The Health Insurance Portability and Accountability Act (HIPAA) is a U.S. federal law enacted in 1996 to protect sensitive patient health information from being disclosed without the patient’s consent or knowledge. Protected Health Information (PHI) is safeguarded under the HIPAA. PHI refers to any information that can identify a patient and relates to their past, present, or future health condition, healthcare services, or payment for healthcare.
PHI includes:
- Personal details like name, address, phone number, or Social Security Number.
- Medical records, test results, or prescriptions.
- Billing information and insurance details.
PHI can be in any format—oral, written, or electronic—and HIPAA ensures it remains private and secure.
Key Components of the HIPAA
- Privacy Rule: Establishes standards to safeguard individuals’ medical records and other protected health information (PHI).
- Security Rule: Sets regulations for protecting electronic PHI (ePHI) through administrative, physical, and technical safeguards.
- Breach Notification Rule: Requires covered entities to notify individuals, the government, and sometimes the media in the event of a data breach.
- Enforcement Rule: Outlines penalties for non-compliance and assigns enforcement authority.
HIPAA applies to two primary groups: Covered Entities and Business Associates.
Covered Entities
Covered entities are organizations or individuals directly involved in healthcare and health insurance operations. These include:
- Healthcare Providers:
- Doctors, dentists, chiropractors, therapists, and any healthcare provider who transmits health information electronically.
- Examples: Hospitals, clinics, nursing homes, pharmacies, and laboratories.
- Health Plans:
- Insurance companies, HMOs (Health Maintenance Organizations), Medicare, Medicaid, and employer-sponsored health plans that provide or pay for medical care.
- Healthcare Clearinghouses:
- Entities that process non-standard health information into a standard format for billing or data management purposes.
Business Associates
Business associates are individuals or entities that perform services for or on behalf of a covered entity and have access to Protected Health Information (PHI).
Examples of business associates:
- Billing companies
- IT service providers managing electronic health records (EHRs)
- Cloud storage or data backup services
Subcontractors
Any subcontractors working with a business associate that handle PHI also fall under HIPAA requirements. For example, if a business associate outsources data storage to another vendor, that vendor must comply with HIPAA regulations.
HIPAA is enforced by the U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR). The OCR investigates complaints, conducts compliance reviews, and issues penalties for violations.
Penalties for Non-Compliance:
- Tier 1: Unknowing violations – $100 to $50,000 per violation.
- Tier 2: Reasonable cause – $1,000 to $50,000 per violation.
- Tier 3: Wilful neglect (corrected) – $10,000 to $50,000 per violation.
- Tier 4: Wilful neglect (uncorrected) – $50,000 per violation.
Annual Maximum Penalty: $1.5 million for repeated violations of the same provision.
Criminal Penalties: Include fines up to $250,000 and imprisonment for severe offenses, such as intentional misuse of PHI.
Compliance to HIPAA not only reduces the risk of penalties but also ensures patient’s trust in the healthcare system which allowing secure transfer of health information within the authorized parties.
HIPAA Solutions
Advoke International provides comprehensive solutions tailored to support your organization in achieving full compliance with the HIPAA.
- HIPAA Gap Analysis
- Privacy Framework Implementation
- Security Framework Implementation
- HIPAA Readiness Assessment
- Complete HIPAA Compliance Review
Frequently Answered Questions
What is PHI under the HIPAA?
PHI stands for Protected Health Information, which includes any data that can identify a patient and relates to their health, healthcare services, or payment for healthcare. Protecting PHI ensures patient confidentiality and complies with legal requirements.
Who does the HIPAA apply to?
The HIPAA applies to:
- Covered entities, such as healthcare providers, health plans, and healthcare clearinghouses.
- Business associates, like vendors and service providers that handle PHI on behalf of covered entities.
What rights do patients have under the HIPAA?
Patients have several rights under the HIPAA, including:
- Access to their medical records.
- Requesting corrections to their records.
- Receiving an account of disclosures of their PHI.
- Filing complaints about privacy violations.
How does HIPAA ensure the security of electronic PHI (ePHI)?
The HIPAA Security Rule requires organizations to implement safeguards, including:
- Administrative Safeguards: Policies, procedures, and workforce training.
- Physical Safeguards: Securing facilities, devices, and workstations.
- Technical Safeguards: Encrypting data and controlling access to systems.
Can an individual sue for a HIPAA violation?
HIPAA does not grant individuals the right to sue for violations. However, they can file a complaint with the Office for Civil Rights (OCR), which investigates alleged violations.

