HIPAA Done Faster & Done Right

HIPAA Compliance

Integrating Agency with Vanta or Drata gets your HIPAA compliance program operational 30%+ faster, with stronger safeguards, at a lower total cost.

Agency is the only company that is a top-tier partner at both Vanta and Drata, the two leading GRC platforms that support HIPAA compliance.

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GRC Platform Agnostic
Lowest All-In Costs
Leverage AI to Improve Standards and Speed
Understand Privacy Rule and Security Rule requirements
Get a complete HIPAA safeguards checklist
Learn exactly what compliance costs and takes

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Trusted by leading companies for HIPAA compliance

What Is HIPAA Compliance?

HIPAA (Health Insurance Portability and Accountability Act) is a U.S. federal law that establishes national standards for protecting the privacy and security of protected health information (PHI). It applies to covered entities—healthcare providers, health plans, and healthcare clearinghouses—as well as their business associates who handle PHI.

HIPAA compliance has become essential for any organization that touches healthcare data. With enforcement actions increasing and breach penalties reaching millions of dollars, demonstrating a robust HIPAA compliance program is critical for winning healthcare contracts, avoiding regulatory action, and maintaining patient trust.

Agency helps healthcare technology companies and business associates achieve HIPAA compliance faster than traditional approaches. Because we are fully agnostic to both GRC platform and auditor, we help organizations build a compliance program that fits their specific PHI handling operations and scales with their business.

Privacy Rule vs Security Rule

HIPAA compliance requires satisfying multiple rules. Understanding the differences between the Privacy Rule, Security Rule, and Breach Notification Rule is essential to building a comprehensive compliance program.

Aspect	Privacy Rule	Security Rule	Breach Notification Rule
What it covers	All forms of PHI (oral, written, electronic)	Electronic PHI (ePHI) only	Breach reporting obligations
Focus	Use and disclosure standards	Administrative, physical, and technical safeguards	Notification timelines and procedures
Key requirements	Notice of Privacy Practices, minimum necessary, patient rights	Risk analysis, access controls, encryption, audit controls	Individual notification within 60 days, HHS notification, media notification for 500+ affected
Applies to	Covered entities (limited BA obligations)	Covered entities and business associates	Covered entities and business associates
Agency prep timeline	4–6 weeks	6–8 weeks	2–4 weeks

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Key HIPAA Rules and Concepts

HIPAA compliance spans multiple rules and concepts. Understanding these components is essential to building a program that protects PHI and satisfies regulatory requirements.

Protected Health Information (PHI)

Any individually identifiable health information created, received, maintained, or transmitted by a covered entity or business associate. Includes medical records, lab results, billing data, and any information that can identify a patient.

Privacy Rule

Establishes standards for when and how PHI can be used and disclosed. Requires Notice of Privacy Practices, minimum necessary use, individual access rights, and accounting of disclosures.

Security Rule

Requires administrative, physical, and technical safeguards to protect ePHI. Mandates risk analysis, access controls, audit controls, integrity controls, and transmission security.

Breach Notification Rule

Requires notification to affected individuals within 60 days of discovering a breach of unsecured PHI. Breaches affecting 500+ individuals must also be reported to HHS and local media.

Business Associate Agreements

Legally required contracts between covered entities and business associates that specify permitted PHI uses, required safeguards, breach reporting obligations, and data return or destruction requirements.

Minimum Necessary Standard

Requires that PHI use, disclosure, and requests be limited to the minimum amount necessary to accomplish the intended purpose. A key principle that drives access control and data handling policies.

