12 February 2026

Calling for credibility of digital regulations in Europe: Feedback to Digital Omnibus Package

European doctors are concerned with several amendments of the Digital Omnibus Package, as they seem to considerably reduce safeguards around personal data use and re-use, in particular when processing health data in AI contexts. While the objective for clarification, coherence and simplification are welcomed, these objectives should not be made at the expense of legal certainty, fundamental rights, and trust in the EU digital rulebook.

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CPME believes that the effectiveness of the EU digital rulebook would be improved through clearer regulatory guidance, consistent enforcement across Member States, and targeted support for SMEs rather than broad omnibus amendments.

CPME stresses that the institutional timelines on the proposal for the Digital Omnibus on AI are preventing meaningful scrutiny and commentary. This may lead to a law which has unintended consequences on patients’ health, safety, and privacy. The European Parliament’s draft report was published on 5 February, with a deadline for proposed amendments for 12 February.

CPME advises against any amendments which can have a negative impact on the implementation of the European Health Data Space Regulation (EHDS), in particular legal definitions (e.g. definition of personal data and of scientific research) and legal basis (e.g. legitimate interest to process personal data for the purposes of AI training, testing and validation, including special categories of data). The EHDS was negotiated under specific premises, aiming for a high-level of trust in accessing and sharing special categories of data, namely data from electronic health records, genetic data, data from wellness apps, personal data from medical devices, among other. Certain proposed amendments from the European Commission can erode that trust.

CPME supports a compromise text in the Digital Omnibus AI reinstating the standard of ‘strict necessity’ from current Article 10(5) of the AI Act for processing special categories of data; restoring the obligation to register in an EU database a high-risk AI system in Annex III when the provider self-exempts it from being a high-risk; maintaining the obligation from providers and deployers to ensure a sufficient level of AI literacy for their staff and persons operating with AI – this is key for the deployment of AI in healthcare; rewording the definition of ‘scientific research’ to include a reference to ethical committees and a discussion on who can (or not) define an ethical standard is needed.

CPME warns against Amending Annex I of the AI Act through the Medical Devices Regulation revision proposed on 16 December 2025. This amendment moves MDR and IVDR from Section A to Section B, and would render important safeguards on high-risk AI systems inapplicable in medical devices, such as human oversight.

Finally, CPME hopes that appropriate timelines are given by co-legislators when discussing the Digital Omnibus on data. The Digital Omnibus is a complex document and must be considered within relevant EU and national legal contexts.

CPME Feedback to Digital Omnibus Package - Calling for credibility of digital regulations in Europe

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