Industry Perspectives
Analysis and curated insights on systemic risk, emerging threats, and the evolving healthcare risk landscape.
Third-Party CVE Decisions: FDA Documentation Guide
Guide for documenting third-party CVEs: track exposure, patient-safety risk, decisions, evidence, closure, and audit readiness.
Read Post >>HIPAA Breach Notice for Third-Party AI
Step-by-step HIPAA breach notice process for AI vendors: assign owners, trace PHI, meet 60-day deadlines, and preserve evidence.
Read Post >>PCI Gaps That Lead to Healthcare Payment Breaches
Map card-data paths, remove unnecessary connections, enforce MFA, confirm vendor PCI duties, and test logging and incident response.
Read Post >>How FDA Guides Postmarket Software Vulnerability Review
A vulnerability score alone doesn't determine patient risk—assess exposure, clinical harm, remediation, disclosure, and verification.
Read Post >>HIPAA Backup Testing: Guide for Recovery Validation
Plan, test, and fix HIPAA backup restores to meet RTO/RPO, verify ePHI integrity, and produce audit-ready recovery evidence.
Read Post >>Healthcare Data De-Identification Guide 2026
HIPAA-focused workflow to inventory, transform, test, document, and govern de-identified healthcare data for safe sharing.
Read Post >>How to Monitor AI Controls in Healthcare
Assign owners, thresholds, dashboards, and retest rules to monitor AI in clinical care and PHI, aligned with NIST, HIPAA, and FDA guidance.
Read Post >>FDA Cybersecurity Testing for Connected Devices
Four-category FDA testing approach to validate security requirements, model threats, find vulnerabilities, and link fixes to SBOMs and postmarket evidence.
Read Post >>HITRUST Certification Framework: Overview
Match HITRUST pathway to actual risk and contracts, verify scope and assessor, and maintain controls—certification doesn't replace HIPAA or a BAA.
Read Post >>10 Internal HIPAA Audit Best Practices
A 10-step internal HIPAA audit guide: scope, ePHI mapping, risk analysis, safeguards testing, logs, training, incident recovery, and verification.
Read Post >>Component Scanning vs Pen Testing for Devices
Compare component scanning and penetration testing for medical devices; when to scan, scope, safety, and how to prioritize fixes, retests.
Read Post >>AI Risk Management in Clinical Workflows
Seven lifecycle gates to assess, validate, monitor, and retire clinical AI while protecting patients and PHI.
Read Post >>Applying ISO 27559 to Clinical Imaging Data
ISO 27559 checklist to de-identify clinical DICOM images: metadata cleanup, burned-in text and face review, risk assessment, and export validation.
Read Post >>AI Vendor Disclosure Framework for HDOs
Treat vendor AI disclosures as a starting point. Verify model limits, data provenance, human review, patient impact, and incident reporting.
Read Post >>How to Build Hybrid Vendor Assessments for PHI
Map PHI flows, verify vendor evidence, and score residual risk to approve PHI access with a HIPAA-based control matrix.
Read Post >>How Biometric Access Control Protects Healthcare Data
Explains using biometrics with identity proofing, encrypted templates, MFA, role-based permissions, logging, and tested failover to protect PHI.
Read Post >>EU vs US Device Software Security Rules
Side‑by‑side guide to EU MDR/IVDR and U.S. Section 524B requirements for SBOMs, patching, and postmarket security records.
Read Post >>7 QSR Records for Device Security Audits
Seven linked record categories to trace device cybersecurity risks from identification through testing, release, and closure.
Read Post >>How Real-Time Alerts Track HIPAA Gaps
Link real-time alerts to controls, owners, and verified fixes to detect, investigate, and close HIPAA monitoring gaps.
Read Post >>Medical Device Security Testing: DAST Guide
A safety-first DAST workflow for testing medical device interfaces, protecting evidence, rating clinical impact, and managing fixes.
Read Post >>Medical Device EHR Integration: 9 Security Checks
Nine end-to-end security checks for device-to-EHR connections covering certificates, access, data integrity, failover, and incident response.
Read Post >>Integrated Delivery Network TPRM: Managing Vendor Risk Across Multiple Facilities
Centralized TPRM for IDNs reduces vendor-related breaches, improves HIPAA compliance, and protects patient safety across multiple healthcare facilities.
Read Post >>Post-Certification Incident Reporting for Medical Devices
Steps to assign owners, preserve evidence, meet FDA MDR deadlines, and maintain audit-ready incident files for medical devices.
Read Post >>SAST for Medical Devices: 7 Testing Methods
Seven static testing methods to evaluate medical-device code and artifacts, with lifecycle guidance on evidence and risk review.
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