Digital Omnibus Package: a crucial chance to restore clarity in Europe’s digital rulebook

Written by the European Hearing Instrument Manufacturers Association (EHIMA)

On 19 November 2025, the European Commission unveiled the Digital Omnibus Package, an effort to bring greater coherence to Europe’s increasingly complex digital rulebook – a move EHIMA welcomes.

Hearing instruments are highly sophisticated medical devices, where patient safety and clinical outcomes guide every stage of development. Although already governed by the Medical Device Regulation (MDR), they are now affected by a growing number of digital laws — from the AI Act and the Data Act to NIS2, the Cyber Resilience Act, the Digital Governance Act and the Free Flow of Data Regulation. These frameworks often overlap with, or even contradict, one another.

The Digital Omnibus Package is therefore an important chance to cut through this regulatory complexity and provide the clarity needed to support innovation in the hearing instrument sector.

Supporting Europe’s digital ambition, but calling for clarity and proportionality

EHIMA fully supports the EU’s ambition to create a digital single market built on trust and ethical innovation. Hearing technology has benefitted enormously from advances in digitalisation and AI, and our industry continues to invest in solutions that improve communication and quality of life for millions of Europeans with hearing loss.

But ambition alone is not enough. Both the AI Act and the Data Act require greater clarity and proportionality to avoid unintended consequences for medical technologies that already operate under strict sectoral rules. Without adjustment, the cumulative effect of Europe’s digital legislation risks slowing innovation and reducing competitiveness.

AI Act: preventing over-classification

A major concern for EHIMA is that the AI Act’s broad classification model treats almost all AI-enabled medical device software as “high-risk” regardless of its actual safety profile. For hearing instruments, this is disproportionate: AI features such as noise reduction, speech enhancement or acoustic scene analysis vastly improve user experience, but do not diagnose, treat or control physiological functions, and even in the event of failure, the impact is limited to poorer sound quality.

The situation is compounded by contradictory amendment timelines in Article 6, which have created legal ambiguity and made it difficult for companies to plan multi-year development cycles around unclear triggers. The Digital Omnibus needs to bring explicit clarity and restore proportionality. AI in hearing instruments should not be treated as high-risk simply because it appears within a medical device. The AI Act should ensure that high-risk classification is reserved for genuinely safety-critical systems and confirm that AI functionalities typical of hearing instruments do not fall into that category. Without such guidance, even benign algorithms risk being swept into a regulatory regime designed for technologies capable of causing real harm, which is neither technically justified nor feasible given the strict size, memory and battery constraints of hearing aids.

A sector that’s already highly regulated

The Digital Omnibus also needs to recognise the regulatory reality of the medical device sector. Hearing instruments already undergo extensive MDR scrutiny, covering risk management, software lifecycle processes, cybersecurity, post-market surveillance and conformity assessment. When horizontal digital legislation duplicates or diverges from these established obligations, the result is unnecessary administrative burden without added safety benefit.

EHIMA therefore supports aligning horizontal legislation with MDR practice. Compliance with MDR harmonised standards should be recognised as meeting equivalent requirements under the AI Act, Data Act and Cyber Resilience Act. This is not special treatment – it is regulatory clarity.

Data obligations must reflect what devices can actually do

The Data Act also requires careful alignment. Its general data access obligations could trigger costly redesigns and new MDR assessments – even where the data in question cannot realistically be stored or shared. Hearing instruments process transient acoustic inputs and internal algorithmic parameters that are technically unsuited for portability and often meaningless to users or third parties.

EHIMA supports data transparency where it is feasible, secure and beneficial (e.g., fitting-relevant data). But expectations for continuous or raw data sharing are unrealistic. They would drain battery life, compromise trade secrets and create obligations that deliver little consumer benefit. The Digital Omnibus should therefore clarify and narrow the Data Act’s scope for medical devices and ensure consistency with the EHDS and MDR.

A call for predictability

Because the Digital Omnibus will directly shape how the AI Act and the Data Act apply in practice, timelines matter. EHIMA recommends extending the application of the AI Act to 2 August 2029 and the Data Act to 21 September 2029. These adjusted dates would prevent rushed or fragmented compliance efforts and give both regulators and industry the necessary time to integrate guidance, harmonised standards and operational processes in a coherent and predictable way.

A chance to get it right

For EHIMA, the Digital Omnibus is not simply a corrective proposal on the horizon – it is a published package that will shape the next phase of Europe’s digital rulebook. Its success will depend on how effectively the EU institutions refine, interpret and implement its measures in the months ahead. If Europe intends to lead in digital health, the next steps must prioritise coherence, proportionality and predictability. The Omnibus provides the basis for this, but its objectives must be carried through into concrete guidance, aligned timelines and practical implementation. EHIMA stands ready to support this process and to work with policymakers to ensure that Europe’s digital legislation remains clear, workable and future-proof for the benefit of patients, professionals and industry alike.

Reference: For more information, please consult EHIMA Stakeholder Consultation Submission to the Digital Omnibus Package, 13 October 2025.