Pathomation develops secure, CE-IVD certified digital pathology software designed for hospital environments, academic medical centers, research institutions, and life sciences organizations. Our image management systems (IMS) and cloud-based platforms are built with cybersecurity, privacy protection, and regulatory compliance at the core.

Security & Data Protection in Digital Pathology

Built for trust: Security by design at Pathomation

From day one, we apply Security by Design and Privacy by Default, ensuring that patient data, research data, and institutional infrastructure are protected throughout the entire software lifecycle.

Security by Design in Our Digital Pathology Software

Cybersecurity is a shared responsibility across the digital pathology ecosystem. We actively collaborate with industry bodies, regulators, standards organizations, suppliers, institutions, academic partners, and security researchers to stay ahead of evolving threats.

Our development approach is risk-based and aligned with healthcare regulatory requirements. We assess:

  • Intended use and clinical context

  • User environment (hospital IT, cloud, hybrid)

  • Data sensitivity and integrity requirements

  • System integrations (LIS, scanners, AI tools)

This allows us to define appropriate technical and organizational controls from the outset, not after deployment.

We apply the same rigorous expectations to our suppliers and technology partners.

Security risk management is embedded in our Quality Management System.

Pathomation operates under an ISO 13485 certified Quality Management System and develops CE-IVD certified software in accordance with applicable European medical device regulations.

Security considerations are integrated into:

  • Software lifecycle processes

  • Risk management documentation

  • Supplier qualification

  • Post-market surveillance

  • Change and release management

This ensures that cybersecurity is treated as a component of product safety, performance, and clinical reliability.

Regulatory & Quality Compliance

Proactive vulnerability detection is part of our development lifecycle.

We utilize AppCheck, a comprehensive vulnerability scanning platform developed by leading penetration testing experts. AppCheck enables structured assessments of:

  • Web applications

  • APIs

  • Infrastructure components

By integrating automated vulnerability scanning into our development and release processes, we detect and address potential security flaws early. This reduces exposure risk and minimizes the need for reactive post-release patches.

Vulnerability Management & Penetration Testing

Post-launch, we continuously monitor trusted cybersecurity sources for emerging threats, vulnerabilities, and industry alerts.

When new risks are identified, we:

  • Assess potential impact on our software

  • Develop security updates or compensating controls where necessary

  • Communicate transparently with affected customers

  • Support mitigation efforts within clinical or research environments

This lifecycle approach protects the confidentiality, integrity, and availability of data across deployments.

Continuous Monitoring & Threat Intelligence

Our solutions support on-premise, cloud, and hybrid deployments, allowing institutions to align with their internal IT governance and security policies.

We work closely with hospital IT teams and infrastructure partners to ensure:

  • Secure authentication mechanisms

  • Role-based access control

  • Secure API integrations

  • Encrypted data transmission

  • Alignment with institutional security frameworks

Deployment Flexibility & Infrastructure Security

The security of your information is one of our top priorities.

If you become aware of a potential vulnerability or security incident related to any of our products, we encourage responsible disclosure.

Please contact us via our helpdesk: Helpdesk – Pathomation

We assess and respond to all security-related reports in a structured and timely manner.

Responsible Disclosure & Incident Reporting