Certified quality and personal-data protection

„We are making 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.“
Dr. Niels Bojunga, SVP Quality Management

Certified quality

Molecular Health Guide® (MH Guide) is the first software registered in Europe as an in vitro diagnostic medical device for analyzing and interpreting tumors. It is continuously optimized by means of clinical validation in studies as well as intense client contact to highly regarded cancer centers in multiple countries.

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.

Both self-paying clients and people whose employers offer COPE® as a form of patient support can rest assured that none of their personal information is communicated to the company. Only the treating physician and the MH Guide-certified physician have access to personally identifying patient data. Molecular Health works exclusively with pseudonymized data; no personal information is conveyed or saved.

As a software manufacturer, we fulfill the IEC 62304 and ISO 14971 standards for the international software life cycle and risk management. As the provider of a software-as-a-service, our quality management system also includes standard operating procedures (SOPs) for operating productive IT systems, IT business continuity and product safety.

CLIA-CERTIFIED


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).

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CAP-ACCREDITED


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.

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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.

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Personal-data protection

In Europe MH Guide SaaS complies with the requirements of BDSG (Bundesdatenschutzgesetz, German data protection law) and GenDG (Gendiagnostik-Gesetz, German Genetic Diagnosic Law).

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.