Who needs to comply with HIPAA?

Covered entities (health plans, health care providers that transmit health information electronically, and health care clearinghouses) and their business associates that handle PHI must comply with HIPAA requirements.

What are the HIPAA Security Rule safeguards?

Administrative, physical, and technical safeguards—such as policies/procedures, workforce training, facility controls, access management, encryption, audit logs, and incident response.

What is a HIPAA risk analysis?

A risk analysis identifies where PHI is created, received, maintained, or transmitted, evaluates potential risks and vulnerabilities, and informs risk management plans and mitigation controls.

When are Business Associate Agreements required?

When a vendor or partner (a business associate) creates, receives, maintains, or transmits PHI on behalf of a covered entity or another business associate, a BAA defining responsibilities is required.

What triggers HIPAA breach notifications?

Unauthorized acquisition, access, use, or disclosure of unsecured PHI generally requires notification to affected individuals and, in some cases, HHS and the media—subject to risk assessment and timing rules.

Where does Audora fit for HIPAA work?

Auditors and assessment teams use Audora as an independent system of record for planning, evidence collection, sampling, testing, review notes, and one-click reporting—streamlining HIPAA assessments and exports.

Frameworks Explained

HIPAA

HIPAA is U.S. law governing the privacy and security of Protected Health Information (PHI/ePHI). Its primary goal is to ensure confidentiality, integrity, and availability of PHI through the Privacy Rule, Security Rule, and Breach Notification Rule, enforced by HHS OCR.

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What is HIPAA’s target audience & industries?

Covered Entities (providers, health plans, clearinghouses) and Business Associates (vendors handling PHI), including health tech, billing, and data services.

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Does it apply to my organization?

You must comply if you are a Covered Entity (providers, plans, clearinghouses) or a Business Associate processing PHI for them. Common triggers: handling ePHI, signing BAAs, integrations with EHRs.

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What are the benefits and risks of conducting a HIPAA Audit?

Legal compliance; reduced regulatory risk
Clear safeguards for ePHI handling and vendor management
Stronger patient and partner trust
Foundation for HITRUST and other healthcare framework
Regulatory compliance and lower breach risk
Trust with patients, providers, and payers
Avoid penalties, investigations, and contract risk

What are the core HIPAA requirements?

Role identification: Covered Entity vs Business Associate; designation of HIPAA Privacy and Security Officers.
Risk analysis & risk management: Inventory ePHI systems, threats/vulnerabilities, likelihood/impact, and documented treatment plans.
Administrative safeguards: Policies/procedures, workforce training, sanctions, contingency planning, incident response, vendor management with BAAs.
Physical safeguards: Facility access controls, workstation/device security, media handling/disposal, environmental protections.
Technical safeguards: Access control (unique IDs, MFA), audit controls/logging, integrity controls, transmission security (TLS/VPN), encryption at rest (where reasonable and appropriate).
Privacy Rule compliance: Minimum necessary, authorized uses/disclosures, Notice of Privacy Practices, individual rights (access, amendment, accounting).
Breach Notification Rule: Incident classification, risk assessment method, notification timelines to individuals/HHS/media, documentation.
Vendor oversight: BAAs with subcontractors, due-diligence, and ongoing monitoring of PHI handling.
Documentation & retention: Policies, training records, risk analyses, incident/breach logs, and audit trails kept per retention rules.
Periodic review: Annual risk analysis updates, policy refresh, training refreshers, and corrective actions.

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What are the general guidelines for executing a HIPAA audit?

Determine role: Covered Entity vs Business Associate; map PHI/ePHI systems and data flows.
Risk analysis & management: Identify threats/vulnerabilities to ePHI; document likelihood/impact; implement mitigations; keep living risk register.
Safeguards: Implement Administrative (policies, training, sanctions, BAAs), Physical (facility/device controls), Technical (MFA, encryption, audit logs, integrity checks).
Privacy Rule: Minimum necessary, uses/disclosures, Notice of Privacy Practices, individual rights handling.
Breach Notification: Define incident classification, risk assessment method, and notification timelines; test the process.
Vendor management: Execute BAAs, assess vendors’ safeguards, restrict PHI access, and monitor performance.
Access management: JML processes, role-based access, quarterly reviews, device/media controls, remote access rules.
Monitoring & response: Centralized logging, alerting, incident response with tabletop exercises; maintain records.
Training & awareness: Role-based HIPAA training; phishing awareness; document attendance and assessments.
Program upkeep: Annual risk analysis update, policy refreshes, audit trails retention, and corrective action tracking.

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What are estimated timelines to complete a SOC 1 audit?

Startup: 4–10 weeks (risk analysis, policies, BAAs, safeguards)
Small: 2–4 months (risk analysis, policies, BAAs, tech safeguards)
Medium: 4–8 months
Large: 6–12 months

What are the typical costs?

Costs vary by size, scope, and readiness by organizations: (T1 / T2)

Startups: 1 - 25 employees, single product, 1 prod environment, 1 region, few to no vendors - $8k–$30k / $6k–$15k
Small Companies: <100, 1–2 products, 1–2 environments, low vendor count - $20k–$60k / $10k–$30k
Medium Companies: 100 - 1,000 employees, multi-product, multi-region, moderate vendor count - $60k–$150k / $30k–$70k
Large Companies: >1,000 employees, complex/regulatory environment, high vendor count - $150k–$400k+ / $70k–$150k+
No official “HIPAA certification.” Costs depend on PHI systems, BAAs, ePHI safeguards (MFA, encryption, logging), and training scale.
(Ranges include typical readiness + audit/assessment (and operating period where applicable). Costs are USD and combine internal enablement/consulting + external auditor/assessor/cert body where relevant).

Where to Learn More

HHS Office for Civil Rights — https://www.hhs.gov/hipaa
NIST SP 800-66 Rev.2 (Implementing the HIPAA Security Rule) — https://csrc.nist.gov/publications/sp/800/66/r2
AMA: HIPAA Privacy & Security Resources — https://www.ama-assn.org/practice-management/hipaa