Our guarantee: quality,
safety, and privacy of data
As an international biotech IT company, our software solutions are used in areas where the sustainable improvement of patient care is at stake, and protecting personal data and patient safety are extremely important. Therefore, our software applications and servers meet strict security requirements and operate with the most advanced encryption standards. Patients whose information is analyzed with MH Guide as part of medical treatment are 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 employee training ensure compliance with medical device and data privacy regulations at all times.
Data privacy
MH Guide complies with the General Data Protection Regulation (GDPR) in Europe, the German Genetic Diagnostics Act (GenDG) in Germany, and the Health Insurance Portability and Accountability Act (HIPAA) in the USA.
Data access
Data access is controlled and all 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 center architecture & cybersecurity compliance
All services are housed in data centers or with hosting providers that are Trusted Site Infrastructure (TSI) and/or ISO 27001 certified and meet the highest industry standards. Molecular Health employs advanced encryption standards (SSL/TLS, AES-256) to safeguard personal health data and stores it with controlled access authorization.
Molecular Health complies with federal and local cybersecurity and health data hosting requirements. Utilized hosting provider AWS is certified according to HDS (Hébergeur de Données de Santé) for France and according to ACN (Agenzia per la cybersicurezza nazionale) for Italy.
Certified quality
MH Guide is one of the first software solutions of its kind to be approved in Europe as an in-vitro diagnostic (IVD) medical device and received a certificate according to the EU regulation 2017/746 (IVDR). This IVDR status is complemented by the following company-level certifications:
MDSAP
Molecular Health is a certified Medical Device Single Audit Program (MDSAP) company with the scope: “Design and Development, Manufacture, Installation and Servicing of In-Vitro Diagnostic Software used in Genetic Testing for Diagnosis 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.”
IVDR & ISO 13485
As an in-vitro diagnostics manufacturer, Molecular Health is certified according to EN ISO 13485:2016. Our certified quality management system includes standard operating procedures (SOPs) for the operation of productive IT systems, IT business continuity, and product safety, and we comply with international standards for software lifecycle and risk management, IEC 62304 and ISO 14971.
CLIA
Molecular Health 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
Molecular Health 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.