{"id":155,"date":"2025-09-30T10:16:31","date_gmt":"2025-09-30T10:16:31","guid":{"rendered":"https:\/\/developpeurs.com\/pauline\/?p=155"},"modified":"2026-04-08T15:25:06","modified_gmt":"2026-04-08T15:25:06","slug":"sanctions-editeurs-services-numeriques-sante-decret-2026","status":"publish","type":"post","link":"https:\/\/lcheurope.com\/en\/sanctions-editeurs-services-numeriques-sante-decret-2026\/","title":{"rendered":"2026 Decree : Penalties for Non-Compliant Digital Health Service Providers"},"content":{"rendered":"
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For digital health service providers :<\/p>

A decree has been published setting out the practical arrangements for imposing financial penalties on digital health service providers that fail to comply with interoperability, security or ethical standards, or that do not hold the required certificate of compliance.<\/p>

The decree therefore completes the legal framework designed to ensure effective compliance with requirements applicable to digital health technologies.<\/p>

It defines the inspection procedure entrusted to the French Digital Health Agency (Agence du Num\u00e9rique en Sant\u00e9 \u2013 ANS), which is already responsible for receiving reports of suspected non-compliance by digital health services with applicable requirements relating to interoperability, security, ethics and certification.<\/p>

\u27a1\ufe0f The ANS may carry out inspections and audits, including on-site visits, and may request demonstrations of the relevant tools and access to their specifications.<\/p>

\u27a1\ufe0f Failure to achieve compliance following a formal order to remedy the situation may trigger a penalty procedure. The decision is taken by the French Minister for Health, based on a proposal from the ANS.<\/p>

\u27a1\ufe0f The ANS proposal will include an assessment of the seriousness of the identified breach and the corresponding financial penalty. The penalty may amount to up to 1% of the service provider\u2019s turnover excluding tax generated in France during the latest financial year, capped at \u20ac1 million. It may also be accompanied by a proposed periodic penalty payment.<\/p>

\u27a1\ufe0f The ANS must assess the seriousness of the breach by taking into account, in particular, the specific requirements of the framework that has not been complied with, the number and nature of the instances of non-compliance, the potential impact on patient care, the risks to public health and the financial consequences for the French Health Insurance system.<\/p>

\u27a1\ufe0f Decree No. 2026-153 of 3 March 2026 relating to the penalties referred to in Article L. 1470-6 III of the French Public Health Code<\/a><\/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":"

Pour vous \u00e9diteurs de service num\u00e9rique en sant\u00e9\u00a0: publication ce jour du d\u00e9cret fixant les modalit\u00e9s pratiques d\u2019application des sanctions financi\u00e8res aux […]<\/p>\n","protected":false},"author":1,"featured_media":482,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-155","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized"],"yoast_head":"\nD\u00e9cret 2026 : sanctions pour les \u00e9diteurs de services num\u00e9riques en sant\u00e9 non conformes<\/title>\n<meta name=\"description\" content=\"Le d\u00e9cret du 3 mars 2026 pr\u00e9cise les sanctions financi\u00e8res applicables aux \u00e9diteurs de services num\u00e9riques en sant\u00e9 ne respectant pas les obligations d\u2019interop\u00e9rabilit\u00e9, de s\u00e9curit\u00e9 ou de certification.\" \/>\n<meta name=\"robots\" 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