We conduct the ePHI inventory, threat and vulnerability analysis, and gap analysis the Security Rule requires — producing written documentation that satisfies regulators, passes enterprise vendor security reviews, and drives a prioritized remediation roadmap.
Talk to our team about your ePHI environment and compliance posture. We reply within 24 hours.
The HIPAA Security Rule requires a thorough, accurate assessment of every risk to ePHI — where it lives, what threatens it, and what controls close the gaps. OCR cites inadequate risk analysis in nearly every major enforcement action.
Every location where ePHI is created, stored, processed, or transmitted — databases, backups, email, mobile devices, third-party apps, and integration points. Organizations consistently find more ePHI than they expected once a thorough inventory is conducted.
External attackers, insider threats, system failures, and environmental disasters — each evaluated against the technical and operational weaknesses they could exploit, including unpatched software, weak authentication, and inadequate access controls.
Each threat-vulnerability combination is scored by the probability it materializes and the impact if it does — regulatory penalties, patient harm, reputational damage, and business disruption. Risk scores drive prioritization, not guesswork.
Current security controls are documented and tested against each identified risk. Gaps are mapped to HIPAA Security Rule implementation specifications — distinguishing required from addressable — so remediation targets the right controls in the right order.
A prioritized, owner-assigned remediation plan with target timelines — the organization's roadmap from current risk posture to defensible compliance. Updated as gaps close and the environment changes.
A written risk assessment report retained for six years — the document OCR auditors request first. Methodology, scope, findings, risk scores, current controls, identified gaps, and remediation recommendations, at a depth that withstands regulatory scrutiny.
A five-step methodology from scope definition to OCR-ready documentation — producing a written risk analysis that satisfies regulators, passes enterprise vendor security reviews, and drives a prioritized remediation roadmap.
OCR audits begin with the risk analysis. Enterprise healthcare customers require it in vendor reviews. A missing or stale assessment is the one finding that immediately puts an organization on the defensive.
Book a Risk Assessment ConsultationThe Office for Civil Rights evaluates risk assessments against each of these components. A gap in any one of them is a finding in an audit or investigation.
A complete inventory of every location where electronic protected health information exists across the organization's environment.
The realistic threat actors and events that could compromise ePHI confidentiality, integrity, or availability.
Technical and operational weaknesses that threats could exploit to compromise ePHI.
Each threat-vulnerability pair is scored by likelihood and potential impact to produce a prioritized risk register.
Existing security controls are evaluated against each risk, and gaps are mapped to HIPAA Security Rule specifications.
Written documentation retained for six years and detailed enough to withstand regulatory scrutiny.
Standards-based tooling and regulatory guidance — referenced to produce a risk analysis that satisfies OCR, enterprise healthcare customers, and provincial health privacy regulators.
H
HIPAA Security Rule
4
45 CFR 164.308(a)(1)
H
HHS SRA Tool
P
PHIPA (Ontario)
H
HIA (Alberta)
N
NIST CSF
N
NIST SP 800-30
H
HITRUST CSF
S
SOC 2 Type II
I
ISO 27001
A
AWS Security Hub
A
Azure Security Center
G
Google SCC
A
AWS Config
A
Azure Policy
A
AWS CloudTrail
A
Azure Monitor
D
Datadog
N
Nessus / Qualys
P
Penetration Testing
A thorough, documented HIPAA risk analysis is the foundation of defensible compliance — and the first thing regulators request. We conduct the assessment, produce OCR-ready documentation, and deliver a prioritized remediation roadmap your team can act on.
Book a Risk Assessment Consultation
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HIPAA does not specify a fixed reassessment interval, but the Security Rule's ongoing risk analysis requirement means the assessment must be revisited whenever significant changes occur — a new system deployed, a new business associate engaged, a security incident, or a material change in how ePHI is processed. Most healthcare compliance professionals recommend a full reassessment at least annually. For fast-growing digital health startups adding features and integrations regularly, this means the risk assessment is a living document rather than a periodic exercise.
The HHS Office for Civil Rights and the Office of the National Coordinator for Health Information Technology jointly developed the Security Risk Assessment Tool — commonly called the SRA Tool — as a free resource to help smaller healthcare organizations conduct HIPAA risk assessments. It provides a structured questionnaire covering the HIPAA Security Rule's requirements, guidance on evaluating threats and vulnerabilities, and functionality to document findings and generate a risk assessment report. While the SRA Tool is most appropriate for smaller organizations with less complex environments, it can be a useful starting point for understanding assessment scope.
A HIPAA risk assessment is an internally focused exercise that systematically evaluates the organization's own risks, vulnerabilities, and controls against HIPAA Security Rule requirements. It is conducted to understand risk posture and identify what needs to improve. A HIPAA security audit is typically an external assessment conducted by a third party evaluating whether the organization's practices and controls meet HIPAA requirements. Audits may be conducted voluntarily for external validation, by healthcare enterprise customers as part of vendor due diligence, or by OCR as part of its compliance oversight program. A solid, current risk assessment is the foundation that makes an external audit go smoothly.
HIPAA's risk analysis requirement applies to any covered entity or business associate that handles ePHI belonging to U.S. patients, regardless of where the organization is located. A Canadian digital health company serving U.S. healthcare organizations is a Business Associate under HIPAA and must comply with the Security Rule — including conducting a risk analysis. For the Canadian patient population, PHIPA in Ontario and equivalent legislation in other provinces impose comparable risk assessment obligations on health information custodians and agents.
