French Business Law - French Legislation

Article R1111-37 of the French Public Health Code

November 6, 2023

Digital health services and tools developed by publishers of public or private digital solutions may be referenced in the digital health space catalogue provided that they comply with: 1° The interoperability and security reference frameworks mentioned in article L. 1470-5; 2° The ethical commitment reference frameworks defined by order of the Minister for Health. The Minister for Health may, by order, set other criteria relating to the quality of digital…

Article R1111-38 of the French Public Health Code

November 6, 2023

A commission for listing digital services and tools in the digital health space service catalogue is created. An order by the Minister for Health shall establish its composition and specify its operating procedures. This commission examines requests for inclusion in the digital health space service catalogue in accordance with the criteria set out in article R. 1111-37 and gives its opinion to the Minister for Health. Only digital tools and…

Article D1111-38-1 of the French Public Health Code

November 6, 2023

The members of the commission for referencing digital services and tools in the digital health space service catalogue mentioned in article R. 1111-38, with the exception of ex officio members, may receive an allowance allocated for their effective participation in the commission’s meetings. The amount of this allowance is set by joint order of the Minister for Health and the Minister for the Budget.

Article R1111-39 of the French Public Health Code

November 6, 2023

The application for registration is made online using a service provided by the Caisse nationale de l’assurance maladie. The application for registration includes the response to a questionnaire assessing whether the applicant meets the criteria set out in Article R. 1111-37, the data protection impact assessment provided for in Article 35 of Regulation (EU) 2016/679 on the protection of individuals with regard to the processing of personal data and on…

Article R1111-40 of the French Public Health Code

November 6, 2023

The shared medical record referred to in article L. 1111-14 is created by the Caisse nationale de l’assurance maladie when the digital health space referred to in article L. 1111-13-1 is opened. The holder is informed of the creation of his medical record and its link with his digital health space, at the time of the individual information provided for in article R. 1111-28. This information specifies, in particular, the…

Article R1111-41 of the French Public Health Code

November 6, 2023

The Caisse nationale de l’assurance maladie is the data controller within the meaning of article 3 of amended law no. 78-17 of 6 January 1978 relating to information technology, files and civil liberties. It ensures that the shared medical record complies with article L. 1111-8 of this code and with the interoperability and security standards mentioned in article L. 1470-5.

Article R1111-42 of the French Public Health Code

November 6, 2023

The shared medical file contains : 1° Data relating to the holder of the shared medical record: a) Data relating to the identity and identification of the holder ; b) Data relating to prevention, health and medical, social and medico-social monitoring, in order to serve the coordination, quality and continuity of care, including in emergencies, in particular vaccination status, medical and paramedical summaries, the liaison letters referred to in article…

Article R1111-43 of the French Public Health Code

November 6, 2023

Without prejudice to the provisions of article R. 1111-34, all actions carried out on the shared medical record, whoever is responsible for them, are traced and kept in the shared medical record, and in particular the date, time and identification of the professional, health institution, social or medico-social institution or service or digital health service mentioned in article R. 1111-37 who consulted or added to the shared medical record. These…

Article R1111-44 of the French Public Health Code

November 6, 2023

The holder of the shared medical record may authorise the digital health services and tools referenced in the digital health space to access certain data in his record under the conditions set out in III of article L. 1111-13-1 and in the fourth paragraph of article R. 1111-32. This decision may be modified at any time by the holder. The shared medical record is accessible electronically to professionals, health establishments,…

Article R1111-45 of the French Public Health Code

November 6, 2023

The holder can access his shared medical record electronically from his digital health space, in accordance with the procedures set out in the first paragraph of article R. 1111-32. He may extract or add data to his shared medical record from his digital health space.

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French Public Health Code

Article R1111-37 of the French Public Health Code

Article R1111-38 of the French Public Health Code

Article D1111-38-1 of the French Public Health Code

Article R1111-39 of the French Public Health Code

Article R1111-40 of the French Public Health Code

Article R1111-41 of the French Public Health Code

Article R1111-42 of the French Public Health Code

Article R1111-43 of the French Public Health Code

Article R1111-44 of the French Public Health Code

Article R1111-45 of the French Public Health Code

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French Public Health Code

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