Our security is as reliable as our data
We make sustainable investments in digital healthcare innovation projects to ensure that everyone affected by the health care system has timely access to top-quality, safe and effective digital solutions in the field of medical devices and pharma.
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, 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 certified in compliance with the quality standards of the US Clinical Laboratory Improvement Amendments (CLIA), which are issued by the US federal agency Centers for Medicare and Medicaid Services (CMS).
Molecular Health has been accredited by the College of American Pathologists (CAP), which means it complies 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 scope 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 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 we apply stringent industry standard safeguards and practices for the various aspects of 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 in the US and the GDPR in Europe as well as the GenDG in Germany.
All Molecular Health personnel with access to patient data is HIPAA- and GDPR-trained. Data access is controlled and fully traceable from end to end.
Data center architecture
All services are located in data centers operating according to the highest standards. 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.
Let’s talk about how our technology can work for you
To find out more, you can call our customer service or send us an e-mail. We would be delighted to provide you with more information or answer your questions.