranteeing the confidentiality of the information related to the health services provided and without any type of discrimination.
Based on these premises, this Law completes the provisions that the General Health Law enunciated as general principles. In this sense, it reinforces and gives special treatment to the right to patient autonomy. In particular, special mention should be made of the regulation on prior instructions which, in accordance with the criteria established in the Oviedo Convention, contemplates the patient's previously expressed wishes within the scope of informed consent. Likewise, the Law deals in depth with everything related to clinical documentation generated in healthcare centres, especially emphasising the consideration and specification of the rights of users in this aspect.
In September 1997, in development of a collaboration agreement between the General Council of the Judiciary and the Ministry of Health and Consumer Affairs, a joint seminar was held on clinical information and documentation, in which the main regulatory and judicial aspects in this area were discussed. At the same time, a group of experts was set up to draw up guidelines for the future development of this subject. This group signed an opinion on 26 November 1997, which has been taken into account in the elaboration of the fundamental principles of this Law.
The attention given to these matters by the General Health Act was a significant step forward, as reflected, inter alia, in Articles 9, 10 and 61. However, the right to information, as a citizen's right when demanding health care, has been subject in recent years to a number of clarifications and additions by laws and provisions of various kinds and ranks, which highlight the need for reform and updating of the regulations contained in the General Health Act. Thus, Organic Law 15/1999, of 13 December, on the Protection of Personal Data, qualifies data relating to the health of citizens as specially protected data, establishing a uniquely rigorous regime for obtaining, keeping and eventually transferring such data.
This defence of confidentiality had already been defended by Community Directive 95/46, of 24 October, which, in addition to reaffirming the defence of the rights and freedoms of European citizens, especially their privacy with regard to information relating to their health, points out the presence of other general interests such as epidemiological studies, situations of serious risk to the health of the community, research and clinical trials which, when they are included in regulations of legal rank, may justify a reasoned exception to the rights of the patient. Thus, a community conception of the right to health is manifested, in which, together with the singular interest of each individual, as the recipient par excellence of health-related information, there are also other agents and legal assets related to public health, which must be considered, with the necessary relevance, in an advanced democratic society. Along these lines, the Council of Europe, in its Recommendation of 13 February 1997 on the protection of medical data, after stating that they must be collected and processed with the consent of the data subject, indicates that the information may be restricted if a law so provides and constitutes a measure necessary for reasons of general interest.
All these circumstances make it advisable to adapt the General Health Law with the aim of clarifying the legal situation and the rights and obligations of health professionals, citizens and health institutions. The aim is to provide the same guarantees in the field of clinical information and documentation to all citizens of the State, thereby strengthening the right to health protection recognized by the Constitution.
CHAPTER I
General principles
Article 1. Scope of application.
The purpose of this Act is to regulate the rights and obligations of patients, users and professionals, as well as public and private health centres and services, in the area of patient autonomy and clinical information and documentation.
Article 2. Basic principles.
1. The dignity of the human person, respect for his or her autonomy of will and privacy shall guide all activity aimed at obtaining, using, storing, safeguarding and transmitting clinical information and documentation.
2. All action in the field of health requires, in general, the prior consent of patients or users. Consent, which must be obtained after the patient has been given adequate information, shall be given in writing in the cases provided for by law.
3. The patient or user has the right to decide freely, after receiving adequate information, among the available clinical options.
4. Every patient or user has the right to refuse treatment, except in cases determined by law. Refusal of treatment shall be recorded in writing.
5. Patients or users have the duty to provide data on their physical condition or health in a fair and truthful manner and to cooperate in obtaining such data, especially when it is necessary for reasons of public interest or for the purpose of health care.
6. All professionals involved in healthcare activity are obliged not only to provide their techniques correctly, but also to comply with their duty to provide information and clinical documentation, and to respect the decisions taken freely and voluntarily by the patient.
