Accreditation HDS

On 22 December 2017, CDC Arkhinéo, obtained "Hébergeur de données de santé" (HDS - healthcare data host) accreditation from the French Ministry of Health. It allows CDC Arkhinéo to "host personal health data within the framework of its electronic archiving service with probative value".


Personal health data gathered by healthcare professionals as part of a course of treatment can thus only be stored by HDS-accredited establishments or an external HDS-accredited host. 


Accreditation is only issued if the host is able to provide ethical, technical, financial and economic guarantees. 


As a result of article L1111-8 of the French Public Health Code, amended by act no. 2016-41 of 26 January 2016 modernising the French healthcare system, all establishments (hospital, pharmaceutical or analytical laboratory, etc.) and all healthcare professionals are obliged to use an HDS-accredited host for the storage of personal health data. 


Any person concerned by the hosting of personal health data has both a right to access this data and the option to oppose its hosting for a legitimate reason.


By obtaining this accreditation, CDC Arkhinéo is consolidating its position as leader in electronic archiving in France and now guarantees the protection and security of personal health data. CDC Arkhinéo is able to store any document containing personal health data (bank/finance sector: preliminary health questionnaire for a mortgage application, hospital sector: patient's consent for surgery, pharmaceutical sector: consent from patients taking part in clinical trials, biological sector: results of biological analyses, surgical reports, etc.).


The health (and e-health) sector is in the midst of change, with secure data storage at the heart of the sector's digital transformation and the concerns of stakeholders and patients who would legitimately like to be reassured about the location, security and confidentiality of their data and that it is not used without their knowledge. 


With an estimated potential of between 2.2 and 3 billion euros a year in France, the e-health market is developing fast. It is developing through the use of new technologies serving patients, such as connected objects, monitoring applications, remote medicine and remote surgery as well as the online sale of medical equipment.