When a ransomware attack hit Maastricht University in December 2019, the entire digital infrastructure collapsed. Nineteen thousand students couldn’t access course materials, researchers faced looming grant deadlines with no access to their data, and the university’s systems remained down for weeks, not days. The institution eventually paid 30 bitcoin (approximately €197,000) to restore operations, but the recovery process dragged on far longer than anyone anticipated. This wasn’t just an IT failure; it was a stark reminder that in healthcare and academic medical settings, cybersecurity incidents don’t just compromise data—they disrupt education, research, and ultimately, the foundations of quality care.

Healthcare organizations sit at a dangerous intersection: they hold some of the most sensitive personal data imaginable, yet they must keep that information instantly accessible to save lives. Lock down systems too tightly, and doctors can’t access critical patient information in emergencies. Leave them too open, and you’re inviting data breaches that can expose millions of patients’ medical histories.

Enter NEN 7510, the Dutch national standard that’s become the gold standard for healthcare information security management. Unlike generic cybersecurity frameworks, NEN 7510 understands that in healthcare, security failures don’t just mean data loss—they can mean the difference between life and death. Whether you’re running a small general practice in Amsterdam, managing a major academic medical center, or providing health IT services to Dutch healthcare organizations, understanding NEN 7510 isn’t optional—it’s legally required.

This blog will walk you through what you need to know about NEN 7510: what it is, why it exists, who needs to comply, how enforcement works, and most importantly, how to implement it successfully in your organization.

What is NEN 7510? 

 

NEN 7510, officially titled “Health informatics — Information security management in healthcare — Part 1: Management system” (NEN 7510-1:2024), is the Dutch national standard specifically designed for information security management in healthcare organizations. Developed by the Netherlands Standardization Institute (NEN) and first published in 2004, with major revisions in 2011, 2017, and most recently in December 2024, NEN 7510 represents one of the most comprehensive healthcare-specific information security standards globally.

The standard provides detailed requirements and guidance for implementing information security management systems tailored to the unique challenges, regulatory requirements, and risk profile of healthcare environments. Built upon the foundation of ISO 27001 while incorporating healthcare-specific requirements, NEN 7510 addresses the complex landscape of medical information systems, patient data protection, medical device security, and healthcare-specific regulatory compliance.

The standard has gained recognition beyond the Netherlands, influencing healthcare information security practices across Europe and serving as a reference model for healthcare cybersecurity frameworks in other countries. NEN 7510 compliance is legally required for healthcare providers in the Netherlands and increasingly referenced in European healthcare regulations and best practices.

 

Understanding the NEN 7510 Family

NEN 7510 consists of two main parts:

  • NEN 7510-1: Sets out the management system requirements (the “what” organizations must do)

  • NEN 7510-2: Provides implementation guidance (the “how” to achieve compliance)

The standard works alongside related standards, including NEN 7512 (secure communication in healthcare) and NEN 7513 (logging and monitoring requirements), which together form a comprehensive framework for healthcare information security.

 

The 2024 Update: The December 2024 revision represents a significant modernization of the standard. It aligns NEN 7510 with ISO/IEC 27001:2022 and ISO/IEC 27002:2022, restructures the control framework to match the latest international standards, and adds enhanced requirements for emerging healthcare technologies, including telemedicine, health apps, and advanced medical devices. Healthcare organizations have until February 20, 2027, to transition from the previous version (NEN 7510-1:2017+A1:2020) to the 2024 edition.

 

Purpose of NEN 7510

 

NEN 7510 serves multiple critical purposes that address the unique information security challenges facing healthcare organizations:

  1. Healthcare-specific information security: The primary purpose is to provide comprehensive information security requirements specifically tailored to healthcare environments, addressing the unique risks, regulations, and operational requirements of medical information systems and patient data protection.

  2. Patient safety and privacy protection: The standard ensures that information security measures protect patient safety by maintaining the integrity and availability of critical medical information while safeguarding patient privacy and confidentiality throughout the care delivery process.

  3. Regulatory compliance integration: NEN 7510 integrates multiple healthcare regulations and requirements, including GDPR, Medical Device Regulation (MDR), and national healthcare laws into a cohesive information security management framework.

