Sophia Genetics earns ISO 13485 and ISO 27001 certification for safe data handling and security

Sophia Genetics, the European leader in Clinical Genomics and Next Generation DNA Sequencing (NGS), has become the first company to achieve both ISO 13485 and ISO 27001 certification for its commitment to safe data handling and security.

The certification from BSI Group Deutschland GmbH recognises the company’s patent pending approach to data encryption, designed to protect the privacy of genomic data. Sophia Genetics operates redundant servers in secure locations that provide customers with the confidence required to sample, analyse and store data from thousands of patients with suspected or confirmed chronic diseases.

ISO 27001 has been awarded to Sophia’s Information Security Management System, covering all internal and external security related information for its customers. Sophia Genetics currently provides data analytics and the secure storing and processing of data for more than 30 leading European hospitals and laboratories, with discussions underway with a number of other institutions to expand this presence.

The company already possesses ISO 13485 certification. This provides accreditation for the comprehensive quality management system that Sophia has in place for its analytics– along with CE-IVD kite marking for its products and services.

Commenting on the award of ISO 27001 certification, Jurgi Camblong, CEO and Co-Founder of Sophia Genetics said:

ISO 27001 certification for Sophia’s Data Driven Medicine Platform is further recognition of our industry leading commitment to data security. There is nothing more important or sensitive to people than their own genetic data and we are proud of our role in safeguarding this to help improve patient diagnosis.

The smart use of data is driving a revolution in diagnosis, leading to a constantly improving understanding of how to treat chronic disease. This can only be done with the confidence and consent of all concerned.

Jean-Pierre Hubaux, Professor and Head of the Laboratory for Computer Communications and Applications at the École Polytechnique Fédérale de Lausanne (EPFL), Switzerland, said:

The secure use of data is an issue of increasing concern in a number of technical fields, and none more so than genomic healthcare – where huge amounts of data are required to enable optimal clinical decision making.

Through its focus on robust data management, Sophia Genetics is providing the basis for the secure roll out of data driven medicine across Europe, allaying fears around potential misuse of data.