Introduction

Recognizing the importance of digital infrastructure across industries, including healthcare, the European Union has updated its cybersecurity legislation with the NIS2 Directive. Healthcare firms confront significant problems and obligations in protecting digital assets and patient data in light of the industry’s designation as a critical sector under Annex I of NIS2.

Alarming new data suggests a rise in cyberattacks on the healthcare sector. In 2022 alone, the European Union Agency for Cybersecurity (ENISA) recorded a 47% rise in cyberattacks on healthcare businesses. In addition to endangering private patient information, these attacks often interfere with essential healthcare operations.

Impact on Both Private and Public Healthcare Sectors

The NIS2 Directive makes no distinction between public and private healthcare entities, acknowledging that cyber threats endanger all aspects of healthcare delivery. Both sectors must now adhere to stringent cybersecurity standards, ensuring a unified defense against escalating cyber threats.

NIS2 Non-compliance Penalties

The requirements of the NIS2 are legally binding on the entities that fall under its purview. Member States have the discretion to penalize non-compliant entities with dissuasive penalties as well as administrative fines. In general, essential entities that fail to comply with its directives may be fined up to €10 million or 2% of their total turnover worldwide – whichever is higher. Important entities that fail to comply with the NIS2 may be fined up to €7 million or 1.7% of global turnover. In addition, non-compliant companies may be forced to suspend their business activities until they meet the NIS2 requirements and achieve 100% compliance. Learn more about the NIS2 Directive.

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Cybersecurity Challenges For Healthcare

Data Protection and Privacy

The massive volumes of personally identifiable patient information present a serious problem for management and security. Keeping up with cybersecurity standards and data protection requirements like GDPR can be a daunting task.

Medical Technology

From patient information management to life-supporting gadgets, modern healthcare is dependent on networked digital systems. It's a fine line to walk between making sure these devices are safe from cyber attacks and limiting their usefulness.

Resource Limitations

Some healthcare organizations, lack the resources for sophisticated cybersecurity measures. This includes financial constraints and a shortage of skilled cybersecurity personnel.

Evolving Threat Landscape

With each passing day, cybercriminals get more cunning in their attacks. Keeping up with these shifts calls for constant awareness and the development of flexible cybersecurity approaches.

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Implications of NIS2 for the Healthcare Industry

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Enhanced Cybersecurity Measures: NIS2 requires healthcare organizations to implement state-of-the-art cybersecurity technologies. This includes advanced threat detection systems, robust firewalls, and regular cybersecurity audits.

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Mandatory Incident Reporting: Healthcare entities must promptly report any significant cyber incidents. This requirement not only helps in quick mitigation but also contributes to a broader understanding of the threat landscape.
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Risk Management and Compliance: Regular risk assessments are mandated to identify potential vulnerabilities. Healthcare providers must also ensure compliance with both NIS2 and other relevant data protection regulations.

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Collaboration and Information Sharing: NIS2 encourages, and in some cases requires, entities to share information about cyber threats and vulnerabilities. This collaboration can significantly enhance the collective cybersecurity posture across the healthcare sector.

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How to Prepare for compliance with the NIS2 Directive

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NIS2 Directive Frequently Asked Questions

1. How will the new NIS2 rules be supervised and enforced?

The NIS2 Directive emphasizes the responsibilities of competent authorities for supervision and enforcement. Key measures include regular and targeted audits, on-site and off-site checks, requests for information, and access to documents or evidence.

NIS2 interacts with the CER Directive and the DORA, focusing on the physical and cyber resilience of critical entities. National competent authorities under both directives must cooperate and exchange information on risks and incidents. The NIS2 Cooperation Group will regularly meet with the Critical Entities Resilience Group, and the DORA addresses cybersecurity risk management and reporting obligations in the financial sector

NIS2 aims to improve cyber risk management through clear responsibilities, appropriate planning, and increased EU cooperation. It requires Member States to appoint national authorities for cyber crisis management, introduces large-scale cybersecurity incident and crisis response plans, and establishes the EU-CYCLONe network for managing large-scale cybersecurity incidents and crises​

NIS2 mandates that all companies address a core set of cybersecurity risk management policies, including incident handling, supply chain security, vulnerability handling, and the use of cryptography. It introduces a multi-stage approach to incident reporting, requiring companies to submit an early warning within 24 hours, an incident notification within 72 hours, and a final report within one month

Don't Wait Until It's Too Late

Contact us for a free initial consultation to plan your implementation of the NIS2 directive together.
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