← Back to all briefings
Compliance 9 min read Published Updated Credibility 91/100

Compliance Briefing — EU Digital Omnibus Proposals Streamline Data and AI Regulations

The European Commission published two Digital Omnibus proposals in November 2025 to streamline compliance across GDPR, AI Act, NIS2, DORA, and Data Act through unified incident reporting, refined personal data definitions, and simplified AI system obligations, reducing regulatory burden while maintaining strong protections.

Zeph Tech Research Lead

Research lead, Zeph Tech

Timeline plotting source publication cadence sized by credibility.
3 publication timestamps supporting this briefing. Source data (JSON)

Executive briefing: The European Commission released two Digital Omnibus legislative proposals in November 2025 aimed at rationalizing the EU's complex digital regulatory framework. The proposals target compliance simplification across the General Data Protection Regulation (GDPR), AI Act, Network and Information Security Directive 2 (NIS2), Digital Operational Resilience Act (DORA), Data Act, and ePrivacy Directive. Organizations operating in EU markets should analyze these proposals to anticipate changes to existing compliance programs while preparing for reduced administrative burden once adopted.

Unified incident reporting through ENISA

One of the most significant changes in the Digital Omnibus proposals establishes a centralized incident reporting portal operated by the European Union Agency for Cybersecurity (ENISA). Currently, organizations face overlapping and sometimes conflicting incident reporting requirements across multiple regulatory frameworks. NIS2 requires reporting significant incidents to national computer security incident response teams (CSIRTs), DORA mandates reporting ICT-related incidents to financial supervisory authorities, and GDPR requires data breach notification to data protection authorities.

The proposed unified reporting mechanism would allow organizations to submit a single incident report through the ENISA portal, which would then route notifications to all relevant authorities. This approach eliminates duplicate reporting efforts while ensuring competent authorities receive necessary information. The proposal also extends notification deadlines from the current 24-72 hour windows to a uniform 96-hour deadline, providing organizations more time to assess incident scope and impact before reporting.

Incident reporting threshold harmonization accompanies the procedural changes. The proposals raise minimum thresholds for mandatory reporting, reducing notification requirements for minor incidents that currently consume significant compliance resources. Organizations should maintain robust incident detection and classification capabilities to determine when unified reporting obligations apply under the new framework.

GDPR personal data definition refinement

The Digital Omnibus proposes significant clarification of the GDPR's personal data definition through a contextual approach. Under current interpretations, data may be considered personal if any party could theoretically re-identify individuals, creating extensive compliance obligations for data that poses minimal practical privacy risk. The proposal introduces a relative definition where data is only considered personal if the current data holder has reasonable means to identify the data subject.

This refinement has substantial implications for data sharing, secondary processing, and AI development activities. Pseudonymized data shared with third parties who lack identification keys would no longer automatically constitute personal data processing by the recipient, potentially enabling broader data use for research, analytics, and machine learning without full GDPR compliance requirements. However, the original data controller retaining identification capability would remain subject to GDPR obligations for their processing activities.

The proposals also introduce new exemptions for processing special category data in AI development and training contexts. Biometric data processing for identity verification under user control receives specific exemption treatment. Additionally, certain AI processing activities may qualify as legitimate interests under GDPR Article 6, reducing reliance on consent as the primary legal basis for AI development data processing. Organizations should assess how these changes affect their data strategy and AI development compliance approaches.

AI Act implementation simplification

The Digital Omnibus addresses implementation challenges emerging from the AI Act's detailed requirements. High-risk AI system obligations face extended deadlines and proportionality adjustments recognizing that many organizations, particularly small and medium enterprises, require additional time and guidance to achieve compliance. The proposals delay certain high-risk system requirements while the European Commission develops more detailed implementing guidance.

Assessment and documentation requirements receive streamlined treatment under the proposals. Rather than requiring exhaustive documentation for every AI system element, the revised approach focuses on material aspects affecting system performance and risk. Conformity assessment procedures may incorporate existing certifications and standards compliance as evidence of requirement satisfaction, reducing duplicate evaluation efforts.