  4. Medical information system security: The standard provides specific guidance for securing electronic health records, medical devices, health information exchanges, telemedicine systems, and other healthcare-specific technologies and processes.

  5. Healthcare continuity and resilience: NEN 7510 ensures that information security measures support healthcare service continuity, emergency response capabilities, and organizational resilience during crises or security incidents.

 

The Structure of NEN 7510 and Control Framework

 

The 2024 revision of NEN 7510 aligns with the modernized control structure of ISO/IEC 27001:2022 and ISO/IEC 27002:2022. This represents a significant shift from the previous Annex A mapping approach, consolidating general and healthcare-specific controls into an integrated framework that reflects current cybersecurity practices and emerging healthcare technology challenges.

 

Core Security Control Categories

  1. Organizational controls – Establishes requirements for information security governance in healthcare organizations, including policy development, roles and responsibilities, security organization structure, and management commitment to patient data protection.

  2. People controls – Addresses personnel security throughout the employment lifecycle, including background screening for healthcare staff, security training specific to healthcare environments, and procedures for personnel changes and termination.

  3. Physical controls – Covers physical security requirements for healthcare facilities, including secure areas for medical equipment, physical access controls, equipment protection, and environmental controls for medical systems.

  4. Technological controls – Provides requirements for technical security measures, including access control, cryptography, network security, system hardening, secure development, and security monitoring tailored to healthcare information systems.

 

Healthcare-Specific Extensions and Enhancements

  1. Medical device security – Comprehensive requirements for securing medical devices, including IoT medical devices, imaging systems, monitoring equipment, and therapeutic devices connected to healthcare networks.

  2. Patient data protection – Detailed requirements for protecting patient data throughout the healthcare delivery process, including consent management, data minimization, and patient rights management.

  3. Healthcare information exchange security – Requirements for securing health information exchanges, interoperability platforms, and cross-organizational healthcare data sharing.

  4. Telemedicine and remote care security – Security requirements for telemedicine platforms, remote monitoring systems, and mobile health applications.

 

Legal Basis and Compliance Requirements

 

Understanding the legal framework behind NEN 7510 is crucial for healthcare organizations operating in the Netherlands.

 

The Legal mandate:NEN 7510 compliance is legally required for healthcare providers in the Netherlands. This mandate derives from the Wet aanvullende bepalingen verwerking persoonsgegevens in de zorg (Wabvpz – Additional Provisions for Personal Data Processing in Healthcare Act). Specifically, Article 3 of the Besluit elektronische gegevensverwerking door zorgaanbieders (Decree on Electronic Data Processing by Healthcare Providers) references NEN 7510-1, NEN 7512, and NEN 7513 as the applicable standards.

 

Compliance vs. certification:It’s important to understand that the legal requirement is to comply with NEN 7510—not necessarily to obtain formal certification. Organizations must implement the standard’s requirements, but certification by an accredited body is one way (though not the only way) to demonstrate compliance to regulators and stakeholders.

 

Do you need to comply?

The legal obligation focuses primarily on:

  • Healthcare providers (zorgaanbieders) delivering direct patient care

  • Responsible parties operating healthcare information exchange systems

  • Organizations processing patient data as part of healthcare delivery

Other organizations in the healthcare ecosystem—such as pharmaceutical companies, health insurers, medical device manufacturers, and healthcare IT vendors—may choose to implement NEN 7510 or be contractually required to do so by their healthcare customers, but they are not uniformly mandated by law unless they fall within the categories above.

 

Certification Process for Organizations Choosing Formal Certification

 

Healthcare organizations seeking formal certification must undergo structured assessment processes conducted by accredited certification bodies:

  1. Initial certification assessment: Comprehensive evaluation of information security management system implementation by accredited certification bodies.

  2. Surveillance audits: Regular intermediate audits to verify continued compliance and effectiveness of security controls.

  3. Recertification: Complete reassessment every three years to maintain certification status.

  4. Corrective action management: A Systematic process for addressing non-conformities and implementing improvement actions.

  5. Continuous improvement: Ongoing enhancement of information security management systems based on risk assessment and performance monitoring.

