HIPAA-aligned security for hospitals, health systems, and clinical networks
EHR and medical-device security, clinical-environment IT, and audit-ready HIPAA and AI governance for mid-market hospitals, health systems, and multi-site clinical networks — operated across Verity, Core, Sentry, and Citadel.
Multi-site clinical networks
Behavioral & substance-use care
Medical device & IoT fleets
Revenue cycle & health IT
Patient safety and data protection are the same problem
Healthcare runs more connected, more regulated, and more attacked infrastructure than almost any other mid-market sector — EHRs, PACS, infusion pumps, and a growing footprint of AI-assisted clinical tools, all touching PHI, all reachable from a clinical network that cannot tolerate downtime the way an office network can. A ransomware event elsewhere is inconvenience; here it can delay a surgery or divert an ambulance. Armorstack treats HIPAA compliance, medical-device security, AI tool governance, and physical access to clinical space as one connected operating problem.
Five frameworks every healthcare organization should know
These are the real, named standards that govern PHI, clinical devices, and behavioral-health data — not generic best practice, but the actual frameworks OCR investigators and auditors will hold you to.
HIPAA Security, Privacy & Breach Notification Rules
The Security Rule governs electronic PHI through administrative, physical, and technical safeguards. The Privacy Rule governs permissible uses and disclosures of all PHI. The Breach Notification Rule requires notifying individuals, HHS, and in some cases media within defined timelines following a breach of unsecured PHI. Together they are the floor every covered entity and business associate must meet.
Source: HHS Office for Civil Rights (hhs.gov/hipaa)HITECH Act
The Health Information Technology for Economic and Clinical Health Act strengthened HIPAA enforcement, extended liability directly to business associates, and established the breach-notification requirements now codified in the Breach Notification Rule — and it materially raised the civil monetary penalties OCR can impose for non-compliance.
Source: HHS Office for Civil Rights (hhs.gov/hipaa)FDA Cybersecurity in Medical Devices (Section 524B)
Section 524B of the Food, Drug & Cosmetic Act, implemented through FDA’s September 2023 premarket guidance, requires makers of internet-connected “cyber devices” to submit a plan for monitoring and patching post-market vulnerabilities, maintain a software bill of materials, and design in reasonable cybersecurity assurance before FDA clearance. Provider organizations inherit exposure through the devices they operate on their networks.
Source: U.S. Food and Drug Administration (fda.gov/medical-devices/cybersecurity)42 CFR Part 2
Federal regulations governing the confidentiality of substance use disorder patient records impose consent and disclosure rules that are, in several respects, stricter than HIPAA itself. Behavioral health and dual-diagnosis providers must segment and control SUD records separately from the rest of the HIPAA-covered record set.
Source: 42 U.S.C. § 290dd-2; SAMHSA (samhsa.gov/about-us/who-we-are/laws-regulations)HITRUST CSF
A certifiable, third-party-assessed framework that harmonizes HIPAA with NIST, ISO 27001, and other control sets into a single assessable standard. Increasingly requested by payers and enterprise partners as proof of a mature security program, on top of — not instead of — HIPAA itself.
Source: HITRUST Alliance (hitrustalliance.net)One operate model, four portfolios
One converged model, four coordinated portfolios — each mapped directly to the standards above.
Shadow AI and cyber operations, with a 24/7 SOC.
24×7 detection tuned to EHR access, medical-IoT/PACS behavior, and AI-assisted clinical tools — mapped to HIPAA Security Rule technical safeguards and FDA post-market expectations.
Physical security on the same record as cyber and identity.
Access control and video for pharmacies, medication rooms, behavioral-health units, and data closets — HIPAA physical safeguards and 42 CFR Part 2 environments.
Governance that survives the board and the auditor.
vCISO-led risk analysis, policy, BA agreements, breach-response readiness, and AI governance for clinical AI tools — audit-ready year-round.
Infrastructure that stays observable as AI workloads scale.
Hardened, redundant infrastructure for EHR, imaging, and revenue-cycle systems, segmented so a business-office incident cannot reach clinical devices.
Healthcare Security & Compliance Questions
What are the three rules of HIPAA compliance?
The Security Rule governs electronic PHI through administrative, physical, and technical safeguards. The Privacy Rule governs permissible uses and disclosures of all PHI, electronic or not. The Breach Notification Rule requires notification to affected individuals, HHS, and in larger breaches the media, within defined timelines.
Does the FDA cybersecurity rule apply to hospitals, or only device manufacturers?
Section 524B’s premarket obligations fall on medical-device manufacturers. But provider organizations inherit real exposure — unpatched connected devices on a clinical network are a documented attack path, and OCR and Joint Commission surveyors increasingly expect providers to show they track manufacturer vulnerability disclosures and patch on a defined cadence.
How is 42 CFR Part 2 different from HIPAA for behavioral health records?
42 CFR Part 2 imposes stricter consent requirements for substance use disorder treatment records than HIPAA requires for general PHI, including more limited circumstances for disclosure without patient consent. Organizations providing dual-diagnosis or SUD care need segmentation and access controls that satisfy the stricter of the two standards.
Is HITRUST CSF certification required, or just HIPAA compliance?
HITRUST is not a legal requirement the way HIPAA is, but a growing number of payers, health information exchanges, and enterprise partners request or require it as third-party proof of a mature security program. Many organizations pursue it once HIPAA fundamentals are solid, as a market-access and partner-trust decision rather than a legal mandate.
What’s in the first engagement?
A structured review of your HIPAA Security Rule technical, administrative, and physical safeguards; medical-device and EHR network exposure; breach-response and business-associate-agreement readiness; and physical access controls in clinical and behavioral-health spaces — benchmarked against the frameworks that actually apply to your organization.
We’re a multi-site clinic group, not a hospital — does this still apply to us?
Yes. HIPAA applies to any covered entity handling PHI regardless of size, and OCR enforcement actions regularly target small and mid-size practice groups, not just hospital systems. Multi-site clinic groups often carry more risk per location because security operations are thinner at each site.