Simplification of the implementation of harmonised rules on artificial intelligence – Digital Omnibus on AI (Omnibus VII)

Siinda members welcome the Commissions Call for Evidence on the Digital Omnibus and the opportunity to help simplify and modernise EU digital rules while preserving fundamental rights, competition and innovation.

FEDMA welcomes the Commissions initiative to simplify and streamline the EUs digital regulatory landscape through the Digital Omnibus. We strongly support efforts to reduce administrative burdens, enhance legal clarity, and ensure the digital rulebook is fit for purpose in a rapidly evolving environment.

The Digital Omnibus must not affect recently adopted rules for general purpose AI. Pour Demain, an independent think tank working towards the responsible development and deployment of general purpose AI, understands the need for regulatory simplification for SMEs in Europe.

IFRRO is an independent, non-profit membership association with over 160 members across over 90 countries, including more than 70 members from the European Union. We facilitate the collective management of reproduction and other rights in text and image-based works through the cooperation of our member Reproduction Rights Organisations (RROs).

The following position paper highlights the legislative and interpretative needs specifically related to digital health and AI regulation. The document reflects the perspectives of Finnish health sector representatives, who maintain close collaboration with innovation-driven enterprises and public organizations.

The Polish Confederation Lewiatan presents a comprehensive position on the EUs Digital Omnibus initiative, urging better alignment of the AI Act, GDPR, ePrivacy Directive, Data Act, and cybersecurity rules. It stresses the need for coherence, proportionality, and innovation-friendly regulation to reduce uncertainty and regulatory burden. Lewiatan highlights a widening gap between the AI Act and GDPR.

Position Paper on the simplification of EU cybersecurity legislations Introduction Gen Digital, the global leader in consumer Cyber Safety with renowned brands including Norton, Avast, Avira, and AVG, welcomes the European Commission’s “Digital Omnibus” initiative.

Opening of the attached position paper · the full paper is on the Commission’s record (source link above)

The European Unions digital rulebook has grown overly complex, with overlapping obligations, inconsistent supervision, and significant compliance burdens that limit innovation across the Single Market. This complexity particularly affects European SMEs, which lack the resources of global technology firms and face barriers to cross-border growth.

Topics Digital Omnibus Table of contents 1. Cybersecurity .............................................................................................................................. 2 1.1. Simplification of the Cyber Resilience Act (CRA) .................................................................. 2 1.2. Harmonization of Reporting Obligations for CRA/NIS 2/DORA .............................................

Opening of the attached position paper · the full paper is on the Commission’s record (source link above)

Stadtwerke München GmbH (SWM) welcomes the reduction of red tape and simplification in the digital sector envisaged by the European Commission. As a municipal utility, we have been working for years to reduce inefficient administrative barriers. Uniform rules and clear legal bases are essential for a successful energy transition.

Filed in German · English published by the European Commission

NHO welcomes the European Commissions efforts to streamline existing rules, reduce administrative burdens, and enhance legal clarity for companies operating across the EU. A more coherent and accessible digital regulatory environment is essential to foster innovation, competitiveness, and sustainable growth on the Single Market, which Norway is a part of through the EEA agreement.

We welcome the European Commissions efforts to simplify and harmonise the digital regulatory landscape. We strongly support the overarching objective of reducing administrative burden and ensuring legal certainty for organisations operating within the EU digital ecosystem.

In the view of the DStV, the European Company Wallet offers great potential for cutting red tape, efficiency and digitalisation. It should be made simple, cost-effective and user-friendly for smaller market participants, while it should be made mandatory for larger companies. The wallet should depict digital power management in accordance with the Once Only principle.

Filed in German · English published by the European Commission

Cisco welcomes the opportunity to comment on the upcoming Digital Package. Amongst other priorities, we understand the focus will be on streamlining regulations about the reuse of public sector data, cybersecurity incident reporting obligations and the optimal application of the AI Act.

Europe's digital regulatory framework has reached a critical point. The proliferation of horizontal and sectoral acts - including the NIS 2 Directive, Cyber Resilience Act (CRA), Artificial Intelligence Act (AI Act), revised eIDAS Regulation, Data Act, and GDPR - has created a complex ecosystem that absorbs resources, slows innovation, and limits the competitiveness of European service providers.