SME-specific measures in the proposals include reduced fees for regulatory procedures, extended implementation timelines, and simplified documentation templates. AI regulatory sandboxes receive enhanced support to help innovators test systems under regulatory supervision before market deployment. These measures aim to maintain Europe's competitive position in AI development while ensuring appropriate governance.

Cross-framework coordination mechanisms

The proposals establish formal coordination mechanisms between regulatory authorities supervising different digital frameworks. Financial supervisory authorities, data protection authorities, AI market surveillance authorities, and cybersecurity competent authorities would participate in structured information sharing and joint enforcement activities. This coordination addresses inconsistent interpretations that have created compliance uncertainty for organizations subject to multiple frameworks.

Competent authority guidance processes receive standardization under the proposals. When novel compliance questions arise, authorities would engage in defined consultation processes before issuing conflicting interpretations. Binding coordination mechanisms would resolve inter-authority disputes affecting cross-regulated entities. These governance improvements should reduce the legal uncertainty organizations currently face when navigating overlapping requirements.

Enforcement coordination provisions address situations where violations implicate multiple regulatory frameworks. Rather than facing separate enforcement proceedings from multiple authorities, organizations would encounter coordinated enforcement respecting ne bis in idem principles against duplicate punishment. Lead authority designation processes would determine primary supervisory responsibility for cross-cutting matters.

Data Act and Data Governance Act alignment

The Digital Omnibus proposals align the Data Act with other digital regulations to eliminate conflicts and reduce compliance complexity. Data portability requirements under GDPR and Data Act receive harmonized implementation, establishing consistent technical standards for data export and transfer. Cloud service switching provisions coordinate with contractual and consumer protection frameworks to prevent conflicting obligations.

Data intermediation services under the Data Governance Act benefit from clarified relationships with other digital regulations. The proposals resolve questions about data intermediary obligations when handling personal data subject to GDPR or sector-specific data regulations. Trust and governance frameworks for data spaces receive integration with broader digital governance mechanisms.

Connected product data access requirements under the Data Act receive clearer boundaries distinguishing mandatory access rights from intellectual property protections. Manufacturers and data holders gain improved certainty about obligations while users and third parties understand their access entitlements. Technical standard development receives accelerated support to enable practical implementation of data access and portability requirements.

NIS2 and DORA harmonization

Financial entities subject to both NIS2 and DORA face particularly complex compliance landscapes that the Digital Omnibus addresses. The proposals clarify that DORA serves as the primary framework for financial sector cybersecurity, with NIS2 requirements satisfied through DORA compliance for in-scope entities. This lex specialis determination eliminates uncertainty about which framework takes precedence when requirements differ.

Incident classification schemas receive harmonization across NIS2 and DORA to enable consistent severity assessment and reporting. Organizations currently maintaining separate classification systems for each framework could consolidate to unified approaches. Detection and response capabilities benefit from aligned expectations about what constitutes adequate monitoring and incident handling.

Third-party risk management requirements under DORA and NIS2 receive coordination to prevent duplicate due diligence and oversight obligations for the same service providers. Critical ICT service provider oversight mechanisms under DORA extend to satisfy NIS2 supply chain security requirements for covered entities. These harmonization measures significantly reduce compliance burden for financial institutions.

Implementation timeline and adoption process

The Digital Omnibus proposals must complete the EU legislative process before taking effect. The European Parliament and Council will review, potentially amend, and ultimately adopt the proposals through ordinary legislative procedure. Based on typical legislative timelines, adoption could occur in late 2026 or 2027, with implementation following transitional periods specified in the final texts.

Organizations should not delay compliance efforts pending Omnibus adoption, as existing regulatory requirements remain fully applicable until amended texts enter into force. However, compliance program design should account for anticipated simplifications to avoid over-investment in capabilities that may become unnecessary. Flexible program architectures that can adapt to evolving requirements provide optimal positioning.

Industry associations and stakeholder organizations have opportunities to influence final provisions through public consultation processes and advocacy engagement. Organizations with specific concerns about current requirements or proposed changes should participate in consultation opportunities and communicate positions through appropriate channels.