HIPAA Compliance Checklist

Administrative Safeguards

Security management process and risk analysis
Workforce security and authorization procedures
Information access management policies
Security awareness and training program
Contingency plan and disaster recovery

Physical Safeguards

Facility access controls and validation procedures
Workstation use and security policies
Device and media controls for ePHI
Physical access audit trail

Technical Safeguards

Access control and unique user identification
Audit controls and activity logging
Integrity controls for ePHI
Transmission security and encryption
Authentication mechanisms

Organizational Requirements

Business Associate Agreements with all vendors handling PHI
Policies and procedures documentation
Documentation retention (six years minimum)
Group health plan requirements where applicable

Breach Notification

Breach detection and investigation procedures
Individual notification within 60 days
HHS notification procedures
Media notification for breaches affecting 500+ individuals
Documentation of breach risk assessments

600+

Companies trust Agency for compliance

6–8 wk

Average time to HIPAA compliance readiness

80%

Reduction in compliance team workload

The HIPAA Compliance Process

Risk Analysis & AssessmentWeek 1–3

Conduct a comprehensive risk analysis of all systems that create, receive, maintain, or transmit ePHI. Identify threats, vulnerabilities, and the likelihood and impact of potential breaches.
Policy & Procedure DevelopmentWeek 2–5

Develop required HIPAA policies including Privacy Practices, Security Policies, Breach Notification procedures, and workforce sanctions. Align with your organization's specific PHI handling operations.
Technical Safeguard ImplementationWeek 4–8

Implement access controls, encryption, audit logging, integrity controls, and transmission security. Configure monitoring and alerting for ePHI access and modification events.
BAA ManagementWeek 3–6

Inventory all business associates with PHI access. Execute or update Business Associate Agreements to meet current HIPAA requirements and document the BA management program.
Workforce TrainingWeek 6–8

Deploy HIPAA security awareness training to all workforce members with PHI access. Implement role-based training for specific functions and document completion records.
Ongoing Monitoring & ComplianceOngoing

Continuous monitoring of ePHI access, regular risk reassessments, annual policy reviews, and workforce retraining. Agency maintains continuous compliance readiness throughout.

What Does HIPAA Compliance Cost?

HIPAA compliance cost depends on several factors unique to your organization. Rather than publishing one-size-fits-all pricing, Agency scopes every engagement individually so you pay only for what you need.

Factors that determine cost:

PHI scope & complexity: The number of systems that create, receive, maintain, or transmit ePHI directly affects implementation effort and technical safeguard requirements.

Current security posture: Organizations with existing security programs require less remediation than those building safeguards from scratch.

GRC platform: Platforms like Vanta and Drata automate evidence collection and control monitoring. Agency integrates natively with both.

Technical controls: Encryption, access control systems, audit logging, and backup infrastructure needed to satisfy Security Rule requirements.

Ongoing maintenance: Annual risk reassessments, workforce retraining, policy updates, and continuous monitoring to maintain compliance posture.

Agency replaces the internal time cost entirely. Our forward-deployed AI agents and engineers operate your compliance program so your team never context-switches into compliance work. Talk to our team for a custom quote based on your specific scope and requirements.

HIPAA Compliance for Your Company Stage

Whether you're a healthtech startup or an enterprise managing PHI across business units, Agency meets you where you are.

Startups

Building a healthtech product that handles PHI. You need HIPAA compliance to close healthcare contracts without hiring a dedicated compliance team.

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Mid-Market

Scaling your PHI handling operations, or adding frameworks like SOC 2 and HITRUST. You need operational efficiency and cross-framework leverage.

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Enterprise

Managing HIPAA compliance across business units and subsidiaries. You need unified governance, continuous monitoring, and audit readiness.

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How Agency Delivers HIPAA Compliance

Agency operates your entire HIPAA compliance program end-to-end—from risk analysis through implementation and continuous monitoring—without adding headcount. We integrate natively with leading GRC platforms like Vanta and Drata to maximize your existing compliance infrastructure.

Continuous Control Validation

Verse C2 orchestrates real-time validation across your GRC platform, cloud infrastructure, identity providers, and endpoint security. Drift is detected and remediated automatically.

Automated Evidence Collection

Umberto eliminates the manual screenshot-and-spreadsheet evidence cycle. Evidence is collected, organized, and maintained automatically—always current, always audit-grade.

AI-Powered Remediation

Rumi AI writes infrastructure-as-code fixes for cloud misconfigurations. Storm Shadow validates every evidence artifact before auditor submission.

