Key Benefits:
The Minister of Health, Family and Disability,
In view of article L. 1111-9 of the Public Health Code,
Stop:
The recommendations for good practice on access to health information are registered Of a person, and in particular accompanying such access, set out in the Annex to this Order.
The Director General of The health and the director of the hospitalization and the organisation of care shall each have responsibility for the execution of this Decree, which shall be published in the Official Journal of the French Republic.
A N N E X E
RECOMMENDATIONS OF THE NATIONAL HEALTH ACCREDITATION AND EVALUATION AGENCY (ANAES) FOR CLINICAL PRACTICE. ACCESS TO INFORMATION ABOUT A PERSON'S HEALTH. PRACTICE AND ACCOMPANIED TERMS
I. -Preamble
The recommendations concern the modalities and the accompaniment of access to health information relating to a person, held by Health care professionals (1), public or private health care institutions, or lodgers (2).
They are intended for all health professionals, regardless of their mode of practice (liberal, public, health care institutions, health care providers, health care providers, health care providers, and health care providers). Health or medico-social structures, etc.) And all the staff of these establishments and structures, all of whom are directly affected by their implementation. They can also be useful to people using the health care system to enable them to be informed about how to access information about their health.
These recommendations are intended to facilitate the application of the articles L. 1111-7, L. 1112-1 and R. 1111-1 to R. 1112-9 of the Public Health Code (Act No. 2002-303 of 4 March 2002 on the rights of the sick and the quality of the health system and Decree n ° 2003-462 of 21 May 2003 on the regulatory provisions Parts I, II and III of the Public Health Code). The aim is to contribute by organisational measures and good practices to the exercise of a right recognised by the law and to organise, if necessary, personalised support for access to health information.
Article L. 1111-7 of the Code Public health provides the person with access to formalized health information. These must be understood as simple: it is the information to which a medium is given (written, photography, recording, etc.).) With the intention of preserving them and without which they would be objectively inaccessible. This information is intended to be collected in what is usual to call the person's file. For this reason, the word folder is used hereafter by ease of writing to refer to all health information about a given person, even if in the current practice the file does not always include all of them. The word folder should not be considered here in a restrictive way, since all the formalised information held by a professional, health care institution or host outside the file is Communicable.
It is to the extent that Some of the notes of health professionals are not intended to be stored, reused or exchanged, because they cannot contribute to the development and follow-up of diagnosis and treatment or to an action of Prevention, which they can be considered as " Personal " And not be communicated: they are then incommunicable and inaccessible to the data subject as to third parties, professionals or not.
Even if the right to access Information about his health effectively enables a person to be informed, most often a posteriori, that he cannot substitute for the right of the person to information about his health, that the law of 4 March 2002 reaffirms Solemnly. Information is an integral part of the care relationship. This information, most often oral in the course of care, allows the individual to make decisions about their health, to inform their consent, and to facilitate their adherence to treatment. It thus contributes to improving the quality of care. The possibility for a person to have direct access to the formalised information only supplements his right to information. It cannot exempt the health care professional from having to regularly communicate to the person the relevant information about his health, which should limit the requests for access to the file and make the discovery unlikely Chance of meaningful information when the individual wishes to access his/her file.
Regular sharing of the collection and analysis of information between the individual and the health care professional contributes to the creation of a record of Quality, taking into account both the demands of the person and the needs of his/her care. Consistent and intelligible information procedures should make it possible to limit the use of comprehensive post-clearance communication.
Access to the information contained in the file is not sufficient to provide information Complete and relevant. A record of hospitalization often contains only one episode or even a snapshot of a person's medical history. In certain circumstances, the content and quality of the file is likely to provide partial, retrospective or even outdated information on its health status at any given time.
Health professionals, institutions Health, health and medico-social structures and information providers must ensure that the procedures for access to the file ensure the essential preservation of confidentiality vis-à-vis third parties (family, entourage, etc.). Employer, banker, insurer, etc.). For its part, the person must exercise his right of access to the file with the full awareness of the strictly personal nature of the health information that she is going to hold. It should be informed of the risks of unmastered use, particularly as a result of the solicitation of third parties who are excluded from the right to direct this information directly to professionals, health care institutions or accommodation providers. These third parties can more easily exert illegitimate pressure so that the person can pass them directly on health information that is relevant to them and maintains confidentiality.