 

Accredited Certification Bodies

Organizations choosing certification must use accredited certification bodies recognized by the Dutch Accreditation Council (RvA). These bodies must demonstrate:

  • Technical competence in healthcare information security and NEN 7510 requirements

  • Healthcare experience with specific training in healthcare environments and medical information systems

  • Regulatory knowledge of healthcare regulations and their intersection with information security requirements

  • Quality assurance through maintained quality management systems and regular competence assessments

 

Documentation and Evidence Requirements

Organizations must maintain comprehensive documentation, including:

  • Information security management system (ISMS) documentation: policies, procedures, and process descriptions specific to healthcare environments

  • Risk assessment and treatment plans: healthcare-specific risk assessments and mitigation strategies

  • Security control implementation evidence: documentation of control implementation and effectiveness testing

  • Incident management records: records of security incidents and responses, including patient safety impacts

  • Training and awareness records: evidence of healthcare-specific security training and awareness programs

 

Governance and Oversight 

 

NEN 7510 operates under a comprehensive governance structure that ensures healthcare-specific expertise and regulatory alignment.

 

Primary Oversight Organizations

  1. Netherlands Standardization Institute (NEN) – Develops, maintains, and publishes NEN 7510 through technical committees comprising healthcare cybersecurity experts, medical professionals, and regulatory specialists. NEN is responsible for updating the standard to reflect evolving healthcare technologies, threats, and regulatory requirements.

  2. Inspectie Gezondheidszorg en Jeugd (IGJ) – The Dutch Health and Youth Care Inspectorate supervises healthcare providers’ compliance with information security requirements as part of overall care quality and safety oversight. IGJ conducts inspections and can take enforcement action when security measures are inadequate.

  3. Autoriteit Persoonsgegevens (AP) – The Dutch Data Protection Authority oversees privacy and data protection aspects related to patient data security and enforces GDPR compliance in healthcare settings. When security failures lead to data breaches, the AP can impose GDPR penalties.

 

Healthcare Industry Coordination

Multiple healthcare stakeholder groups contribute to NEN 7510 governance and implementation:

  • Healthcare organizations: Hospitals, clinics, and other healthcare providers contribute practical implementation experience and feedback

  • Medical technology industry: Medical device manufacturers and healthcare IT vendors provide technical expertise and implementation guidance

  • Healthcare associations: Professional associations and industry groups coordinate implementation support and best practice sharing

  • Academic medical centers: Universities and research institutions contribute research and education support for NEN 7510 implementation

  • Patient advocacy groups: Patient organizations provide input on privacy protection and patient rights aspects of the standard

 

International Alignment and Recognition

NEN 7510 maintains alignment with international standards and frameworks:

  • ISO 27001 compatibility: The 2024 revision is designed to align seamlessly with ISO/IEC 27001:2022 while adding healthcare-specific requirements

  • European Union alignment: NEN 7510 aligns with EU healthcare regulations, including GDPR and Medical Device Regulation

  • International reference: Other countries reference NEN 7510 as a model for healthcare information security standards, though it remains primarily a Dutch standard

  • Standards harmonization: NEN collaborates with international standards organizations to promote healthcare cybersecurity standardization

 

Enforcement and Compliance Landscape

 

Understanding who enforces what, is essential for healthcare organizations navigating NEN 7510 compliance.

Regulatory Enforcement Authority

  1. Inspectie Gezondheidszorg en Jeugd (IGJ) has primary enforcement authority for healthcare quality and safety, including information security posture:

  • Inspection powers: Authority to conduct on-site inspections of healthcare organizations to verify NEN 7510 compliance as part of the overall care quality assessment

  • Compliance orders: Power to issue binding orders requiring specific compliance actions within defined timeframes

  • Operational restrictions: Power to restrict or suspend healthcare operations for organizations with serious compliance failures that threaten patient safety

  • Public disclosure: Authority to publicly disclose compliance violations and enforcement actions

 

  1. Autoriteit Persoonsgegevens (AP) enforces GDPR requirements, including the security obligations within GDPR:

  • GDPR fines: Authority to impose GDPR fines up to 4% of annual global turnover or €20 million, whichever is higher, for inadequate security measures

  • Breach penalties: Additional penalties for security incidents resulting in patient data breaches

  • Reporting violations: Enforcement action for failure to properly report security incidents to the data protection authority

  • Corrective measures: Power to order specific security improvements to address GDPR compliance gaps

 

Integration with Healthcare Regulations

NEN 7510 is integrated with multiple healthcare regulatory requirements:

  • Care quality legislation: Compliance supports adherence to Dutch healthcare quality and safety laws

  • Patient rights legislation: The standard supports compliance with patient rights and privacy protection laws

  • Medical device regulations: NEN 7510 requirements align with EU Medical Device Regulation compliance obligations

  • Health insurance regulations: Healthcare insurers may require NEN 7510 compliance for contracted providers

  • Professional standards: Medical professional bodies reference NEN 7510 in their professional standards and ethics guidelines

 

European Union Regulatory Context

NEN 7510 compliance supports broader EU regulatory compliance:

  • General Data Protection Regulation (GDPR): The standard provides detailed implementation guidance for GDPR security requirements in healthcare contexts.

  • Medical Device Regulation (MDR): NEN 7510 addresses cybersecurity requirements for medical devices under EU MDR.

  • NIS2 Directive: Healthcare organizations subject to the NIS2 Directive can use NEN 7510 to address many cybersecurity expectations, though NEN 7510 alone is not sufficient for complete NIS2 compliance. Organizations should map NEN 7510 controls to NIS2 requirements and implement additional measures as needed for full NIS2 readiness.

  • Cross-border healthcare directive: The standard supports secure health information exchange across EU borders.

 

Key Provisions and Healthcare-Specific Requirements

 

NEN 7510 contains comprehensive requirements specifically tailored to healthcare environments, addressing both general information security and healthcare-specific needs.

 

Patient Data Protection Requirements

  • Data classification and handling: Comprehensive requirements for classifying patient data based on sensitivity levels, implementing appropriate protection measures, and ensuring secure handling throughout the care process.

  • Consent management: Detailed requirements for managing patient consent for data processing, including consent documentation, withdrawal procedures, and consent-based access controls.

  • Patient rights implementation: Requirements for implementing patient rights, including data access, correction, deletion, and portability while maintaining medical record integrity and legal requirements.

  • Cross-border data transfer: Specific requirements for secure transfer of patient data across borders, including adequacy assessments and appropriate safeguards.

 

Medical System Security Requirements

  • Electronic health record security: Comprehensive security requirements for EHR systems, including access controls, audit logging, data integrity protection, and backup procedures.

  • Medical device cybersecurity: Detailed requirements for securing medical devices, including network connectivity controls, device authentication, software update management, and vulnerability management.

  • Health information exchange security: Requirements for securing health information exchanges, including participant authentication, data encryption, access logging, and incident response coordination.

  • Telemedicine security: Specific requirements for telemedicine platforms, including patient identity verification, communication encryption, and remote access security.

 

Healthcare Operations Security

  • Emergency and disaster response: Requirements for maintaining healthcare service continuity during emergencies, including backup systems, alternative communication methods, and crisis management procedures.

  • Medical staff access management: Specialized access control requirements for healthcare professionals, including emergency access procedures, role-based permissions, and access monitoring.

  • Visitor and patient access controls: Requirements for managing physical and logical access by patients, visitors, contractors, and other non-staff individuals in healthcare environments.

  • Medical equipment protection: Physical and logical security requirements for protecting medical equipment from tampering, unauthorized access, and environmental threats.

 

Healthcare-Specific Incident Response

  • Patient safety integration: Requirements for coordinating information security incident response with patient safety programs and medical error reporting systems.

  • Regulatory notification: Specific requirements for notifying healthcare regulators (IGJ), data protection authorities (AP), and other relevant agencies of security incidents affecting patient data or care delivery.

  • Medical device incident response: Specialized procedures for responding to security incidents involving medical devices, including coordination with device manufacturers and regulatory authorities.

  • Care continuity during incidents: Requirements for maintaining essential healthcare services during security incidents, including backup procedures and alternative care delivery methods.

 

Industries and Healthcare Sectors Impacted

 

NEN 7510 has comprehensive applicability across healthcare sectors in the Netherlands, with varying levels of legal obligation and practical adoption.

 

Core Healthcare Sectors (Legally Required)

  1. Hospitals and health systems – Acute care hospitals, specialty hospitals, academic medical centers, and integrated health systems must implement comprehensive NEN 7510 compliance programs covering all aspects of hospital operations.

