Subsection 1: General provisions

In order to analyse their medical activity, public and private health care institutions shall, in accordance with the conditions laid down in this section, summarise and process in computerised form the data contained in the medical file referred to in article L. 1112-1 which is collected, for each patient, by the practitioner in charge of the medical or medico-technical structure or by the practitioner who provided care to the patient…

Decrees issued by the ministers responsible for health and social security determine, depending on the category of establishment in which the care is provided and the nature of this care as defined in article L. 6111-2: 1° The data which must be collected and processed ; 2° The nomenclatures and classifications to be adopted; 3° The methods and minimum length of time for which files must be kept.

The practitioner in charge of a medical or medico-technical structure, or the practitioner who provided the care, is responsible, as far as he is concerned, for the completeness and quality of the information he sends for processing to the doctor responsible for medical information in the institution or, for institutions belonging to a regional hospital grouping, in the supporting institution. The doctor responsible for medical information contributes to the development…

Doctors responsible for collecting nominative medical data or for processing files containing such data are subject to the obligation of secrecy, breach of which is punishable in accordance with articles 226-13 and 226-14 of the French Criminal Code. The following are also subject to the obligation of secrecy, breach of which is punishable in accordance with articles 226-13 and 226-14 of the French Penal Code: 1° Persons in the health…

I.-The statutory auditor will only receive, through the intermediary of a doctor acting under his responsibility as an expert, the personal data mentioned in article R. 6113-1 which are necessary to verify, by sampling on the basis of relevant samples of files, the reliability and traceability of the data used to calculate the establishment’s revenue. II.-The doctor referred to in I who is called upon by the statutory auditor must:…

I.- External service providers who assist the doctor responsible for medical information in the performance of his duties under article R. 6113-4 may only access, under the latter’s responsibility and control, the personal data mentioned in article R. 6113-1 that is strictly necessary for the performance of their own duties. II.-The contract signed with the director of the establishment under the conditions provided for in Article 28 of Regulation (EU)…

After receiving the opinion of the establishment’s medical commission or, in the case of establishments that are part of a regional hospital grouping, the medical college or the grouping medical commission, or the medical conference, as appropriate, the establishment’s representative or the representative of the support establishment in the case of establishments that are part of a regional hospital grouping takes all necessary steps, in conjunction with the chair of…

Persons receiving care in the establishment are informed by means of the welcome booklet or another written document: 1° That data concerning them is processed automatically under the conditions laid down by law no. 78-17 of 6 January 1978 relating to information technology, files and civil liberties; 2° That this data is transmitted to the doctor responsible for medical information and to the persons working under his authority or control…

The doctor responsible for medical information sends the medical board or conference and the establishment’s representative the information required to analyse activity, both for the establishment as a whole and for each of the medical structures or what takes their place. Within a regional hospital grouping, the doctor in charge of the regional medical information department sends the commission of the establishment concerned, the medical college or the grouping medical…

The competent bodies of the health care organisation define, after consultation with the medical commission or conference, the procedures for implementing the collection, processing, validation and internal transmission of medical data defined in 1° of article R. 6113-2 or collected at the initiative of the health care organisation, and in particular the obligations of the practitioners concerned with regard to the transmission and quality control of the data as well…