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HIPAA/HITECH Assessments

Validate your organization’s alignment with healthcare privacy and security requirements through independent assessments.
At Insight Assurance, we conduct HIPAA and HITECH assessments to help healthcare organizations and their partners evaluate risk, validate safeguards, and support compliance with patient data protection laws. Our independent approach brings clarity to your privacy and security posture, helping reduce risk without adding complexity.
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A doctor in a white coat shows HIPAA-compliant information on a tablet to a patient, who is seated and resting her hands on her lap.

What Are HIPAA & HITECH?

The Health Insurance Portability and Accountability Act (HIPAA) and the Health Information Technology for Economic and Clinical Health Act (HITECH) are U.S. laws that govern the privacy and security of protected health information (PHI). Together, they set standards for access controls, breach prevention, and risk management in healthcare.
A person wearing a white coat types on a laptop keyboard at a desk, ensuring HIPAA compliance while handling sensitive information.
These laws apply to covered entities and business associates that handle PHI in healthcare-related operations. A HIPAA/HITECH assessment evaluates whether your organization’s policies, technical safeguards, and procedures align with these federal requirements.

Why Conduct a HIPAA/HITECH Assessment?

With increasing regulatory scrutiny and cyber threats in healthcare, an independent assessment can help surface risk, validate existing controls, and strengthen your overall privacy and security program.

Key Benefits:

Stronger Patient Data Protection

Identify gaps in how PHI is stored, transmitted, and accessed.

Regulatory Alignment

Map your practices to HIPAA and HITECH security and privacy requirements.

Risk Mitigation

Evaluate how your organization identifies and responds to privacy and security risks.

Stakeholder Trust

Demonstrate a clear commitment to data protection for patients, partners, and regulators.

Our HIPAA/HITECH Assessment Services

Every assessment is conducted by experienced professionals and scoped to reflect your organization’s role, structure, and operational environment. Services may include:
  • Risk assessments
  • Policy development
  • Staff training
  • Security controls implementation
  • Ongoing compliance monitoring

Frequently Asked Questions

Who is considered a covered entity under HIPAA?

HIPAA defines three categories of covered entities: healthcare providers that transmit health information electronically (including hospitals, clinics, physicians, pharmacies, and nursing homes), health plans (including health insurance companies, HMOs, and employer-sponsored health plans), and healthcare clearinghouses that process nonstandard health information into standard formats. If your organization falls into one of these categories and handles protected health information, HIPAA applies directly to you — not just through a business associate relationship. 

A business associate is any organization or individual that creates, receives, maintains, or transmits protected health information on behalf of a covered entity. This includes a wide range of technology companies, cloud platforms, billing services, managed IT providers, data analytics firms, and other service providers operating in the healthcare space. Under HITECH, business associates became directly liable for HIPAA compliance — meaning they are subject to the same penalties as covered entities for violations. A signed Business Associate Agreement (BAA) is required between covered entities and their business associates, but the BAA does not substitute for actually implementing the required safeguards. 

HIPAA is composed of three main rules. The Privacy Rule governs the use and disclosure of protected health information — establishing when and how PHI can be shared, the rights patients have over their information, and the administrative requirements for managing those rights. The Security Rule applies specifically to electronic PHI (ePHI) and requires covered entities and business associates to implement administrative, physical, and technical safeguards to ensure the confidentiality, integrity, and availability of ePHI. A third rule — the Breach Notification Rule — addresses what organizations must do when a breach of unsecured PHI occurs and is addressed separately below. Most HIPAA security assessments focus on the Security Rule, while a comprehensive compliance program addresses all three.

The Breach Notification Rule requires covered entities to notify affected individuals, the HHS Secretary, and in some cases the media following a breach of unsecured PHI. Notification to affected individuals must occur within 60 days of discovering the breach. Breaches affecting 500 or more individuals in a state or jurisdiction must also be reported to prominent media outlets in that area. All breaches must be reported to HHS — smaller breaches may be reported annually, while breaches affecting 500 or more individuals must be reported within 60 days of discovery. Business associates must notify covered entities of breaches without unreasonable delay and within 60 days of discovery.

A HIPAA risk assessment — required under the HIPAA Security Rule — identifies and evaluates potential risks and vulnerabilities to the confidentiality, integrity, and availability of ePHI within the organization’s environment. It covers where ePHI is stored, processed, and transmitted; the threats and vulnerabilities that could affect that information; the likelihood and impact of those threats; and the current controls in place to mitigate them. The risk assessment is not a one-time exercise — it must be reviewed and updated on an ongoing basis and in response to significant environmental or operational changes. 

HIPAA penalties are tiered based on the level of culpability. Violations where the organization was unaware of the violation and could not reasonably have known carry the lowest penalty tier — a minimum of $100 per violation up to $50,000. Violations due to reasonable cause carry a minimum of $1,000 per violation. Willful neglect that is corrected carries a minimum of $10,000 per violation. Willful neglect that is not corrected carries a minimum of $50,000 per violation, with an annual cap of $1.9 million per violation category. Civil penalties can be accompanied by criminal charges for egregious violations, and the HHS Office for Civil Rights has significantly increased enforcement activity in recent years. 

Not in the traditional sense — there is no official HIPAA certification issued by a government body. HIPAA compliance is demonstrated through documented risk assessments, implemented safeguards, trained workforce members, executed Business Associate Agreements, and an ongoing compliance program. However, organizations can now achieve recognized HIPAA certification through the HITRUST framework. By adding a HIPAA Trust Report to an e1, i1, or r2 HITRUST assessment, organizations receive a formal designation recognizing their alignment with HIPAA requirements — evaluated and validated through the HITRUST CSF. This is the closest thing to a certifiable HIPAA credential currently available and is increasingly recognized by enterprise healthcare clients and payers. Organizations should be cautious of other vendors claiming to offer “HIPAA certification” outside of this framework — no such official government-issued designation exists.

HIPAA establishes the legal baseline for protecting health information. HITRUST CSF builds on HIPAA by incorporating its requirements into a certifiable, prescriptive framework alongside NIST, ISO 27001, and other standards — providing a more structured path to demonstrating compliance. SOC 2 addresses security, availability, and privacy controls for service organizations broadly, and a SOC 2 report can provide evidence relevant to HIPAA compliance but does not map directly to HIPAA requirements. Many healthcare technology organizations pursue a combination — a HIPAA assessment establishes the legal baseline, HITRUST provides certifiable assurance for enterprise healthcare clients, and SOC 2 satisfies broader enterprise procurement requirements. 

Why Choose Insight Assurance?

We help healthcare providers and business associates evaluate HIPAA and HITECH compliance with independence, clarity, and care.

Industry Expertise

Our team understands the regulatory and operational challenges specific to healthcare environments.

Independent Assessments

We operate as a third-party auditor providing clear, objective evaluations you can trust.

Global Knowledge

Our auditors bring Big Four backgrounds and international experience to deliver insights you can trust across industries and borders.

Human-First Approach

We communicate clearly, work collaboratively, and tailor every engagement to your team’s needs and capacity.

AI-Enhanced Workflows

Fieldguide’s platform powers a more efficient audit process with faster control mapping and reporting.

Clear, Practical Findings

Our reports focus on what matters — security, compliance, and meaningful next steps.

Ready to Evaluate HIPAA/HITECH Compliance?

Let’s bring clarity to your compliance efforts. Whether you’re conducting a new assessment or refining your program, Insight Assurance helps you move forward with confidence.

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