Section 3: Digital health space, shared medical file and pharmaceutical file

The shared medical record referred to in article L. 1111-14 is integrated into the digital health space, of which it is one of the components.

I.-The digital health space is opened automatically, unless the person or their legal representative objects. The person concerned or their legal representative is informed of the opening of the digital health space, the conditions under which this space operates, their responsibilities as a manager of health data in a digital space and the procedures for closing it in application of 3° of IV. The data subject or his/her legal representative…

The State and one or more public authorities or public persons designated by decree shall be responsible for the design, implementation, administration, hosting and governance of the digital health space in accordance with the conditions laid down by decree of the Conseil d’Etat, issued after consultation of the Commission nationale de l’informatique et des libertés. The design and implementation of the digital health space will take into account the difficulties…

In order to promote the prevention, coordination, quality and continuity of care, each person has access to a shared medical record, under the conditions and subject to the guarantees provided for in articles L. 1110-4 and L. 1470-5 and in compliance with medical confidentiality. The automatic opening of the digital health space, under the conditions laid down in I and V of article L. 1111-13-1, which provide for the possibility…

In compliance with the ethical rules applicable to them as well as articles L. 1110-4, L. 1470-5 and L. 1111-2, each healthcare professional, regardless of how or where they practice, must enter into the shared medical record, at the time of each procedure or consultation, the diagnostic and therapeutic elements necessary for the coordination of the care of the person being cared for, the list of which is set by…

The coordinating doctor referred to in V of article L. 313-12 of the Social Action and Family Code has access to the shared medical record of the person accommodated in the institution subject to the agreement of the latter or, if the person accommodated is an adult subject to a legal protection measure with representation relating to the person and is not capable of expressing his or her wishes, of…

I.-Health professionals will access the shared medical record of a person who is unable to express their wishes, in the event of a situation involving an immediate risk to their health, unless this person has previously expressed their express opposition to their record being consulted or added to in such a situation. The regulating doctor at the emergency medical assistance call reception and regulation centre mentioned in article L. 6311-2…

Access to the shared medical record may not be requested except in the cases provided for in articles L. 1111-15 and L. 1111-16, even with the consent of the person concerned. In particular, access to the shared medical record is prohibited when concluding a contract relating to supplementary health cover and when concluding any other contract requiring an assessment of the state of health of one of the parties. Without…

The holder has direct electronic access to the content of his file. He may also access the list of professionals who have access to his shared medical file. They may modify this list at any time. He/she may, at any time, examine the traces of access to his/her record.

A decree in the Conseil d’Etat, issued after consultation with the Commission nationale de l’informatique et des libertés and the national councils of the health professions, shall set the conditions for application of the articles in this section relating to the shared medical record. It specifies the conditions for creating and closing the shared medical record provided for in the first paragraph of article L. 1111-14, the conditions for implementing…