7. The person who prepares or has access to the clinical information and documentation is obliged to keep due reserve.
Article 3. Legal definitions.
For the purposes of this Act, the following definitions shall apply
Health centre: the organised group of professionals, facilities and technical means that carry out activities and provide services to care for the health of patients and users.
Medical certificate: the written statement by a doctor attesting to a person's state of health at a given time.
Informed consent: the free, voluntary and conscious agreement of a patient, expressed in the full use of his or her faculties after receiving the appropriate information, to an action affecting his or her health.
Clinical documentation: the support of any type or class containing a set of data and information of a healthcare nature.
Clinical history: the set of documents containing data, assessments and information of any kind on the situation and clinical evolution of a patient throughout the care process.
Clinical information: any data, whatever its form, class or type, which makes it possible to acquire or extend knowledge about the physical state and health of a person, or the way in which it is preserved, cared for, improved or recovered.
Discharge report: the document issued by the doctor in charge at a health centre at the end of each patient's care process, which specifies the patient's data, a summary of his or her clinical history, the care activity provided, the diagnosis and the therapeutic recommendations.
Intervention in the field of healthcare: any action carried out for preventive, diagnostic, therapeutic, rehabilitative or research purposes.
Free choice: the right of the patient or user to freely and voluntarily choose between two or more care alternatives, between several doctors or between care centres, under the terms and conditions established by the competent health services, in each case.
Responsible physician: the professional who is responsible for coordinating the information and health care of the patient or user, with the character of main interlocutor of the same in all matters relating to their care and information during the care process, without prejudice to the obligations of other professionals involved in the actions of care.
Patient: the person who requires health care and is subject to professional care for the maintenance or recovery of his or her health.
Healthcare service: the healthcare unit with its own organization, equipped with the technical resources and qualified personnel to carry out healthcare activities.
User: the person who uses the health services of education and health promotion, disease prevention and health information.
CHAPTER II
The right to health information
Article 4. Right to care information.
1. Patients have the right to know, on the occasion of any action in the field of their health, all available information about it, except those cases that are exempted by law. Furthermore, everyone has the right to have their wishes not to be informed respected. The information, which as a general rule shall be provided verbally and recorded in the medical record, includes at least the purpose and nature of each intervention, its risks and consequences.
2. The clinical information is part of all care actions, will be true, will be communicated to the patient in an understandable and appropriate to their needs and will help them to make decisions according to their own free will.
3. The physician responsible for the patient shall ensure that the patient's right to information is fulfilled. The professionals who treat you during the care process or who apply a particular technique or procedure to you shall also be responsible for informing you.
Article 5. Holder of the right to care information.
1. The holder of the right to information is the patient. The persons linked to him, for family reasons or in fact, will also be informed insofar as the patient expressly or tacitly allows it.
2. The patient shall be informed, even in the event of incapacity, in a manner appropriate to his ability to understand, in compliance with the duty to inform also his legal representative.
3. Where, in the opinion of the attending physician, the patient lacks the capacity to understand the information because of his physical or mental condition, the information shall be brought to the attention of the persons connected with him for family or factual reasons.
4. The right to health information of patients may be limited by the proven existence of a state of therapeutic need. Therapeutic necessity means the ability of a doctor to act professionally without first informing the patient, when for objective reasons knowledge of his own situation could seriously harm his health.
In such cases, the doctor shall make a reasoned record of the circumstances in the medical record and shall communicate his decision to those persons linked to the patient by family or factual reasons.
Article 6. Right to epidemiological information.
Citizens have the right to know the health problems of the community when they imply a risk to public health or to their individual health, and the right to have this information disseminated in true, understandable and adequate terms for the protection of health, as established by law.
CHAPTER III
Right to privacy
Article 7. The right to privacy.
Everyone has the right to respect for the confidential nature of information concerning him or her, and to have access to such information without prior authorization granted by law.
