Matheson EU Legislative Insights
Expert analysis of the EU legislation shaping Ireland’s Presidency agenda.
Matheson EU Legislative Insights is a fortnightly update focusing on key aspects of the legislative agenda during the course of Ireland’s Presidency of the Council of the European Union.
Every two weeks, Matheson experts will review a key piece of legislation to provide an “at-a-glance” summary of its strategic context, objectives and implications. Should you have any queries in respect of the contents of the update, please do not hesitate to contact your usual Matheson LLP contact or any member of our team detailed below.
In focus: AI Digital Omnibus amendments to the AI Act
What is the Revision of the AI Act?
On 19 November 2025, the European Commission proposed the Digital Omnibus Package. The package, consisting of two separate regulations (Regulations (EU) 2025/0360 and 2025/0359), aims to simplify and refine the EU’s digital regulatory framework, cut compliance costs for companies (particularly for start-ups) and facilitate competition and innovation across the EU.
The AI Digital Omnibus proposes targeted amendments to the AI Act, the world’s first comprehensive horizontal legal framework for artificial intelligence. Since the AI Act entered into force, stakeholders, including SMEs, start-ups and industry groups, have identified areas where the obligations are disproportionately complex relative to the risk presented; where overlaps with sector-specific legislation create duplicative compliance burdens; and where technical provisions require refinement.
In addition, delays in the designation of national competent authorities and the lack of harmonised technical standards, guidelines and support tools have also presented challenges for in-scope entities. As such, the AI Digital Omnibus seeks to simplify the AI Act and address some of the implementation challenges, while maintaining the core safeguards aimed at protecting fundamental rights.
Who is affected by the AI Digital Omnibus?
The targeted amendments proposed in the AI Digital Omnibus will be relevant to entities and individuals in scope of the AI Act, namely those that provide, place on the market, put into service, deploy, develop, import, distribute or use AI systems and general-purpose AI (“GPAI”) models in the EU, regardless of whether they are located within or outside the EU. As such, a broad range of businesses will be caught by the amended rules, including technology companies, financial services firms, healthcare, insurance and HR technology providers and public authorities.
Importantly, given that the AI Digital Omnibus delays the timeline for implementation of the rules for high-risk AI systems, organisations developing and/or deploying such systems will, in particular, benefit from the amendments. SMCs will also benefit from the extended the regulatory privileges afforded to them under Article 99 of the AI Act.
At a glance: the AI Digital Omnibus amendments to the AI Act
| What it is | Regulation (EU) 2025/0359 (“AI Digital Omnibus”) proposes targeted amendments to Regulation (EU) 2024/1689 (“AI Act”) with the aim of simplifying and streamlining the AI Act and addressing some of its implementation challenges, while retaining the core risk-based architecture of the original instrument. |
| The legal instrument | Regulation (EU) 2025/0359 |
| Common name | “AI Act revision” / “AI Digital Omnibus” |
| Who it targets | Any and all entities and individuals caught within the scope of the AI Act, including: providers, deployers, importers and distributors of AI systems and general-purpose AI (“GPAI”) models (regardless of whether they are located within or outside the EU). This includes technology companies, financial services firms, healthcare, insurance and HR technology providers and public authorities. Small mid-cap enterprises (“SMCs”) will benefit the most from the AI Digital Omnibus. |
| Proposal date | 19 November 2025, as part of the Digital Omnibus package |
| Current stage | The AI Digital Omnibus was formally adopted by both the European Parliament and the European Council on 16 June 2026 and 29 June 2026 respectively. It is set to be published in the Official Journal of the European Union shortly and will enter into force three days after publication. |
| Key institutional leads | Executive Vice-President Henna Virkkunen (EPP/Finland); Commissioner Michael McGrath (Renew/Ireland) |
| Matheson key contacts | Marie McGinley, Davinia Brennan and Sarah Jayne Hanna |
What does this mean for your business?
As the legislative procedure for the AI Digital Omnibus has concluded, businesses now have some welcome clarity on the nature and scope of the amendments to the AI Act. Despite the delayed implementation of the high-risk AI system rules, it is critical that businesses continue with their AI Act compliance efforts and finalise their AI governance frameworks as soon as possible. This includes mapping all AI systems and GPAI models, assessing whether any AI systems are high-risk (see our article on the European Commission’s guidance on what AI systems qualify as “high-risk” here), determining which operator role you play and your related obligations, preparing technical and compliance documentation and putting in place internal policies, and procedures.
Management boards and directors should also engage with their stakeholders to ensure effective AI governance and compliance (see our article discussing key board issues here).
For more information on your obligations under the AI Act, see our comprehensive AI Guide for Businesses.
