WE’RE AUDITED REGULARLY, SO YOU CAN BE REASSURED
Quality matters. That is why Molecular Health’s comprehensive quality management system is DIN EN ISO 13485-certified. It is also subject to regular audits by notified bodies and accrediting agencies, so you can trust that our products for clinical services are properly managed, and are effective and safe.
As a software manufacturer, we comply with the international software lifecycle and risk management standards IEC 62304 and ISO 14971. As a Software as a Service provider, our quality management system also covers Standard Operating Procedures for the management of productive IT-systems, IT-business continuity, and product security.
In 2016, Molecular Health was CLIA certified and CAP accredited – the first international bioinformatics dry laboratory to achieve this. This confirms that Molecular Health complies with US clinical laboratory standards for dry-laboratory operation and the validity, handling, and reporting of dry-laboratory results.
Molecular Health is committed to protecting privacy and security of all data. We comply with the requirements of HIPAA in the US (Health Insurance Portability and Accountability Act), and in EU the requirements of BDSG (Bundesdatenschutzgesetz, German data protection law) and GenDG (Gendiagnostik-Gesetz, German Genetic Diagnosic Law). We apply stringent industry standard safeguards and practices for the various aspects of data privacy and security management:
Data transfer: clinical data and patient information is encrypted during transmission and storage, using advanced encryption standards (SSL/TLS, AES-256). All services are located in ISO 27001-certified data centers.
Data storage: To ensure maximum data privacy compliance, MH maintains the geographical integrity of patient genomic data: all NGS data is analyzed in the region of origin.
Data access: All MH employees with access to patient data are HIPAA-trained. Data access is controlled and fully traceable from end to end.
Data center architecture: All services used by MH are located in data centers operating according to the highest standards. To ensure compliance with HIPAA requirements, MH concludes Business Associate Agreements (BAA) with all providers processing US patient data. Our cloud data centers and co-locations are ISO 27001-accredited and observe the highest industry standards for data security.