2. Health centres shall take appropriate measures to guarantee the rights referred to in the previous paragraph and shall draw up, where appropriate, the rules and procedures to be followed in order to guarantee legal access to patients' data.
CHAPTER IV
Respect for the autonomy of the patient
Article 8. Informed consent.
1. Any action in the field of a patient's health requires the free and voluntary consent of the person concerned, after having received the information provided for in Article 4 and assessed the options available in the case.
2. Consent shall, as a general rule, be verbal.
However, it shall be given in writing in the following cases: surgical intervention, invasive diagnostic and therapeutic procedures and, in general, the performance of procedures involving known and foreseeable risks or disadvantages to the health of the patient.
3. The written consent of the patient shall be necessary for each of the actions specified in the previous point of this article, leaving aside the possibility of incorporating annexes and other general data, and shall have sufficient information on the procedure of application and its risks.
4. Every patient or user has the right to be warned about the possibility of using the prognostic, diagnostic and therapeutic procedures applied to him/her in a teaching or research project, which in no case may entail additional risk to his/her health.
5. The patient may freely revoke his consent in writing at any time.
Article 9. Limits on informed consent and consent by proxy.
1. The patient's refusal to receive information is limited by the interest of the patient's own health, that of third parties, that of the community and by the therapeutic requirements of the case. When the patient expressly expresses his wish not to be informed, his will shall be respected by making his renunciation known in writing, without prejudice to obtaining his prior consent for the intervention.
2. Doctors may carry out essential clinical interventions in favour of the health of the patient, without the need to obtain his consent, in the following cases
a) When there is a risk to public health due to health reasons established by law. In any case, once the pertinent measures have been adopted, in accordance with the provisions of Organic Law 3/1986, they shall be communicated to the judicial authority within a maximum period of 24 hours, provided that they provide for the compulsory internment of persons.
(b) When there is an immediate serious risk to the physical or psychological integrity of the sick person and it is not possible to obtain his or her authorisation, consulting, where circumstances allow, his or her family members or persons actually linked to him or her.
3. Consent shall be given by proxy in the following cases
(a) When the patient is not capable of taking decisions, at the discretion of the doctor responsible for the care, or when his physical or psychological condition does not allow him to take charge of his situation. If the patient does not have a legal representative, consent shall be given by persons connected with the patient for family or factual reasons.
(b) Where the patient's capacity has been changed by a court decision and this is stated in the judgment.
c) When the minor patient is not intellectually or emotionally capable of understanding the scope of the intervention. In this case, consent will be given by the minor's legal representative, after having heard his or her opinion, in accordance with the provisions of Article 9 of Organic Law 1/1996, of 15 January, on the Legal Protection of Minors.
4. In the case of emancipated minors or minors over 16 years of age who are not in cases b) and c) of the previous section, consent cannot be given by proxy.
Notwithstanding the provisions of the preceding paragraph, in the case of an act that poses a serious risk to the life or health of the minor, at the discretion of the physician, consent shall be given by the minor's legal representative, after hearing and taking into account the minor's opinion.
5. The practice of clinical trials and the practice of assisted human reproduction techniques are governed by the general provisions on the age of majority and by the special implementing provisions.
The voluntary interruption of pregnancy of minors or persons with judicially modified capacity shall require, in addition to their expression of will, the express consent of their legal representatives. In this case, disputes arising from the provision of consent by legal representatives shall be resolved in accordance with the provisions of the Civil Code.
6. In cases where consent is to be given by the legal representative or by persons related to him/her for family or factual reasons in any of the cases described in paragraphs 3 to 5, the decision shall always be taken with regard to the greatest benefit for the life or health of the patient. Those decisions that are contrary to these interests must be brought to the attention of the judicial authority, directly or through the Public Prosecutor's Office, so that it may adopt the corresponding decision, unless, for reasons of urgency, it is not possible to obtain judicial authorization, in which case the health professionals shall take the necessary measures to safeguard the life or health of the patient, protected by the causes of justification for the fulfillment of a duty and a state of necessity.
