Digital Product Development Engineered for US Genomics, Healthcare, and Life Sciences Organizations

Look for a partner who can distinguish CLIA requirements from HIPAA requirements, has production experience with genomic file formats like FASTQ, BAM, and VCF, and has integrated with LIMS systems using HL7 v2 or FHIR R4. NonStop's engineering teams work inside this exact environment, engineered for the CLIA and CAP environment your lab operates in.

CLIA governs the accuracy, traceability, and validation of clinical laboratory testing, including software used in the testing process. HIPAA governs the privacy and security of patient health information. A genomics platform needs to be engineered for both, but they are not the same requirement, and a vendor who conflates them usually has not built for a regulated lab before.

A forward-deployed engineering model embeds engineers directly inside your team through integration and production, rather than handing off a build after a demo. NonStop offers this model, including on-site deployment for US-based clients, to close the gap between a working prototype and a system running reliably at clinical volume.

Yes. Certification belongs to the laboratory, not the software vendor. An engineering partner can build and maintain systems engineered for the CLIA and CAP environment while the certification itself remains entirely with the lab.

Yes. NonStop builds HL7 and FHIR R4 integration layers that connect genomics and bioinformatics platforms to Epic, Cerner, and other EHR systems, along with LIMS and sequencer interfaces where required.

Ask whether the vendor has handled genomic data specifically, not just general healthcare data. Ask how they integrate with existing LIMS and EHR systems. Ask who stays on the project after the initial build, and for how long. Ask them to name the specific regulations, like CLIA, CAP, and HIPAA, that shape their engineering decisions.