Worldwide biomedical knowledge, structured, linked, and easily accessible
Dataome was designed to intelligently process the growing medical and molecular biological knowledge to enable medical progress. It structures and integrates clinical and molecular data using artificial intelligence (AI) and machine learning (ML). Then, medical and data science experts review and curate the processed information. As a result, Dataome offers unique data quality and linking that greatly expands analytical capabilities. This improves understanding of diseases, enhances patient care, and makes drug development more efficient.
Two powerful solutions that build on Dataome
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.
MH Guide complies with GDPR in Europe, GenDG in Germany, and the Health Insurance Portability and Accountability Act (HIPAA) in the USA.
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
All services are housed in data centers that are Trusted Site Infrastructure (TSI) or ISO 27001 certified and meet the highest industry standards.
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 receive a certificate according to the EU regulation 2017/746 (IVDR). This IVDR status is complemented by the following company-level certifications:
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.
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).
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.