RESPONSE TO THE PUBLIC CONSULTATION SIMPLIFICATION DIGITAL PACKAGE AND OMNIBUS On behalf of the Spanish Railway Association (Mafex), representing the Spanish railway industry, we submit our response to the European Commissions public consultation Simplification Digital Package and Omnibus.

Europes digital future depends on trust. As the European Union advances its ambitious simplification agenda through the Digital Omnibus, a unique opportunity arises to reduce complexity, lower compliance costs, and strengthen Europes digital and data sovereignty. To succeed, trust must be embedded at the foundation of this effort.

As a leading sensor and automation company, SICK fully supports the ZVEI position calling for a Digital Omnibus to eliminate redundant, overlapping, and inconsistent EU digital regulations. Europes industrial competitiveness increasingly depends on clarity and coherence in digital law.

HealthTech Finland thanks the Commission for opening the Call for Evidence for the simplification of rules for data, cybersecurity and artificial intelligence (Digital Omnibus) Concerns raised by health technology SMEs require specific attention through targeted solutions.

Kaspersky, a global cybersecurity company committed to supporting secure and resilient digital infrastructure across the EU and globally, welcomes the European Unions efforts to reduce the administrative costs for compliance for businesses, administrations and citizens in the European Union in application of several regulations of the Unions digital acquis without compromising the objectives of the underlying rules.

LightingEurope's feedback for the Digital Omnibus consultation focuses on the effective implementation of the Cyber Resilience Act (CRA), providing recommendations to ensure clear compliance requirements for the lighting sector.

We are an SME specialised in digital innovation and transformation for Health and Public Administration, working across data interoperability, cybersecurity, and responsible AI. We support the Digital Omnibus initiatives goal to simplify the EU digital framework while maintaining high standards of protection and trust.

This submission represents the official input of the Czech Republic to the public consultation, specifically in the section Targeted adjustments to the Artificial Intelligence Act to ensure the optimal application of the rules.

The opinion of the Ministry of Economics of the Republic of Latvia during the discussion on the Digital Omnibus package stresses the need to simplify and modernise the EU’s digital regulation, in particular the application of Artificial Intelligence (AI) and data regulation, reducing the administrative burden on businesses and promoting innovation.

Filed in Latvian · English published by the European Commission

Workday submits the attached recommendations to the European Commission in response to their call for evidence on the upcoming Digital Omnibus. Workday is the AI platform for managing people, money and agents. The Workday platform is built with AI at the core to help customers elevate people, supercharge work, and move their business forever forward.

Based on our experience as a global provider of information-based analytics and decision tools for professional and business customers, we have identified the following opportunities to make the EU more competitive and secure. Streamlining the EUs data acquis The current patchwork of data frameworks creates unnecessary cost, duplication and legal uncertainty.

Elia Group, comprising two electricity transmission system operators - Elia in Belgium and 50Hertz in northeast Germany - believes that the upcoming Digital Omnibus is an opportunity for the European Commission to help: - Unlocking the value of data by supporting Member States in implementing the enabling EU framework for access and sharing of data, including the Data Act, as well as stimulating Member States to…

Telekom Austria AG welcomes the European Commissions efforts to simplify and harmonize the EUs digital regulatory environment through the Digital Omnibus initiative. From our perspective, genuine simplification and harmonization require an ambitious, comprehensive approachnot just tweaking individual regulations, but ensuring that all digital legislation fits together consistently and efficiently.

The European Banking Federation (EBF) appreciates the opportunity to provide feedback to the call for evidence. Please find attached our recommendations on how to ensure a more efficient and coherent regulatory framework that upholds key policy objectives, such as financial stability, data protection and consumer protection, while fostering growth and competitiveness.

AI Act - Stop-the-clock: The AI Acts high-risk rules are complex and will impact a wide range of businesses and public authorities in the EU. Standardization experts have already spent over three years translating the regulations requirements into practical implementationsand they are not finished.

ZVEI welcomes this consultation and fully supports the European Commissions efforts to simplify and streamline EU digital regulation. The goal of a 25% reduction of administrative costs for all businesses and 35% for SMEs by 2030 is ambitious and necessary.

