HIPAA compliance isn't optional. The headache is.

The Health Insurance Portability and Accountability Act (HIPAA) is a federal law that establishes national standards for protecting sensitive patient health information. It applies to covered entities (healthcare providers, health plans, and healthcare clearinghouses) and their business associates.

HIPAA includes several rules, but the most relevant for compliance are the Privacy Rule (how PHI can be used and disclosed) and the Security Rule (safeguards for electronic PHI).

‍

PHI is any individually identifiable health information that relates to a person's physical or mental health, healthcare services, or payment for healthcare. This includes:

• Medical records and test results
• Treatment histories
• Insurance information
• Billing records
• Any data that could identify a patient combined with health information

When PHI is stored or transmitted electronically, it's called ePHI—and it's subject to the HIPAA Security Rule's technical safeguards.

‍

HIPAA applies to two categories of organizations:

Covered Entities:

• Healthcare providers (hospitals, clinics, physicians, dentists, pharmacies)
• Health plans (insurers, HMOs, employer health plans)
• Healthcare clearinghouses

Business Associates:

• Any organization that handles PHI on behalf of a covered entity
• This includes health tech vendors, cloud providers, billing services, consultants, and many SaaS companies serving healthcare

If you're not sure whether you're a business associate, ask yourself: does a healthcare organization share patient data with you to perform a service? If yes, you probably need a Business Associate Agreement and HIPAA compliance.

‍

The HIPAA Security Rule requires three categories of safeguards for ePHI:

Administrative Safeguards:

• Risk analysis and management
• Workforce training
• Access management policies
• Incident response procedures

Physical Safeguards:

• Facility access controls
• Workstation security
• Device and media controls

Technical Safeguards:

• Access controls
• Audit controls
• Integrity controls
• Transmission security

Hicomply helps you implement and document all three categories with pre-built policies, automated evidence collection, and continuous monitoring.

‍

HIPAA is a federal law with specific requirements but no formal certification process. Compliance is demonstrated through documentation, policies, and the ability to pass an audit.

HITRUST CSF is a certifiable framework that incorporates HIPAA requirements along with other standards (ISO 27001, NIST, PCI DSS). HITRUST certification provides third-party validation that's often preferred by large healthcare organizations.

Many organizations start with HIPAA compliance and pursue HITRUST certification as they mature or as customers require it. Hicomply supports both, and work done for HIPAA accelerates HITRUST readiness.

‍

HIPAA violations can result in significant penalties:

• Tier 1: $100–$50,000 per violation (unknowing)
• Tier 2: $1,000–$50,000 per violation (reasonable cause)
• Tier 3: $10,000–$50,000 per violation (willful neglect, corrected)
• Tier 4: $50,000+ per violation (willful neglect, not corrected)

Annual caps can reach $1.5 million or more per violation category. Beyond fines, breaches damage reputation, trigger costly notifications, and can end business relationships with covered entities.

‍

HIPAA requires covered entities and business associates to conduct a risk analysis, but doesn't specify frequency. However, best practices and OCR guidance suggest:

• Annual risk assessments at minimum
• Additional assessments when significant changes occur (new systems, acquisitions, breaches)
• Continuous monitoring to catch issues between formal assessments

Hicomply provides ongoing risk visibility so you're not relying on point-in-time snapshots.

‍

A BAA is a contract between a covered entity and a business associate that establishes what PHI the business associate can access, how they must protect it, and what happens in case of a breach.

BAAs are legally required before a business associate can handle PHI. Without one, both parties are at risk of HIPAA violations.

Hicomply helps you track BAAs, monitor business associate compliance status, and maintain documentation for audits.

‍

Most compliance platforms charge per seat, per device, or per framework—which means your costs grow every time your team does. Hicomply includes unlimited users within fair use (up to 500 employees), so you can get your whole organization into the platform without budget anxiety.

For HIPAA specifically, this matters because compliance requires organization-wide participation: clinical staff, IT, privacy officers, leadership, and business associates all need visibility and accountability. You shouldn't have to choose between broad adoption and budget constraints.

‍

Timelines vary based on your current security posture and organizational complexity. For most organizations:

• Initial assessment: 2-4 weeks to complete a risk analysis and identify gaps
• Remediation: 1-3 months to implement required safeguards and policies
• Ongoing compliance: Continuous monitoring, training, and documentation

With Hicomply, teams typically reach audit-ready status in 90 days—including risk analysis, policy implementation, and monitoring setup.

‍

Yes. HIPAA's safeguards overlap significantly with other compliance frameworks:

• SOC 2: Security controls and access management align closely
• HITRUST: HIPAA is a core component of the HITRUST CSF
• State privacy laws: Many state health privacy laws build on HIPAA requirements
• ISO 27001: Information security management practices translate directly

Hicomply maps controls across frameworks, so work done for HIPAA accelerates progress toward other certifications.

‍