  2. Primary care and general practice – General practitioners, family medicine practices, community health centers, and primary care networks must comply with NEN 7510 requirements scaled to their size and complexity.

  3. Mental health services – Psychiatric hospitals, mental health clinics, addiction treatment centers, and behavioral health providers face specific requirements for protecting sensitive mental health information.

  4. Long-term care and nursing homes – Nursing homes, assisted living facilities, home healthcare agencies, and long-term care providers must implement NEN 7510 controls appropriate to their care environments.

  5. Specialized medical services – Diagnostic imaging centers, laboratories, dialysis centers, cancer treatment centers, and other specialized medical services must comply with sector-specific requirements.

  6. Healthcare information exchange operators – Organizations responsible for operating health information exchanges and interoperability platforms have legal obligations under NEN 7510.

 

Healthcare Supporting Industries (Often Contractually Required)

  1. Health information technology – EHR vendors, health information exchange operators, healthcare cloud service providers, and medical software developers often implement NEN 7510 controls to serve healthcare customers and meet contractual requirements.

  2. Medical device manufacturing – Medical device manufacturers, particularly those producing connected devices, increasingly ensure their products support customer NEN 7510 compliance requirements.

  3. Healthcare consulting and services – Healthcare consultants, medical billing companies, coding services, and other healthcare service providers may implement NEN 7510 when handling patient data under contracts with healthcare providers.

  4. Pharmaceutical and life sciences – Pharmaceutical companies, clinical research organizations, and life sciences companies conducting clinical trials may implement NEN 7510 controls for patient data protection when working with Dutch healthcare providers.

  5. Health insurance and payers – Health insurance companies, government payers, and other healthcare financing organizations may implement NEN 7510 requirements for processing patient and claims data, though their primary legal obligations stem from other regulations.

 

International Healthcare Organizations

  1. Multinational healthcare companies – Global healthcare companies operating in the Netherlands must implement NEN 7510 compliance for their Dutch operations, while often extending these practices globally.

  2. Cross-border healthcare providers – Healthcare organizations providing services across European borders may implement NEN 7510 to ensure secure patient data sharing and regulatory compliance.

  3. International medical tourism – Healthcare organizations serving international patients may implement appropriate controls for managing patient data across jurisdictions.

  4. Global health technology companies – International health technology companies often ensure their products and services support NEN 7510 compliance requirements for Dutch healthcare customers.

 

Penalties and Consequences of Non-Compliance

 

Non-compliance with NEN 7510 can result in severe consequences for healthcare organizations, given the legal requirements and robust enforcement mechanisms.

 

Direct Regulatory Penalties from IGJ

  • Compliance orders: Healthcare organizations may receive binding orders requiring specific remediation measures within defined timeframes, often at significant cost and operational disruption.

  • Operational restrictions: The IGJ may impose restrictions on healthcare operations, including suspension of specific services, limitations on patient data processing, or requirements for enhanced oversight when security deficiencies threaten patient safety.

  • License and accreditation impact: Non-compliance can affect healthcare licenses, accreditation status, and authorization to provide specific healthcare services or participate in government programs.

  • Public disclosure: The IGJ can publicly disclose compliance violations and enforcement actions, causing significant reputational damage.

 

GDPR Enforcement by the Autoriteit Persoonsgegevens

  • Data protection authority fines: Failure to implement adequate information security controls may result in GDPR fines up to 4% of annual global turnover or €20 million, whichever is higher.

  • Privacy breach penalties: Inadequate security controls leading to patient data breaches can result in substantial penalties under GDPR enforcement.

  • Regulatory reporting violations: Failure to properly report security incidents to the AP can result in separate penalties and enforcement actions.

  • Corrective action requirements: Organizations may be required to implement specific security improvements and provide evidence of compliance.

 

Professional and Reputational Consequences

  • Medical professional sanctions: Healthcare professionals may face disciplinary action from professional bodies for failing to protect patient information in accordance with NEN 7510 requirements and professional standards.

  • Reputation damage and patient trust: Enforcement actions and compliance failures, often publicly disclosed, cause significant reputational damage and loss of patient trust, affecting patient choice and referral patterns.

  • Insurance and financial impact: Non-compliance can affect professional liability insurance coverage, increase insurance premiums, and impact access to capital and financial services.

