Book I: Health establishments

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…

When a health care institution uses an external service provider mentioned in 4° of the I of article R. 6113-5 to implement the activities mentioned in this chapter, this service provider may not retain the data made available by the institution beyond the period strictly necessary for the activities entrusted to it as set out in the contract mentioned in the I of article R. 6113-5-2. At the end of…

Records of all access, consultation, creation and modification of patient data are kept for a period of six months at a time by the health care organisation. Traces of actions carried out by the service providers mentioned in 4° of the I of Article R. 6113-5, and in particular the date, time and identification of the staff concerned, are made available to the doctor responsible for medical information, for the…

On the basis of and within the limits of the data supplied by practitioners and transmitted by the doctor responsible for medical information under the conditions laid down inarticle R. 6113-8, the representative of the establishment or, for care activities jointly operated by a health cooperation grouping authorised to bill for care under the conditions laid down in article R. 6133-14, the group administrator sends non-nominative statistics to the central…