Assess a target system against HIPAA Privacy Rule, Security Rule, and Breach Notification Rule using the hipaa-foundation repository, including entity-role triage, addressable-spec handling, domain selection, evidence mapping, and structured draft output.
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Assess a target system against HIPAA Privacy Rule, Security Rule, and Breach Notification Rule using the hipaa-foundation repository, including entity-role triage, addressable-spec handling, domain selection, evidence mapping, and structured draft output.
Use this skill to produce conservative draft HIPAA assessments of software systems.
This skill is the workflow layer only. It is not the knowledge base itself. The canonical corpus stays in the hipaa-foundation repository under core/.
For fast navigation inside this skill package, start with START-HERE.md and references/index.yaml. They point back to canonical files under the resolved foundation repo. They do not replace them.
Source hierarchy
FOUNDATION_ROOT/core/regulations/*.yamlauthoritative_text — binding regulatory text
FOUNDATION_ROOT/core/guidance/*.yaml — OCR guidance and interpretive context
FOUNDATION_ROOT/core/domains/*.yaml and checklist files — non-authoritative assessment guidance
target-system evidence — determines the actual finding
When to use
Use this skill when:
the user asks to assess, review, or evaluate a system against HIPAA
the hipaa-foundation repository is available directly or through a separate checkout
Prerequisites
Before starting, you need:
a target system to assess
enough repo-local evidence to begin answering the triage questions
a resolvable hipaa-foundation repository
If the target system or foundation root cannot be identified, stop and ask for the missing path. Otherwise inspect the target repo first and ask follow-up questions only if the assessment is still blocked.
Locate the foundation repo
Resolve the foundation root before reading any core/ files.
Resolution order (implemented in scripts/resolve-foundation-root.sh):
HIPAA_FOUNDATION_ROOT environment variable (fail closed if set but invalid)
Current working directory if it is the foundation repo
Sibling of the target repo root (walk up to .git, check sibling)
Sibling of cwd (fallback if not inside a git repo)
Run scripts/resolve-foundation-root.sh from this skill package. Once resolved, treat that absolute path as and read all referenced files from there.
FOUNDATION_ROOT
Workflow
Before triage, explore the target repo directly. Use code, docs, infrastructure config, tests, and any in-repo architecture or procedural material as assessment evidence.
Ask follow-up questions only when a required decision cannot be derived from the reviewed corpus and the assessment would otherwise be blocked.
Entity type must be determined from evidence in the reviewed corpus: governance documents, BAAs, formal scope statements, or explicit entity classification records. Do not infer entity type from system function, clinical branding, device names, or health-data content. If the corpus does not confirm entity type, use tbd with low confidence.
When entity_type is tbd and ePHI is clearly in scope, the usual applicable_rules posture is security_rule, breach_notification_rule, and enforcement_rule. Do not add privacy_rule unless entity status is confirmed from the corpus. Always include enforcement_rule for context.
Before selecting domains, produce a structured triage block.
Apply domain_selection_rules from triage.yaml to populate in_scope_domains.
Read only the domain files listed in in_scope_domains. Skip excluded domains entirely.
Retain entity-and-applicability in working context throughout the assessment. It governs downstream scope judgments.
If entity_type is tbd, read FOUNDATION_ROOT/docs/example-assessment-entity-tbd.md for patterns on handling unconfirmed entity type, excluded Privacy domains, and evidence-basis limitations.
If entity_type is business_associate or ba_subcontractor, read FOUNDATION_ROOT/docs/example-assessment-ba.md for BA-specific assessment patterns.
If entity_type is covered_entity, read FOUNDATION_ROOT/docs/example-assessment.md for covered-entity assessment patterns.
If entity_type is not_regulated, state why and stop.
Step 2 -- Select domains
Read:
FOUNDATION_ROOT/core/index/domain-inventory.yaml
Select domains from the canonical inventory based on entity type, applicable rules, and PHI scope.
Step 3 -- Explore evidence
Read:
FOUNDATION_ROOT/core/checklists/evidence-map.yaml
Use the evidence map while exploring:
code
infrastructure
docs
external governance evidence
Evidence basis branching:
If evidence_basis is repo-only, read the repo_only_notes in each in-scope domain file's assessment_guidance before scanning. These notes identify which controls are typically organizational and should not be rated Gap on repo-only evidence alone.
If evidence_basis includes external evidence, also consult the external evidence expectations in each domain's regulation files.
Read the domain file (review_questions, deep_assessment_probes, assessment_guidance).
Read the domain's regulation_files/standards for orientation.
Read the domain's regulation_files/implementation_specifications for detail on each standard's required and addressable specs.
Read all listed regulation files for the current domain before moving to the next domain. Do not front-load regulation files for all domains at once. Work domain by domain.
For every in-scope domain:
compare expected evidence to reviewed evidence
separate missing evidence from observed gaps
for Security Rule addressable specs, capture the disposition: implemented, alternative, documented_exception, or not_evidenced
a documented exception backed by a risk analysis is Adequate, not a gap
keep conclusions proportional to the evidence basis
Addressable-spec handling:
required + implemented -> Adequate
required + not implemented -> Gap
addressable + implemented -> Adequate
addressable + alternative (documented) -> Adequate
addressable + not_evidenced -> Partial or Not assessed depending on evidence basis
Repo-only realism rule:
Many HIPAA obligations are organizational. On repo-only evidence, the following should typically be Not assessed or Partial, not Gap:
notices of privacy practices
authorizations
accounting of disclosures
sanctions policy execution evidence
executed BAAs
training completion records
breach investigation and notification workflow execution evidence
Domain severity anchors:
For systems with strong technical controls but weak governance, default to Minor or Observation
Escalate only with explicit rationale
State the escalation rationale if overriding the domain default
begin with the exact disclaimer as the very first content: This is a draft assessment for human compliance review. It is not a compliance determination and not a substitute for legal counsel.
end with the same exact disclaimer as the very last content
include the triage block before findings
include a domain ratings summary table with an addressable_disposition column for Security Rule specs
include a detailed finding section for every row that is not Adequate or Not applicable
show basis_type for each non-trivial finding
If part11-foundation is also being used:
keep the same factual evidence across both assessments
let part11-foundation own Part 11 record/signature scope and control ratings
let hipaa-foundation own HIPAA Privacy/Security/Breach findings
do not force identical labels when the repos are answering different questions
If gamp5-foundation is also being used:
let gamp5-foundation own lifecycle, validation, and supplier methodology
HIPAA risk analysis and GAMP risk assessment are related but distinct