FIGIEFA, representing Europes independent automotive parts distributors and their associated repair chains, welcomes the Digital Omnibus as an opportunity to simplify and harmonise the EUs digital legislation. However, simplification must not lead to deregulation. The EUs digital legislative instruments are essential to create a level playing field and stimulate innovation.

To whom this may concern, PHOENIX group welcomes the Commissions initiative aimed at setting digital simplification agenda for the years to come and bringing immediate relief to businesses across the EU. PHOENIX group is the largest European integrated healthcare provider with 224 sites in the business areas of pharmaceutical wholesale and pre-wholesale across 29 European countries and with more than 3,200…

BusinessEurope appreciates the opportunity to provide feedback to the call for evidence. This document puts forward a series of concrete examples to illustrate where and how (digital) regulation can and must be simplified to reduce the burdens that hold back European businesses.

SIA Tet makes the following recommendation: In view of the need to ensure the diversity of EU and national information spaces, it is necessary to provide in legislation for the possibility of using target (advertising) cookies as an alternative to paying for internet media content, while retaining the possibility for the data subject to opt out of such cookies at any time.

Filed in Latvian · English published by the European Commission

Simplification – digital package and omnibus Free Trade Europa and Freelance Movement Submission We would like to draw your attention to the need to ensure coherence across the GDPR, AI Act, and Platform Work Directive (Chapter III related to data & algorithmic obligations) with regards to the governance of automated decision-making through the use of technology.

Opening of the attached position paper · the full paper is on the Commission’s record (source link above)

The Test & Measurement Coalition (TMC, represented by its permanent secretariat EPPA) welcomes the Commissions Digital Omnibus initiative. As a coalition representing approximately 60% of global production in the industrial test and measurement sector, we strongly support the Commissions efforts to optimise costs related to the administrative burden on companies without compromising protection of the environment and…

TIC Council, the international trade association representing the independent Testing, Inspection and Certification (TIC) sector, sees the Digital Omnibus as an opportunity to promote efficient and proportionate legislation, without compromising the core policy objectives of protection, safety, and security.

Technology Industries of Finland welcomes the European Commissions initiative to streamline the EUs digital regulation framework through the Digital Package for Simplification. The package is an opportunity to remove unnecessary burdens, overlaps and inconsistencies, ensuring legislation supports innovation, investment and competitiveness. 1.

The Actuarial Association of Europe welcomes the initiative on regulatory simplification through the Digital Omnibus, including elements that focus on ensuring the smooth application of the AI Act. As a profession extensively engaged in insurance, pensions, financial services and risk management, actuaries are involved in the design, deployment, and oversight of AI systems.

I represent the Internet. Time to act! Foundation from Poland. We're a group of lawyers and programmers of web technologies with over 12 years of experience in the field. Here's our feedback. 1. On a centralized consent mechanism: Any attempt to create a single, centralized method for expressing user consent is unlikely to be implemented effectively while preserving privacy.

The contribution of Palombar Nature Conservation and Rural Heritage to the public consultation on the European Commission’s Omnibus Digital Proposal A Palombar, as a civil society organisation dedicated to nature conservation, environmental protection and the enhancement of rural heritage, is concerned about the Omnibus Digital Proposal put forward by the European Commission.

Filed in Portuguese · English published by the European Commission

Medical Device Regulation (MDR) Software Overclassification Rule 11 of MDR effectively classifies nearly all healthcare software as at least a Class II device. In contrast, other jurisdictions exempt software meeting the definition of clinical decision support.

Based on our long-term experience as a marketing agency working primarily with small and medium-sized enterprises (SMEs), we do not recommend continuing with the current system of cookie banners and mandatory consent collection. 1.

Milestone Systems supports the AI Act as a necessary and forward-looking framework. We commend the Commissions ambitious goal of reducing administrative burdens. Achieving this will be instrumental in enabling businesses like Milestone Systems to focus resources on innovation and growth, rather than on navigating complex compliance requirements.

Zimmer Biomet, a global leader in medical technology, supports the European Unions digital ambitions and shares the European Commissions objective to foster innovation that benefits patients and health systems. In healthcare, connected medical technologies enable personalized prevention, faster diagnosis, and patient-specific treatments.

