Who Must Comply with HIPAA?
Two types of organizations are required to follow HIPAA rules
Covered Entities
- Hospitals and health systems
- Physician practices and clinics
- Dentists, chiropractors, psychologists
- Nursing homes and home health agencies
- Pharmacies
- Health insurance companies
- Health maintenance organizations (HMOs)
- Government health programs (Medicare, Medicaid)
- Healthcare clearinghouses
Business Associates
- Medical billing companies
- EHR/EMR software vendors
- Cloud service providers handling PHI
- IT service providers with PHI access
- Medical transcription services
- Accountants with access to PHI
- Attorneys handling PHI
- Claims processing companies
- Any vendor that creates, receives, maintains, or transmits PHI
The Healthcare Breach Epidemic
Healthcare is the most targeted industry—and the most expensive to breach
The Three HIPAA Rules
Understanding what HIPAA actually requires
Establishes national standards for protecting individuals' medical records and personal health information (PHI).
Limits use and disclosure of PHI
Gives patients rights over their health information
Requires Notice of Privacy Practices
Minimum necessary standard
Requires administrative, physical, and technical safeguards to ensure confidentiality, integrity, and availability of electronic PHI (ePHI).
Risk analysis and management
Workforce security training
Access controls and audit controls
Encryption and transmission security
Requires covered entities and business associates to notify affected individuals, HHS, and media following a breach of unsecured PHI.
60-day notification deadline
Individual notification requirements
HHS notification (breach portal)
Media notification (500+ affected)
Business associate reporting obligations
Recent Healthcare Breaches
Real incidents that resulted in massive fines and patient harm
HIPAA Compliance in 90 Days
We've helped healthcare organizations and their business associates achieve HIPAA compliance with our proven 90-day methodology. Stop worrying about OCR investigations and start protecting patient data with confidence.
- Complete HIPAA risk analysis (OCR's #1 requirement)
- Privacy and Security Rule policy library
- Workforce training program
- Business Associate Agreement templates
- Incident response and breach notification procedures
- Technical safeguard implementation guidance
- Ongoing compliance monitoring with dashr.ai
Report Ready 90
- Comprehensive HIPAA risk analysis
- 40+ policies (Privacy + Security Rules)
- Workforce training materials
- BA Agreement templates
- Incident response procedures
- Technical control guidance
- dashr.ai platform (Year 1 free)
- Mock audit before go-live
Our 90-Day HIPAA Process
From risk analysis to compliance—systematically
Risk Analysis
Comprehensive assessment of your PHI environment, threats, vulnerabilities, and current safeguards. The foundation OCR requires.
Gap Remediation
Develop and implement policies, procedures, and technical controls to address identified gaps. We do the heavy lifting.
Training & Documentation
Workforce training, BA agreements, and complete documentation package. Everything you need for OCR compliance.
Validation & Handoff
Mock audit, final review, and handoff with ongoing monitoring through dashr.ai. You're ready for anything.
Business Associate Compliance
If your company handles PHI on behalf of healthcare organizations, you're a Business Associate—and you must comply with HIPAA. This includes IT vendors, cloud providers, billing companies, and any service that touches patient data.
Business Associates must implement the same Security Rule safeguards as covered entities, report breaches within 60 days, ensure subcontractors are also compliant, and maintain documentation for 6 years. You can face direct OCR enforcement and penalties.
Before any PHI is shared, you must have a signed Business Associate Agreement (BAA) that specifies permitted uses, safeguards required, breach reporting procedures, and termination conditions. Without a valid BAA, PHI cannot be legally shared.
Proposed Security Rule updates will require covered entities to obtain written verifications that each BA has deployed required safeguards. This means BAs who can't demonstrate compliance may lose contracts with healthcare clients.
Healthcare organizations increasingly require proof of HIPAA compliance before signing contracts. Having a documented compliance program—and potentially SOC 2 certification—differentiates you from competitors who can't demonstrate security.
HIPAA Compliance FAQ
No. Unlike SOC 2 or ISO 27001, there is no official "HIPAA certification" from HHS. However, you can undergo third-party HIPAA assessments and pair them with SOC 2 or HITRUST certifications to demonstrate compliance maturity. OCR looks for documented evidence of your compliance program—risk analysis, policies, training records, and incident response procedures.
OCR investigates complaints filed by patients or employees, breaches affecting 500+ individuals (which are publicly posted on the breach portal), and media reports of potential violations. OCR also conducts random compliance audits. The key defense is having a documented compliance program BEFORE an investigation begins—the breach itself is often just the trigger.
Failure to conduct a thorough, enterprise-wide risk analysis. This is the #1 cited violation in OCR settlements and the focus of their 2024-2025 Risk Analysis Initiative. A proper risk analysis identifies where PHI exists, what threats and vulnerabilities apply, and what safeguards are in place. It must be documented and updated regularly.
It depends. HIPAA is required by law for covered entities and business associates—there's no option. SOC 2 is voluntary but increasingly requested by healthcare clients who want third-party validation of your security controls. Many healthcare technology vendors get both: HIPAA for legal compliance, SOC 2 for competitive advantage and customer trust.
Starting from scratch, most organizations can achieve a solid HIPAA compliance posture in 60-90 days with focused effort. This includes risk analysis, policy development, control implementation, and training. Maintaining compliance is ongoing—you'll need regular risk assessments, annual training, and continuous monitoring.
Telehealth creates additional HIPAA considerations: video platforms must have BAAs, patient communications must be secured, and remote access to PHI must be controlled. The pandemic-era OCR enforcement discretion has ended—telehealth must now meet the same HIPAA standards as in-person care. We help organizations implement compliant telehealth programs.
Protect Your Patients. Protect Your Organization.
Healthcare breaches are at an all-time high. Don't wait for an OCR investigation to get compliant.