To determine if your services are covered by HIPAA, you need to identify if your organization falls under the category of a "covered entity" or if you handle protected health information (PHI) as part of your business operations.
To determine whether or not your services are covered by HIPAA, here are some questions to consider:
HIPAA applies to two main categories: covered entities and business associates.
Covered entities
These include organizations that directly handle PHI, such as:
Business associates
A business associate is any entity or individual that performs functions or services on behalf of a covered entity and involves PHI. Common examples include:
If your organization falls into one of these categories, HIPAA compliance is necessary.
PHI includes any information related to a patient’s health that can be used to identify them. Examples include:
If your business creates, receives, maintains, or transmits PHI, you must comply with HIPAA regulations.
Even if you do not directly provide medical care, your services might still fall under HIPAA if they involve supporting healthcare operations. Examples include:
If your work involves handling PHI, you need to ensure HIPAA compliance.
A business associate agreement (BAA) is a contract between a covered entity and a business associate. It outlines the responsibilities of the business associate in protecting PHI.
If a healthcare provider asks your business to sign a BAA, it means they believe your services involve PHI. Signing a BAA legally binds you to HIPAA compliance and requires you to follow security measures to protect patient data.
Read more: What types of organizations need BAAs?
If your business does not handle PHI, HIPAA may not apply to you. However, some organizations voluntarily follow HIPAA guidelines as a best practice, particularly if they work with healthcare clients. Implementing strong security and privacy policies can help establish trust and prevent data breaches.
According to the HHS, individuals, organizations, and agencies classified as covered entities under HIPAA are required to adhere to the HIPAA Privacy Rule's standards for safeguarding health information privacy and security. The standards state, “If a covered entity engages a business associate to help it carry out its health care activities and functions, the covered entity must have a written business associate contract or other arrangement with the business associate that establishes specifically what the business associate has been engaged to do and requires the business associate to comply with the Rules’ requirements to protect the privacy and security of protected health information. In addition to these contractual obligations, business associates are directly liable for compliance with certain provisions of the HIPAA Rules.”
See also: HIPAA Compliant Email: The Definitive Guide
If you unintentionally receive PHI but do not normally process or store it, you should securely delete or return the information and notify the sender.
You can ensure compliance by: