HIPAA-Aligned Security for Hospitals, Health Systems, and Clinical Networks
EHR and medical-device security, clinical-environment IT, and audit-ready HIPAA governance for mid-market hospitals, health systems, and multi-site clinical networks — delivered across Armorstack’s four portfolios: 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 organizations run more connected, more regulated, and more attacked infrastructure than almost any other mid-market sector — EHRs, PACS imaging systems, infusion pumps, and a growing footprint of AI-assisted clinical tools, all touching Protected Health Information, all reachable from a clinical network that can’t tolerate downtime the way a typical office network can. A ransomware event that would be an inconvenience elsewhere can delay a surgery or divert an ambulance. Armorstack’s converged model treats HIPAA compliance, medical-device security, and physical access to clinical space as one connected problem, because a breach rarely respects the line between them.
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)How Armorstack Secures Healthcare Organizations
One converged model, four coordinated portfolios — each mapped directly to the standards above.
EHR, Medical-Device & Network Monitoring
24×7 detection tuned to clinical network traffic — EHR access patterns, medical-IoT and PACS behavior, and the AI-assisted clinical tools showing up in scribing and diagnostics workflows — mapped to HIPAA Security Rule technical safeguards and FDA’s post-market vulnerability monitoring expectations.
Physical Security for Clinical Environments
Access control and video surveillance for pharmacies, medication rooms, behavioral-health units, and data closets — supporting HIPAA’s physical safeguard requirements and the elevated confidentiality obligations of 42 CFR Part 2 environments.
HIPAA Risk Assessment & Governance
vCISO-led risk analysis, policy, and evidence management that keeps Security Rule documentation and breach-response readiness audit-ready year-round — not assembled after an OCR inquiry arrives.
Resilient Clinical IT Backbone
Hardened, redundant infrastructure for EHR, imaging, and revenue-cycle systems, segmented so a business-office incident can’t reach clinical devices — built for the uptime a care environment actually requires.
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 does an Armorstack Healthcare Security Assessment look at?
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.
Ready to Close the Gap Between HIPAA Paper and HIPAA Practice?
Talk to Armorstack about a Healthcare Security Assessment — scoped to your EHR, your devices, and your actual clinical environment.
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