Like HIPAA in the United States, France’s HDS regulations and the related certification serve to verify an organization's compliance with a baseline set of requirements regarding all personal health data hosting. As mandated by the French Public Health Code (Article L.1111-8), all organizations hosting personal health data collected during healthcare activities in France must achieve HDS certification by undergoing an assessment by an accredited auditing organization that will evaluate your adherence to the stipulated rigorous control framework.
With Schellman as your trusted partner, you can focus on providing the best possible care to your patients and be confident in the knowledge that their sensitive health information is secure.
Robert Tylka is a Principal at Schellman. With over 16 years of experience in providing IT attestation and compliance services, Robert currently leads the Midwest practice at Schellman where he specializes in SOC 1, SOC 2, ISO 27001, and HIPAA reporting. In his portfolio, he also oversees engagements that include FedRAMP, HITRUST, PCI, and various Privacy reviews.
Together, we’ll conduct a web-based scoping exercise and our team will work with you to understand your unique needs before determining the resources necessary to complete the assessment.
Schellman recommends a readiness assessment be performed to streamline the fieldwork process and ensure that you are adequately prepared for the full assessment. Should you opt to do so:
Together with you, we will hold an HDS Readiness Assessment Kick-Off meeting.
We will then perform the Readiness Assessment and provide you with the resulting gap report.
After we provide you with our Auditor Plan and Information Request List, you’ll then electronically submit the requested documentation to us, which we will review while also conducting interviews to assess conformity.
(NOTE: An on-site assessment is mandatory but multi-site can be sampled.)
After a few weeks post-fieldwork, we will provide you with your detailed HDS Report that includes our findings—including identified nonconformities and opportunities for improvement—as well as a roadmap for ongoing compliance with HDS. We will issue the corresponding certificate to you one week after the HDS Report is provided and report your certification results to ANS.