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Decree No. 2015 - 1263 Of October 9, 2015, Authorizing The Creation Of Processing Of Personal Data For The Implementation Of Acts Of Telemedicine From Experiments Based On Article 36 Of Act No. 2013 - 1203 23...

Original Language Title: Décret n° 2015-1263 du 9 octobre 2015 autorisant la création de traitements de données à caractère personnel pour la mise en œuvre des actes de télémédecine issus des expérimentations fondées sur l'article 36 de la loi n° 2013-1203 du 23...

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Keywords

STATUS OF THE PUBLIC HEALTH, NETWORK, NETWORK OF SANTEE, TELEMEDECINE, NETWORK OF ASSESSMENT,


JORF n°0238 of 14 October 2015 page 19004
text No. 7



Decree No. 2015-1263 of 9 October 2015 authorizing the creation of personal data processing for the implementation of telemedicine acts derived from experiments based on article 36 of Act No. 2013-1203 of 23 December 2013 on the financing of social security for 2014

NOR: AFSH1507867D ELI: https://www.legifrance.gouv.fr/eli/decret/2015/10/9/AFSH1507867D/jo/texte
Alias: https://www.legifrance.gouv.fr/eli/decret/2015/10/9/2015-1263/jo/texte


Publics concerned: patients supported in telemedicine activities and health professionals involved.
Subject: creation of personal data processing for the implementation of telemedicine acts.
Entry into force: the text comes into force on the day after its publication.
Notice: The purpose of this decree is to regulate the transmission of data induced by telemedicine activities from the experiments provided for in section 36 of the Social Security Financing Act for 2014 and, in particular, to permit the communication of the registration number to the national directory for the identification of natural persons (NIR) of the patient to the remote health professional performing the act, with a view to its payment. The implementation of telemedicine experiments must also be accompanied by a specific billing modality without the patient's physical presence, by derogation fromArticle R. 161-43 of the Social Security Code.
References: the decree is taken for the application of theArticle 36 of Act No. 2013-1203 of 23 December 2013 Social Security Funding for 2014. The texts amended by this decree are available on the website Légifrance (http://www.legifrance.gouv.fr).
The Prime Minister,
On the report of the Minister of Social Affairs, Health and Women ' s Rights,
Vu le Public Health Codeincluding articles L. 6316-1, R. 6316-1 and R. 6316-2;
Vu le Social Security Codeincluding articles L. 162-1-7 and R. 161-43;
Vu la Act No. 78-17 of 6 January 1978 modified with respect to information technology, files and freedoms, including 1° of the I of its article 27;
Vu la Act No. 2013-1203 of 23 December 2013 the financing of social security for 2014, including its article 36;
Vu le Decree No. 2014-1523 of 16 December 2014 authorizing the creation of a personal data treatment for the detection of diabetic retinopathy;
Vu la deliberation no. 2014-239 of 12 June 2014 the National Commission on Information and Freedoms on the implementation by health professionals and institutions, as well as professionals in the medical-social sector authorized by law, of personal data processing with the aim of electronic exchange of health data through a secure messaging system;
Considering the opinion of the National Commission on Informatics and Freedoms of 2 April 2015;
Having regard to the advice of the Board of the National Health Insurance Fund for Employees dated 5 May 2015;
Considering the opinion of the Central Board of Directors of the Agricultural Social Mutuality of 12 May 2015;
Considering the opinion of the Industrial Accidents and Occupational Diseases Commission of 13 May 2015;
Having regard to the advice of the Council of the National Health Insurance Union dated 21 May 2015;
The State Council (Social Section) heard,
Decrete:

Article 1 Learn more about this article...


I. - For the purposes of section 36 of the Social Security Financing Act for 2014, which provides, on an experimental basis, the realization of telemedicine acts as defined in theArticle L. 6316-1 of the Public Health Code, professionals referred to in article R. 6316-1 of the same code who participate in the conduct of these same acts are authorized to implement personal data processing, in accordance with the provisions of 1° of Article 27 of the Law of 6 January 1978 referred to above.
II. - The purpose of these personal data processing is to:
1° Coordinated and, where appropriate, joint care of a patient by the professionals referred to in I by telemedicine under the conditions laid down in articles L. 6316-1 and R. 6316-1 to R. 6316-5 and R. 6316-8 to R. 6316-11 of the same code;
2° The transmission to the remote health professional or to the structure within which it operates, data necessary for the billing of the telemedicine act that it performs and for the transmission of this data to the compulsory health insurance organization and to the relevant complementary health insurance agency.
III. - Provides the quality of treatment officials to the professionals referred to in I who implement it, whether they solicit the act in question or perform it, and in case they do not exercise their activity in a liberal way, the employers of these professionals.
IV. - The person responsible for the processing shall send to the National Commission on Information and Freedoms a commitment to conformity of the treatment with the requirements of this decree.

Article 2 Learn more about this article...


The personal data used by the treatments referred to in Article 1 of this Decree are:
1° The information necessary for the billing of the telemedicine act carried out by the remote health professional:
(a) The registration number on the National Register for the Identification of Physical Persons (NIR) and, where applicable, any temporary registration number that would have been assigned to them, for persons pending the issuance of a registration number on the National Register for the Identification of Physical Persons, a waiting ID number (NIA) assigned by the National Insurance Fund for Old Age Employees from the Civil Status Data;
(b) Names, names, date of birth, place of residence, affiliation agency under the mandatory plan and patient's supplementary health insurance organization;
2° The information necessary for the transmission of the report of the act made to the patient and to the professionals referred to in I of the article 1st participant in his/her care: name, first name, telephone number, postal address, secure email address of health professionals and, where he/she exists and the patient has given his/her consent, data required for the filing of the report in his/her personal medical file;
3° Clinical data, including analysis and examination results, possible clichés, images, photos and other digital media required to carry out the telemedicine act by the health professional required remotely.