  • Competitive disadvantage: Healthcare organizations with compliance failures may lose competitive advantages in patient choice, provider network participation, and partnership opportunities.

 

Legal and Civil Liability

  • Patient litigation: Patients affected by security incidents may pursue civil litigation against healthcare organizations for failure to implement adequate protection measures.

  • Breach of duty claims: Healthcare organizations may face claims for breach of professional duty of care related to patient information protection failures.

  • Contractual violations: Non-compliance may constitute breach of contracts with patients, payers, business associates, and technology vendors.

  • Shareholder and stakeholder actions: For-profit healthcare organizations may face shareholder litigation and stakeholder actions related to compliance failures and resulting financial impacts.

 

Employee Responsibilities & Organizational Implementation

 

NEN 7510 implementation requires comprehensive engagement and accountability across all roles and functions within healthcare organizations.

 

Senior Leadership and Executive Responsibilities

  1. Information security governance: Healthcare executives must establish information security governance structures that integrate with clinical governance, quality management, and patient safety programs while ensuring adequate resources and strategic direction.

  2. Patient safety integration: Leadership must ensure that information security measures support rather than impede patient safety and quality of care, with an appropriate balance between security and clinical workflow requirements.

  3. Regulatory compliance oversight: Executives must ensure organizational compliance with NEN 7510 and related healthcare regulations while maintaining oversight of compliance programs and addressing deficiencies promptly.

  4. Risk management and decision making: Leadership must make risk-based decisions about information security investments, accept residual risks appropriately, and ensure that security measures align with organizational mission and values.

  5. Stakeholder communication: Executives must communicate effectively with patients, staff, regulators, and other stakeholders about information security measures and any incidents that may affect patient care or data protection.

 

Clinical and Medical Staff Responsibilities

  1. Patient data protection: Healthcare professionals must handle patient information according to NEN 7510 requirements, including appropriate access controls, secure communication practices, and confidentiality protections throughout care delivery.

  2. System usage and security: Clinical staff must use healthcare information systems securely, including proper authentication, following access control procedures, and reporting security concerns or incidents promptly.

  3. Medical device security: Healthcare professionals using connected medical devices must follow security procedures, including device authentication, secure configuration, and incident reporting for device-related security issues.

  4. Patient communication: Clinical staff must communicate appropriately with patients about information security measures, obtain necessary consents for data processing, and address patient concerns about data protection.

  5. Incident recognition and reporting: Healthcare professionals must recognize potential security incidents that could affect patient safety or data protection and report them through established channels promptly.

 

Information Technology and Security Team Responsibilities

  1. Technical control implementation: IT professionals must implement and maintain technical security controls specific to healthcare environments, including medical device security, health information exchange security, and EHR protection.

  2. Healthcare system administration: IT staff must administer healthcare information systems securely, including user access management, system configuration, patch management, and security monitoring tailored to healthcare requirements.

  3. Medical device management: IT teams must manage the security of connected medical devices, including network segmentation, device monitoring, vulnerability management, and coordination with clinical engineering teams.

  4. Incident response coordination: IT security teams must coordinate incident response activities with clinical teams, patient safety officers, and healthcare regulators while maintaining focus on patient care continuity.

  5. Compliance monitoring and reporting: IT teams must monitor compliance with NEN 7510 technical requirements and provide regular reporting on security posture, incidents, and compliance status to healthcare leadership.

 

Privacy and Compliance Officers

  1. Privacy program management: Privacy officers must develop and maintain comprehensive privacy programs that comply with NEN 7510, GDPR, and other applicable healthcare privacy regulations.

  2. Patient rights management: Privacy professionals must implement patient rights management, including access requests, correction procedures, deletion rights, and consent management systems.

  3. Regulatory coordination: Compliance officers must coordinate with healthcare regulators (IGJ), data protection authorities (AP), and other oversight bodies regarding NEN 7510 compliance and incident reporting.

  4. Policy development and training: Privacy and compliance teams must develop healthcare-specific privacy and security policies and deliver training programs tailored to different healthcare roles and functions.

  5. Audit and assessment coordination: Compliance officers must coordinate internal and external audits, manage assessment processes, and ensure appropriate follow-up on audit findings and recommendations.

 

Quality and Patient Safety Teams

  1. Security-safety integration: Patient safety officers must integrate information security considerations into patient safety programs and ensure that security measures support rather than compromise patient safety objectives.

