SUMMARY:

On 19th November the European Commission has unveiled its awaited Digital Package aimed at simplifying EU digital rules and fostering innovation.

The package includes a Digital Omnibus proposal on AI, aimed streamlining regulations on AI, cybersecurity, and data, alongside a Data Union Strategy and the European Business Wallet aimed at reducing administrative burdens (see attached).

The Commission also launched the public consultation and call for evidence on the Digital Fitness Check (planned for Q4 2027), open for submissions until 11 March 2026 (FESI will circulate a first draft of response in the coming weeks).

MORE INFORMATION:

1. Digital Omnibus

The Digital Omnibus Regulation Proposal on AI proposes targeted amendments to the AI Act, simplifying cybersecurity reporting (NIS2 Directive, GDPR, DORA), and improving access to data (Data Act). Key elements of the proposal include:

Targeted amendments to the AI Act:

• The timeline for applying high-risk rules is adjusted to a maximum of 16 months, so the rules start applying once the Commission confirms the needed standards and support tools (including foreseen guidelines) are available (see article 1§31).
• Simplification of requirements for SMEs by extending certain simplifications, including reduced documentation requirements.‍
• Simplifying cybersecurity reporting: introduction of a a single-entry point for cybersecurity incident reporting, consolidating obligations currently applying to companies across multiple laws (NIS2, GDPR, DORA) for streamlined compliance.‍
• Privacy & cookies: amendments to the GDPR and cookie rules will harmonise privacy practices and reduce user disruptions. The amendments will notably reduce the number of times cookie banners pop up and allow users to indicate their consent with one-click and save their cookie preferences through central settings of preferences in browsers and operating system.‍
• Data: consolidation of EU data rules through the already existing Data Act Regulation, merging four pieces of legislation into one.

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2. Data Union Strategy

The Digital Package also includes a new Data Union Strategy (communication - non-binding) outlining additional measures to unlock more high-quality data for AI by expanding access, such as data labs. Key elements includes:

• ‍A Data Act Legal Helpdesk, complementing further measures to support implementation of the Data Act.‍
• Strengthened Europe's data sovereignty through a strategic approach to international data policy: anti-leakage toolbox, measures to protect sensitive non-personal data and guidelines to assess fair treatment of EU data abroad.

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3. European Business Wallet
The Digital Package finally includes a Proposal for a Regulation on the establishment of European Business Wallet, a new digital tool designed to simplify business operations across EU Member States. Key elements includes:

• Businesses opting for the Wallet will be able to digitally sign, timestamp and seal documents; securely create, store and exchange verified documents; and communicate securely with other businesses or public administrations in their own and the other 26 Member States.
• After adoption, all levels of public administration across the EU, including EU institutions, bodies and agencies, will have two years to implement the use of the Business Wallets with transitory measures for leveraging existing similar systems at Member State level.  ‍
• Companies will not be obliged to use the European Business Wallets. The Regulation places obligations solely on public sector bodies to accept its core functions, while companies remain free to decide whether to adopt the wallets for their commercial operations or interactions with public authorities. 

The Commission has today also launched the second step of the simplification agenda, with a wide consultation on the Digital Fitness Check (see attached) open until 11 March 2026. The Fitness Check will ‘stress test' how the rulebook delivers on its competitiveness objective, and examine the coherence and cumulative impact of the EU's digital rules.

‍NEXT STEPS:

• FESI will further assess the different proposals in more details and update its position paper on the Digital Omnibus. We will also circulate shortly a first draft response to the consultation on the Digital Fitness Check.
• Members are invited to check the proposals internally and flag to FESI any provisions that would impact their businesses.
• The legislative proposals (Omnibus and Digital wallets) will now be submitted to the European Parliament and the Council for adoption. FESI will closely monitor the legislative process and update members of any relevant developments.