From qa-compliance
Reference catalog of HIPAA Security Rule-aligned test patterns - administrative safeguards (45 CFR §164.308: workforce training, access management, contingency planning), physical safeguards (§164.310: facility access, workstation security, device disposal), technical safeguards (§164.312: access control, audit logs, integrity, transmission security); PHI handling assertions in fixtures; minimum-necessary tests per §164.502(b); BAA-scope boundary verification. Use when authoring HIPAA-readiness tests for any product handling Protected Health Information.
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[hipaa-hhs]: https://www.hhs.gov/hipaa/
Reference catalog of test patterns by HIPAA Security Rule section
(45 CFR §164). Pair with audit-trail-test-author
for §164.312(b) audit-log requirements. Anchors:
hhs.gov/hipaa and NIST SP 800-66.
Per HHS, PHI = individually identifiable health information + created/received/maintained/transmitted by a covered entity. The 18 HIPAA identifiers per §164.514(b)(2) (Safe Harbor):
1. Name
2. Geographic subdivisions smaller than state (ZIP codes need restrictions)
3. All elements of dates (except year) for dates directly related to an individual
4. Telephone numbers
5. Vehicle identifiers + license plates
6. Fax numbers
7. Device identifiers + serial numbers
8. Email addresses
9. Web URLs
10. SSN
11. IP addresses
12. Medical record numbers
13. Biometric identifiers (fingerprints, voiceprints)
14. Health plan beneficiary numbers
15. Full-face photos + comparable images
16. Account numbers
17. Any other unique identifying number / characteristic / code
18. Certificate / license numbers
Test fixtures for HIPAA-scope systems MUST avoid these 18
identifiers (or use the synthetic-pii-generator
to generate safe substitutes).
def test_user_role_grants_only_minimum_necessary_phi():
"""§164.502(b) minimum necessary standard."""
user = User.objects.create(role='billing-clerk')
# Billing clerks access financial PHI but NOT clinical notes
assert user.can_access(PhiType.BILLING)
assert not user.can_access(PhiType.CLINICAL_NOTES)
assert not user.can_access(PhiType.GENETIC_TEST_RESULTS)
Test that training-completion is enforced before access grant:
def test_user_cannot_access_phi_without_training_completion():
user = User.objects.create(role='nurse', hipaa_training_completed=False)
response = client.get('/patient/123/records', headers={'Authorization': f'Bearer {user.token}'})
assert response.status_code == 403
assert 'training_required' in response.json()['error']
def test_phi_overwritten_when_device_decommissioned():
device = Device.objects.create(serial='ABC123', has_phi=True)
decommission(device)
# Device record marked as wiped + audit log entry
device.refresh_from_db()
assert device.status == 'wiped'
assert device.wipe_method in ['NIST 800-88 Clear', 'NIST 800-88 Purge']
assert AuditLog.objects.filter(action='device_wipe', subject=device.serial).exists()
def test_phi_access_requires_unique_user_id():
"""§164.312(a)(2)(i) Unique User Identification — no shared accounts."""
# System must reject login attempts on generic / shared accounts:
response = client.post('/login', json={'username': 'admin', 'password': 'secret'})
assert response.status_code == 403 # generic 'admin' account forbidden
Cross-ref audit-trail-test-author:
def test_phi_access_creates_audit_record():
"""§164.312(b): record + examine activity in info systems containing PHI."""
user = User.objects.create(role='nurse')
client.get(f'/patient/{patient.id}/records', headers={'Authorization': f'Bearer {user.token}'})
audit = AuditLog.objects.filter(
actor=user.id,
action='phi_access',
subject=f'patient:{patient.id}',
).first()
assert audit is not None
assert audit.timestamp is not None
assert audit.tamper_evident_hash is not None # required for integrity
def test_phi_modification_requires_authentication_and_audit():
"""§164.312(c)(1): protect ePHI from improper alteration / destruction."""
user_unauth = User.objects.create(role='intake-staff')
response = client.put(
f'/patient/{patient.id}/records',
json={'diagnosis': 'modified'},
headers={'Authorization': f'Bearer {user_unauth.token}'},
)
assert response.status_code == 403 # intake staff cannot modify clinical
# Even authorized modification is logged:
user_doc = User.objects.create(role='physician')
response = client.put(
f'/patient/{patient.id}/records',
json={'diagnosis': 'updated'},
headers={'Authorization': f'Bearer {user_doc.token}'},
)
audit = AuditLog.objects.filter(
action='phi_modify',
subject=f'patient:{patient.id}',
actor=user_doc.id,
).first()
assert audit.before_value == 'original'
assert audit.after_value == 'updated'
def test_phi_transmitted_only_via_encrypted_channels():
"""§164.312(e)(2)(ii): encryption in transit for PHI."""
# Plaintext HTTP must redirect or refuse:
response = http_client.get('http://api.example.com/patient/123')
assert response.status_code in [301, 308, 403]
# HTTPS must use TLS 1.2+ + secure ciphers:
tls_info = inspect_tls('https://api.example.com')
assert tls_info.protocol >= 'TLSv1.2'
assert tls_info.cipher in ALLOWED_CIPHERS
def test_query_returns_only_minimum_necessary_fields():
response = client.get(
'/patient/123/billing-summary',
headers={'Authorization': f'Bearer {billing_clerk_token}'},
)
body = response.json()
# Billing summary should NOT include clinical notes or sensitive fields:
assert 'amount_due' in body
assert 'insurance_provider' in body
assert 'clinical_notes' not in body
assert 'medications' not in body
assert 'genetic_test_results' not in body
def test_phi_only_processed_for_baa_purposes():
# Test fixture: BAA scope = appointment-scheduling only
baa = BusinessAssociateAgreement.objects.get(partner='SchedulingVendor')
assert baa.allowed_purposes == ['appointment_scheduling']
# Vendor SHOULD NOT be able to access PHI for non-scheduling purposes:
vendor_user = User.objects.create(employer='SchedulingVendor')
response = client.get(
'/patient/123/billing',
headers={'Authorization': f'Bearer {vendor_user.token}'},
)
assert response.status_code == 403
| Anti-pattern | Why it fails | Fix |
|---|---|---|
| Real PHI in test fixtures | HIPAA violation in tests | synthetic-pii-generator + de-identified data |
| Audit log without tamper-evidence | Logs can be modified post-incident | Hash-chain or signed-batch log integrity (§164.312(b)) |
| Role-based access without minimum-necessary check | Over-broad access; minimum-necessary violation | Per-PHI-type test (Step §164.502(b)) |
| Skip BAA scope tests | Vendor accesses PHI outside agreement | Step §164.504(e) scope test |
| Allow plaintext HTTP for PHI even in dev | Production drift; eventual leak | Always enforce HTTPS (Step §164.312(e)) |
gdpr-test-patterns,
ccpa-test-patterns - sister
privacy-pattern catalogsaudit-trail-test-author -
§164.312(b) audit log requirementssynthetic-pii-generator -
cross-plugin: safe PHI fixture generationcompliance-readiness-reviewer - agentnpx claudepluginhub testland/qa --plugin qa-complianceProvides CDSS development patterns for drug interaction checking, dose validation, clinical scoring (NEWS2, qSOFA), and alert classification integrated into EMR workflows.