Key Benefits:
Public concerned: National Institute of Health and Medical Research (INSERM), Caisse nationale de l'assurance maladie des travailleurs wages, Caisse nationale d'assurance vieuxsse, professionnels de santé etsearch participant à l' étude, personnes participant à l'études.
Purpose: Implementing a data processing by the INSERM, with authorization for the National Health Insurance Fund of employed workers to use the registration number on the national directory of natural persons.
Entry into force: this decree comes into force on the day after its publication.
Notice: The decree authorizes INSEERM to implement a personal data processing in order to study the long-term global fate of survivors of a solid tumour of the child diagnosed before the year 2000 in France. This study requires, among other things, the use of data from the inter-regime national health insurance system managed by the National Health Insurance Fund for Employees. The decree authorizes the Caisse Nationale to use the registration number on the national directory of natural persons, in order to collect the relevant data and to communicate it to the INSERM.
References: This decree is available on the website Légifrance (http :// www. legifrance. gouv. en).
The Prime Minister,
On the report of the Minister of Social Affairs and Health,
Vu le Social Security Codeincluding article L. 161-28-1;
Vu la Act No. 78-17 of 6 January 1978 modified on computers, files and freedoms;
Vu le Decree No. 98-37 of 16 January 1998 authorizing access to data relating to the death of individuals listed in the National Identification Register of Physical Persons (NRIPP) as part of health research;
Vu the opinion of the National Commission on Informatics and Freedoms of 18 July 2013;
Having regard to the advice of the Board of Directors of the National Health Insurance Fund for Employees dated 27 August 2013;
Having regard to the advice of the Board of Directors of the National Old Age Insurance Fund dated 12 December 2013;
The State Council (Social Section) heard,
Decrete:
The National Institute of Health and Medical Research is authorized to implement an automated personal data processing related to the study called "FCCSS" that addresses the long-term global fate of survivors of a solid tumour of the child diagnosed before the year 2000 in France.
The purpose of this personal data processing is to:
1° To estimate the incidence and resounding of long-term iatrogen pathologies after treatment of a child's solid tumor;
2° Identify and quantify the risk factors associated with these pathologies, in order to be able to reduce iatrogen risks by customizing treatments;
3° Identify preclinical markers of the progression of these pathologies, in order to be able to improve the precocity of their diagnosis and treatment;
4° To allow the establishment of specialized follow-up consultations and necessary preventive actions.
I. - The categories of personal data and information recorded in the treatment authorized by section 1 are:
1° Identification data and information on persons under study collected under the following conditions:
(a) Data on persons under the "FCCSS" study extracted from the data treatments of pre-existing cohort studies or therapeutic tests, the registers of general and specialized cancers, and the medical information systems of health institutions and medical records of oncology services, including, under the conditions prescribed by theArticle 57 of the Act of 6 January 1978 referred to above, their surname, name of use, name, date and place of birth and sex;
(b) Data from persons participating in the study taken from the interregistered national directory of health insurance beneficiaries under the conditions mentioned in V of Article R. 161-37 of the Social Security Codeand for persons who have died under the conditions provided for by the decree of 16 January 1998 referred to aboveincluding:
- their postal address;
- where applicable, indication of death;
(c) Data collected from persons under study:
- their telephone number and e-mail address;
- consent to participate in the study and consent to access data of the interregistered national health insurance information system (SNIIR-AM) concerning them;
- data on their social and socio-economic situation related to the consequences of the disease, its care and quality of life, such as social coverage, household composition, the characteristics of the place of residence, leisure activities, the use of care, training, diplomas, access to insurance and loans, participation in social life;
― the identification data of the attending physician with his or her postal address and, where applicable, the consent of the person under study to the transmission of the information of the study to that attending physician;
(d) The contact details of the persons under study, collected from La Poste services to ensure that these data are updated;
2° Health data relating to persons under study, collected under the conditions set out in the articles 56 and 57 of the Act of 6 January 1978 referred to above, and for persons who died under the conditions provided for by the decree of 16 January 1998 referred to above :
(a) Data extracted from the data processing referred to in 1° of I of this article:
clinical data corresponding to the characteristics and extension of tumours;
― data on received treatments such as surgery, radiotherapy, growth hormone, chemotherapy and marrow transplantation;
- where applicable, data describing the iatrogen pathologies already identified from cohort studies and specialized follow-up consultations;
(b) Data collected from persons under study and, with the consent of these persons, from health professionals involved in their care, including medical data on their current state of health and the pathologies that have occurred since the treatment of their tumor;
(c) Vital status and, where appropriate, causes of death;
3° Relevant data for the completion of the study on persons under study, collected under the conditions set out in section 57 of the above-mentioned Act of 1978, extracted, from the maximum age of these bases, the bases of the national interregistered information system of health insurance (SNIIR-AM) created by the maximum age of these bases.Article L. 161-28-1 of the Social Security Code :
(a) Data on the consumption of health care: dates of care and dates of reimbursement, medical reasons for hospitalization, acts performed, length of stay, way of exit, and codes of main pathologies and diagnostics, associated or linked, and technical acts performed by health professionals, including biological examinations or medical devices;
(b) Data on the use of city care for medical acts, biology, medical devices and medicines;
(c) Data on the social situation in relation to the treatment of the disease, including:
- the indication of social coverage and possible affiliation with universal disease coverage;
– the possible diagnosis of long-term conditions.
