HIPAA Protections, Exclusions, and Covered Entities Explained

HIPAA Protections, Exclusions, and Covered Entities Explained

Table of Contents

This guide explains HIPAA Protections and outlines who must comply with the law and who are exempted. Many individuals misunderstand HIPAA, thinking it covers all health information, which is not the case.

Understanding HIPAA Protections is essential for compliance. It helps organizations avoid fines, safeguard data, and inform patients of their rights.

This guide is intended for healthcare organizations, employers, and businesses. Additionally, it serves to inform patients about their privacy rights, as they want to understand how their information is protected and safeguarded.

What Is HIPAA and Why Does It Exist?

HIPAA stands for the Health Insurance Portability and Accountability Act, which was enacted by the U.S. government in 1996. Its primary purpose is to protect patient data and ensure that health insurance remains portable. HIPAA also aims to prevent healthcare fraud.

As a current regulation, HIPAA governs the use of health information and sets a national standard for the privacy of personal information. It provides individuals with control over their health records.

It’s essential to distinguish between the HIPAA law and the HIPAA rules. The HIPAA law refers to the primary legislation enacted by Congress, while the HIPAA rules consist of specific regulations that implement the law. These regulations include the Privacy Rule, the Security Rule, and the Breach Notification Rule.

What Does HIPAA Protect?

HIPAA is designed to safeguard Protected Health Information (PHI), which is any health-related information that can be linked to an individual. The goal is to ensure that personal health data remains private, secure, and only shared when legally permitted.

What Is Protected Health Information (PHI) Under HIPAA?

The primary focus of HIPAA protections is the safeguarding of Protected Health Information (PHI). PHI refers to health information that can be linked to a specific individual.

The key aspect of PHI is that it consists of individually identifiable health information. If the data can identify you, it is considered PHI. This includes information about your health status as well as details about the payment for your care.

The typical examples of PHI are:

  • Your name and address.
  • Your birth date or social security number.
  • Your medical record numbers.
  • Your fingerprints or full-face photos.
  • Your past, present, or future health conditions.

Does HIPAA Protect Electronic, Paper, and Verbal Health Information?

Yes. HIPAA Protections apply to all formats.

  • ePHI is electronic information. This is information on servers or computers.
  • Paper information is non-electronic PHI. This involves physical files and charts.
  • Verbal PHI refers to speech information. This involves physicians discussing a patient.

The protection remains unchanged in the format. Digital files must be secure. Paper files must be locked. Verbal talk must be private. HIPAA Protections follow the data everywhere.

Which HIPAA Rules Provide These Protections?

HIPAA protections are enforced through three key rules that govern how health information is handled, shared, and secured. Each rule addresses a specific aspect of patient privacy and data security.

How Does the HIPAA Privacy Rule Protect Patient Information?

The Privacy Rule establishes your rights and restricts the use of your data by Covered Entities. They cannot share or sell your information without your consent.

Patient rights are also provided in this rule:

  • The right to see your records.
  • The right to a copy of your records.
  • The right to demand correction.
  • The entitlement to know who viewed your information.

This builds trust and makes patients feel secure, ensuring the system’s integrity.

How Does the HIPAA Security Rule Protect Electronic Protected Health Information (ePHI)?

The Security Rule focuses on Electronic Protected Health Information (ePHI). It establishes standards for digital safety and includes three levels of protection.

  • Administrative Safeguards: These refer to the policies and procedures established within an office to protect sensitive information. They include staff training and involve conducting risk evaluations.
  • Physical Safeguards: These measures ensure the physical security of hardware and facilities. They include locked rooms and secure workstations to prevent unauthorized access.
  • Technical Safeguards: These refer to the protective measures implemented in networks and software to ensure security and integrity. They include the use of passwords and encryption to secure data.

What Is the HIPAA Breach Notification Rule?

This rule guides groups on handling lost data in situations where protected health information (PHI) is accessed by unauthorized individuals. Additionally, the following procedures should also be implemented: 

  • Covered Entities must inform the patient.
  • They must notify the government.
  • Sometimes, they must communicate with the news media.
  • This must happen within 60 days of finding the breach.

What Is a Covered Entity Under HIPAA?

A Covered Entity is any organization or individual that is legally required to comply with HIPAA because they handle Protected Health Information (PHI) as part of their operations. Determining whether your organization qualifies as a Covered Entity is critical, as HIPAA regulations apply only to these specific groups.

Many people assume that all businesses dealing with health information must follow HIPAA. This is a common misconception. Only certain organizations are legally obligated to comply, and understanding your status helps avoid potential legal and financial penalties.

What Types of Organizations Are Considered Covered Entities?

Health Plans

Health plans cover the costs of medical care and manage a significant amount of Protected Health Information (PHI). This includes individual coverage provided by insurers such as Blue Cross and Aetna. Employer-sponsored health plansare also included, as well as government programs like Medicare and Medicaid. Additionally, military health programs fall under this category.