Provisions of the Articles New L. 1111-7, L. 1112-1 and R. 1111-1 to R. 1112-9 of the code of public health concern both new cases and those constituted prior to the issuance of the decree of 29 April 2002. Article R. 1112-2 of the Public Health Code specifies the minimum composition of the file in public and private health institutions. It requires the structuring of new files, improving their quality and facilitating their access.
For health professionals, the file is first an instrument of work and exchange with other professionals, recording the A diagnostic, therapeutic or preventive approach and the care received by the individual. It is also a training and evaluation tool and a support of information essential to improve health knowledge and practices in compliance with the rules in force.
It should be noted that the minimum composition of the Files in health care institutions have been amended in accordance with successive regulations; the difference in structure does not call into question the right of access, in accordance with the provisions referred to above, to the files and to the Health information (fact sheets, etc.) Incorporated under the conditions of the previous regulation.
II. -The file: an element of quality of care
The file provides the best conditions for the collection and retention of information held by health professionals, health care institutions and health care providers.
The record keeping of the record must be able to respond to any request for consultation or transmission of information from health professionals such as the person. When the file is structured, exploitable and legible, especially when it contains regular syntheses, understanding is facilitated. Every health professional has an obligation to ensure the quality of this tool. The status of the information it contains, their scalability justifies a hierarchy of nature to clarify their use and to promote the appropriation of often complex and provisional data.
Article R. 1112-1 states that, in Public or private health facilities, the file is organized into three parts, only the first two of which can be communicated to the person on request:
1. Formalised information gathered during the external consultations dispensed in the institution, during reception at the emergency department or at the time of admission and during the hospital stay;
2. Formalized information at the end of hospital stay;
3. Information indicating that they have been collected from third parties not involved in therapeutic or third-party care.
Information relevant to the continuity of care is provided to the person at the end of the Stay or, if requested, sent to the doctor of choice.
In order to improve the quality of the care, article R. 1112-2 can help structure files outside health care facilities.
When This is possible, especially if the record is computerized, it is desirable to establish a record of the records on the record, kept up to date, with the possibility of providing a copy to the person requesting it.
It is Recommended to make clear in the file a statement concerning the choice of the person for access to and transmission of health information, which must be updated and verified on a regular basis: Person can return to his or her choice at any time. This is:
-the refusal of the person to transmit information about his or her health to other health professionals (for example, a doctor);
-the possible refusal of relatives to be informed;
-identification of The person of trust who will be informed and consulted in the event that the person is out of the state to express his or her will and receive the information necessary for that purpose (art. L. 1111-6 of the Public Health Code);
-refusal to disclose certain information to right holders in the event of death;
-refusal by a minor to disclose information about his or her health to the right holders Parental (cf. Chapter V concerning minors).
In accordance with Article L. 1110-4 of the Public Health Code, the duly informed person may object to the transmission of information concerning him. It is not possible to ask them to opt in a comprehensive and definitive way for the transmission of information between health professionals.
The dialogue with the person allows:
-to inform him of his rights;
- To remind him of the strictly personal nature of the information contained in the file vis-vis third parties (family, entourage, employer, banker, insurer, etc.).
Finally, it is recalled that the person has the right to be held in Ignorance of a diagnosis, with the exception of a communicable disease, or prognosis, and that the health care professional cannot release the information if it does not consent.
III. -Information of the person on access to the file
It is recommended that information about the regulations and the practical aspects of access to the file should be made available and easily accessible (home booklet In health or social care facilities, booklet or poster in private offices, etc.). In health care facilities, this information is the subject of an explanatory chapter in the establishment's home booklet (Art. R. 1112-9 of the Public Health Code).
This device is used to inform the person:
-of his or her rights;
-the possibility of transmitting and filing information with a host. The accommodation of the data at the request of the professional or health care institution may take place only with the express consent of the data subject;
-the composition of the file;
-possible direct access to the data Health information (on-site consultation, sending copies by mail to the person or physician of his or her choice);
-measures adopted by default where the person does not specify the health care provider 's Method of communication that it holds;
-the medical escort device put in place and proposed to the person by the institution;
-legal deadlines for communication;
-the costs entailed by the possible application of Reproduction and sending of documents (reproduction and sending of copies of all or part of the file in case of initial request for mailing or after consultation on the spot).
