A new decree specifies the implementation methods for the certification of service providers and equipment distributors (PSDM), in the context of strengthening quality, safety, and compliance requirements in the home care sector.
This text provides two major clarifications: the establishment of a provisional certification for new entrants and the regulation of access to patient data during audits.
Provisional certification for new PSDM
The decree states that providers starting their activities will be able to benefit from a provisional certification valid for one year, granted on the condition of a commitment to comply with the good professional practices defined by the applicable reference framework.
During this period, PSDM will have to take the necessary steps to obtain their definitive certification.
In practice:
- possibility to start activities without immediate complete certification
- obligation for rapid compliance
- essential anticipation of certification audits
Pseudonymization of data during audits
The decree also introduces an important requirement regarding data protection:
PSDM will now have to proceed with the pseudonymization of user files to which certifying bodies have access, whether during certification audits or controls.
This measure aims to:
- ensure the confidentiality of health data
- ensure respect for medical secrecy
- enhance compliance with GDPR
A global strengthening of compliance requirements
Beyond these clarifications, this decree is part of a broader movement to structure the PSDM sector.
Certification is indeed a central issue, as it will condition access to reimbursement for services by the health insurance and aims to guarantee the quality and safety of services provided to patients.
It imposes on the concerned actors:
- the establishment of robust internal procedures
- enhanced traceability
- an organization compliant with the reference framework of the High Authority of Health
Key points
This new decree:
- facilitates the entry of new PSDM into the market through provisional certification
- strengthens obligations regarding data protection
- confirms the structuring role of certification in the sector
For the concerned actors, compliance can no longer be delayed and requires prior preparation, both organizationally and legally.
