Molecular Health is committed to protecting the privacy and security of all data in the cloud
We invest in digital infrastructure, running our own cloud compliant with the requirements of HIPAA in the US (Health Insurance Portability and Accountability Act), and we apply stringent industry-standard safeguards and practices for data privacy and security management:
Clinical data and patient information are encrypted during transmission and storage, using advanced encryption standards (SSL/TLS, AES-256). All services are located in Trusted Site Infrastructure (TSI) or ISO 27001-certified data centers.
To ensure maximum data privacy and security, Molecular Health complies with the requirements of HIPAA (ePHI) in the US and the GDPR in Europe, as well as the GenDG in Germany.
All Molecular Health personnel with access to patient data are HIPAA- and GDPR-trained and follow our QMS procedures based on ISO-13485, as well as CLIA and CAP requirements.
Data center architecture
All services are located in data centers (housing) that operate according to the highest standards. Hardware and software is operated by Molecular Health experts following the rules of a CAP/CLIA-certified dry lab. To ensure compliance with HIPAA requirements, Molecular Health concludes Business Associate Agreements (BAA) with all providers processing US patient data. Our cloud data centers and co-locations are Trusted Site Infrastructure (TSI) or ISO 27001-certified and observe the highest industry standards for data security.
We are 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, 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 certified in compliance with the quality standards of the US Clinical Laboratory Improvement Amendments (CLIA), issued by the US federal agency Centers for Medicare and Medicaid Services (CMS).
Molecular Health is accredited by the College of American Pathologists (CAP) confirming our compliance with US laboratory standards to ensure the proper validity, handling, and reporting of dry-laboratory results.
DIN EN ISO 13485
Molecular Health GmbH is DIN EN ISO 13485-certified for the design, development and manufacture of software systems for the integrated analysis of clinical and genomic patient data to support treatment decisions and provisioning of related services. Molecular Health is also MDSAP-certified (Medical Device Single Audit Program).