Heva : Design office RMOT - ST
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CNIL and transparency
France has a number of medico-administrative databases containing exhaustive, centralized information provided by social security organizations and hospitals.
These medico-administrative databases are reimbursement databases. Although they were created with the aim of tracking healthcare expenditure (payment of benefits, calculation of budget allocations, etc.), they are also an invaluable resource for a wide range of healthcare research activities. They provide exhaustive, permanent coverage of the entire population in a variety of fields, and enable health data to be collected individually and prospectively, in order to develop a better understanding of care pathways and the cumulative costs of different pathologies on a national or regional scale. Few countries have this type of nationwide information system, which can be used to gain knowledge of the healthcare system and improve its operation.
Given the growing interest of public and private research players in epidemiological or medico-economic studies based on these databases, and given the risk of invasion of privacy, the law to modernize the healthcare system reformed the system for accessing medico-administrative health data in 2016. This law modifies the legal framework, the opening of these databases and their governance.
The two main objectives of this law concerning data are:
- Open access to all data that does not present a risk of re-identification, by distributing it in the form of Open Data datasets; ;
- Limit and regulate access to indirectly nominative data (risk of re-identification), based on the following criteria: public interest purpose, quality of the protocol, need for access to data, security of procedures and quality of the applicant.
In 2017, this law led to the creation of the’National Institute for Health Data (INDS), which becomes the single point of entry for requests for access to the medico-administrative databases making up the new National Health Data System (SNDS).
The « Health data platform »or « Health Data Hub (HDH)» was created on November 30, 2019. It replaces the INDS and expands its previous missions in order to cross-reference the healthcare databases available in France and facilitate their use by the many research and development teams, while fully respecting the privacy of healthcare system users.
The company Heva, as a certified design office for the implementation of health data processing, via the HDH and the CNIL, carries out studies on all the databases making up the SNDS, in particular the following:
-The PMSI (Programme de médicalisation des systèmes d'information), which is a medico-administrative database managed by the’Agence Technique de l'Information sur l'Hospitalisation (Technical Agency for Hospital Information) (ATIH) since 2000. It collects all the activity of healthcare establishments; ;
- SNIIRAM (Système National d'Information Inter Régimes de l'Assurance Maladie) which is a medico-administrative database managed by the Caisse Nationale d'Assurance Maladie (CNAM), which collects all health insurance reimbursements made in towns and cities, the Inter-regime consumption datamart (DCIR) and hospitalization data by chaining with the PMSI; ;
You will find below the various information and transparency measures concerning the studies carried out on the medico-administrative databases in which Heva is involved.
PMSI data
Heva carries out projects using PMSI data (within the framework of MR006 as well as that of Single Decision n°2019-112) and informs that, in order to exercise the rights of access and rectification to data and the rights of opposition and limitation of the processing of such data, the persons concerned by the processing address their request, in accordance with the provisions of Decree no. 2021-848 of June 29, 2021 on the processing of personal data known as the «national health data system". The persons concerned also have the right to lodge a complaint with the Commission Nationale de l'Informatique et des Libertés (CNIL), 3 Place de Fontenoy, 75007 Paris.
SNDS data
Heva carries out projects using data from the SNDS and in accordance with the provisions of Article 14 of the RGPD, informs those concerned by such processing of the provision below of collective information notes relating to the protection of personal data in the context of studies requiring access to data from the National Health Data System (SNDS).
As the design office responsible for treatment implementation, Heva is involved in the following projects:
| Customer | Study | Note d’informations |
| Bristol Myers Squibb (BMS) | TENOR |  |
| Sanofi Pasteur | DRIVEN | |
| GSK | MOONBEAM | |
| PFIZER | RAPALAM | |
| argenx | MINOS | |
| EISAI | Association entre la prise d’antipsychotiques et les ré-hospitalisations psychiatriques | |
| Novartis Gene Therapies Switzerland GmbH | Épidémiologie et prise en charge thérapeutique des patients atteints d’amyotrophie spinale en France de 2011 à 2022 (EPI-SMA). | |
| Cook Research Incorporated | REALIZE-Fen | |
| Cook Research Incorporated | ZTBranch | |
| MICROVENTION/ TERUMO | PISCES | |
| ROCHE SAS | LINKATEZO | |
| AMGEN | ROMEO | |
| ABBOTT | ADAPTIVE | |
| Novartis | SJÖ-TIME | |
| Bristol Myers Squibb (BMS) | EDELWEISS | |
| Bristol Myers Squibb (BMS) | MYOSOTYS | |
To exercise their rights of access to and rectification of data and their rights to object to and limit the processing of such data, the persons concerned by the processing shall send their request, providing proof of their identity by any means, to the director of the Health Data Platform or to the director of the compulsory health insurance managing body to which they belong, in accordance with the provisions of Decree no. 2021-848 of June 29, 2021 relating to the processing of personal data known as the «National Health Data System».
Data subjects also have the right to lodge a complaint with the Commission Nationale de l'Informatique et des Libertés (CNIL), 3 Place de Fontenoy, 75007 Paris.
Autres données
| Customer | Study | Note d’informations |
| GSK | Helios | |