This paper outlines recommendations from Japan Business Council in Europe (JBCE) on behalf of Japanese businesses operating in the EU on key digital legislation, focusing on the Data Act, cybersecurity frameworks such as the Cyber Resilience Act (CRA) and the Directive on measures for a high common level of cybersecurity across the Union (NIS2), and the Artificial Intelligence (AI) Act.

The Federation of European Risk Management Associations (FERMA) brings together 23 risk management associations in 22 European countries, representing more than 6000 risk managers active in a wide range of business sectors. Cybersecurity has always been a key concern for FERMA members.

PII Guard welcomes the Commissions initiative to simplify and harmonise the EU digital acquis. Divergent national implementations of the ePrivacy Directive and differing interpretations of GDPR and related acts create legal uncertainty, competitive distortion, and excessive compliance costs especially for SMEs.

As a premium provider of trusted AI solutions globally, IDEMIA supports the European Commissions initiative to seek simplification in the implementation of the AI Act. With full implementation of the Act scheduled for in less than a year, industry needs consistent application of the rules throughout the EU and legal clarity, in particular when it comes to high-risk AI systems.

The Fédération des Industries Ferroviaires (FIF), representing companies in the French railway sector, wishes to draw the attention of the European Commission to the potentially negative effects of recent digital regulations, in particular the Cyber Resilience Act (CRA), the Data Act and the Artificial Intelligence Act (AI Act), where applicable to the industrial railway sector.

Filed in French · English published by the European Commission

The Belgian insurance industry fully supports DORA's goal of digital operational resilience. The sector has already made significant investments in digital operational resilience and stands ready to meet these challenges. However, the current incident reporting requirements introduce unnecessary costs and administrative burdens, particularly for insurers and smaller firms.

U.di.Con. APS welcomes the European Commission’s Digital Omnibus Package, recognising its value in simplifying the regulatory framework and reducing administrative burdens that do not generate benefits for consumers. However, simplification must never reduce the levels of protection: clear and understandable rules remain essential.

Filed in Italian · English published by the European Commission

FACILITATE FIRM LEVEL DATA ACCESS FOR POLICY ANALYSIS. Having access to granular business information data (revenues, investments, employment...) is essential to assess how to improve EU competitiveness and evaluate the impacts of the measures taken to do so.

The European Lotteries (EL) welcomes the Commissions initiative to simplify and align the EUs digital rulebook. From the perspective of the regulated lotteries and gambling sector, simplification should enhance coherence and enforcement of existing rules not lead to new harmonisation in areas that remain under national competence. Gambling is regulated nationally to protect consumers and public order.

October 2027 EVOLIS's proposals in response to the ongoing consultation on the Digital Omnibus Package. The manufacturers represented by EVOLIS welcome the objectives of the Digital Omnibus package to simplify, align and harmonise the current regulatory landscape and EVOLIS generally supports the EU's digital transformation, enacted through various new pieces of legislation.

Opening of the attached position paper · the full paper is on the Commission’s record (source link above)

The TÜV Association welcomes the European Commissions efforts to streamline and simplify the EUs digital regulatory framework. Clear, coherent, and predictable rules are crucial for strengthening the competitiveness of the European digital economy and ensuring the effective functioning of the Single Market.

Who we are: Our five organisations are committed to shaping a democratic and public interest-oriented digitalisation. Openness, transparency, participation and the protection of fundamental rights are central to this. We are working on the interface of digitalisation and society to strengthen citizens’ rights and reduce power asymmetries in the digital space.

Filed in German · English published by the European Commission

Uber B.V. Boulevard Louis Schmidt 29 1040 Etterbeek Transparency register : [phone removed] October 2025 Call for Evidence: Digital Omnibus (Digital Package on Simplification) At Uber, we are proud to offer shared mobility and delivery services across 24 Member States.

