A new decree clarifies the implementation of the certification requirements applicable to service providers and distributors of medical equipment (PSDMs), against a backdrop of increasingly stringent quality, safety and compliance requirements in the home healthcare sector.
The decree provides two major clarifications: the introduction of provisional certification for new market entrants and the regulation of access to patient data during audits.
Provisional certification for new PSDMs
The decree provides that service providers starting their activity may benefit from provisional certification for a period of one yearsubject to a commitment to comply with the professional best practices set out in the applicable certification framework.
During this period, PSDMs will be required to take the necessary steps to obtain their final certification.
In practice :
- the possibility of starting operations without immediately obtaining full certification
- the obligation to achieve compliance rapidly
- the need to prepare for certification audits in advance
Pseudonymisation of data during audits
The decree also introduces an important data protection requirement :
PSDMs will now be required to pseudonymise users’ records to which certification bodies have access, whether during certification audits or inspections.
This measure is intended in particular to :
- ensure the confidentiality of health data
- protect medical confidentiality
- strengthen GDPR compliance
Strengthening compliance requirements across the sector
Beyond these clarifications, the decree forms part of a broader effort to structure the PSDM sector.
Certification is a key issue, as it will determine eligibility for reimbursement of services by the French Health Insurance system and aims to ensure the quality and safety of services provided to patients.
It requires the relevant operators to implement:
- robust internal procedures
- enhanced traceability
- an organisation compliant with the framework established by the French National Authority for Health (Haute Autorité de Santé – HAS)
Key takeaways
This new decree :
- facilitates market entry for new PSDMs through provisional certification
- strengthens data protection requirements
- confirms the central role of certification in structuring the sector
For the operators concerned, compliance can no longer be postponed and requires advance preparation, both from an organisational and legal perspective.