GDPR Compliance

The General Data Protection Regulation (GDPR) is a comprehensive data protection law that came into effect across the European Union in May 2018. It establishes strict requirements for the collection, processing, storage, and transfer of personal data, with enhanced protections for special categories of data, which includes health information like medical images. GDPR is particularly important for healthcare imaging because medical images and associated metadata contain highly sensitive personal data. Radiological images often include identifiable information directly within the image data and always contain associated personal information in metadata, such as patient identifiers, demographics, and clinical information. Under GDPR, healthcare providers must have a valid legal basis for processing this data (usually patient consent or legitimate medical purpose), must implement appropriate security measures, and must respect patient rights regarding their data. Non-compliance can result in significant penalties—up to €20 million or 4% of annual global turnover—as well as reputational damage and loss of patient trust. Moreover, GDPR compliance is especially complex in imaging environments due to the long-term storage requirements for diagnostic images, the need to share images across healthcare organizations for continuity of care, and the increasing use of AI and machine learning technologies for image analysis, all of which raise additional data protection considerations.

NovelPACS provides a comprehensive consent management framework specifically designed for the complexities of medical imaging data processing under GDPR. Our solution begins with configurable digital consent forms that clearly explain, in plain language, all purposes for which imaging data will be used, from primary clinical care to potential research or AI training. These forms can be customized to your organization's specific needs while ensuring all GDPR requirements for valid consent are met. For capturing consent, the system supports multiple approaches including electronic signatures on tablets, integration with patient portals, and digitization of paper forms with secure signature verification. Each consent record is securely stored with cryptographic validation to prevent tampering, capturing not just the consent itself but also the specific version of the consent language presented, timestamp, identity verification method, and the specific purposes consented to. The system maintains a comprehensive consent history for each patient, allowing for easy verification of consent status for any particular use. What truly sets our consent management apart is how it's integrated throughout the entire imaging workflow. Every access to patient images automatically checks against appropriate consent records, with granular enforcement that can restrict specific uses based on the consent given. For example, images might be available for clinical care but restricted from research use based on patient preferences. When consent requirements change, our system helps identify affected data sets and can automate the process of obtaining fresh consent through configurable notification workflows. For situations where legal bases other than consent are relied upon (such as vital interests or public health), the system similarly documents and enforces these alternative legal bases for processing, ensuring all data use remains compliant with GDPR requirements.

NovelPACS implements multiple layers of technical measures to ensure GDPR compliance through appropriate security of personal data. At the storage level, we employ AES-256 encryption for all data at rest, with secure key management using hardware security modules (HSMs) and regular key rotation. All data transmissions are protected using TLS 1.3 with forward secrecy and strong cipher suites, ensuring data confidentiality during network transfer. For access control, our system implements fine-grained, role-based permissions with the principle of least privilege, further enhanced by context-aware access controls that consider factors like location, time, and purpose when authorizing data access. Authentication is secured through multi-factor options including biometrics, FIDO2 security keys, and mobile authenticator apps. To support data minimization, we provide advanced anonymization and pseudonymization tools specifically optimized for medical imaging data. Our AI-enhanced anonymization can detect and remove protected health information embedded within image pixels (like burned-in patient details), while maintaining the diagnostic value of the images. For pseudonymized data used in research or analytics, we maintain secure mapping tables with strong access controls to allow re-identification only when specifically authorized. Comprehensive audit logging captures all interactions with personal data, recording who accessed what data, when, and for what purpose. These logs are stored in a tamper-evident format using cryptographic hashing to prevent modification, and are retained for configurable periods to support compliance verification and incident investigation. Automated monitoring systems continuously analyze access patterns to detect potential data breaches or unusual behavior, with configurable alerting thresholds and incident response workflows. For data retention control, the system implements automated policies that can identify and manage data that has reached the end of its required retention period, with options for secure deletion, anonymization, or archiving based on configurable rules. All these technical measures are regularly tested through vulnerability assessments, penetration testing, and security audits to ensure their continued effectiveness in protecting personal data.

