{"id":471,"date":"2026-04-08T15:16:46","date_gmt":"2026-04-08T15:16:46","guid":{"rendered":"https:\/\/lcheurope.com\/?p=471"},"modified":"2026-04-08T15:20:19","modified_gmt":"2026-04-08T15:20:19","slug":"certification-psdm-decret-2026","status":"publish","type":"post","link":"https:\/\/lcheurope.com\/en\/certification-psdm-decret-2026\/","title":{"rendered":"PSDM Certification: New Decree and 2026 Requirements"},"content":{"rendered":"
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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.<\/p>

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.<\/p>

Provisional certification for new PSDMs<\/h3>

The decree provides that service providers starting their activity may benefit from provisional certification for a period of one year<\/strong>subject to a commitment to comply with the professional best practices set out in the applicable certification framework.<\/p>

During this period, PSDMs will be required to take the necessary steps to obtain their final certification.<\/p>

In practice :<\/p>

  • the possibility of starting operations without immediately obtaining full certification<\/li>
  • the obligation to achieve compliance rapidly<\/li>
  • the need to prepare for certification audits in advance<\/li><\/ul>

    Pseudonymisation of data during audits<\/h3>

    The decree also introduces an important data protection requirement :
    PSDMs will now be required to pseudonymise users\u2019 records<\/strong> to which certification bodies have access, whether during certification audits or inspections.<\/p>

    This measure is intended in particular to :<\/p>

    • ensure the confidentiality of health data<\/li>
    • protect medical confidentiality<\/li>
    • strengthen GDPR compliance<\/li><\/ul>

      Strengthening compliance requirements across the sector<\/h3>

      Beyond these clarifications, the decree forms part of a broader effort to structure the PSDM sector.<\/p>

      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.<\/p>

      It requires the relevant operators to implement:<\/p>

      • robust internal procedures<\/li>
      • enhanced traceability<\/li>
      • an organisation compliant with the framework established by the French National Authority for Health (Haute Autorit\u00e9 de Sant\u00e9 \u2013 HAS)<\/li><\/ul>

        Key takeaways<\/h3>

        This new decree :<\/p>

        • facilitates market entry for new PSDMs through provisional certification<\/li>
        • strengthens data protection requirements<\/li>
        • confirms the central role of certification in structuring the sector<\/li><\/ul>

          For the operators concerned, compliance can no longer be postponed and requires advance preparation, both from an organisational and legal perspective.<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>","protected":false},"excerpt":{"rendered":"

          Un nouveau d\u00e9cret vient pr\u00e9ciser les modalit\u00e9s de mise en \u0153uvre de la certification des prestataires de services et distributeurs de mat\u00e9riel […]<\/p>\n","protected":false},"author":1,"featured_media":472,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-471","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized"],"yoast_head":"\nCertification PSDM : nouveau d\u00e9cret et obligations 2026<\/title>\n<meta name=\"description\" content=\"Un d\u00e9cret pr\u00e9cise les modalit\u00e9s de certification des PSDM : certification provisoire, pseudonymisation des donn\u00e9es et nouvelles obligations.\" \/>\n<meta name=\"robots\" content=\"noindex, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<meta property=\"og:locale\" content=\"en_GB\" \/>\n<meta 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