Opening of the attached position paper · the full paper is on the Commission’s record (source link above)

City of Stockholm Executive Office, International Affairs Unit Ragnar Ös tbergs Pl an 1 Ref. Ares(2025)8620488 - 10/10/2025 2025-10-08 Page 1 (1) 105 35 Stoc kholm Telefon [phone removed] fanny .stahlkr [email removed] start.stock holm The City of Stockholm’s comments to the European Commission’s digital omnibus The City of Stockholm welcomes the European Commission’s proposal to reduce administrative burdens within…

Opening of the attached position paper · the full paper is on the Commission’s record (source link above)

1. Simplify e-Privacy rules to facilitate data uses that drive innovation The data protection and privacy regulatory framework is based on two separate legal instruments that both regulate the use of data from different perspectives: (1) the GDPR regulating the processing of personal data, directly applicable in national laws and (2) the e-Privacy Directive regulating the placing and reading of information (cookies)…

Opening of the attached position paper · the full paper is on the Commission’s record (source link above)

In Sok’s view, lighter regulation in the digital sector is key to improving the business environment and improving Europe’s competitiveness. Regulatory streamlining has the potential to boost investment and growth. Regulatory streamlining must focus on creating a predictable, clear and equitable environment, eliminating overlaps and contradictions and seeking as uniform interpretations as possible across the EU.

Filed in Finnish · English published by the European Commission

The Finnish National Agency for Education supports the objectives of the Simplification Digital Package and Omnibus initiative and considers them appropriate from the perspective of public administration. We welcome the European Commissions efforts to reduce administrative burdens, streamline regulatory requirements, and promote digitalisation while maintaining high standards of transparency and accountability.

Digital innovation will continue accelerating, creating new opportunities and disruption for policymakers to navigate. At a time when Europe is facing significant challenges to preserve its competitiveness, the choices the EU makes during the 2024-2029 political cycle related to how technology is developed, deployed, and governed will be critical to Europeans continued security, prosperity, and well-being.

Intro The immense regulatory burden stifles competitiveness and pace of innovation of European tech companies: every day, we are losing ground to the USA and China! The growing patchwork of digital regulation (AI Act, Data Act, Cyber Resilience Act) imposes significant and costly implementation efforts on European operators.

Europe must refrain from any de-regulatory efforts in the name of flexibility for corporations or to enhance competitiveness. For Europe's AI strategies to succeed and foster trust, it must be built on pillars of public ownership, democratic governance of digital infrastructure, sustainability, and robust worker involvement.

Compagnie nationale des comaires aux comptes (CNCC) would like to how as follows: With regard to the AI Act, CNCC fully supports this important piece of legislation. Artificial intelligence, in its current guise as Large Language Models, and even more so in the future, with the potential rise of General Artificial Intelligence and its ensuing consequences is a development that is too serious for its regulation to be…

Filed in French · English published by the European Commission

The Commission’s initiative for a digital simplification package is welcomed in principle. As pointed out by the European Commission in its call for evidence, there is a need for uniform application of the rules and greater legal clarity. This objective is becoming increasingly ambitious in view of the multitude of horizontal and sector-specific rules adopted in recent years.

Filed in German · English published by the European Commission

FEDIL welcomes and strongly support this initiative to simplify and harmonize the EUs digital regulatory framework. We outline key challenges and priorities expressed by our members, who are facing increasing regulatory complexity in the digital space and propose concrete solutions to make digital regulation smarter, clearer, and more innovation-friendly, ensuring the Digital Omnibus becomes a true lever for…

Swedtrain urges the EU to recognize the specific challenges the railway industry faces in implementing the Cyber Resilience Act (CRA). While the regulation aims to strengthen cybersecurity for products with digital elements - a goal we fully support - it risks creating significant obstacles for our sector if not adapted to our operational realities.

The German Caritas Association (DCV) is the umbrella association of Catholic Welfare Services in Germany, supporting 12 million people per year, employing around 740000 people. Caritas is an important pillar of the German welfare state and contributes significantly to social services of general interest. The DCV welcomes the Commission’s intention to assess the effectiveness of digital laws.

Filed in German · English published by the European Commission

The Online Trust Coalition (OTC), a Dutch public and private partnership, and NOREA, the occupational group of registered IT auditors in the Netherlands, have taken the initiative to develop a reporting standard for digital control: the International Digital Reporting Standards (IDRS). The standard can be used by organisations to prepare an annual report on their digital (IT) control from a holistic perspective.