II. - The persons under study are clearly informed of the voluntary and optional nature of their participation in the study and the absence of a consequence of a refusal to participate in the study and the possibility of ending their participation at any time.
I. - To provide annually to the National Institute of Health and Medical Research the data referred to in 3° I of Article 2, the National Fund for Health Insurance of Employees is authorized to use the registration number on the national directory of natural persons (NIR) of persons under study.
II. - The registration number on the National Register of Natural Persons (NIR) can only be used to allow the National Institute of Health and Medical Research to make a match with the data on these individuals extracted from the National System of Interregime Information of Health Insurance (SNIIR-AM).
III. - In order to obtain these data, the National Health Insurance Fund for Employees will transmit to the National Health Insurance Fund for Employees, responsible for the management of the interregistered national directory of health insurance beneficiaries, the data referred to in 1° of Article 2 which was communicated to it by the National Institute of Health and Medical Research.
IV. - The Caisse Nationale de l'assurance vieuxsse des travailleurs wages reconstitutes the registration number on the national directory of natural persons and transmits it to the Caisse Nationale d'assurance maladie des travailleurs wages, which numbers it without delay.
V. - The National Health Insurance Fund for Employees shall, after a second encryption of the registration number in the national directory of encrypted natural persons, extract the individual data mentioned in the 3rd I of Article 2 of this decree, from the national system of interregistered information of health insurance (SNIIR-AM).
VI. - It transmits these data to the National Institute of Health and Medical Research through a secure flow. This data communication does not include the identification number on the national directory of natural persons under study but an anonymized identifier.
VII. - The approximation of the information relating to persons under study with this data from the national inter-regime information system of health insurance (SNIIR-AM) is carried out by the National Institute of Health and Medical Research.
I. - Only the researchers of the National Institute of Health and Medical Research, their students and their French or foreign scientific collaborators empowered by the President and CEO of the National Institute of Health and Medical Research have access to anonymized data to the strict extent that they are necessary for the implementation of their research.
II. - After identifying themselves with a health professional card, the doctors of the oncoping services participating in the study have access to the only personal data concerning their patients who have expressed their consent to the transmission of these.
III. - Access to data by these persons authorized by the President and CEO of the National Institute of Health and Medical Research are secured under the conditions specified in theArticle 34 of the Act of 6 January 1978 referred to above. Named data and anonymized data are subject to strict separation.
I. - The National Institute of Health and Medical Research is responsible for the implementation of security measures to ensure the confidentiality and integrity of the retention, backup and transmission of personal data recorded in the treatment.
II. - Identification data are strictly separated from other data. The system ensures traceability of the actions carried out on these data. Traces of this data cannot be retained for more than one year.
III. - The data of the study held in paper form are kept in a secure location.
The data is collected for twenty years and then retained for the duration required for the "FCCSS" study, which is twenty years after the collection has been finalized. At the end of this retention period, the data is anonymized in their entirety.
The National Institute of Health and Medical Research is implementing public information on the implementation of the study, the creation of automated treatment, its purposes and the rights of the persons concerned. This information also specifies the conditions for the exercise of the right of opposition of the persons established to the first and third paragraphs of Article 56 of the Law of 6 January 1978 referred to above.
The rights to access and rectification of data, as provided for in sections 39 and 40 of the above-mentioned Act of 6 June 1978, are exercised with the President and CEO of the National Institute of Health and Medical Research.
The Minister of Social Affairs and Health is responsible for the execution of this Order, which will be published in the Official Journal of the French Republic.
Done on 3 February 2014.
Jean-Marc Ayrault
By the Prime Minister:
Minister of Social Affairs
and Health,
Marisol Touraine
