Key Benefits:
Publics concerned: Liberal health professionals.
Purpose: Implementation of a new organization for the detection of diabetic retinopathy.
Entry into force: the text comes into force on the day after publication.
Notice: a liberal orthoptist may, at the office of an ophthalmologist or remotely, carry out the taking of a retinography subsequently analyzed by a doctor.
This decree defines the organization of this telemedicine act and supervises the necessary data transmissions between the orthoptist and the doctor reader.
It allows the doctor reader to charge his deferred reading of retinographs in the absence of the patient.
References: this decree is implemented articles L. 6316-1 of the Public Health CodeL. 162-1-7 and L. 161-31 Social Security Code and Act No. 78-17 of 6 January 1978 modified on computers, files and freedoms. It is available on the website Légifrance (http :// www. legifrance. gouv. en).
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. 6316-6 and R. 6316-8;
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 in relation to computer science, files and freedoms, including articles 26 and 27;
Vu la deliberation no. 2014-239 of 12 June 2014 the National Commission on Computer Science and Freedoms;
Having regard to the advice of the Board of the National Health Insurance Fund of Employee Workers dated 17 June 2014;
Considering the advice of the Central Board of Directors of the Agricultural Social Mutuality of July 3, 2014;
Having regard to the advice of the National Union of Health Insurance Funds Council dated 3 July 2014;
Vu the opinion of the National Commission on Informatics and Freedoms of 9 October 2014 ;
The State Council (Social Section) heard,
Decrete:
The detection of diabetic retinopathy with the realization of clichés by orthoptist and delayed reading by a doctor outside the patient's presence is an act of telemedicine within the meaning ofArticle L. 6316-1 of the Public Health Code.
This method of detection of diabetic retinopathy is an act listed in the list of acts and services mentioned inArticle L. 162-1-7 of the Social Security Code.
By derogation fromArticle R. 6316-6 of the Public Health Code, this telemedicine activity is not the subject of a national program or contract. By derogation from section R. 6316-8 of the same code, health care professionals who choose to practise it are referred to the health insurance organization they report to.
For the purpose of implementing the telemedicine act referred to in Article 1 of this Decree, is authorized, pursuant to IV of Article 26 of the Law of 6 January 1978 referred to above, the creation of a personal data processing. The quality of treatment officials is the orthoptists and the doctors who implement it, or, where applicable, their employer. The person responsible for the treatment shall send to the National Commission on Informatics and Freedoms a commitment to conformity of treatment with the requirements of this decree.
The purpose of this treatment is to:
1° To allow coordinated care of a diabetic patient between an orthoptist and a doctor;
2° To transmit to the relevant health insurance organization the data necessary for the development of the care sheets referred to in theArticle R. 161-49 of the Social Security Code.
The personal data used by the processing are:
1° For the purpose mentioned in the 2nd of Article 2 of this Decree, the registration number on the National Register for the Identification of Physical Persons (NIR) and the person or persons previously assigned to it or, for persons pending the attribution of a registration number to the National Register for the Identification of Physical Persons, a waiting ID number (NIA) assigned by the National Fund for Civil Status Insurance of Employee Workers;
2° The information required for the billing of the deferred reading done by the physician: name, first name, date of birth and patient affiliation and, where applicable, the reasons for which the financial participation of the insured person is limited or deleted under the section L. 322-3 and article L. 861-3 the Social Security and Security CodeArticle L. 115 of the Code of Military Disability Pensions and War Victims ;
3° The information required for the transmission of the examination report to the patient and to the prescribing physician: name, first name, telephone number and postal address of the patient and the prescribing physician;
4° Digital clichés of each eye of the patient made by the orthoptist;
5° The clinical data necessary for the interpretation of the clichés, communicated in writing by the doctor prescriptor to the orthoptist, after scanning, including the glycated hemoglobin rate, possible hypertension and diabetes seniority;
6° Electronic addresses of health professionals using secure health messaging referred to in Article 5 of this Order.
Prior to the completion of the retinography, the prescribing physician and orthoptist collect the patient's free and informed consent, each at the time of his or her consultation, after informing him or her, under the conditions provided for in theArticle 32 of the Act of 6 January 1978 referred to above, the procedure for carrying out the act and transmitting the data referred to in section 3 of this decree to the doctor who shall make the deferred reading of the photographs.
The transmission of the data referred to in Article 3 of this Order is by secure health messaging authorized by the deliberation no. 2014-239 of 12 June 2014 the National Commission on Computer Science and Freedoms.
The doctor who performs the deferred reading of the clichés shall be the recipient of all the data referred to in section 3 of this Order.
The data referred to in Article 3 of this Decree shall be retained:
1° By orthoptists for a maximum period of thirty days after their transmission to the doctor who performs the delayed reading of the clichés;
2° By the doctors who make the deferred reading of the clichés, for the data mentioned in 1°, 2° and 3°, for a maximum period of ninety days, under the conditions specified in article 3 of the deliberation of the National Commission of Computer Science and Freedoms referred to in section 5 of this decree;
3° Exclusively in the patient's medical file for the data mentioned in 4° and 5°.
These data may be hosted by a third party with approval in accordance with provisions of Article L. 1111-8 of the Public Health Code.
The storage and archiving of data are carried out under security conditions that comply with provisions of Article 34 of the Act of 6 January 1978 referred to above.
The rights of access and rectification provided by the articles 39 and 40 of the law of January 6, 1978 referred to above applies to the orthoptist who made the photographs, the doctor who performed their deferred reading or, if any, their employer.
Derogation from provisions of Article R. 161-43 of the Social Security Code, the signature of the care sheet by the insured or the beneficiary is not required for electronic care sheets or paper-based care sheets related to the billing of the deferred reading act of a color retinography outside the patient's presence.
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 16 December 2014.
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
