Illumina Connected Analytics Cohorts

Illumina Connected Analytics features an information security program that leverages the Amazon Web Services infrastructure and provides multiple layers of security. Its risk management program conforms to the specifications of the Health Insurance Portability and Accountability Act (HIPAA) Security Role and the Health Information Technology for Economic and Clinical Health (HITECH) Breach Notification Rule.

Illumina has received ISO 27001 certification of its information security management system (ISMS) supporting Illumina Connected Analytics. This certification ensures that sensitive data contained or collected by these solutions are protected. The certification was performed by Schellman, an ANSI National Accreditation Board (ANAB) and United Kingdom Accreditation Service (UKAS) accredited certification body based in the US.

Illumina Connected Analytics features multiple system controls that you can use to manage authorization, authentication, and data control, including deletion as needed. Access logs are retained for seven years. These features help researchers ensure compliance with the General Data Protection Regulation (GDPR).

llumina Connected Analytics (ICA) was developed in accordance with Illumina’s Software Life Cycle (SLC) process under Illumina’s Quality Management System.

Illumina operates and maintains a Quality Management System (QMS) which complies with the requirements of ISO 13485. The scope of the QMS covers the Design, Development, Manufacture, Distribution, Installation and Servicing of Genotyping, Gene Expression and PCR – products instruments and software - used for genetic analysis. Additionally, processes within Illumina’s QMS have adopted industry best practices and relevant standards, such as ISO 14971 for Risk Management and IE62304 for SLC.

Illumina Connected Analytics is compliant with global and local data privacy and requirements with 27701:2019 certification and guaranteed data residency.