NIS2 Compliance Requirements for the Healthcare Industry in Germany

Like the General Data Protection Regulation (GDPR), NIS2 carries considerable fines for organizations that cannot meet their mandates. It also holds individuals accountable for failure to comply, and it mandates far more transparency and collaboration to help stop security breaches within their digital infrastructure.

Healthcare organizations in Germany must follow several compliance mandates to protect their critical infrastructure. HIPAA for Germany, GDPR, and the German Federal Data Protection Act.

Compliance mandates overwhelm healthcare organizations looking for ways to lower their security operations costs. To help meet these requirements, organizations turn to ForeNova's managed detection and response (MDR) services.

Why is NIS2 Necessary for all Healthcare Providers in Germany?

Healthcare providers are still in the middle of the digital transformation journey, modernizing their various medical applications, upgrading devices, and extending access to electronic medical records. They need to account for the requirements for NIS2 by deploying required security measures and incident response plans during or after the transformation projects.

NIS2 mandates that all healthcare providers meet and exceed the compliance requirements.

Here is a list of the most critical NIS2 mandates all Germany-based healthcare providers need to enable or execute:

1. Perform a risk analysis on all healthcare-related applications, current cybersecurity practices, and devices before and after the modernization project is finished to determine better what remediation steps will be required to meet NIS2.
2. Embedding automated incident response and remediation capabilities within normal business operations helps reduce cybersecurity risks. Attempting to respond to every cyberattack with manual resources is no longer a valid option. Hackers leveraging adversarial artificial intelligence (AI) and machine learning (ML) capabilities increase their attack velocity, requiring healthcare providers to counter this threat with automated response functions. Managed detection and response (MDR) providers like ForeNova assist healthcare clients in meeting this challenge.
3. All healthcare providers must maintain backup and recovery capability to ensure that all relevant healthcare data is accessible and retrievable during a ransomware attack.
4. Healthcare providers have become increasingly dependent on global supply chains for medicines, medical devices, operating room equipment, and hospital supplies. Each provider must implement all necessary cyber controls to prevent attacks that steal medical data, breach other ecosystem parties within the supply chain, and disrupt hospital operations.
5. Develop and implement a vulnerability management program to include continuous assessment, reporting, and recommendations for remediation.
6. A significant part of the NIS2 mandate for healthcare focuses on physical security. Hospitals, clinics, and remote locations must implement and sustain proper physical security controls, including biometric access to sensitive hospital areas, badge readers, surveillance cameras, and trained security officers.
7. Access to applications, systems, network devices, and workstations must be protected using multi-factor authentication (MFA), which is essential in meeting NIS2. Medical record breaches will occur once the hacker steals healthcare workers' initial username and password credentials. Without MFA, which offers a second level of authentication, hackers will have easy access to medical data.
8. Under NIS2, healthcare providers must enable encryption in all areas where personally identifiable information resides, including hosted applications, email systems, and databases. All data, whether in transit or at rest, must be encrypted.
9. All healthcare providers in Germany and the rest of the EU member states must ensure that all employees complete cybersecurity awareness training to comply with NIS2.
10. Another area addressed within the NIS2 mandate is the need for all healthcare providers to encrypt all phone, email, and text messaging.

Meeting and exceeding these ten requirements under NIS2 are critical for all healthcare providers in Germany. Failure to achieve and sustain these ten directives will cause several fines and penalties improved by the German national authority.

Corporate Accountability

Prior to changes within NIS2, if management teams cut funding for cybersecurity controls, managed services contract renewals, or reduced security operations resources, they would not become personally liable for negligence and intentional misconduct under NIS2.

NIS2 in Germany states, "Management within a healthcare provider is liable for any damages caused by the organization during a data breach or other cyberattack. Fines could exceed €10,000,000 or up to 2% annual turnover and suspension of services."

Authorities could levy additional fines against the German health organization for failing to notify them within 24 hours of the security breach. The health organization must also file a formal report detailing the event within 72 hours of the initial notification, including a root cause analysis and other important artifacts.

Along with financial implications, German health organizations also face an impact on their reputation as trusted healthcare providers. The organization will face countless lawsuits for non-compliance.

How Should German Healthcare Providers Collaborate With National Authorities Surrounding NIS2?

NIS2 is an EU-wide cybersecurity law. Member states, including Germany, have the right to extend other requirements within the NIS2 framework specific to healthcare organizations operating within their borders.

The German government plans to update its NIS2 directive to reflect the changing global threat landscape and its impact on citizens' personal information. In current drafts, the government added cybersecurity certifications for critical facilities to provide updated artifacts to the Federal Office of Information Security regarding their cybersecurity technical and operations every three years.

German healthcare organizations in the third category will need to ensure they comply with this additional NIS2 mandate. NIS2 may not apply to some entities because their size or other factors prevent them from being classified as essential or necessary. Germany recognized this and drafted a third category.

This third category is called critical facilities. While this supplement is still in draft stages, it shows the power each member state, including Germany, has in adding additional requirements for health providers beyond the initial scope of NIS2 compliance.

What is the Role of MDR Services For Meeting NIS2 Compliance?

With the adoption of NIS2, healthcare providers in Germany need to adopt a more proactive approach to security operations and focus more on a risk-based approach to protecting their regulated data.

This change in focus towards security operations and risk management alters how the organization needs to handle incident response, threat hunting, access to threat intelligence, and updating encryption policies and implementation. These changes in how the organization becomes more proactive and risk-based oriented directly reflect how management will become far more liable for breaches than in previous years.

• Managed Detection and Response (MDR) offerings continue to become a lifesaver for many healthcare organizations regarding meeting Germain NIS2 directives. The value delivered by MDR offerings remains exceptional to healthcare organizations in Germany requiring automated incident response and other advanced capabilities.
• 24x7x365 continuous monitoring of all healthcare systems, applications, and databases (NIS2)
• MDR services help lower operations costs than staffing in-house security operations resources, infrastructure, and maintenance costs for security tools to handle everyday cybersecurity incidents. Cost savings are becoming a primary justification for investing in an MDR service.
• ForeNova future proofing helps keep their clients updated with the latest protection capabilities to help prevent attacks using artificial intelligence (AI) without impacting the users.
• MDR's ability to automate NIS2 compliance reporting and event notification is also a critical service. Healthcare organizations in Germany have a very strict notification of a security event along with a 72-hour deadline for root cause analysis. MDR's experience in compliance automated reporting helps healthcare providers meet NIS2 requirements.
• Access to global talent helps MDR providers like ForeNova meet their service level agreement (SLA). Healthcare providers in Germany need help retaining security operations talent. ForeNova's ability to staff to meet their clients' NIS2 and other compliance requirements is one of their key differentiators in the managed services space.
• MDR providers also help organizations stay current on compliance requirements by constantly evaluating new security adaptive control solutions, including artificial intelligence (AI) and machine learning (ML) capabilities, to enhance automated incident response and reporting.

Why ForeNova?

NIS2 in Germany, like other EU compliance mandates, will constantly change. The AI Act, DORA, and NIS2 will continuously become updated as the global threat landscape changes. Partnering with ForeNova, health providers in Germany will be a firm focused on helping them meet and exceed NIS2 and other compliance mandates while reducing risk and operations costs.

Are you interested in knowing more? Click here to schedule an MDR demo today with the ForeNova team!