DIGINNOV

We help organisations turn regulatory questions into work that teams can assign and track. We start with the activities, services or systems in scope, review available policies and records, and discuss where teams need clearer responsibilities, controls or evidence.

How we work

  1. Define scope

    Identify the activities, systems and roles to review and the requirements that may apply.

    Output · Scope and requirements map

  2. Review controls and evidence

    Compare policies, controls and records with the requirements in scope and document gaps.

    Output · Gap and evidence register

  3. Prioritise actions

    Agree what to address first, who owns each action and what evidence will show progress.

    Output · Prioritised action plan

EU compliance frameworks

GDPR · General Data Protection Regulation

The GDPR governs how organisations collect, use, store and share personal data. It sets duties for controllers and processors and gives individuals rights over their data.

Key provisions

Identify a lawful basis and collect only what is necessary (Arts. 5–6). Explain how data is used and respond to rights requests (Arts. 12–22). Build in data protection and appropriate security, notify qualifying breaches and assess high-risk processing (Arts. 25, 32–35).

Risks of non-compliance

Authorities can restrict or order a halt to processing. Depending on the infringement, fines can reach €10 million or 2% of worldwide annual turnover, or €20 million or 4%, whichever is higher within the applicable tier for undertakings (Arts. 58, 83).

Legal references

AI Act · EU Artificial Intelligence Act

The AI Act sets rules for AI systems and general-purpose AI models. The obligations depend on the organisation’s role, the system’s intended use and its risk classification.

Key provisions

Take measures to support AI literacy and screen for prohibited practices (Arts. 4–5). For high-risk systems, address requirements such as risk management, data governance, documentation and human oversight, including separate duties for deployers (Arts. 9–15, 26). Check transparency duties for specified uses, including certain AI-generated content (Art. 50).

Risks of non-compliance

Prohibited practices can attract fines of up to €35 million or 7% of worldwide annual turnover. Certain other breaches can attract up to €15 million or 3%. Article 99 sets specific rules for calculating fines, including lower ceilings for SMEs.

Legal references

NIS2 · Network and Information Systems Directive

NIS2 strengthens cybersecurity in specified sectors. The applicable requirements depend on factors such as the services provided, the size of the entity and its classification under national law.

Key provisions

Assign management oversight of cybersecurity (Art. 20). Put measures in place for incident handling, business continuity and supply-chain security (Art. 21). Report significant incidents to the competent authority or incident response team within the applicable deadlines (Art. 23).

Risks of non-compliance

Authorities can issue corrective orders and impose fines under national law. For breaches of Arts. 21 or 23, NIS2 requires national maximum fines of at least €10 million or 2% of worldwide annual turnover for essential entities and €7 million or 1.4% for important entities, whichever is higher in each case (Art. 34).

Legal references

CER · Critical Entities Resilience Directive

The CER Directive helps protect essential services from disruption. It applies to critical entities identified by national authorities and addresses risks such as natural hazards, accidents and deliberate acts (Arts. 6, 12).

Key provisions

Assess the risks that could disrupt essential services (Art. 12). Put proportionate measures in place to prevent incidents, protect facilities, respond and recover (Art. 13). Notify incidents that significantly disrupt, or could significantly disrupt, essential services (Art. 15).

Risks of non-compliance

Authorities can inspect entities, require evidence and order corrective action. Penalties are set under national law, so the applicable sanctions depend on the country and the infringement (Arts. 21–22).

Legal references

What you can expect

Scope and requirements map
The activities and systems reviewed, the roles involved and questions that require further assessment.
Gap and evidence register
Existing controls and documentation alongside gaps, owners and evidence still to collect.
Prioritised action plan
Practical measures, owners and dependencies that your legal, security and operational teams can use to organise follow-up.