Article 3 Learn more about this article...


The professionals referred to in I of section 1 or, where applicable, their employer, who are responsible for the treatment, shall perform their duty of information under the conditions specified in theArticle 32 of the Act of 6 January 1978 referred to above.
This duty of information also covers the modalities for the realization of the act and the transmission of the data referred to in Article 2 of this decree to the health professional required for the realization of the act of telemedicine in accordance with the provisions of Article L. 1111-2 of the Public Health Code.
Prior to the completion of the telemedicine act, the patient's consent is collected in accordance with the provisions of Article L. 1111-4 of the same code.

Article 4 Learn more about this article...


I. - The transmission of the data referred to in Article 2 of this Decree shall be:
1° Be by secure health messaging authorized by the deliberation of 12 June 2014 of the National Commission for Information and Freedoms referred to above;
2° Either, when it is intended to allow billing, by means of a device that contributes to the development of an invoice.
This device:
(a) Provides a service quality at least equivalent to that rendered by the secure health messaging mentioned in the 1st of this article;
(b) Compliance with the conditions for the implementation of telemedicine activities described in the Public Health Code ;
(c) Compliance with the provisions of the SESAM-Vital specifications updated by the SESAM-VITALE GIE;
(d) Guarantees the integrity, confidentiality and availability of data that are transmitted;
(e) Ensures that the exchanged information flows are traced and, where appropriate, hosted by a registered health data host.
II. - The health professional who remotely performs the act of telemedicine is the recipient of all the data mentioned in article 2 of this decree.
The recipient professionals of the record referred to in 2° of the same article 2 are recipients of the data referred to in 1° and 2° of the same article 2.
The competent obligatory health insurance agency is the recipient of the data mentioned in 1° and 2° of the same article 2.
Competent supplementary health insurance organizations are recipients of the data referred to in 1° of the same Article 2.

Article 5 Learn more about this article...


The data referred to in Article 2 of this Decree shall be retained:
1° By the prescribing physician, the applicant professional of a telemedicine act or, where applicable, their employer, for a maximum period of thirty days following their transmission to the health professional who performs the telemedicine act;
2° By the health professional who performs the act of telemedicine, for a maximum period of ninety days, under the conditions specified by Article 3 of the deliberation of June 12, 2014 of the National Commission of Computer Science and Freedoms referred to above;
3° Exclusively in the patient's medical record of the data referred to in the 3rd of Article 2 of this Order, in conditions and times in accordance with the applicable law applicable to liberal health professionals, health institutions, and medical and social facilities and services. The retention periods of thirty and ninety days, respectively mentioned in 1° and 2° of this article, are intended only to allow the realization of the telemedicine act, the transmission of the report of the act or the billing of telemedicine.
The data referred to in this section may be hosted by a third party with an approval in accordance with provisions of Article L. 1111-8 of the Public Health Code.
The storage and archiving of the data mentioned in 1°, 2° and 3° of this article shall be carried out in conditions of security in accordance with provisions of Article 34 of the Act of 6 January 1978 referred to above.

Article 6 Learn more about this article...


The rights of access and rectification provided by the articles 39 and 40 of the law of 6 January 1978 referred to above shall be exercised with one of the professionals mentioned in I of Article 1 of this decree involved in the care or, if any, of their employer.

Article 7 Learn more about this article...


Derogation from provisions of Article R. 161-43 of the Social Security Codethe signature of the care sheet or the voucher established for the billing of the corresponding fees, regardless of the support and mode of transmission, by the insured or recipient, is not required.

Article 8 Learn more about this article...


Subject to the presentation to the National Commission on Informatics and Freedoms, by the person responsible for each processing, of the compliance undertaking referred to in Article IV, the personal data processings under this Order are authorized for the duration of the experiments provided for in Article 36 of the Act of 23 December 2013 on the financing of social security for 2014 referred to above.

Article 9 Learn more about this article...


The aforementioned decree of 16 December 2014 authorizing the creation of a personal data treatment for the detection of diabetic retinopathy is thus amended:
1° In the third paragraph of Article 1, after the words: "health professionals" are added the words: "or their employer, when they do not exercise their activity in a liberal capacity";
2° The second part of section 2 is replaced by the following provisions:
« 2° To allow the transmission, to the distant health professional or to the structure within which he or she exercises, when he or she does not exercise his or her business as a liberal, data that are necessary for the billing of the telemedicine act that he or she carries out and their transmission to the competent compulsory health insurance agency. » ;
3° At 2° of section 6, after the words: "By doctors who perform the deferred reading of the clichés" are added the words: "or, if any, their employer";
4° Section 8 is replaced by the following:


“Art. 8. - By derogation provisions of Article R. 161-43 of the Social Security Code, the signature by the insured person or recipient of the care sheet or voucher established for the billing of the billing fees for the deferred reading of a color retinography outside the patient's presence, regardless of the support and mode of transmission is not required. »

Article 10 Learn more about this article...


The Minister of Finance and Public Accounts and the Minister of Social Affairs, Health and Women ' s Rights are responsible for the execution of this Order, which will be published in the Official Journal of the French Republic.


Done on October 9, 2015.


Manuel Valls

By the Prime Minister:


Minister of Social Affairs, Health and Women ' s Rights,

Marisol Touraine


Minister of Finance and Public Accounts,

Michel Sapin


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