B3S for Hospitals

B3S Compliant ISMS for Hospitals

Hospitals and healthcare organizations face particular challenges when it comes to information security. As operators of critical infrastructure (KRITIS), they are subject to specific legal requirements – especially under section 8a of the German BSI Act (BSIG). The sector-specific security standard (B3S) for hospitals defines clear requirements for an effective Information Security Management System (ISMS) and serves as a recognized benchmark for demonstrating compliance to supervisory authorities.

Implementing a B3S-aligned ISMS requires not only a solid understanding of regulatory expectations but, above all, a structured integration into existing clinical, technical, and administrative processes.

Consileon supports hospitals in establishing, further developing, and preparing a B3S-compliant ISMS – from initial analysis and implementation through to successful evidence of compliance for the BSI.

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1

What is B3S?

The sector-specific security standard (B3S) for hospitals is a security framework recognized by the German Federal Office for Information Security (BSI) in accordance with section 8a of the German BSI Act (BSIG). It specifies the legal requirements for operators of critical infrastructure (KRITIS) in the healthcare sector and defines the organizational and technical measures necessary to ensure information security.

In terms of content, B3S is aligned with established standards such as ISO/IEC 27001 but supplements them with concrete requirements tailored to the specific structures, processes, and care environments of hospitals. Its objective is to sustainably ensure the availability of critical medical systems, the protection of sensitive patient data, and the resilience of clinical operations.

2

For which organizations is B3S relevant?

B3S is mandatory for hospitals classified as operators of critical infrastructure (KRITIS). The decisive threshold is 30,000 full inpatient cases per year, as defined by law. Facilities exceeding this threshold are required under the BSI Critical Infrastructure Regulation to regularly provide the German Federal Office for Information Security (BSI) with evidence of appropriate organizational and technical security measures. This particularly affects large acute care hospitals, university medical centers, and hospital groups that collectively reach the threshold.

Regardless of the legal obligation, B3S can also be beneficial for smaller hospitals and other healthcare institutions. Many organizations adopt the standard voluntarily as a structured framework to systematically enhance their information security and prepare for future regulatory requirements.

3

How is an ISMS in accordance with B3S implemented?

The implementation of a B3S-compliant ISMS begins with a structured analysis of the hospital’s existing IT and process landscape. Critical systems, medical applications, administrative processes, and interfaces with service providers are identified and assessed with regard to their protection requirements. On this basis, a systematic risk analysis is conducted, from which specific organizational and technical measures are derived.

Particular challenges in the hospital environment include the high diversity of systems, the close interconnection of medical technology and IT, and continuous 24/7 operations. An effective ISMS aligned with B3S therefore requires clearly defined responsibilities, coordinated emergency concepts, regular staff training, and the ongoing review and enhancement of security measures. The objective is to sustainably ensure the availability of clinical operations, the protection of sensitive patient data, and the overall resilience of the organization.

How Consileon supports hospitals with B3S

Consileon provides comprehensive support to hospitals and healthcare institutions in implementing a B3S-compliant Information Security Management System (ISMS). We assist with a structured implementation approach – from determining protection requirements and conducting risk assessments to integrating appropriate organizational and technical measures into your clinical and administrative processes.

Through maturity and gap analyses, we create transparency into your current implementation level and identify prioritized areas for action. We also support you in providing evidence to the German Federal Office for Information Security (BSI), preparing internal assessments, and assisting with audit-ready documentation – enabling you to meet regulatory requirements efficiently, reliably, and in a structured manner.

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B3S is more than a regulatory obligation. It is the foundation for stable clinical processes and the sustainable protection of sensitive patient data. We support you in embedding information security in a structured manner and in meeting BSI requirements with robust, audit-ready compliance.

Nico Boll
Project Manager
+49 1737563688
nico.boll@consileon.de

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B3S Consulting for Hospitals