Security-first compliance
for HIPAA
Run the HIPAA Security Rule and Breach Notification Rule in one place. Daily tests show that your safeguards work, and AI drafts your risk analysis. You write down every Addressable decision where a reviewer can find it.
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Read our HIPAA guide- Security Rule standards and specifications
- 54
- Security Rule standards and specifications
- Automated tests
- 100+
- Automated tests, run daily
- Evidence base
- 1
- Evidence base for every framework
What is HIPAA?
HIPAA Security and Breach Notification Rules (45 CFR Part 164, Subparts A, C and D)
Health Insurance Portability and Accountability Act
Healthcare data security
HIPAA is the US law that protects health information. Its Security Rule (45 CFR Part 164, Subparts A and C) applies to covered entities and their business associates.
It has 18 standards across Administrative (§164.308), Physical (§164.310) and Technical (§164.312) safeguards. It also has 36 implementation specifications: 14 Required and 22 Addressable.
Addressable does not mean optional. You either implement it, or you write down why it is not reasonable and appropriate. In that case, you also put an equivalent alternative measure in place where one is reasonable.
Why Strac Comply for HIPAA
OCR says the risk analysis at §164.308(a)(1)(ii)(A) is the most commonly cited Security Rule deficiency in its enforcement actions. It fails because it goes stale or misses where ePHI lives.
Strac Comply keeps yours current. AI drafts the Security Risk Analysis and ePHI inventory, and you approve the risk register with a name and a date. Daily tests show that the safeguards work.
How Strac Comply runs HIPAA
Strac Comply collects evidence every day, not the week before your audit.
Daily tests on AWS, Google Workspace, Azure, Entra and more. They cover the safeguards a reviewer checks first: encryption, access control, audit logs and backups
AI drafts the documents a reviewer asks for first: the Security Risk Analysis, the ePHI inventory and the Business Associate Agreement register. You review and approve each one
Your vendor register tracks the Business Associate Agreement for each vendor. Your §164.308(b)(1) and §164.314(a) evidence is a register you hand over, not a folder someone assembles
Record a determination for each of the 22 Addressable specifications. Say whether you implemented it, met it with an equivalent alternative measure, or found it not reasonable and appropriate. Add your written rationale, as §164.306(d)(3) requires
A breach log for breaches that affect fewer than 500 people, with notice deadlines Strac Comply works out for you. Policies keep every version, and acknowledgments, training and test results keep their dates. So you can show what was in force on any date
54 Security Rule standards and specifications. One evidence base.
A sample of the evidence behind the controls auditors look at first.
§164.308(a)(1)Security management process
Risk register with dated approvals + Security Risk Analysis
§164.308(a)(5)Security awareness and training
Training campaigns + per-person completion records
§164.308(b)(1)Business associate contracts
Vendor register + agreement status per vendor
§164.310(d)(1)Device and media controls
Policy library + media disposal records on file
§164.312(a)(1)Access control
MFA and public-access tests on AWS, Google Workspace and Azure
§164.312(b)Audit controls
CloudTrail, Entra and GCP audit-log tests
How long does HIPAA take?
About 2 to 4 months
To a documented Security Rule program. There is no official certification.
Step 1
Scope and ePHI
1 to 2 weeks
Step 2
Risk analysis
2 to 4 weeks
Step 3
Safeguards, policies and BAAs
4 to 8 weeks
Step 4
Training and review
1 to 3 weeks
Frequently asked questions
What do we send a customer who asks for HIPAA proof?
You send 4 things, and Strac Comply builds them as you go.
First, a Trust portal page you send as a link. It shows your frameworks, your posture and the documents you choose to publish.
Second, an audit binder that pins every policy version, document, test result and written determination to the moment it was current. You download it as a package or share it by magic link. A reviewer then works in their own portal, not inside your account.
Third, a current risk analysis with a dated management approval. Fourth, the records a reviewer samples: training completions and policy acknowledgments per person, and Business Associate Agreements per vendor.
Most healthcare buyers also ask for a SOC 2 report, and the same evidence supports it.
Which parts of HIPAA does this cover?
Strac Comply covers the Security Rule (45 CFR Part 164, Subparts A and C). That means 18 standards and 36 implementation specifications across the Administrative, Physical and Technical Safeguards. It also covers §164.314 and §164.316.
Breach notification (§164.400 to §164.414) is a control set too, not only a policy. It covers the notice duties and the 4-factor risk assessment that decides whether you notify. It also covers the log of breaches that affect fewer than 500 people.
The individual notice is due without unreasonable delay and no later than 60 calendar days after discovery. That is a deadline, not a grace period.
The Privacy Rule (minimum necessary, notice of privacy practices, accounting of disclosures) is not run as a control program here. The AI vCISO can still answer questions about it.
Most health tech companies are business associates. A business associate owes the Security Rule, the breach notice duties and its own subcontractor agreements.
A covered entity also owes the Privacy Rule administrative requirements at §164.530: a privacy official, privacy training, a sanctions policy and a complaints process. Those stay yours to run.
What does "Addressable" require?
An Addressable specification is not optional. It is never "not applicable" either. You decide whether it is reasonable and appropriate for you.
Where it is not, you write down why. You also put an equivalent alternative measure in place if one is reasonable and appropriate. You need that written rationale under §164.306(d)(3).
Under §164.316(b)(2)(i), you must keep it six years from creation or from the date it was last in effect, whichever is later. Strac Comply keeps each determination as a versioned document, so the decision is still there years later.
Encryption is where this comes up most. Both §164.312(a)(2)(iv) and §164.312(e)(2)(ii) are Addressable rather than Required. Implement it anyway.
ePHI encrypted to HHS guidance, with the key safe, is not a reportable breach at all.
Does HIPAA work carry over to SOC 2 or ISO 27001?
Yes, and it is most of the work. The Technical Safeguards at §164.312 overlap heavily with SOC 2 CC6 and CC7 and ISO 27001 Annex A 8.x.
The same encryption, access control and audit logging tests count toward all 3, and you collect them once. If you already run SOC 2, HIPAA adds mostly scoping and documentation, not a second round of evidence collection.
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