7. Consent by proxy shall be appropriate to the circumstances and proportionate to the needs to be met, always in the interest of the patient and with respect for his or her personal dignity. The patient shall participate as far as possible in decision-making throughout the health care process. If the patient is a person with a disability, appropriate support measures shall be provided, including information in appropriate formats, following the rules laid down by the principle of Design for All, in a way that is accessible and understandable to persons with disabilities, in order to facilitate their independent consent.
Article 10. Conditions of information and written consent.
1. The practitioner shall provide the patient with the following basic information prior to obtaining the patient's written consent:
a) The relevant or important consequences of the intervention that are certain to arise.
b) The risks related to the patient's personal or professional circumstances.
c) The risks likely to occur under normal conditions, according to experience and the state of science or directly related to the type of intervention.
d) Contra-indications.
2. The doctor in charge shall consider in each case that the more doubtful the result of an intervention, the more necessary the prior written consent of the patient is.
Article 11. Prior instructions.
By means of the document of prior instructions, a person of full age, capable and free, manifests in advance his or her will, so that it is complied with when he or she reaches situations in which he or she is not capable of expressing it personally, regarding the care and treatment of his or her health or, after his or her death, the destination of his or her body or organs. The issuer of the document may also appoint a representative to act as his or her interlocutor with the doctor or the health care team to ensure that the prior instructions are carried out.
2. Each health service shall regulate the appropriate procedure to ensure that, where necessary, the prior instructions of each person are complied with, which must always be in writing.
3. Prior instructions that are contrary to the legal system or to the lex artis and those that do not correspond to the situation foreseen by the person concerned at the time of giving them shall not be applied. The patient's medical history shall contain a reasoned record of the notes relating to these provisions.
4. The prior instructions may be freely revoked at any time by leaving a written record.
5. In order to ensure the effectiveness throughout the national territory of the prior instructions expressed by patients and formalised in accordance with the provisions of the legislation of the respective Autonomous Communities, the National Registry of Prior Instructions will be created at the Ministry of Health and Consumer Affairs, which will be governed by the rules that are determined by regulation, following agreement by the Interterritorial Council of the National Health System.
Article 12. Information in the National Health System
In addition to the rights recognized in the preceding articles, patients and users of the National Health System shall have the right to receive information on the available care services and units, their quality and the requirements for access to them.
2. Health services shall have at their disposal a guide or charter of services specifying the rights and obligations of users, the benefits available, the care characteristics of the centre or service, and its staffing, facilities and technical means.
All users will be provided with information on the participation guides and on suggestions and complaints.
3. Each health service will regulate the procedures and systems to guarantee effective compliance with the provisions of this article.
Article 13. Right to information for choice of doctor and centre.
Users and patients of the National Health System, both in primary and specialized care, shall have the right to the corresponding prior information to choose a doctor, and also a center, in accordance with the terms and conditions established by the competent health services.
CHAPTER V
The medical history
Article 14. Definition and filing of medical records.
1. The clinical history comprises all the documents relating to the care processes of each patient, with the identification of the doctors and other professionals who have intervened in them, with the aim of obtaining the maximum possible integration of the clinical documentation of each patient, at least in the scope of each centre.
2. Each centre shall archive the clinical records of its patients, whatever the paper, audiovisual, computer or other support on which they are recorded, in such a way as to guarantee their security, their correct conservation and the recovery of the information.
3. The health administrations shall establish the mechanisms that guarantee the authenticity of the content of the clinical history and of the changes operated on it, as well as the possibility of its future reproduction.
4. The Autonomous Communities shall approve the necessary provisions so that health centres can adopt the appropriate technical and organisational measures to file and protect clinical records and prevent their destruction or accidental loss.
Article 15. Content of the medical history of each patient.
