Your EHR stack is open source. HIPAA and EU CRA require you to govern all of it.
Healthcare software runs on HL7 FHIR stacks, telehealth WebRTC libraries, clinical API frameworks, and patient data integration middleware. Every one carries open-source risk. HIPAA and EU CRA require you to govern all of it.
HAPI FHIR, OpenMRS, WebRTC, OHIF Viewer, clinical NLP, patient portal frameworks. Each one carries vulnerability, license, and HIPAA risk most engineering teams have never fully mapped. Black Duck maps all of it — automatically.
X-DLM™ routes every finding into governed Polarion workflows before OCR, a hospital buyer, or an EU regulator asks for the evidence.
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Third-party software components in healthcare applications are the leading cause of breaches — and engineering teams are the first line of prevention.
Of successful healthcare data breaches involve third-party vendors and their software. Business associate software supply chains are the primary attack vector. Source: HIPAA Journal 2026.
Of healthcare and health tech software codebases contain at least one high or critical open-source vulnerability — among the highest rates of any industry. Source: OSSRA 2026.
Known vulnerabilities in Black Duck's KnowledgeBase — with BDSA advisories on average 100 days ahead of NVD. For healthcare software where PHI exposure triggers immediate HIPAA notification obligations, that lead time is critical.
HIPAA Breach Notification Rule deadline from breach discovery to OCR notification. A vulnerability in a PHI-touching component identified before exploitation prevents the 60-day clock from starting.
Sources: HIPAA Journal Healthcare Data Breach Statistics 2026. OSSRA 2026. MedicalITG 2026. HIPAA Breach Notification Rule §164.404.
HIPAA Security Rule risk analysis. EU CRA SBOM. Hospital procurement security evidence. All automated.
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Scan every PHI-touching component in your healthcare software
Black Duck identifies vulnerabilities in HL7 FHIR implementation libraries (HAPI FHIR, Microsoft FHIR Server), DICOM imaging frameworks, WebRTC telehealth libraries, healthcare database connectors, clinical NLP models, patient portal JavaScript frameworks, and healthcare-specific open-source middleware. PHI-adjacent component risk is classified separately — triggering HIPAA-specific response workflows in Polarion.
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HIPAA Security Rule §164.308 risk analysis — continuous, not periodic
HIPAA requires ongoing risk analysis of threats to PHI — not annual point-in-time reviews. X-DLM™ routes every Black Duck finding into a Polarion risk management workflow with PHI impact assessment, HIPAA Security Rule classification, remediation assignment, and documented risk acceptance or mitigation decision. OCR audit-ready evidence is a byproduct of how your engineering team already works.
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EU CRA SBOM generation for healthcare software products
Black Duck generates machine-readable SBOMs in SPDX and CycloneDX covering every component in your healthcare software product — for EU CRA conformity, NIS2 hospital supply chain security requirements, and NHS/European healthcare IT procurement questionnaires. X-DLM™ version-controls SBOMs in Polarion, linked to vulnerability decisions and release records.
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License governance for AI-generated clinical code
Healthcare engineering teams use AI coding assistants for clinical algorithm development, diagnostic decision support, and healthcare integration scripting. Black Duck detects GPL/AGPL license conflicts in AI-generated code at the snippet level — protecting healthcare software IP from copyleft contamination that could surface at M&A, hospital contract review, or EU CRA conformity assessment.
See how Siemens Polarion and Black Duck become one governed software risk workflow.
X-DLM™ turns Black Duck software supply chain intelligence into Siemens Polarion work items, requirements links, approvals, escalation paths, and continuously maintained evidence.
Brand authority buyers recognize
Backed by Siemens lifecycle governance and Black Duck AppSec intelligence.
Siemens Polarion ALM
Polarion provides the lifecycle system of record for requirements, tests, approvals, traceability, workflow automation, audit evidence, and regulated software delivery.
Black Duck Software Composition Analysis
Black Duck identifies open source and third-party components across source, binaries, containers, firmware, snippets, AI-generated code, and C/C++ environments without package managers.
The most common healthcare software engineering objections — answered
"We go through SOC 2 every year — that covers our security posture."
SOC 2 Type II certifies that security controls operated effectively during the audit period. It does not produce a machine-readable SBOM, does not automate HIPAA Security Rule §164.308 risk analysis evidence, and does not execute EU CRA's 24-hour vulnerability reporting requirement. X-DLM™ fills the gaps SOC 2 doesn't cover — and makes your SOC 2 audit significantly faster.
"We validate everything before release — HIPAA compliance is our QA team's job."
HIPAA Security Rule §164.308(a)(1) requires ongoing risk analysis — not point-in-time pre-release validation. A vulnerability discovered in a component after release that wasn't in your last risk analysis is a gap OCR has fined healthcare software vendors for. X-DLM™ maintains continuous vulnerability monitoring and risk evidence — not just pre-release snapshots.
From open-source PHI risk to HIPAA-defensible evidence.
EU CRA SBOM. HIPAA Security Rule audit trail. Hospital procurement trust.
See how X-DLM™ integrates Black Duck and Siemens Polarion to scan healthcare software for PHI-adjacent open-source risk, automate HIPAA Security Rule vulnerability management evidence, produce EU CRA-compliant SBOMs, and govern AI-generated clinical code — for healthcare software engineering teams.