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DORA, EU CRA, and the AI Act: Understanding Europe's New Compliance Wave

The European Union is raising the bar on digital and AI-related compliance. With three major regulatory frameworks, DORA, the EU Cyber Resilience Act, and the AI Act, set to reshape global operations, organizations across industries must act now to stay ahead of risk and aligned with evolving expectations. It is reasonable to expect some of these frameworks to make it into U.S. regulations, so being pro-active now, can save you time and stress later.

Whether you operate in the EU or just sell, service, or store data from EU users, these laws can apply to you. Here’s what you need to know:

🔐 DORA (Digital Operational Resilience Act)

Who it applies to: Financial entities (banks, investment firms, insurance companies) and their ICT (information and communications technology) providers
Enforcement Date: January 17, 2025

What it requires:

• End-to-end operational resilience: Entities must be able to withstand, respond to, and recover from ICT-related disruptions and threats.

• Risk assessments and incident response plans: Ongoing risk analysis, impact evaluations, and incident classification are mandatory.

• ICT third-party risk management: Vendors and tech partners must be monitored and held to the same standards.

• Mandatory threat-led penetration testing (TLPT): Certain firms must undergo advanced testing of their cybersecurity defenses.

Why it matters:
Even U.S.-based firms servicing EU financial companies or acting as cloud or data vendors could fall under DORA’s scope. The regulation is designed to close gaps exposed by cyberattacks and operational outages in the financial sector.

🛡️ EU Cyber Resilience Act (CRA)

Who it applies to: Manufacturers and distributors of software, hardware, and connected devices (including IoT) intended for the EU market
Expected Enforcement: Gradual application beginning 2025, with some requirements enforced immediately

What it requires:

• Secure-by-design development: All digital products must meet baseline cybersecurity standards before being sold in the EU.

• Ongoing vulnerability management: Developers must maintain security through patches, updates, and disclosures—even post-sale.

• Incident reporting within 24 hours of becoming aware of active exploitation.

• Product categorization by risk level, with higher standards for critical products like password managers or OS components.

Why it matters:
If you sell apps, software tools, SaaS platforms, or IoT devices to EU customers, you must prove cyber resilience or face market bans or fines. Non-compliance could cost up to €15 million or 2.5% of global turnover.

🤖 EU AI Act

Who it applies to: Developers, importers, and deployers of AI systems used within the EU
Expected Enforcement: Passed in 2024, with phased compliance deadlines starting in mid-2025

What it requires:

• Risk-based classification of AI systems:

  • Unacceptable risk: Prohibited (e.g., social scoring by governments)

  • High-risk: Subject to strict requirements (e.g., medical devices, biometric ID)

  • Limited/Minimal risk: Subject to transparency obligations

• High-risk AI obligations include:

  • Data governance and documentation

  • Human oversight and explainability

  • Risk management and incident reporting

• Foundation models and generative AI tools will also be regulated under specific transparency and safety rules

Why it matters:
If your business develops or uses AI that impacts decision-making (e.g., in healthcare, hiring, finance), the AI Act may require extensive documentation, audits, and transparency mechanisms even if your headquarters are outside the EU.

📣 VanRein Compliance Helps You Prepare

Even if these regulations aren’t "local," their impact will be global especially for SaaS, healthcare, finance, and tech companies. VanRein Compliance offers proactive services that align your organization with these emerging standards:

✅ AI Audit Services – Benchmark your systems against ISO 42001, the EU AI Act, and U.S. Executive Orders
✅ NIST Cybersecurity Audits – Evaluate your current cyber posture with internationally respected frameworks
✅ Disaster Recovery & Cybersecurity Tabletop Exercises – Prepare your team for AI failures, breaches, or regulatory investigations
✅ Custom Policy Development – Implement enforceable standards for AI, data protection, and operational resilience
✅ Incident Response Playbooks – Align with DORA and CRA expectations for incident readiness

The global compliance tide is rising. Are you ready to surf it or risk getting swept away?
Connect with VanRein Compliance today to prepare your operations, secure your systems, and build trust with regulators and customers alike.

💻 NAEO Webinar: AI Data Security & Compliance

VanRein Compliance CEO and Co-Founder Rob Van Buskirk will be presenting in a special NAEO Webinar tomorrow, June 11 at 1 PM ET.

This session is a follow-up to recent conference discussions and will explore AI data security, evolving compliance challenges, and how organizations can prepare for what’s next.

Don’t miss it! Click the register link and secure your spot now!

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Building a Compliant AI Program: A Quickstart Guide

AI isn’t coming—it’s already here, transforming how we work, communicate, and serve customers. But for every breakthrough comes a new risk. As regulators across the globe launch frameworks like the EU AI Act, U.S. Executive Orders, and ISO 42001, companies using or developing AI must quickly move from experimentation to responsible implementation.

Here’s how to begin building a compliant, future-ready AI program—even if you’re just starting out.

🧱 Start with Structure

1. Appoint an AI Governance Lead
Whether it’s your Compliance Officer, CTO, or a cross-functional committee, someone must own oversight of your organization’s AI strategy and risks. Document accountability and ensure regular reporting to executive leadership.

2. Classify Your AI Systems
Not all AI tools are the same. Identify which systems are:

• Internally developed or externally sourced

• Supporting internal operations (e.g., analytics)

• Influencing user-facing decisions (e.g., chatbots, loan pre-approval, hiring screens)

3. Conduct Risk Assessments
Follow a structured risk framework to evaluate each system’s impact, particularly regarding bias, privacy, security, and explainability. Systems used in healthcare, HR, or finance often fall under “high-risk” categories in regulatory frameworks.

🧩 Operationalize Compliance

4. Maintain an AI Inventory
Keep a real-time, documented list of all AI tools and models in use. Note vendor information, data inputs, and decision outcomes. This is critical for audits, transparency, and trust-building.

5. Create Accountability Logs
Track model changes, training data updates, feedback loops, and human-in-the-loop decision checks. These logs are required by most upcoming AI laws and demonstrate organizational responsibility.

6. Integrate Explainability and Human Oversight
Ensure key decisions made or influenced by AI are explainable to users and auditable by regulators. This may involve incorporating human review at critical decision points.

7. Review Vendor and Foundation Model Compliance
If you’re relying on third-party tools or generative models (like GPT-based systems), assess how your vendors manage compliance, security, and data ethics.

✅ VRC’s AI Audit Services Matter

With regulatory momentum building fast, even early-stage AI adopters need expert support to ensure compliance. That’s where our AI Audit Services come in.

Key Features:

• Comprehensive audit against ISO 42001, EU AI Act, and U.S. frameworks

• Gap analysis across governance, risk management, data use, and model safety

• Actionable compliance roadmap with templates, policies, and process controls

• Optional Tabletop Exercises simulating AI-specific incidents (e.g., hallucination, misuse, or data leakage)

• Audit-ready documentation for regulators, clients, and stakeholders

Return of Investment:

• Build trust with customers and investors

• Get ahead of upcoming laws before they hit

• Avoid costly rework or fines down the line

• Align AI use with your company’s core values and brand promise

AI innovation should come with built-in responsibility.
Let VanRein Compliance help you adopt, govern, and scale AI with confidence.