Personal Healthcare data hosts

In this era of « e-health », IT systems user (such as software publishers, IT hosters, pharmaceutical groups… )  must comply with the Public Health Code requirements through the Personal Healthcare data hosting (« Hébergeur de données de santé »). 

In this way it follows the ASIP Santé (Agency of the French Ministry of Health) demands, which are to enter the numeric era by creating the best conditions for it to grow and expand within the extent of safety and confidentiality laws.

Accreditation is based on an evaluation of the applicant’s capabilities, focusing on the financial, ethical and security aspects of the services. French Decree no. 2006-6 dated January 2006 states the accreditation’s conditions of personal healthcare data hosting services.

Getting the personal healthcare data hosting accreditation allows you to comply with the legislative framework which guarantee confidentiality and traceability to secure patients datas.

The accreditation is issued by the Ministry of Health for a renewable period of three years, following a positive opinion given by the “comité d’instruction” (agreement comitee) of the ASIP-Santé, known as the French Data Protection Authority (CNIL) along with the Hosting System Accreditation Committee.

Renewal must be requested bat least 6 months before expiration of the accreditation, because of the time needed for the reassessment.

Decree Nr?2002-303 dated March 4^th, 2002 and the article L.1?111-8 of the CSP (Health public French Code) compels all data hosts to submit an accreditation application. Operating off license is punished by three years’ imprisonment and a € 45,000 fine, as well as the cancelation of the data host’s contract.

Are you subjet to the accreditation?

• As a software publisher
• As an external provider of Health IT
• Being a firm operating within the health sector
• being the natural or legal person in charge of personal healthcare datas provided par healthcare professionals.

The accreditation is consequently crucial for you: it is the key to reconcile security and modernity, as well as securing your business relations.

What we offer

The application to the personal healthcare data hosting accreditation involves fitted software, as well as business and legal advice, to support the complexity of the process which may take time and bring complex issues, involving specific file setting up and a long term commitment.

ETIXIS’s added value is based on its ability to offer extensive and thorough expertise,  in a field of application made to the very shape of your company.

 A range of services suited et adaptable to your needs:

1^st accreditation application:

• Prior diagnosis
• Application draft
• Training to risk analysis approach (as recommended by the ASIP Santé)
• Annual self-evaluation coaching (audit, update drafting, etc.)

2^nd accreditation application (following unfavorable recommendation):

• Failure analysis
• Assessment and monitoring regarding the remaining work before the application
• Application update coaching

Application’s renewal

Customizable advice and support onto the application’s renewal

• Audits based on ISO 190011, 27001 standards
• Application draft
• Proofreading (quality and compliance) prior to sending the application to the ASIP Santé

No matter the offer you choose, ETIXIS guarantees ethics, expertise, dutiful care and reactivity, step by step.

Contact us !