ISO 27001 and NIS2: what self-built AI means for your ISMS

What changes in your ISMS when you build AI yourself?

An information security management system (ISMS) covers all important assets and services of an organisation. An AI that many staff use with sensitive data is part of it, wherever it comes from. If you build it yourself from open-source components, you take on an additional role: you are not only the operator, but also the developer and system builder of the solution. The requirements that a provider would otherwise meet for its product then sit in your ISMS.

Which ISO 27001 requirements matter most?

ISO/IEC 27001:2022 requires risk treatment with controls from Annex A, as far as they are needed for your risks. For a self-built AI, these are mainly:

Topic (Annex A)	What it means for a self-built AI
Technical vulnerabilities (8.8)	monitor and patch all layers from the driver to the interface; see Security updates
Configuration and changes (8.9, 8.32)	record settings, test and approve changes
Secure development (8.25, 8.28)	develop and review your own connections and extensions securely
Access control (5.15 ff.)	permissions from identity management, including for specialist systems
Logging (8.15)	who did what and when, protected against alteration
Suppliers and supply chain (5.19 to 5.23)	assess open-source projects, models and service providers
Business continuity (5.30)	plan and rehearse recovery

There is no ISO 27001 product certificate. What is certified is an organisation’s ISMS with a defined scope.

What does NIS2 require?

The NIS2 Directive obliges essential and important entities to take risk management measures (Art. 21). These include risk analysis, incident handling, business continuity, supply chain security, security in acquisition, development and maintenance including vulnerability handling, training, access control and multi-factor authentication. For a self-built AI, this means: you carry the points on development, maintenance and vulnerabilities yourself instead of checking them at a supplier.

How is NIS2 implemented in Germany, Austria and Switzerland?

• Germany: The NIS2 Implementation Act has been in force since 6 December 2025 and has recast the BSI Act (BSIG). The measures are set out in § 30 BSIG. Depending on their size, many hospitals fall under it as important or particularly important entities. According to the prevailing view, the federal act does not in principle cover municipal administration; the federal states regulate their administrations themselves. Municipal companies, such as public utilities or IT service providers, may be affected.
• Austria: The Network and Information Systems Security Act 2026 (NISG 2026, BGBl. I No. 94/2025) was promulgated on 23 December 2025; its main provisions have applied since 1 October 2026. It implements NIS2 and requires risk management measures from essential and important entities, including in healthcare.
• Switzerland: Switzerland is not bound by NIS2. Since 1 April 2025, the Information Security Act (ISA) has required cyberattacks on critical infrastructure to be reported within 24 hours to the Federal Office for Cyber Security (BACS). Those covered include federal, cantonal and municipal authorities as well as hospitals on a cantonal hospital list.

Whether your organisation is affected is something to clarify with the competent authority’s applicability check and your information security officer.

What do auditors check with self-built AI?

• an up-to-date list of all components with version and origin, including the models
• proof that security advisories are tracked and updates are installed
• permissions concept and logs, with retention periods
• a risk analysis for the AI, for example on data leakage and manipulated instructions
• an emergency plan and rehearsed recovery
• responsibilities with deputies; see Bus factor

How does this work with basebox?

basebox is certified to ISO 27001; the certificate covers the management system of basebox GmbH, including the production, implementation and operation of the software. For NIS2, KRITIS (German critical infrastructure rules) and the B3S for hospitals (the sector-specific security standard), you receive proof for your own obligations. We are currently preparing a mapping of our measures to the B3S; you can have it on request. For the cloud, the BSI C5 Type 1 attestation is in progress. We are implementing the Cyber Resilience Act: the software bill of materials and the reporting channel for vulnerabilities are in place, and the remaining obligations will follow by December 2027. For the server on your premises, the certificate describes basebox as a supplier; the operation of the server is covered by your own ISMS. Answers for your security review are available at /sicherheit/fragen.

Not legal advice: This guide gives an overview, as of 11 October 2026. Whether and how NIS2, the BSIG, the NISG 2026 or the ISA apply to your organisation is something to check with your information security officer and, where necessary, legal counsel.