The Health Insurance Portability and Accountability Act of 1996 (HIPAA) is a federal legislation mandating the establishment of nationwide standards to safeguard confidential patient health data from unauthorized disclosure without patient consent or awareness. The U.S. Department of Health and Human Services (HHS) introduced the HIPAA Privacy Rule to enforce the requirements outlined in HIPAA. Additionally, the HIPAA Security Rule offers protection for a specific subset of information covered by the Privacy Rule.
HIPAA Privacy Rule Overview:
The Privacy Rule sets forth standards governing the usage and disclosure of individuals’ health information, referred to as protected health information (PHI), by entities subject to its provisions. These entities, termed “covered entities,” encompass various individuals and organizations.
Covered Entities Under HIPAA:
Covered entities include:
Healthcare providers: Encompasses all healthcare providers, regardless of practice size, who electronically transmit health information for specific transactions outlined by HHS.
Health plans: Includes various insurers such as health, dental, vision, and prescription drug insurers, along with health maintenance organizations (HMOs) and government- or church-sponsored health plans, among others.
Healthcare clearinghouses: Entities tasked with processing nonstandard health information into standardized formats, primarily when providing processing services to health plans or healthcare providers.
Business associates: Individuals or organizations, excluding covered entity workforce members, engaged in utilizing or disclosing individually identifiable health information to perform functions, activities, or services for a covered entity.
Permitted Uses and Disclosures
HIPAA permits covered entities to use and disclose PHI, without individual authorization, for specific purposes or circumstances, including:
- Disclosure to the individual
- Treatment, payment, and healthcare operations
- Opportunity for individuals to agree or object to PHI disclosure
- Incident to a permitted use and disclosure
- Limited dataset usage for research, public health, or healthcare operations
- Public interest and benefit activities, encompassing 12 national priority purposes such as legal requirements, public health activities, and research under certain conditions.
HIPAA Security Compliance
The HIPAA Security Rule, complementing the Privacy Rule’s protection of PHI, focuses on safeguarding a specific subset of information governed by the Privacy Rule. This subset pertains to individually identifiable health information generated, received, maintained, or transmitted in electronic form, known as electronic protected health information (e-PHI). Notably, the Security Rule does not extend to PHI communicated orally or in writing.
Key Compliance Requirements under the HIPAA Security Rule include:
- Ensuring the confidentiality, integrity, and availability of all e-PHI.
- Identifying and mitigating anticipated threats to the security of electronic health information.
- Preventing anticipated unauthorized uses or disclosures not permitted by the rule.
- Ensuring workforce compliance certification.
- In addressing permissive uses and disclosures, covered entities are encouraged to adhere to professional ethics and exercise discretion. The enforcement of HIPAA regulations falls under the purview of the HHS Office for Civil Rights, with all grievances directed to this office. Violations of HIPAA may lead to civil monetary penalties or criminal charges.