1. The clinical history comprises all the documents relating to the care processes of each patient, with the identification of the doctors and other professionals who have intervened in them, in order to obtain the maximum possible integration of the clinical documentation of each patient, at least, in the scope of each centre.
2. Each centre shall archive the clinical records of its patients, whatever the paper, audiovisual, computer or other support on which they are recorded, in such a way as to guarantee their security, their correct conservation and the recovery of the information.
3. The health administrations shall establish the mechanisms that guarantee the authenticity of the content of the clinical history and of the changes operated on it, as well as the possibility of its future reproduction.
4. The Autonomous Communities shall approve the necessary provisions so that health centres can adopt the appropriate technical and organisational measures to file and protect clinical records and prevent their destruction or accidental loss.
Article 15. Content of the medical history of each patient.
1. The clinical history will incorporate the information considered transcendental for the true and updated knowledge of the state of health of the patient. Every patient or user has the right to have recorded, in writing or with the most appropriate technical support, the information obtained in all the care processes carried out by the health service, both in the area of primary care and in that of specialised care.
2. The main purpose of the medical record shall be to facilitate health care, leaving a record of all the data which, under medical criteria, allow a true and up-to-date knowledge of the state of health.
The minimum content of the medical record shall be as follows:
a) The documentation relating to the clinical-statistical sheet
b) Authorisation for admission.
c) The emergency report.
d) The anamnesis and physical examination
e) The evolution.
f) Medical orders.
g) The consultation form.
h) Reports on complementary explorations.
i) Informed consent.
j) The anesthesia report.
k) The operating room or birth registration report.
l) The pathological anatomy report
m) The nursing care development and planning
n) The nursing therapeutic application.
ñ) The constants graph.
o) The clinical discharge report.
Paragraphs b), c), i), j), k), l), ñ) and o) shall only be required when filling in the clinical record when hospitalisation processes are involved or when so stipulated.
3. In the case of birth, the medical record shall contain, in addition to the information referred to in this paragraph, the results of any biometric, medical or analytical tests which may be necessary to establish the filiation link with the mother, in accordance with the terms laid down by regulation.
4. The medical record shall be kept with unit and integration criteria, in each care institution as a minimum, in order to facilitate the best and most appropriate knowledge by doctors of the data of a given patient in each care process.
Article 16. Uses of medical records.
1. The medical record is a tool designed primarily to ensure adequate care for the patient. The healthcare professionals at the centre who carry out the diagnosis or treatment of the patient have access to the patient's clinical history as a fundamental instrument for adequate care.
2. Each centre shall establish the methods that make it possible for the professionals who assist the patient to have access to the clinical history of each patient at all times.
3. Access to the clinical history for judicial, epidemiological, public health, research or teaching purposes is governed by the provisions of current legislation on the protection of personal data, and by Law 14/1986, of 25 April, the General Health Act, and other applicable regulations in each case. Access to medical records for these purposes requires the preservation of the patient's personal identification data, separated from those of a clinical-assistential nature, so that, as a general rule, anonymity is ensured, unless the patient himself has given his consent not to separate them.
Exceptions are made for the cases of research foreseen in section 2 of the seventeenth additional provision of the Organic Law on the Protection of Personal Data and the Guarantee of Digital Rights.
Likewise, an exception is made for cases of investigation by the judicial authority in which it is considered essential to unify the identification data with the clinical assistance, in which case the judges and courts will have the corresponding process. Access to the data and documents of the clinical history is strictly limited to the specific purposes of each case.
When it is necessary for the prevention of a serious risk or danger to the health of the population, the health administrations referred to in Law 33/2011 of 4 October, General of Public Health, may access the identification data of patients for epidemiological reasons or for the protection of public health. The access must be made, in any case, by a health professional subject to professional secrecy or by another person also subject to an equivalent obligation of secrecy, prior motivation by the Administration that requested the access to the data.