This device also allows:
-to propose a form that the May be able to use, if desired, to clarify the application. This document should be easily understandable and help to clarify the key points for correctly answering the request: the identification of the applicant and the documents to be provided if necessary in order to ascertain the identity of the applicant, the nature Of the application (set of file or part of the file corresponding to a particular hospitalization or special parts of the file), the desired modalities of communication (sending, communication on site to the hospital or cabinet, sending to a Person-designated physician). The request does not have to be motivated by the person if the information it requests relates to it;
-to remind the person of the precautions to be taken in respect of the strictly personal nature of the information it is going to hold, In particular vis-vis third parties (family, entourage, employer, banker, insurer, etc.).
After a death, a person entitled, in addition to the fact that he or she must justify his/her legal status, must specify the reason why he or she needs to know Information requested. A form may be proposed so that the person entitled can specify the three purposes provided by the law that motivates his or her application (know the cause of death, defend the memory of the deceased, assert his or her own rights).
IV. -Case Communication
Most requests can be made orally as part of the care relationship. This needs to be addressed and this process should be encouraged. However, the specific arrangements provided for by the law should be turned down, taking into account the places of care (city office, health or medico-social establishment, etc.).
It is recalled the time constraints imposed on the Answers to requests for access to information: the person can access the information directly or through a doctor whom it designates and obtain communication no later than 8 days after the request and at the earliest after A 48-hour cooling-off period has been observed. This period of communication shall be extended to 2 months when the medical information is more than 5 years from the date on which the medical information was established. This period may also be 2 months in the particular case of referral to the departmental commission of psychiatric hospitalizations.
Health information may be communicated to a person authorised by the patient, by his or her Legal representatives (in the case of a minor or major under guardianship) or by his successors in title in the event of death, if the person has an express mandate and can justify his or her identity. The person authorised may have a conflict of interests and other interests other than those of the principal (the person concerned by the health information). It is recommended to remind the principal of the personal character of the information that will be communicated to the mandated person.
IV-1. Receipt and management of the application
In all cases, it is appropriate before any request is processed that the recipient (head of the institution, health professional or host) ensures the identity of the applicant, As required by the submission of supporting documents that depend on the quality of the applicant. No request can be satisfied without any certainty regarding the identity of the applicant.
To facilitate the processing of the application, it is recommended to inform the individual that his/her application will be easier to honour if it states at the outset:
Providing the necessary parts so that it can be verified (for example, in the case of a postal request, double-sided photocopying of an identity document);
-the nature of the application: the whole file or part of the corresponding file Special hospitalization or special parts of the file;
-the desired means of communication: mailing, on-site communication to the hospital or office, mailing to a designated physician.
Application does not need to be
all cases, it is recommended to the professional, the institution or the host:
-acknowledge receipt of the application by any means, even if it is Imprecise and follow up with the same diligence;
-inform the person of the costs associated with the reproduction and sending of the documents, as a result of the nature and volume of the file;
-describe and propose the accompaniment provided by the The institution, which the person may refuse;
-to indicate whether the physician recommends the presence of a third party during this consultation, a recommendation that the person is not obliged to accept without this refusal being prejudicial to the person 's
Where the person has not specified in his or her application the terms and conditions of communication that they wish, it is recommended:
-to propose that they complete a standard form, in order to facilitate the processing of their application. Both imprecise requests and lack of choice as to the different possibilities of access to the file;
-describe the default procedure provided for by the institution or health professional, which applies in the absence of Accuracy or in the case of non-response of the applicant to the communication procedures.
Where the doctor wishes to make the consultation of the information conditional on the presence of a doctor (a hypothesis which must remain exceptional and limited only to Information collected in the context of hospitalization without consent), it is appropriate:
-to ask the patient to refer to the doctor for which he wishes to be accompanied;
-to specify that he may object to this accompaniment, but That in this case the departmental committee for psychiatric hospitalizations will be seized and its opinion will be required.
If the person has requested a shipment, it is advisable to specify the following points in the reply acknowledging receipt Of the request:
-recall the strictly personal nature of the information contained in the file, in particular with regard to third parties (family and entourage, employer, insurer ...) ;
-inform the person of the costs associated with the reproduction and sending of the documents, due to the nature and volume of the file. If necessary, a second letter shall be sent as soon as possible, presenting an estimate of the estimated cost of the reproduction, if the first letter did not specify it;
-propose a consultation of the file on the spot, in particular When the cost of reproduction is significant, recommending or not recommending the presence of a third party. In the case of refusal or failure to reply, the terms initially chosen by the person are followed within the time prescribed by the regulations.
Particular cases of right
. That reference is made to the opinion of the Committee on Access to Administrative Documents, applicable to the public sector, or to the civil case-law in respect of the private sector.