Cross-Framework Mapping

Armada PSCO maps HIPAA safeguards to SOC 2, ISO 27001, HITRUST, and other frameworks automatically. Work done for HIPAA carries forward to every additional certification.

GRC Platform Integration

Agency connects directly to your existing Vanta or Drata instance. We automate evidence collection, sync control status, and keep your GRC dashboard current—so your platform investment delivers maximum value with zero manual upkeep.

Automated Documentation

M79 generates system descriptions and management assertions. Caruso maintains network diagrams. Every artifact is documented and traceable.

Managed Detection & Response

Agency MDR covers all endpoints with compliance-grade incident documentation, investigation, and response—satisfying HIPAA Security Rule incident response requirements.

Frequently Asked Questions

What is HIPAA?

HIPAA (Health Insurance Portability and Accountability Act) is a U.S. federal law enacted in 1996 that establishes national standards for protecting sensitive patient health information. It requires covered entities and their business associates to implement administrative, physical, and technical safeguards to ensure the confidentiality, integrity, and availability of protected health information (PHI).

Who must comply with HIPAA?

HIPAA applies to covered entities — health plans, healthcare clearinghouses, and healthcare providers who transmit health information electronically — and their business associates. Business associates are organizations that create, receive, maintain, or transmit PHI on behalf of a covered entity, including cloud service providers, IT vendors, billing companies, and consultants with PHI access.

What is the difference between the Privacy Rule and the Security Rule?

The Privacy Rule establishes standards for how PHI can be used and disclosed, covering all forms of PHI (oral, written, electronic). The Security Rule specifically addresses electronic PHI (ePHI) and requires administrative, physical, and technical safeguards to protect it. Both rules must be satisfied for full HIPAA compliance.

What are the penalties for HIPAA violations?

HIPAA penalties are structured across four tiers based on the level of negligence: unknowing, reasonable cause, willful neglect (corrected), and willful neglect (not corrected). Fines scale significantly at each tier, with annual maximums per violation category. Criminal penalties can include substantial fines and imprisonment. The Office for Civil Rights (OCR) has been increasing enforcement actions, making a robust compliance program essential.

What is PHI and ePHI?

Protected Health Information (PHI) is any individually identifiable health information created, received, maintained, or transmitted by a covered entity or business associate. This includes medical records, lab results, billing information, and any data that can identify a patient. Electronic PHI (ePHI) is PHI that is created, stored, transmitted, or received electronically.

What is a Business Associate Agreement (BAA)?

A BAA is a legally required contract between a covered entity and a business associate that establishes the permitted uses and disclosures of PHI by the business associate. It must specify safeguards the business associate will implement, reporting obligations for breaches, and that PHI will be returned or destroyed when the relationship ends.

How long does HIPAA compliance take?

Initial HIPAA compliance typically takes 3 to 6 months for most organizations. This includes risk analysis, policy development, technical safeguard implementation, workforce training, and BAA management. With Agency, organizations can achieve compliance readiness in as little as 6 to 8 weeks because our forward-deployed AI agents handle control implementation and evidence collection.

Is there a HIPAA certification?

There is no official HIPAA certification issued by the U.S. Department of Health and Human Services (HHS). However, organizations can undergo third-party assessments to validate their HIPAA compliance posture. Frameworks like HITRUST provide a certifiable framework that incorporates HIPAA requirements. Agency helps organizations achieve demonstrable HIPAA compliance through structured programs and continuous monitoring.

Related Frameworks

SOC 2 ISO 27001 GDPR HITRUST CMMC

Related Challenges

Audited Compliance Cross-Framework Complexity Fragmented Governance Policy & Access Trust & Transparency Questionnaire Fatigue

Platform Products

Verse C2

Command-and-control AI automation platform

Umberto

AI compliance evidence engine

Armada PSCO

Unified control ontology and mapping

Looking for expert Managed and Advisory Services? Head over to Agency Comply →

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