  2. Incident coordination: Quality and safety teams must coordinate security incident response with patient safety incident management and ensure appropriate consideration of patient safety impacts.

  3. Risk assessment integration: Patient safety professionals must integrate cybersecurity risks into overall patient safety risk assessments and quality improvement programs.

  4. Performance monitoring: Quality teams must monitor the impact of security measures on clinical performance and patient outcomes while identifying opportunities for improvement.

 

Support and Administrative Staff

  1. Administrative data protection: Administrative personnel must handle patient information securely, including proper access controls, secure communication, and appropriate data handling procedures.

  2. Vendor and contractor coordination: Administrative staff must ensure that vendors, contractors, and business associates comply with NEN 7510 requirements and maintain appropriate security measures.

  3. Training participation: All support staff must participate in NEN 7510 training programs and understand their role in protecting patient information and maintaining organizational compliance.

  4. Security awareness: Administrative personnel must maintain awareness of security threats and procedures while reporting suspicious activities or potential security incidents promptly.

 

Transitioning to NEN 7510:2024

 

Healthcare organizations currently compliant with NEN 7510-1:2017+A1:2020 have until February 20, 2027, to transition to the 2024 revision. This transition window provides time for organizations to:

  1. Conduct gap assessments: Evaluate current ISMS against the 2024 requirements, particularly the restructured control framework aligned with ISO/IEC 27001:2022.

  2. Update documentation: Revise policies, procedures, and control documentation to reflect the new structure and any new or enhanced requirements.

  3. Implement new or enhanced controls: Address any gaps identified in the assessment, particularly around emerging technologies like advanced telemedicine and mobile health applications.

  4. Train personnel: Ensure staff understand the updated requirements and any changes to their responsibilities.

  5. Prepare for recertification: Organizations with formal certification should coordinate with their certification body to schedule transition assessments within the deadline.

Starting the transition process early—rather than waiting until the deadline approaches—allows organizations to spread out the effort and avoid last-minute compliance pressures.

 

Best Practices for NEN 7510 Implementation and Compliance

 

Healthcare organizations implementing NEN 7510 should follow comprehensive best practices that address the unique challenges of healthcare information security.

 

Strategic Planning and Governance

  1. Integrate with your healthcare mission: Align your information security program with your healthcare mission, values, and patient care objectives. Security measures should support rather than impede quality care delivery.

  2. Establish healthcare-specific governance: Create governance structures that integrate information security with clinical governance, quality management, patient safety, and healthcare operations.

  3. Develop a risk-based approach: Implement risk assessment methodologies that consider both traditional cybersecurity risks and healthcare-specific risks, including patient safety, clinical workflow, and medical device security.

  4. Ensure regulatory integration: Align NEN 7510 implementation with other healthcare regulations, including GDPR, medical device regulations, and clinical quality standards.

 

Clinical Workflow Integration

  1. Design security for care delivery: Implement security controls that integrate into clinical workflows rather than adding burden to healthcare providers while maintaining usability and efficiency.

  2. Address emergency access needs: Develop security procedures that accommodate emergency access requirements for patient care while maintaining appropriate controls and audit capabilities.

  3. Support mobile and remote care: Implement security measures that support telemedicine, mobile health applications, and remote patient monitoring while protecting patient data and care delivery.

  4. Enable secure collaboration: Facilitate secure information sharing among healthcare providers, departments, and organizations involved in patient care while maintaining appropriate access controls.

 

Technical Implementation Excellence

  1. Implement healthcare-specific controls: Deploy technical controls specifically designed for healthcare environments, including medical device security, health information exchange protection, and EHR security.

  2. Address medical device security: Develop comprehensive programs for managing the security of connected medical devices, including network segmentation, device monitoring, and vulnerability management.

  3. Ensure interoperability security: Implement security measures for health information exchange and interoperability while maintaining the ability to share patient information for care coordination.

  4. Deploy advanced threat protection: Implement advanced cybersecurity technologies appropriate for healthcare environments, including behavioral analysis, threat intelligence, and automated response capabilities.

 

Patient-Centered Privacy Protection

  1. Implement patient rights management: Develop comprehensive systems for managing patient rights, including access requests, correction procedures, consent management, and data portability.

