The HIPAA Privacy Rule applies to entities and individuals involved in the healthcare industry who handle protected health information (PHI). The entities covered by the Privacy Rule fall into three main categories: covered entities, business associates, and hybrid entities.

1. Covered Entities:

The Privacy Rule primarily applies to covered entities, which include:

1. Healthcare Providers:
   • Doctors, dentists, hospitals, clinics, nursing homes, and other entities that provide healthcare services and transmit health information electronically.
2. Health Plans:
   • Health insurance companies, HMOs, company health plans, government programs that pay for healthcare (e.g., Medicare and Medicaid), and other organizations that pay for healthcare.
3. Healthcare Clearinghouses:
   • Entities that process non-standard health information they receive from another entity into a standard (i.e., standard electronic format or data content), or vice versa.

2. Business Associates:

In addition to covered entities, the Privacy Rule also applies to business associates. Business associates are individuals or organizations that perform certain functions or activities on behalf of, or provide services to, a covered entity and involve the use or disclosure of PHI. Examples of business associates include:

• Billing companies
• Third-party administrators
• IT service providers
• Legal counsel
• Transcription services

Business associates are required to comply with the Privacy Rule and are subject to the same standards and regulations regarding the protection of PHI.

3. Hybrid Entities:

Some entities are considered hybrid entities because they perform both covered and non-covered functions. A hybrid entity can choose to designate specific parts of its organization as covered components subject to the Privacy Rule, while other components remain exempt. This allows certain parts of an organization that do not handle PHI to be excluded from the regulatory requirements.

Individuals Not Covered by the Privacy Rule:

Individuals acting in their personal capacity, such as family members or friends who are not providing healthcare services in a professional capacity, are generally not covered by the Privacy Rule. Also, employers, life insurers, schools, and certain state agencies are not covered entities under HIPAA.

It’s important to note that the Privacy Rule protects PHI in any form, whether electronic, paper, or oral. Covered entities and business associates must ensure the confidentiality, integrity, and availability of PHI and adhere to the standards and requirements outlined in the Privacy Rule. The Privacy Rule is a critical component of HIPAA that safeguards the privacy of individuals’ health information in the context of healthcare services and transactions.