Article L. 1110-4 of the Public Health Code provides that secrecy Shall not prevent the information concerning a deceased person from being issued to his successors in title in so far as they are necessary to enable them to know the causes of death, to defend the memory of the Or to assert their rights, unless otherwise expressed by the person before his or her death. Those conditions, once combined, have access to the whole medical file (opinion of the Committee on Access to Administrative Documents Nos. 20034659 and 20034213 of 20 November 2003), excluding information collected from third parties
Article R. 1111-7 of the same code states that the right of a deceased person who wishes to access the medical information concerning that person must Stating at the time of his application the ground for which he needs to be aware of this information, and that the refusal, if any, to be refused must be justified and does not preclude the issue of a medical certificate, provided that This certificate does not contain information that is covered by the medical confidentiality.
The health professional or institution must, therefore, ensure before any communication:
-the identity of the applicant and the quality of the applicant's entitlement;
-du Reason for the application in order to determine whether it corresponds to one of the cases provided for by the legislator;
-the absence of opposition by the deceased.
In the case of information filed with a host by a professional or institution of Health.
The health professional or institution must agree to any communication of the information by the host. If the host is refused to notify the applicant of the information by the professional or health care institution, the provider must ensure access to the file in accordance with the provisions applicable to the applicant.
IV-2. How to communicate the
folder and support access
Communication of the file to the person often responds to a request for information, which occurs a posteriori; it can compensate for an earlier deficit Information. Particular attention should therefore be paid to this type of request during the communication of the dossier. The presence or availability of a physician may make it possible to respond to this expectation, but must not interfere with the person's wish to consult his or her file directly. In order to do so, it is recommended that a consultation be carried out by appointment, whether it is for a request for consultation of the file, a request for the furnishing of copies of the file or a request for an ex post explanation. It must be considered in the same way as another medical procedure under the rules of ethics and good practice.
The purpose of this consultation is to promote direct access and understanding by the person of the information. Concerning. It cannot be equated with a reconciliation interview.
As with any other consultation, it must be referred to in the file.
When the person and the health care provider or institution are remote or when the person Cannot travel, it is recommended to provide access to the file through a physician selected by the person. In the case of refusal or if this proposal is not accepted within the time limit for communicating the case, the copy of the file is sent directly to the person.
When the person expresses no choice between the different modalities of the Communication of the case, it is recommended that on-site consultation with personalised care in the context of a medical interview be proposed by default.
In case of on-site consultation, it is recommended to propose a device In the service or establishment, in a suitable space. The conditions must allow the integrity of the file to be maintained (avoid theft, damage, tampering, torn pages, etc.).
In the context of an accompanied consultation, the establishment proposes a doctor who may be present or Will be available to answer any questions from the applicant. Ideally, this physician will be the one who has taken care of the person.
After the file has been consulted, follow-up of the person should be arranged if necessary.
In the particular case of the presence of a third party during the consultation The file, at the request of the person or the doctor, it is essential to inform:
-the applicant that the third party will be aware of strictly personal information about his or her health;
-the third person whom it is Held criminally to respect the confidentiality of the person's health information.
If the applicant wishes the presence of a third party, but cannot designate a person in his or her entourage, the use of a person who Has no conflict of interest with regard to the information concerning his health (person from the voluntary sector, social worker, doctor other than the holder of the information which the applicant wishes to have access to) may be offered to him, Not only at the time of the on-site consultation of the case, but also in the possible follow-up.
In the event of sending a copy of the file, the accompanying mail must also inform the possible difficulties of interpretation of the documents. Information and, where appropriate, the consequences which the person may have on the disclosure of certain information; a medical consultation should be suggested where necessary.
In the case of a post of a copy of the file or of the Copies requested after consultation on the spot, it is proposed to be sent by registered mail with notice of receipt, which guarantees the best of confidentiality. The preparation of a check list attached to the file with the list of copies sent to the patient is recommended.
Concerning the copies of the file, Article R. 1111-2 of the Public Health Code provides that they are established on a support similar to the The one used by the health professional, the health care provider or the host, or on paper, at the choice of the applicant and within the limits of the technical possibilities of the professional or body concerned. The potential inability to reproduce certain elements of the record (such as x-ray) should not impede their communication to the individual. In such circumstances, the right of access can only be exercised through on-site consultation.
In the specific case of psychiatry.