  2. Ensure transparent communication: Provide clear, understandable communication to patients about how their information is protected and used while respecting their privacy choices and preferences.

  3. Address consent complexity: Implement sophisticated consent management systems that can handle complex healthcare consent scenarios, including emergency care, research participation, and multi-provider care.

  4. Support patient engagement: Enable secure patient access to their health information while maintaining appropriate security controls and supporting patient engagement in their care.

 

Continuous Improvement and Monitoring

  1. Implement healthcare-specific monitoring: Deploy monitoring systems that can detect security threats while minimizing false positives that could disrupt clinical care or create alert fatigue.

  2. Conduct regular risk assessments: Perform periodic risk assessments that address evolving healthcare threats, new technologies, changing regulations, and organizational changes.

  3. Measure security effectiveness: Develop metrics and key performance indicators that measure both security effectiveness and impact on clinical operations and patient care quality.

  4. Foster security culture: Build an organizational culture that values both cybersecurity and patient care while promoting security awareness and accountability throughout the healthcare organization.

 

NEN 7510 represents a sophisticated approach to healthcare information security that recognizes the unique challenges of protecting patient data while maintaining the accessibility and reliability that healthcare delivery demands. For Dutch healthcare organizations, it’s not just a compliance checkbox—it’s a framework for building resilient, secure systems that protect both patient privacy and patient safety.

As healthcare becomes increasingly digital, with telemedicine, connected medical devices, and health information exchanges becoming standard rather than exceptional, the importance of comprehensive information security management only grows. The 2024 revision of NEN 7510 reflects this reality, incorporating modern cybersecurity practices and addressing emerging technologies while maintaining its focus on the fundamental goal: ensuring that healthcare information security supports the delivery of safe, high-quality patient care.

Whether you’re beginning your NEN 7510 journey or preparing to transition to the 2024 revision, remember that successful implementation isn’t about perfect security—it’s about implementing appropriate, risk-based controls that protect what matters most while enabling healthcare professionals to do their vital work.

 

How databrackets can help you comply with CAIQ

 

Our team of security experts has supported organizations across a wide variety of industries, for over 15 years, to align their processes with security frameworks like  ISO 27001:2022, SOC 2, FedRAMP, CMMC, NIST SP 800-53, NIST Cybersecurity Framework, NIST SP 800-171,  HIPAA,  etc. We are an authorized certifying body for ISO 27001, a authorized C3PAO for CMMC and an authorized 3PAO for FedRAMP. We also have partnerships to help clients prepare for and obtain other global security certifications. 

 

We offer Consulting Services for NEN 7510. Our Deliverables include:

·       Gap Assessment report

·       Policies and Procedures

·       User awareness training

·       Implementation design guidance

·       Vulnerability Assessment and Pen Testing

·       Ongoing support during remediation

 

You can partner with us to prove your compliance with NEN 7510 on an annual basis and engage our team to support your organization.  Schedule a Consultation or  Connect with an Expert to understand how we can customize our services to meet your specific requirements.  

 

Technical Expert: Srini Kolathur

Director, databrackets.com

The technical information presented in this blog has been carefully reviewed and verified by our Director, Srini Kolathur. Srini is results-driven security and compliance professional with over 20 years of experience supporting, leading, and managing global IT security, compliance, support, and risk assessment in fortune 100 companies. Some of his key areas of focus are SOC 2, ISO 27001, NIST 800-171, NIST 800-53, NIST Cybersecurity Framework,  HIPAA, Security Risk Assessment, CMMC 2.0 among others. He is a CMMC Registered Practitioner (RP), CISSP, CISA, CISM, MBA. He is active in several community groups including Rotary International and TiE.

Author: Aditi Salhotra

Manager – Digital Marketing and Business Development, databrackets.com

Aditi is a Digital Marketing and Business Development Professional at databrackets.com. She is a strong advocate of good cyber hygiene and is proud of the company’s mission to safeguard organizations from cyber threats and ensure their business continuity in adverse situations.

She has written this blog in collaboration with a technical team. All technical information presented has also been verified by our Director and Technical Expert – Mr. Srini Kolathur

Last Updated on December 17, 2025 By Srini KolathurIn cybersecurity, Data Privacy, NEN 7510