What is Digital Hospital Quality Certification?
The Digital Hospital Quality certification (QHN in French) is a seal of guarantee for the quality of digital solutions used in health structures. This is granted in concertation with:
- Health structure federations
- Industrials federations
- The French Ministry of Health, which runs this programme with the support of the ANS.
The certification is valid for three years, with a maintenance audit each year.
To apply to the HOP’EN programme, which is part of the five-year national action plan for hospital IS harmonisation and the “Increase the digital transformation” roadmap (action 19), you must meet several criteria. These requirements are set out in the DGOS/PF5/2019/32 instruction published on 12 February 2019.
The programme was launched by the DGOS (General Direction of Care Offer) as part of the health system transformation strategy “My Health 2022” and its digital component. Its main goal is to align health structures’ ISs to smooth out the user/patient experience, in order for all to benefit from the same level of quality in services.
If your Quality Management System (SMQ) follows the referential guidelines, you may be granted the QHN certificate. The label proves that you take part in the Digital Hospital harmonisation processes and are adapting your solutions to the digital health ecosystem.
The certificate is issued by one of the Certifying Institutions under convention with the ANS.
The QHN certificate guarantees that:
- The software solutions have been tested before they were installed;
- Industrials are transparent about the evolution of their solutions;
- The implementation of these solutions is effective and done by trained, reliable experts.
QHN Certification in 1 click
QHN Certification in numbers
4 industrials are currently QHN-certified
4 Certifying institutions are under convention with the ANS
20 Requirements regarding system quality management
The ANS provides you with all the useful documentation
To allow health structures to apply for the HOP’EN programme, they need to fill the Engagement Document.
Your application for certification must be addressed to one of the certifying organisations. If you’re not already ISO 9001- or ISO 13485-certified, you must request both the QHN certification and the ISO 9001 or ISO 13485 certification.
Frequently Asked Questions
The ANS answers the most common questions about QHN certification
The cost is determined by the certifying body which grants the certificate.
The daily cost to conduct the audits is at their discretion. The industrial is free to choose which certifying body they want to work with to become certified.
For further information on this topic, we suggest you contact the certifying bodies that have signed a convention agreement with the ANS, listed below:
Cette réponse vous a-t-elle été utile ?
Yes, you need to have the ISO 9001 or the ISO 13485 certification to be eligible. You may begin the QHN certification process while you are in the course of making an application for/or renewing these ISO 9001 or the ISO 13485 certifications.
Cette réponse vous a-t-elle été utile ?
Yes, as long as the industrial remains responsible for the compliance of these processes with the requirements set out to obtain the QHN certification – regardless of hired external contractors or if some of the components are published or made by third-party companies.
Indeed, in the whole production system’s organisation, the industrial is the direct contact with a health professional or structure, and must make sure each requirement set out in the “Référentiel Qualité Hôpital Numérique” (QHN Referential, available in our Documentation section) is met.
Cette réponse vous a-t-elle été utile ?
The ANS can walk you through the process
The Industrials Hub support team is here to answer your questions.
Partners