4. The administration and management staff of the health centres may only access the data in the medical records relating to their own functions.
5. Duly accredited health personnel who perform inspection, evaluation, accreditation and planning functions have access to clinical records in the performance of their functions of checking the quality of care, respect for patient rights or any other obligation of the centre in relation to patients and users or the health administration itself.
6. The personnel who access the clinical history data in the exercise of their functions are subject to the duty of secrecy.
7. The Autonomous Communities shall regulate the procedure so that access to the medical record and its use is recorded.
Article 17. The conservation of clinical documentation.
1. Health centres are obliged to keep clinical documentation in conditions that guarantee its correct maintenance and safety, although not necessarily in the original format, for the proper care of the patient for the appropriate time in each case and at least five years from the date of discharge from each care process.
However, the data in the medical history related to the birth of the patient, including the results of biometric, medical or analytical tests that, where appropriate, are necessary to determine the filiation link with the mother, will not be destroyed and will be transferred, once the death of the patient is known, to the definitive files of the corresponding Administration, where they will be kept with the appropriate security measures for the purposes of data protection legislation.
2. The clinical documentation shall also be kept for legal purposes in accordance with the legislation in force. It shall also be kept when there are epidemiological, investigative or organizational and operational reasons for the National Health System. They shall be processed in such a way as to avoid as far as possible the identification of the persons concerned.
Without prejudice to the right referred to in the following article, the data from the medical history related to biometric, medical or analytical tests that are necessary to determine the filiation link with the mother of the newborn child may only be communicated at the request of the court, within the corresponding criminal process or in the event of a claim or judicial challenge of the maternal filiation.
3. Health professionals have a duty to cooperate in the creation and maintenance of orderly and sequential clinical documentation of the patient care process.
4. The management of clinical records by centres with hospitalised patients, or by those that attend a sufficient number of patients under any other care modality, according to the criteria of the health services, shall be carried out through the admission and clinical documentation unit, which is responsible for integrating the clinical records into a single archive. The custody of these clinical records will be the responsibility of the health centre management.
5. Health professionals who carry out their activity individually are responsible for the management and custody of the care documentation they generate.
6. The technical safety measures established by the legislation regulating the conservation of files containing personal data and, in general, by the Organic Law 15/1999, on the Protection of Personal Data, are applicable to clinical documentation.
Article 18. Rights of access to medical records.
1. The patient has the right of access, subject to the reservations set out in paragraph 3 of this Article, to the documentation in the medical record and to obtain a copy of the data contained therein. Healthcare establishments shall regulate the procedure to ensure that these rights are respected.
2. The patient's right of access to the medical file may also be exercised by duly accredited representation.
3. The right of access of the patient to the documentation of the medical record may not be exercised to the detriment of the right of third parties to the confidentiality of the data contained therein collected in the therapeutic interest of the patient, nor to the detriment of the right of the professionals involved in its preparation, who may oppose the right of access by reserving their subjective notes.
4. Health centres and individual practitioners shall only provide access to the medical records of deceased patients to persons linked to them, for family or factual reasons, unless the deceased had expressly prohibited it and it is so accredited. In any case, access by a third party to the medical record on the grounds of a risk to their health shall be limited to the relevant data. Information affecting the privacy of the deceased or the subjective notes of the professionals, as well as information that could be harmful to third parties, shall not be provided.
Article 19. Rights related to the custody of medical records.
The patient has the right for health centres to establish a mechanism for active and diligent custody of clinical records. This custody will allow the collection, integration, recovery and communication of information subject to the principle of confidentiality in accordance with the provisions of Article 16 of this Law.
CHAPTER VI
Discharge report and other clinical documentation
Article 20. Discharge report.
Every patient, family member or person linked to him/her, if applicable, will have the right to receive from the health centre or service, once the care process has been completed, a discharge report with the minimum contents determined in article 3. The characteristics, requirements and conditions of the discharge reports will be determined by the regulations of the autonomous health administrations.
