Quality & Security | Molecular Health

Quality & security

Certified quality and personal data protection


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.

Certified quality

Molecular Health Guide (MH Guide) is the first software of its kind registered in Europe as an in vitro diagnostic medical device.

 

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 GmbH is MDSAP certified for the Design and Development, Manufacture, Installation, and Servicing of in-Vitro diagnostic Software used in the Genetic Testing for the diagnoses of Hereditary Diseases or Predispositions to a Medical Condition or a Disease and Prediction of Treatment Response Including Point of Care in-Vitro Diagnostic Medical Devices.

 

Both self-paying and reimbursed patients or those whose employers offer the Corporate Oncology Program for Employees (COPE) 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 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.
 

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CLIA-certified

Molecular Health GmbH 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 GmbH 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.


Personal data protection

MH Guide meets the requirements of HIPAA in the US and the GDPR in Europe as well as the GenDG in Germany.

Data transfer

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.



Data privacy

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.



Data access

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 care team or help desk or send us an e-mail. We would be delighted to provide you with more information or answer your questions.


EU: +49 6221 43851-150
E-Mail: CustomerCareEU@molecularhealth.com