Health Care Providers

Health care providers are the individuals and organizations that deliver medical care. They represent the most common type of Covered Entity. This category includes clinics, doctors’ offices, hospitals, pharmacies, laboratories, as well as dental practices and nursing homes.

Healthcare Providers follow a specific rule: they qualify as a Covered Entity only when they use electronic transactions. This means they submit insurance claims electronically. 

Health Care Clearinghouses

Healthcare clearinghouses act as “the middlemen”, converting data from one format to a standardized format. This process facilitates communication between different computer systems. Due to the large volume of data they manage, they are usually required to comply with HIPAA protections.

Who Enforces HIPAA Compliance for Covered Entities?

These rules are enforced by the U.S. government, specifically by the U.S. Department of Health and Human Services (HHS). Within the HHS, the Office for Civil Rights (OCR) is responsible for several tasks.

  • They receive patient complaints.
  • They conduct investigations into data breaches.
  • They conduct audits to ensure safety.

If a group violates the rules, the OCR may impose a fine. Such penalties are expensive, encouraging everyone to take compliance seriously.

Who Is NOT Covered by HIPAA?

HIPAA is often misunderstood as a universal privacy law, but in reality, it applies only to the healthcare ecosystem. This includes physicians, health plans, and healthcare clearinghouses, along with their Business Associates. Organizations outside this ecosystem—despite handling health information—are generally not required to follow HIPAA.

How HIPAA Excludes Employers and Employment Records

This is a highly popular point of misunderstanding; Employers are generally not Covered Entities, despite them accessing patients’ health details. Take note that: 

  • HIPAA does not offer protection to HR files.
  • HIPAA does not protect sick leave records.
  • A job drug test result is not normally confidential.

There is an important distinction to note. While HIPAA regulations must be followed in relation to your health plan at work, you are typically not paid directly by your employer (the company itself).

When is employer data considered HIPAA-protected? This designation applies only when the employer serves as the health plan administrator. In other cases, different privacy laws govern the handling of employment records.

Does HIPAA Apply to Schools and Student Health Records?

It is commonly understood that school clinics are required to comply with HIPAA; however, in most cases, they do not. Instead, student records are protected by a different law known as FERPA, which stands for the Family Educational Rights and Privacy Act.

When a health record is part of an education record, HIPAA does not apply. This is an important distinction.

  • School nurses usually fall under FERPA.
  • Campus clinics that serve only students fall under FERPA.

When does HIPAA apply in a school setting? HIPAA comes into play when the school clinic treats non-students and when it submits insurance billing for those services electronically. In most other situations, FERPA is the following regulation.

Are Life, Disability, and Workers’ Compensation Insurers Covered by HIPAA?

No, these types of insurance do not qualify as Health Plans under the law. 

  • Life insurers are excluded.
  • This is not the case with disability insurers.
  • The workers’ compensation carriers are not excluded.

These groups have role-based exclusions, enabling them to collect medical information for claim processing purposes. However, they are not required to follow HIPAA protections; instead, they adhere to state laws and regulations. This is why they may ask you to log in to access your files.

Are Wellness Apps, Fitness Trackers, and Health Websites Covered by HIPAA?

Most wellness applications and fitness trackers are not insured, which is a common misconception. For example, if you purchase a watch that monitors your heart rate, the information it collects is not protected under the Health Insurance Portability and Accountability Act (HIPAA). This is because the developer of the app is typically a consumer technology firm and is not considered a Covered Entity. As a result, they are not obligated to follow federal health privacy regulations.

However, there is an exception. If your doctor prescribes an app to monitor your heart, it may be covered under certain circumstances. Additionally, if the app transmits data directly to a Covered Entity, it could also fall under HIPAA regulations. Moreover, if your Health Plan is paying for the app, it is likely to be covered as well.

What Is a Business Associate Under HIPAA?

A Business Associate is an individual or company that provides services to a Covered Entity. They do not offer health care directly but must handle Protected Health Information (PHI) to perform their duties. Common examples include:

  • Server management IT providers.
  • Payment processing and billing companies.
  • Medical data is stored on cloud hosts.
  • Attorneys or accountants to whom patient files are visible.

What Are Business Associates Required to Do Under HIPAA?

Previously, these groups did not have direct responsibilities regarding data protection. However, this changed in 2013 when they became required to follow HIPAA protections, just like doctors do. 

They must implement security measures and conduct risk analyses. Additionally, they have a duty to report any data breaches that occur. If they lose data, it must be reported promptly. This helps safeguard the integrity of the entire data chain.

Why Is a Business Associate Agreement (BAA) Required?

