We guarantee quality, safety, and privacy of personal data
Molecular Health is an international biotech IT company. Our software solutions are used in areas where the sustainable improvement of patient care is at stake, and where the protection of personal data and patient safety are extremely important. Our software applications and servers therefore meet the strictest security requirements and operate with the most advanced encryption standards. In addition, rigorous risk- and quality-management routines and regular training of our employees ensure compliance with data privacy regulations.
Certified quality
As an in-vitro diagnostics partner, we are certified according to EN ISO 13485:2016 – for the design, development, and production of software systems for the integrated analysis of clinical and genomic patient data to support treatment decisions, as well as for the provision of related services.
Molecular Health is a certified MDSAP (Medical Device Single Audit Program) company for the design, development, production, installation, and maintenance of in-vitro diagnostic software used in genetic testing to diagnose hereditary conditions or predispositions to a medical condition or disease, and to predict treatment response. This includes in-vitro diagnostics at the point of care.
Our software application MH Guide, together with its modules, is one of the first software solutions of its kind to be approved in Europe as an in-vitro diagnostic (IVD) medical device to receive a certificate according to the EU regulation 2017/746 (IVDR).
As a manufacturer, Molecular Health complies with the international standards for software lifecycle and risk management, IEC 62304 and ISO 14971.
Our EN ISO 13485:2016 certified quality management system also includes standard operating procedures (SOPs) for the operation of productive IT systems, IT business continuity, and product safety.
CLIA-Certified
Molecular Health GmbH is certified according to 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).
CAP-accredited
Molecular Health GmbH is accredited by the College of American Pathologists (CAP), meaning that it complies with US laboratory standards to ensure proper validity, handling, and reporting of dry lab results.
EN ISO 13485
Molecular Health GmbH is certified according to EN ISO 13485:2016 – for the design, development, and production of software systems for the integrated analysis of clinical and genomic patient data to support treatment decisions, as well as for the provision of related services.
We process patient-related data securely
Our software applications are based on advanced technologies that enable the interpretation of genetic data. Patients whose information is analyzed with MH Guide as part of medical treatment can be assured that their personal data is always encrypted or pseudonymized before being transferred to Molecular Health. Only the attending physician has access to patient data that allows conclusions to be drawn about identity. No personal information is transmitted or stored that is not necessary for the analysis. In addition, strict risk- and quality-management routines and regular training of our employees ensure compliance with data privacy regulations at all times.
Sensitive data is safe with us
Data privacy
MH Guide complies with GDPR in Europe, GenDG in Germany, and the Health Insurance Portability and Accountability Act (HIPAA) in the USA.
Data access
All Molecular Health employees with access to patient data are trained in accordance with the General Data Protection Regulation (GDPR) and the American Health Insurance Portability and Accountability Act (HIPAA). Data access is controlled.
Data center architecture
All services are housed in data centers that are Trusted Site Infrastructure (TSI) or ISO 27001 certified and meet the highest industry standards.
"At Molecular Health, we strive to sustainably improve patient care through innovative solutions. We never compromise on quality, safety, or privacy."
PhD Niels Bojunga
Senior Vice President of Quality Management
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