PathCam Software: Healthcare‑Ready & Globally Compliant
At PathCam, patient safety, data integrity, and operational excellence drive every line of code we write.
Our quality and security programs align with internationally recognized standards—giving hospitals,
research centers, and diagnostic labs confidence that PathCam integrates smoothly into even the most
regulated environments.
International Standards We Meet — and Exceed
ISO/IEC 27001:2022 – Information Security Management Systems
We operate an ISO 27001‑aligned ISMS that covers the full data lifecycle, from encrypted image
capture to archival storage and secure deletion. Controls map directly to the guidance published
by the ISO/IEC JTC 1/SC 27 committee on cybersecurity and privacy protection.
ISO 9001:2015 – Quality Management (SME Handbook)
Our quality framework follows the ISO 9001:2015 “Small Enterprises” model, emphasizing risk‑based
thinking, continual improvement, and documented procedures for software validation, device
integration, and customer feedback.
ISO/TS 17117‑2:2022 – Health Informatics: Terminological Resources
PathCam’s annotation engine and LIS integrations conform to the capability benchmarks defined in
Part 2 of ISO 17117, ensuring consistent medical terminology across EHR and PACS workflows.- Additional Health‑IT Standards
We track the latest guidance from ISO TC 215 (Health Informatics)
and related families for IT applications in healthcare technology.
Regulatory & Framework Alignment
| Area | Frameworks & How PathCam Complies |
|---|---|
| Protected Health Information | HIPAA, HITECH, BAAs – ePHI is encrypted in transit (TLS 1.3) and at rest (AES‑256); role‑based access controls and audit logging satisfy the Privacy, Security, and Breach Notification Rules. |
| Global Data Privacy | GDPR, CCPA, PIPEDA, LGPD, POPI – Data‑subject rights (access, erasure, opt‑out) are built into our support workflows; regional data residency is available on request. |
| Security Assurance | SOC 2 Trust Services Criteria, NIST Cybersecurity Framework mappings, and PCI DSS where payment processing is involved. Annual third‑party penetration tests and continuous vulnerability scanning validate control effectiveness. |
| Workplace & Safety | OSHA guidelines for ergonomic workstation setup and electrical safety are incorporated into our installation manuals for pathology labs. |
Beyond the Checklist: Our “Above & Beyond” Practices
- Secure‑by‑Design Development – Threat‑modeling and static code analysis are baked
into every sprint. - End‑to‑End Encryption – Camera firmware, USB transport, and cloud backup channels
all use FIPS‑validated cryptography. - Continuous Training – All PathCam staff complete annual HIPAA, GDPR, and secure‑coding
refreshers; completion is logged for audit readiness. - Comprehensive Documentation – Policy libraries, risk assessments, and validation
reports are available under NDA to client compliance teams.
Need Proof or Have Questions?
Our compliance engineers are ready to supply certificates, gap analyses, or mapping documents to your
internal standards. If your institution requires confirmation against additional ISO, national, or
industry benchmarks, let us know—we’ll gladly demonstrate how PathCam meets or exceeds them.
Contact PathCam Compliance Support
CS@PathCam.com | +1 313‑355‑2338 | pathcam.com/support
Together, we can deliver faster diagnostics while safeguarding the privacy and safety of every patient
you serve.