A Business Associate Agreement (BAA) is a legal contract that is required by law. It establishes a connection between the Covered Entity and the Business Associate. The BAA outlines the specific measures the vendor must take to protect sensitive data and restricts their use of this information. Engaging a vendor that does not have a BAA presents a significant risk and constitutes a violation of the Privacy Rule. Valid agreements are essential for compliance.

What Information Is Not Protected by HIPAA at All?

Health data is not always confidential, as some information is entirely outside the protections of HIPAA (Health Insurance Portability and Accountability Act). 

  • De-identified Data: This type of data has had all personal identifiers removed. If individuals cannot be identified from it, then it is not considered Protected Health Information (PHI).
  • Shared Health Information: HIPAA does not protect your health status when you voluntarily share it on social media. By posting it, you are choosing to disclose this information.
  • Published Data: Information that is available in the public domain is not protected and can be accessed freely.

Understanding these distinctions enables researchers to safely utilize health data while allowing the public to stay informed without violating privacy laws.

Common HIPAA Misconceptions About Protections and Coverage

HIPAA can be confusing to many individuals, leading to common misconceptions and myths. Some include that HIPAA applies to medical information, but this is not entirely accurate. Many applications and employers are exempt from HIPAA regulations. Additionally, the assertion that employers must comply with HIPAA for all health-related information is also incorrect; most sick leave notes found in workplaces are considered employment records rather than medical records.

While some applications claim to be HIPAA-compliant, it’s dangerous to assume that all of them meet these standards. In reality, the level of protection provided by many consumer apps is often minimal. Being aware of these myths will keep you safe, as it gives you an idea of when to request a BAA.

How Can Organizations Determine If HIPAA Applies to Them?

To check your status, follow a basic process known as role-based analysis.

  1. Do you generate, receive, or transmit health information? If not, HIPAA likely does not apply to you. 
  2. Do you provide health plans or clearinghouse services? If your answer is yes, then you are considered a Covered Entity.
  3. Do you offer services to a Covered Entity? If you handle their Protected Health Information (PHI), you are classified as a Business Associate.

Why Understanding HIPAA Protections and Exclusions Matters

Clarity is power. By understanding the scope of your operations, you can reduce compliance risks. This means you won’t waste money on unnecessary protective measures, and you’ll avoid the hefty fines from the Office for Civil Rights (OCR).

This level of transparency fosters trust among patients. They will feel relieved knowing you can explain how their data is secured. It showcases your professionalism and your commitment to transparency.

Final Summary: HIPAA Protections, Exclusions, and Covered Entities at a Glance

When implemented correctly, an understanding of HIPAA can empower groups to be intense and focused.

HIPAA Safeguards

HIPAA protects all forms of Protected Health Information (PHI), including electronic, paper, and verbal data.

Who Does HIPAA Apply To

HIPAA applies to Covered Entities and their Business Associates.

Who HIPAA Excludes

 HIPAA generally does not apply to most employers, schools governed by FERPA, and consumer applications.

Any organization that handles data must establish clear scope and boundaries. This builds trust and enables leaders to make informed decisions. As a result, HIPAA has become a vital component of the modern healthcare landscape.

Frequently Asked Questions (FAQs)

Q1: What is covered by HIPAA, and what kinds of information is considered PHI?

HIPAA safeguards Protected Health Information (PHI), which includes any data that can be used to identify a patient. This includes medical histories, Social Security numbers, and names.

Q2: What is a covered entity according to HIPAA, and what is its definition?

A group that must comply with HIPAA is referred to as a Covered Entity. This is defined by its role in healthcare and its billing practices.

Q3: Which organizations are considered covered entities under HIPAA?

This includes healthcare providers, health plans, and healthcare clearinghouses.

Q4: Why are there other organizations and information types not covered by HIPAA?

HIPAA is not a comprehensive privacy law; it was designed specifically for the healthcare sector. Other laws, such as FERPA, address different areas.

Q5: How does HIPAA exclude information considered education records under FERPA law?

If a student’s record is used for school purposes, FERPA applies. This prevents the issue of having multiple laws affecting the same student.

Q6: Should employers comply with HIPAA regarding employee health information?

Generally, employment records are not considered Protected Health Information (PHI). However, the company’s health insurance plan should comply with HIPAA regulations.

Q7: Do wellness apps and fitness trackers fall under HIPAA protections?

Typically, this does not apply unless provided by a Covered Entity, such as a doctor or hospital.

Q8: Who qualifies as a business associate under HIPAA?

Any provider of Protected Health Information (PHI) to a Covered Entity, including billing companies and IT firms.

Q9: Which health information does not fall under the protection of HIPAA?

Information that has been de-identified and shared publicly or by the individual is not protected.

Q10: What should an organization do to find out whether HIPAA applies to them?

They should verify whether they qualify as a Covered Entity or a Business Associate by using a decision flowchart.




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