Psychiatric patients (including inpatients without their consent) have one Direct access to health information collected as part of their hospitalization. Exceptionally and in the event of a risk of a particular gravity, access to information collected in the context of hospitalization without consent (hospitalisation ex officio or upon request of a third party) may be subject to the presence of a Physician designated by the applicant. If the applicant refuses the presence of the doctor, the departmental committee for psychiatric hospitalizations is seized and its opinion is binding on the applicant and the holder of the information.
It is recalled that the relatives do not hold the Right of access to the file. However, the legislature intended that, in the event of a serious diagnosis or prognosis, the medical secret does not preclude the family, the relatives of the sick person or the person of confidence from receiving the necessary information intended for their To provide direct support to it, except as opposed to it.
In the particular case of people with communication difficulties, the transmission of information must be adapted to their opportunities and difficulties The understanding must be specifically addressed.
IV-3. Cost of access to the file
It is recommended that the person be able to know the cost of communicating the copies of the file that they wish to have, in order to assist them in making a decision on their request to reproduce All or part of its file.
The law specifies that consultation of the on-site file is free of charge. In the case of a request for copies, whatever the medium, only the costs of reproduction and sending are chargeable to the applicant. It is appropriate to limit the cost of consumables and amortization of equipment.
It is recommended that the personal circumstances of poor claimants be taken into account in order to enable them to assert their right of access to the Information about their health.
V. -Special cases of minors
The right of access to all information concerning the health of the minor is exercised by the owners of the authority Parental. But this right is exercised subject to the minor's opposition or his request that the holders of parental authority access information about his or her health only through a doctor.
Two situations must be distinguished :
-the general case where, as the law specifies, the right of access is exercised by the holder (s) of the parental authority; the minor may not object to this request, however he may request that access be granted by The intermediary of a doctor;
-the case provided for in Article L. 1111-5, where the minor who wishes to keep the secret has obtained that the doctor agrees to practice the care necessary to safeguard his health without obtaining the consent of the Holders of parental authority. In this respect, Article R. 1111-6 provides that the minor may object to the communication to the holder (s) of the parental authority of the information corresponding to that particular situation. In this case, the opposition of the minor is recorded in the file and, in the case of a request for access by the holder (s) of the parental authority, the professional must endeavour to convince the minor to lift his opposition. In the case of a child, the minor may request that the right of access of the holder (s) of the parental authority be exercised through a doctor designated by the latter. The opposition or limitation may concern only one of the two parents.
Where the minor is seeking care alone, or when his age, the family context, the pathology presented seem to justify it, it is desirable that the doctor Informs you of this possibility. The objective is to provide access to care and to establish a relationship of trust with health care professionals without the fear that their parents will be informed of the findings and medical procedures. Indeed, the prospect of a revelation to his parents of the reason for his use of the health care professional should not deter him from receiving treatment.
But the health care professional must try to convince the minor to let his parents access Information on his or her health, in particular through a doctor, so that a dialogue within the family is maintained or resumed, and that the minor can receive support.
In a request to communicate the file of a Minor, in case of doubt concerning the applicant as to the quality of the holder of the parental authority, supporting documents may be requested. If the requesting parent cannot provide any part, it is appropriate to refuse the application or suggest with the agreement to contact the other parent in order to be informed about the exercise of parental
. Under Article L. 1111-5, the doctor must check whether the minor also wishes to object to access by the holder of the parental authority to his file. Seizures of a request made by the holder of the parental authority, while the minor objected to the communication, the doctor must endeavour to check with the latter the constancy of this will and to bring it to the attention of the Account for items that might change this choice. It is only in the situation where, despite these efforts, the minor maintains his opposition that the request of the holder of the parental authority cannot be satisfied.
As regards the right to request access to information by The intermediary of a doctor, it seems necessary to ask beforehand the position of the minor, where the parents have never intervened in the care, or when the age, the family context, the pathology presented seem to justify it, Or where the minor is personally entitled to the reimbursement of benefits in kind for sickness insurance and supplementary coverage.
If the request for the communication of the file emanates from a minor, Article L. 1111-7 does not The minor is the holder of the right of access to information held by health professionals and institutions. But the law (art. L. 1111-2 of the Public Health Code and 371-1 of the Civil Code) provides that the minor has the right to receive information himself and to participate in the decision-making concerning him in a manner adapted to his degree of maturity. It is therefore desirable that particular attention be paid to such a request for access to the elements of the file. It must allow the minor to complete the information received and to benefit from further explanations, taking into account the age attained when making the request. It may be very useful to take back with him the elements of his file and their impact on his adult life.
Done at Paris, March 5, 2004.
Jean-François Mattei