The Financial Federation thanks for the opportunity to submit consultation responses on the European Commission’s Digital Omnibus Packe. We support the need to simplify digital rules to remove administrative burdens that do not create value. The Finansforbundet calls for guarantees for employee protection and social dialogue to become a fundamental principle of regulatory simplification.

Filed in Danish · English published by the European Commission

Current approaches to regulation face important gaps when dealing with complex systems that include AI. There are significant challenges in ensuring trust, transparency, and reliability, especially because these systems often lack clear explanations for their behavior and can be difficult to test or predict.

The German Association of Local Public Utilities Verband kommunaler Unternehmen (VKU) represents over 1,600 local public utilities in Germany, operating in the sectors of energy, water/waste water, waste management and telecommunication. We enclose our position paper on the European Commission's consultation on the Digital Omnibus.

The Federation of Austrian Industries fully supports the European Commission's objective to simplify and streamline the EU digital regulatory framework. Concerning this Call for Evidence, the Ferderation of Austrian Industries would like to communicate the most pressing issues in our membership on a number of acts in the EU's digital rulebook.

VDMA welcomes the European Commission's plan to simplify digital regulations with a Digital Omnibus. The EU´s acquis for digital regulation is, together with other regulations, increasingly becoming a burden for innovation and competitiveness, outweighing the benefits.

Duty free and travel retail is a unique retail channel catering to the international traveller and a significant source of income and marketing opportunities for European businesses. It requires tailored legislative and regulatory solutions to those used in European domestic markets.

CECE - the Committee for European Construction Equipment - fully supports the European Commissions objective to simplify and streamline the EU digital regulatory framework, ensuring it fosters innovation, competitiveness, and legal certainty across the Single Market.

Our feedback outlines how the European Trade Indexes Registry (EUTIR) can strengthen the EUs Digital Omnibus initiative by providing a unified, cross-sector trust infrastructure that ensures interoperability, reduces administrative burdensespecially for SMEsand enhances legal certainty across digital trade, sustainability, customs, and financial frameworks.

ANEC contributes to this call for evidence focusing on the possible postponement of the applicability of the AI Act in case the Harmonised Standards for high-risk AI systems would not be ready on time. Postponing the applicability of the AI Act because the development of harmonized standards is delayed or for any other reason, would undermine both the purpose and credibility of the regulation.

1. Reduce Administrative Burden, Including Reporting Obligations Simplify documentation requirements for clinical investigations and post-market surveillance (PMS), e.g., removing duplication in adverse event reporting, Provide clear guidance on PMCF design, expectation and clinical evidence required for minor device modifications.

FME welcomes the European Commissions ambition to simplify and harmonize digital legislation through the Digital Omnibus Package and reduce administrative burdens by 25% and 35% for SMEs. This package offers a much-needed opportunity to move from fragmented rulemaking to a truly coherent implementation-oriented framework, mindful of SMEs and that will strengthen Europes competitiveness.

Thank you for the opportunity to give input for this call for evidence. Please find attached the full response from Danish Standards (DS). Danish Standards (DS) recommends that the EU build on existing standards to ensure harmonisation and reduce burdens on businesses. Standards can provide a common language and uniform processes that strengthen compliance and reduce fragmentation.

With reference to the Call for Evidence regarding the Digital Omnibus published by the European Commission, the Austrian Federal Economic Chamber would like to communicate a number of initial thoughts and considerations regarding the three general topics addressed there, without prejudice to a more clear-cut response that may result from an analysis of a future document by the European Commissions that may contain…

We strongly support the Commission's Simplification agenda and its goals of reducing administrative costs and enhancing legal clarity for businesses and citizens. As a constructive contribution, we offer a practical example of a measure that currently runs counter to these objectives, but which can be revised to fully align with them.

Based on my practical experience, but also on the PhD Research I am conducting on the GDPR, I believe there are evident concerns which arise with respect to GDPR's limitations in cases of data subjects' rights. What I mean by this is that the current framework for data subject rights from the GDPR (specifically chapter 3, and not tangential rights from other disciplines like the right to compensation) is not…

Our position Digital Omnibus Priorities for simplifying the EU’s digital rules AmCham EU speaks for American companies committed to Europe on trade, investment and competitiveness issues. It aims to ensure a growth-orientated business and investment climate in Europe.