NovelPACS provides comprehensive tools for managing the entire lifecycle of data subject rights requests in compliance with GDPR requirements. Our rights management module begins with customizable intake forms for each type of request (access, rectification, erasure, etc.), which can be integrated into your patient portal or used standalone. Each received request automatically initiates a structured workflow with configurable approval steps, task assignments, and deadline tracking to ensure timely responses within the GDPR-mandated timeframes. For subject access requests, the system performs automated discovery of all relevant data across the entire imaging ecosystem—including active storage, archives, and connected systems—providing a complete inventory of the subject's personal data. This data can be exported in multiple formats including DICOM, structured JSON, or PDF reports, depending on the subject's preferences and technical requirements. Rectification requests are handled through validated correction workflows that maintain both the original and corrected data versions with comprehensive audit trails documenting who made changes, when, and why. For erasure requests ("right to be forgotten"), the system implements cryptographic erasure techniques that render data permanently inaccessible, with verification processes to confirm successful deletion across all storage locations including backups and distributed systems. The platform includes sophisticated data portability features that can export imaging studies and associated data in standard formats that preserve both clinical context and technical fidelity, facilitating transfer to other providers or systems. For restriction of processing requests, the system can place configurable limitations on how specific data is used while maintaining its availability for specific approved purposes. All rights request processing is comprehensively documented, creating an audit trail that demonstrates your organization's compliance efforts. This documentation includes records of verification procedures used to confirm the requester's identity, all communications with the data subject, internal processing steps, and the final resolution of the request. The system also helps identify and manage exceptions where requests cannot be fully fulfilled due to legal obligations or other valid exemptions, ensuring proper justification and documentation in such cases.

NovelPACS offers comprehensive documentation tools that help healthcare organizations meet GDPR's accountability and documentation requirements with minimal administrative burden. At the core of our documentation system is an automated Records of Processing Activities (RoPA) generator that continuously monitors system usage to maintain an up-to-date inventory of all processing activities involving personal data. This RoPA automatically captures the categories of data processed, processing purposes, data subjects affected, retention periods, security measures applied, and potential data recipients—all elements required under Article 30 of GDPR. For high-risk processing operations, our platform includes structured Data Protection Impact Assessment (DPIA) templates specifically designed for medical imaging scenarios. These templates guide users through risk identification, assessment, and mitigation planning with imaging-specific considerations already incorporated. The system maintains version history of all DPIAs and can automatically flag when changes to processing activities might require DPIA updates. The platform includes a comprehensive suite of policy templates covering required GDPR documentation such as privacy notices, consent forms, breach notification procedures, and data retention policies. These templates are customizable to your organization's specific needs while ensuring all regulatory requirements are addressed. For organizations working with third-party processors or acting as processors themselves, we provide data processing agreement templates and tracking tools to manage processor relationships and compliance status. The system maintains detailed technical documentation of all security and privacy measures implemented, including encryption methods, access control systems, anonymization techniques, and audit mechanisms. This documentation is continuously updated as the system evolves, ensuring it accurately reflects current implementation. All documentation is maintained in a secure, versioned repository with access controls and audit trails to prevent unauthorized modification. The documentation can be exported in various formats for regulatory inquiries, demonstrating your compliance posture at any point in time. Our documentation system also supports customization for specific regulatory environments, allowing organizations to address additional documentation requirements specific to their jurisdiction or sector beyond the core GDPR requirements.

NovelPACS implements a comprehensive approach to handling international data transfers in compliance with evolving GDPR requirements following Schrems II and subsequent regulatory guidance. Our system begins with geographic data tracking that automatically identifies and documents where personal data is stored and processed within your imaging ecosystem. This monitoring extends to all system components including cloud storage, processing pipelines, and third-party integrations. For transfers outside the European Economic Area (EEA), the platform implements a tiered compliance framework: For countries with adequacy decisions, the system documents reliance on these decisions while monitoring for any changes in adequacy status that might affect compliance. For transfers to non-adequate countries, the system supports implementation of appropriate safeguards including Standard Contractual Clauses (SCCs) with the latest European Commission approved versions, Binding Corporate Rules, and codes of conduct with automated documentation. Following Schrems II requirements, the platform includes tools for conducting and documenting Transfer Impact Assessments (TIAs) that evaluate the legal and practical protections in destination countries. These assessments consider factors like government access laws, independent oversight mechanisms, and effective remedies for data subjects. To address cases where TIAs identify gaps in protection, the system helps implement and document supplementary measures including enhanced encryption with EU-based key management, pseudonymization techniques that render data unintelligible without additional information kept in the EU, and contractual supplementary measures with verification mechanisms. For multi-region deployments, the platform includes data localization capabilities that can restrict specific data sets to particular geographic regions, with technical enforcement to prevent unauthorized transfers. The system maintains comprehensive documentation of all transfer mechanisms, supplementary measures, and risk assessments, which can be quickly produced for supervisory authorities if required. Our compliance team continuously monitors regulatory developments regarding international transfers and provides regular updates to ensure the system remains aligned with evolving requirements. This approach provides healthcare organizations with a robust framework for managing international data transfers that balances operational needs with GDPR compliance obligations.