Industry Perspectives

Explains FDA premarket cybersecurity requirements—SBOM, postmarket plan, secure development, and traceable evidence for medical device software.

Verify cloud vendors’ HIPAA compliance with BAAs, SIEM, audit logs, CSPM and CASB/DLP through continuous, evidence-based monitoring.

Checklist to verify a cloud vendor's ISO 27001: validate certificate, scope, SoA, controls and renewals for PHI protection.

Five essential doc groups—risk file, architecture/threat model, SBOM, testing evidence, and postmarket records—for FDA-ready device cybersecurity.

Written EHR breach playbooks speed containment, preserve patient care, guide HIPAA decisions, and ensure safe recovery.

Visibility alone isn't enough: pair SBOMs with IEC 81001-5-1/QMS, vendor SLAs, and platform-scale management for FDA compliance.

Six-part compliance stack - GDPR, ICO, NHS, WHO, OECD, ENISA - practical checklist to govern healthcare AI across the full lifecycle.

Six controls—policy, inventory, risk review, sanitization, chain-of-custody, and vendor proof—plus six-year records to secure PHI disposal.

Manage third‑party vendor threats to healthcare networks, security, and uptime with frameworks, SLAs, audits, and continuous monitoring to protect patients.

Protect patient safety by managing vendor risks to oncology equipment, drugs, and IoMT through continuous monitoring, compliance, and incident planning.

Guidance for mental health facilities to manage vendor risks, protect patient privacy and safety, meet HIPAA/42 CFR Part 2, and maintain continuous monitoring.

Best practices for vetting long-term care vendors to protect residents, meet HIPAA/CMS requirements, and reduce cybersecurity and continuity risks.

How rural hospitals can reduce vendor-related cyber and operational risks with inventories, risk tiering, stronger contracts, continuity plans, and scalable automation.

Machine-readable SBOMs, VEX, and update processes for medical devices to meet FDA and EU cybersecurity requirements.

Learn 5 steps for healthcare breach recovery, from outage response and claims backup to clearinghouse redundancy and cyber risk planning.

Four-step framework to map data flows, confirm HIPAA/GDPR rules, validate cross-border security controls, and monitor PHI vendors.

Learn 4 rules for safe AI network governance, from policy guardrails and compliance checks to network visibility and agent controls.

AI speeds threat discovery and dynamic risk scoring in the clinical SDLC, but human oversight, traceability, and governance remain essential.

Patch management is a lifecycle safety duty: track SBOMs, assess clinical risk before each update, and keep audit-ready records per FDA.

Connected medical devices require complete premarket cybersecurity evidence and active postmarket controls to avoid review delays and enforcement.

FDA requires device-level proof for cryptography: use current algorithms, test failure cases, document key lifecycle and traceability.

Compare Safe Harbor vs Expert Determination for mHealth apps; remove device IDs, location, free text; test, document, and reassess.

Data integrity failures endanger patients; secure access, validate interfaces, and verify restores before cutover.

Compare cyber threats to device component suppliers—patient safety, production downtime, software supply-chain and firmware risks.