HIPAA Compliance Services
HIPAA compliance is non-negotiable for companies handling protected health information. Whether you're a healthtech startup, a healthcare provider, or a business associate supporting healthcare organizations, we help you build security programs that protect patient data and meet regulatory requirements.
Understanding HIPAA Requirements
HIPAA (Health Insurance Portability and Accountability Act) establishes national standards for protecting sensitive patient health information. If you handle PHI (Protected Health Information), you must comply with HIPAA's Privacy, Security, and Breach Notification Rules.
Who Must Comply:
- Covered Entities: Healthcare providers, health plans, healthcare clearinghouses
- Business Associates: Companies that create, receive, maintain, or transmit PHI on behalf of covered entities (this includes most healthtech companies)
The HIPAA Security Rule Requirements:
- Administrative Safeguards: Policies, procedures, risk assessments, workforce training, contingency planning
- Physical Safeguards: Facility access controls, workstation security, device and media controls
- Technical Safeguards: Access controls, audit controls, integrity controls, transmission security
Key Compliance Elements:
- Conduct regular risk assessments
- Implement appropriate security controls
- Maintain required policies and procedures
- Train workforce on HIPAA requirements
- Execute Business Associate Agreements (BAAs) with vendors
- Have breach notification procedures in place
HIPAA vs. HITRUST: Understanding the Difference
HIPAA is federal law—it tells you what you must protect but gives flexibility in how. There's no official HIPAA certification; compliance is demonstrated through documentation, audits, and your ability to respond to OCR inquiries.
HITRUST CSF is a certifiable framework that incorporates HIPAA requirements plus controls from ISO 27001, NIST, PCI DSS, and other standards. HITRUST certification provides a formal, third-party validated attestation of your security program.
When HIPAA Compliance Is Sufficient:
- Smaller healthcare organizations and early-stage healthtech
- Customers who accept your Security Risk Assessment and BAA
- Situations where formal certification isn't required
When HITRUST Is Required:
- Enterprise healthcare customers (many large health systems require it)
- Health insurance companies
- Situations where formal certification differentiates you
- Organizations seeking comprehensive security framework alignment
Many organizations start with HIPAA compliance and move to HITRUST as customer requirements demand. We help you make the right choice for your situation and build programs that can scale to HITRUST when needed.
Our Approach to HIPAA Compliance
We approach HIPAA as part of building comprehensive healthcare security programs—not checkbox compliance that leaves you vulnerable.
Risk Assessment HIPAA requires regular risk assessments. We conduct thorough evaluations that:
- Identify where PHI exists across your environment
- Evaluate threats and vulnerabilities specific to your operations
- Assess current control effectiveness
- Prioritize risks based on likelihood and impact
- Document findings for regulatory requirements
Gap Remediation Based on risk assessment findings, we help you address gaps:
- Develop required policies and procedures
- Implement technical controls for PHI protection
- Establish workforce training programs
- Create incident response and breach notification procedures
- Build vendor management and BAA processes
Ongoing Compliance HIPAA isn't one-time—it's continuous:
- Regular risk assessment updates
- Policy maintenance as operations change
- Workforce training refreshers
- Audit log reviews and monitoring
- Vendor compliance verification
- Breach notification procedure testing
Business Associate Requirements
If you're a healthtech company or vendor serving healthcare organizations, you're likely a Business Associate under HIPAA. This creates specific obligations:
What Business Associates Must Do:
- Sign Business Associate Agreements with covered entities
- Implement HIPAA Security Rule safeguards
- Report breaches to covered entities promptly
- Ensure subcontractors (your vendors handling PHI) also comply
- Maintain required documentation and policies
Common Business Associate Challenges:
- Understanding which data elements are PHI
- Implementing appropriate technical controls
- Managing BAA requirements across multiple customers
- Demonstrating compliance to enterprise healthcare customers
- Scaling compliance as you grow
We help healthtech companies navigate Business Associate requirements efficiently, building programs that satisfy healthcare customers while supporting business growth.
Realistic HIPAA Compliance Timelines
Initial HIPAA Compliance Program: 3-6 months
- Risk assessment: 2-4 weeks
- Policy and procedure development: 4-8 weeks
- Control implementation: 4-12 weeks (varies by gaps)
- Workforce training: 2-4 weeks
- Documentation completion: 2-4 weeks
HITRUST Certification (if pursuing): Add 6-12 months
- HITRUST readiness assessment
- Additional control implementation
- Validated assessment by authorized assessor
- HITRUST review and certification
Factors That Affect Timeline:
- Current security program maturity
- Complexity of PHI handling
- Number of systems and vendors involved
- Resource availability for implementation
- Whether pursuing HITRUST certification
Common HIPAA Questions
Is there official HIPAA certification?
No. Unlike SOC 2 or HITRUST, there's no official HIPAA certification. Compliance is demonstrated through risk assessments, policies, controls, and your ability to respond to OCR investigations. Many organizations obtain third-party HIPAA assessments to validate compliance and satisfy customer requirements.
What triggers a HIPAA breach notification?
Breach notification is required when unsecured PHI is accessed, acquired, used, or disclosed in a way not permitted by the Privacy Rule. You must notify affected individuals, HHS, and potentially media (for large breaches). Notification timelines and requirements vary by breach size.
How do we handle PHI in cloud environments?
Cloud providers like AWS, Azure, and GCP offer HIPAA-eligible services and will sign BAAs. You're responsible for configuring these services appropriately and ensuring your applications handle PHI correctly. We help design architectures that leverage cloud HIPAA capabilities while maintaining compliance.
What are the penalties for HIPAA violations?
OCR can impose civil monetary penalties ranging from $100 to $50,000 per violation, with annual caps up to $1.5 million per violation category. Criminal penalties apply for knowing violations. Beyond regulatory penalties, breaches damage reputation and customer relationships.
Do we need HIPAA compliance for de-identified data?
Properly de-identified data is not PHI and isn't subject to HIPAA. However, de-identification has specific requirements (Expert Determination or Safe Harbor methods). Many companies think their data is de-identified when it's not. We help you understand whether your data qualifies and implement appropriate protections.
Ready to Address HIPAA Compliance?
Let's discuss your PHI handling requirements and build a practical compliance program.