The BrightInsight Platform achieves the French HDS certification

BrightInsight Platform achieves the French HDS certification to strengthen the security and protection of personal health data

As providers of the leading regulated Internet of Things (IoT) platform for biopharma and medtech, BrightInsight is committed to achieving the utmost privacy, security, regulatory and quality certifications to minimize customer risk and protect sensitive health information. I am excited to share that the BrightInsight Platform has achieved the French HDS (“Hébergeur de Données de Santé”) certification. HDS requires very rigorous and robust compliance controls, and BrightInsight’s certification further affirms our commitment to protecting sensitive health information.

HDS & ASIP Santé Compliance

Introduced by the French governmental agency for health, “Agence Française de la Santé Numérique” (ASIP Santé), the goal of the HDS certification is to strengthen the security and protection of personal health data. Achieving this certification demonstrates that BrightInsight provides a framework for technical and governance measures to protect personal health data. Governed by French law, the HDS certification validates that BrightInsight ensures data confidentiality, integrity, and availability for its biopharma and medtech customers.

BrightInsight is one of the first managed service platforms to receive this certification. We pursued the HDS certification to underscore our ability to scale our privacy and security tools and processes for our customers while protecting sensitive health data.

Why the HDS Certification Matters

• With HDS certification, BrightInsight customers and partners who host French Personal Health Information (PHI) are now able to use BrightInsight services to store and process personal health data.
• The HDS certification confirms the BrightInsight Platform’s data hosting activities are compliant, including development, management, support and maintenance of cloud infrastructure and cloud-based information systems that process large volumes of health data
• This certification validates the high level of safety and protection that BrightInsight can offer our biopharma and medtech customers, who will be able to rely on this cloud infrastructure to store, analyze and manage patient data
• You can view more details about our HDS certificate here

Every line of our regulated BrightInsight Platform is built under a Quality Management System to support and optimize regulated drugs, devices and software through integrated data and actionable insights. The HDS certification adds to the list of internationally recognized certifications for BrightInsight, including:

• ISO13485:2016 certification of our Quality Management System
• Software development lifecycle process that conforms to IEC 62304
• HITRUST CSF® v9.1 certification
• HITRUST NIST Cybersecurity Framework certification
• ISO/IEC 27001:2013 certification
• HIPAA and GDPR compliance
• Certification under both the EU-U.S. and Swiss-U.S. Privacy Shield frameworks

You can learn more about BrightInsight’s compliance certifications here.