compliance & security

Solutions for Healthcare compliance

Genomcore makes compliance and security straightforward. Our features help healthcare, diagnostics, and biomedical companies overcome regulatory challenges while streamlining digital solution development.

Take full control of personal data

Manage Personal Identifiable Information (PII) with intuitive tools, designed to simplify compliance and protect sensitive data.

Seamless PII management

Each attribute or section within UMD Records can be flagged as a PII field. This makes data anonymization processes straightforward, and also allows for role-based pseudo-anonymization.

Ownership at your fingertips

Many objects in the UMD can be linked to the legal owner of the information (such as a patient). This allows for built-in operations for data access, removal, or transfer.

Certification support for IVD and medical devices

Genomcore's technology streamlines the certification process for Software as Medical Device (SaMD - MDSa) for In Vitro Diagnostics (IVD), following ISO 13485 and IEC 62304 standards.

Transform your algorithms into certified solutions

Turn your data science scripts and healthcare algorithms into compliant, certifiable software without complex coding or infrastructure setup.

Get expert assistance with technical documentation

Our team helps you prepare and complete the required technical documentation, ensuring your compliance journey is smooth and audit-ready.

Safe by Design: Your Complete Compliance Solution

From semantic modeling to full auditability and certifications, Genomcore is built with compliance in mind. We combine structured data governance, strong access control and global regulatory support under one unified platform.

Structured biomedical data

Model and standardize data using ontologies and domain-specific templates

Access control

Define granular permissions and track usage with full audit logs

Data governance

Ensure traceability and consistency across all workflows and modules

Data privacy and security

We've built our platform with robust security and compliance measures at its core. By meeting the highest standards for data management and security, Genomcore simplifies regulatory compliance and safeguards patient trust.

  • Information technology

  • Security techniques

  • Information security management systems

  • Requirements

  • Information technology

  • Security techniques

  • Code of practice for information security controls based on ISO/IEC 27002 for cloud services

  • Information technology

  • Security techniques

  • Code of practice for protection of personally identifiable information (PII) in public clouds acting as PII processors

  • ENS RD 311/2022 — Reinforced technical and organizational controls

Interested in Genomcore?

Tell us your needs and let’s schedule a demo call

Let’s make data actionable

Explore all use cases