Compliance program implications

The Digital Omnibus proposals have significant implications for existing compliance programs:

Incident response: Organizations should prepare to transition incident reporting to unified ENISA portal once operational. Current multi-track reporting processes may require modification, but overall reporting burden should decrease with extended timelines and raised thresholds.

Data protection: Privacy programs should monitor personal data definition changes and assess impacts on data processing activities. Pseudonymization strategies may provide enhanced compliance benefits under the contextual approach to personal data.

AI governance: AI system inventories and risk assessments should continue under current AI Act requirements while preparing for potential simplifications. Documentation practices should maintain flexibility to adapt to revised requirements.

Cross-framework coordination: Organizations maintaining separate compliance programs for different regulatory frameworks should explore integration opportunities that anticipate coordinated regulatory approaches.

Recommended actions for the next 90 days

  • Analyze Digital Omnibus proposals to identify provisions affecting current compliance programs and planned initiatives.
  • Assess incident reporting processes for readiness to transition to unified ENISA portal once implementation guidance becomes available.
  • Review data processing activities to identify how contextual personal data definitions might affect compliance obligations and enable new use cases.
  • Evaluate AI system documentation and assessment approaches for flexibility to adapt to simplified requirements while maintaining current compliance.
  • Monitor legislative progress through European Parliament and Council proceedings to anticipate adoption timeline and final provisions.
  • Engage industry associations to communicate organizational perspectives on Omnibus proposals through consultation processes.
  • Brief executive leadership and boards on regulatory simplification developments and their implications for compliance strategy and resource allocation.
  • Coordinate with legal counsel to assess how proposed changes affect regulatory risk assessments and compliance priorities.

Zeph Tech analysis

The EU Digital Omnibus proposals represent a significant and welcome effort to rationalize Europe's increasingly complex digital regulatory landscape. Organizations have struggled with overlapping, sometimes conflicting requirements across GDPR, NIS2, DORA, AI Act, and Data Act frameworks. The Commission's recognition that regulatory complexity imposes costs without proportionate benefits signals a maturing approach to digital governance.

However, organizations should approach these proposals with measured expectations. Legislative processes typically modify Commission proposals substantially, and stakeholder lobbying may introduce new complexities even as others are addressed. The multi-year adoption timeline means existing compliance obligations remain fully applicable during the interim period. Organizations that have invested significantly in current compliance approaches should not abandon those investments prematurely.

The contextual approach to personal data represents the most substantive policy shift in the proposals. If adopted as proposed, this change could significantly affect data ecosystem dynamics, enabling data sharing and AI development activities that current interpretations restrict. Organizations should assess strategic opportunities this change might enable while monitoring how data protection authorities respond to the proposal.

Unified incident reporting through ENISA addresses a genuine pain point for organizations facing multiple, sometimes contradictory notification requirements with different timelines. The extended 96-hour deadline provides meaningful additional time for incident assessment. However, practical implementation will require significant technical infrastructure development and inter-authority coordination that may prove challenging.

Zeph Tech will continue monitoring Digital Omnibus developments through the legislative process and provide updated guidance as adoption approaches.

Timeline plotting source publication cadence sized by credibility.
3 publication timestamps supporting this briefing. Source data (JSON)
Horizontal bar chart of credibility scores per cited source.
Credibility scores for every source cited in this briefing. Source data (JSON)

Related briefings

Curated signals from the same pillar or overlapping topics.

Continue in the Compliance pillar

Return to the hub for curated research and deep-dive guides.

Visit pillar hub

Latest guides

  • EU Digital Omnibus
  • GDPR Reform
  • AI Act Implementation
  • NIS2 Harmonization
  • DORA Coordination
  • Regulatory Simplification
Back to curated briefings

Comments

Community

We publish only high-quality, respectful contributions. Every submission is reviewed for clarity, sourcing, and safety before it appears here.

    Share your perspective

    Submissions showing "Awaiting moderation" are in review. Spam, low-effort posts, or unverifiable claims will be rejected. We verify submissions with the email you provide, and we never publish or sell that address.

    Verification

    Complete the CAPTCHA to submit.