Opening of the attached position paper · the full paper is on the Commission’s record (source link above)

Dear European Commission, I want to express my gratitude for the Commission's work on the Digital Omnibus initiative, which aims to streamline digital regulations. The proposed targets of cutting compliance costs by 25% for all businesses and 35% for small and medium enterprises are praiseworthy and crucial.

We have developed the AI Act and The Agile safety plan that helps companies. We are now using it in real cases. Link: https://link.springer.com/book/10.1007/978-3-031-80504-2 In addition we have developed the CRF method that is relevant both for safety and cybersecurity together with AI.

Overlapping and unclear requirements for reporting cyber incidents across several EU-level policies and between different countries pose significant operational and compliance challenges for entities under scope. In some cases, organisations are required to notify several national bodies of the same cyber incident.

Didomi welcomes the Commissions objective to simplify the EUs digital framework and reduce cookie consent fatigue while maintaining strong data protection standards. As a Consent Management Platform (CMP) provider, we support this ambition but believe that neither browser-based consent nor a relaxation of ePrivacy rules would achieve these goals.

Mitigating the risks generated by the Cyber Resilience Act (CRA) on the EU railway sector. The Cyber Resilience Act (CRA) came into force on December 10, 2024, with full applicability set for December 11, 2027. The CRAs main objective is to enforce essential security requirements and their maintenance across product lifecycle for all products with digital elements (PDE).

We support the Commissions agenda to simplify the digital policy regulatory framework through the first Digital Omnibus. However, we would also like to emphasize that further simplification steps remain necessary, as this package will not resolve the most pressing issues. The most influential digital laws such as the GDPR, the CRA or the Data Actand their interplay are notably left unaddressed.

According to Akava, effective and balanced regulation of the digital sector, AI, etc. is an important issue. In this context, we mainly take a position on the basic lines of development of regulation in the sector.

Data is the foundation of AI. To make Europe a global leader, France and the EU must strengthen and fully implement open data policies, ensuring robust, reliable, and sovereign AI models. 1. Key challenges in proactive availability of datasets from the public sector The biggest challenge is the absence of binding obligations or real incentives for Member States to proactively publish datasets.

regulations: - Audits which tackle overlapping topics - Reporting in case of overlapping topics - Incident handling for the same incident to multiple stakeholders Audits: All laws around cybersecurity, resilience, etc. should include a sentence "if not already covered by sector specific conformity assessment" (or likewise) in case a conformity assessment or evidence is foreseen.

The EU’s ambitions to ensure security and uniform standards also in the digital world are to be explicitly welcomed. However, there is still room for improvement in some places. There are three points in particular: On the one hand, the AI Act should, among other things, include clarifying rules on authorisation procedures: If a product is already subject to an authorisation procedure under other regulations…

Filed in German · English published by the European Commission

The EU has finally taken the right direction: digital regulation is being simplified through omnibus initiatives. This is essential. For example, the current regulatory framework for telecommunications has become far too complex compared to the pace of technological development. Legislation must keep up with the times and promote Europes competitiveness, not hinder it.

Adigital, the Spanish Association of the Digital Economy, appreciates the opportunity to provide feedback. The attached file includes "The Spanish Business Proposal for Regulatory Simplification in the European Unions Digital Agenda".

Europes competitiveness is under severe pressure, as the Draghi and Letta reports stressed recently. The EU has fallen behind the USA and China in terms of growth, productivity and innovative strength. Europe is at risk of being left behind in key technologies, such as artificial intelligence.

While fully committed to EU policy objectives in the digitalisation field, in particular when it comes to the critical topic of cybersecurity, UNIFE - the Association of the European Rail Supply Industry - underlines that certain regulations focus on consumer goods sectors and not on the characteristics of tailor-made industrial goods sectors such as rail (e.g.

The Commissions Digital Omnibus rightly targets immediate simplification where it can cut compliance costs without weakening core protections. But with respect to the Artificial Intelligence Act, the Commission should avoid substantive amendments to primary law in this Omnibus.