French Public Health Code
In forceI.-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 is also informed of the procedures for exercising his/her right to object before the digital health space is opened.
Each holder has access to his or her digital health space free of charge.
For each holder, the identifier for their digital health space is the national health identifier referred to in article L. 1111-8-1 when they have such an identifier. For recipients of State medical aid as referred to inarticle L. 251-1 of the Code de l'Action Sociale et des Familles, the identifier for their digital health space is created in accordance with the procedures specified by the Conseil d'Etat decree referred to in V of this article.
II -The digital health space is accessible online to its holder, or the holder's legal representative, duly identified and authenticated. It enables the holder to access :
1° Their administrative data ;
2° Their shared medical record ;
3° Any health constants produced by applications or connected objects referenced in application of III, or any other health data useful for the prevention, coordination, quality and continuity of care;
4° All data relating to the reimbursement of healthcare expenses;
5° Tools enabling secure exchanges with players in the healthcare system, including a secure health messaging system enabling the holder to exchange information with healthcare professionals and establishments, and tools enabling access to telehealth services;
6° Any digital service, in particular services developed to promote prevention and make care pathways more fluid, homecare services, services providing assistance with orientation and assessing the quality of care, services aimed at informing users about the care on offer and the rights to which they are entitled, as well as any digital health application referenced in application of the same III ;
7° Where applicable, data relating to the reception and support provided by the social and medico-social establishments and services mentioned inArticle L. 312-1 of the Social Action and Family Code.
III - In order to be referenced and integrated into the digital health space, the digital services and tools mentioned in 2° to 7° of II of this article, whether developed by public or private players, must comply with the interoperability and security guidelines drawn up by the group mentioned in article L. 1111-24, the ethical commitment guidelines and the labels and standards imposed in the digital health space mentioned in article L. 1111-13-2. These guidelines, labels and standards take account of the implementation by digital services and tools of measures to help people who have difficulty accessing the Internet and using IT and digital tools.
The digital services and tools referenced may only access the data in the holder's digital health space with the express agreement of the holder, who is duly informed of the purposes and methods of this access when these services and tools are installed, and for the purposes of prevention, diagnosis, care or social and medico-social monitoring, for a retention period that is strictly proportionate to these purposes.
IV - The holder or his/her legal representative is the sole manager and user.
It may decide at any time:
1° To offer temporary or permanent access to its digital health space to a health establishment, a health professional, the members of a care team within the meaning of article L. 1110-12 or any other professional involved in its care pursuant to article L. 1110-4, or to terminate such access ;
2° Extract data from the digital health space in application of the provisions relating to the right of access and portability of data provided for in Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of individuals with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) ;
3° To close their digital health space. The death of the holder will result in the closure of their digital health space.
As from the closure of the digital health space, in the absence of an express request to destroy its content by the holder or the holder's legal representative, the said content is archived for ten years, during which time it remains accessible to the holder, the holder's legal representative, the holder's successors in title, the holder's cohabitee or the holder's partner in a civil solidarity pact, under the conditions and within the limits laid down in V of article L. 1110-4.
The communication of all or part of the data in the digital health space may not be required of the holder of this space when concluding a contract relating to supplementary health cover or when concluding or applying any other contract, with the exception of contracts relating to digital services and tools referenced in application of III of this article.
A minor may object to the entry in his or her digital health space, in one or more of the elements listed in 1° to 7° of II of this article, or in his or her pharmaceutical record, of any data relating to the treatment provided under the conditions set out in articles L. 1111-5, L. 1111-5-1, L. 2212-7 and L. 6211-3-1 or relating to the reimbursement of said treatment and the health products prescribed or administered.
V.-The terms and conditions for the application of this article are defined by decree in the Conseil d'Etat, issued after consultation with the Commission nationale de l'informatique et des libertés.