Article 21. Discharge of the patient.
1. If the prescribed treatment is not accepted, the patient or user shall be asked to sign the voluntary discharge. If he does not sign it, the management of the health centre, on the proposal of the doctor in charge, may order the compulsory discharge under the conditions regulated by law.
The fact of not accepting the prescribed treatment shall not give rise to compulsory discharge when alternative treatments exist, even if they are of a palliative nature, provided that they are provided by the health centre and the patient agrees to receive them. These circumstances shall be duly documented.
2. In the event that the patient does not accept the discharge, the management of the centre, after checking the corresponding clinical report, will hear the patient and, if he persists in his refusal, will inform the judge so that he can confirm or revoke the decision.
Article 22. Issue of medical certificates.
Every patient or user has the right to be provided with certificates accrediting his or her state of health. These will be free of charge when a legal or regulatory provision so establishes.
Article 23. Professional obligations for technical, statistical and administrative information
Health professionals, in addition to the obligations indicated with regard to clinical information, have the duty to complete protocols, records, reports, statistics and other care or administrative documentation, which are related to the clinical processes in which they intervene, and those required by the competent health centres or services and health authorities, including those related to medical research and epidemiological information.
First additional provision. Character of basic legislation.
This Act has the status of basic legislation, in accordance with the provisions of Article 149.1.1 and 16 of the Constitution.
The State and the Autonomous Communities shall adopt, within the scope of their respective powers, the measures necessary for the effectiveness of this Act.
Second additional provision. Supplementary application.
The rules of this Law relating to health care information, information for the exercise of freedom of choice of doctor and centre, the informed consent of the patient and clinical documentation, will be of supplementary application in medical research projects, in the processes of extraction and transplant of organs, in those of application of assisted human reproduction techniques and in those that lack special regulation.
Third additional provision. Coordination of medical records.
The Ministry of Health and Consumer Affairs, in coordination and with the collaboration of the competent Autonomous Communities in this area, shall promote, with the participation of all interested parties, the implementation of a system of compatibility which, in view of the evolution and availability of technical resources, and the diversity of systems and types of clinical records, shall make it possible for healthcare centres in Spain that attend the same patient to use them, in order to avoid those who are attended in different centres being subjected to unnecessary examinations and procedures.
Additional provision four. Needs associated with disability.
The State and the Autonomous Communities, within the scope of their respective powers, shall issue the necessary provisions to guarantee patients or users with special needs associated with disability the rights to autonomy, information and clinical documentation regulated by this Law.
Additional provision five. Information and documentation on medicines and medical devices.
The information, documentation and advertising relating to medicines and health products, as well as the system of prescriptions and the corresponding prescription orders, shall be regulated by their specific regulations, without prejudice to the application of the rules established in this Law regarding the prescription and use of medicines or health products during care processes.
Sixth additional provision. Penalty regime.
Violations of the provisions of this Law are subject to the penalty regime provided for in Chapter VI of Title I of Law 14/1986, General Health, without prejudice to civil or criminal liability and professional or statutory liability under the law.
Unique transitional provision. Discharge report.
The discharge report shall be governed by the provisions of the Order of the Ministry of Health, of 6 September 1984, until such time as the provisions of article 20 of this Act are legally implemented.
Unique derogating provision. General and specific derogations.
Provisions of equal or lesser rank that are contrary to the provisions of this Law are hereby repealed, specifically Article 10(5), (6), (8), (9) and (11), Article 11(4) and Article 61 of Law 14/1986, on General Health.
Unique final disposition. Entry into force.
This Law shall enter into force within six months from the day following its publication in the "Official State Gazette".
Therefore, I command all Spaniards, individuals and authorities, to keep and make keep this Law.
Madrid, November 14, 2002.
JUAN CARLOS R.
The President of the Government,
JOSÉ MARÍA AZNAR LÓPEZ
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