Discover how you can simplify regulatory compliance for your business with the top HIPAA compliance tools in 2025.
HIPAA Compliance
The Health Insurance Portability and Accountability Act of 1996, or HIPAA, is a set of rules that specify how protected health information may be used and disclosed legally (PHI). The Office for Civil Rights (OCR) and the Department of Health and Human Services (HHS) both enforce HIPAA compliance laws (OCR).
The OCR’s responsibility in preserving medical HIPAA compliance takes the form of routine advice on brand-new healthcare-related issues and in looking into common HIPAA infractions.
HIPAA compliance is a living culture that healthcare companies must adopt into their operations to safeguard the privacy, security, and integrity of protected health information. It is achieved through a set of interlocking regulatory rules.
What is PHI?
The data that a healthcare provider gathers to identify a patient and select the most suitable care is known as protected health information (PHI), sometimes known as personal health information. This data includes demographic data, medical histories, test and laboratory findings, mental health issues, insurance information, and other data.
The main law governing the use, access, and disclosure of PHI in the United States is the Health Insurance Portability and Accountability Act (HIPAA) of 1996. PHI, as defined by HIPAA, includes information about a person’s past, present, or future health as well as information on how that person was treated and how much it cost. Any HIPAA-covered organization is subject to HIPAA regulations regarding the creation, collection, transmission, maintenance, and storage of this data.
The healthcare industry deals with private information about patients, such as birthdates, medical problems, and insurance claims. PHI describes a patient’s medical history, including symptoms, different treatments, and outcomes, whether in a paper-based record or an electronic health record (EHR) system.
Categories of enterprises that must adhere to HIPAA requirements
Covered Entities
According to HIPAA regulations, a covered entity is any company that acquires, produces, or transmits PHI electronically. Healthcare providers, clearinghouses, and insurance companies are examples of healthcare organizations that fall under the definition of covered entities.
Business Associates
According to HIPAA regulations, a business associate is any company that is in contact with PHI while working for a covered entity under a contract. Because there are so many different service providers that can handle, transmit, or process PHI, there are a ton of examples of business associates. Billing companies, practice management companies, third-party consultants, EHR platforms, MSPs, IT providers, faxing companies, shredding companies, physical storage providers, cloud storage providers, email hosting services, attorneys, accountants, and many more are typical examples of business associates impacted by HIPAA rules.
HIPAA Rules
The HIPAA Privacy Rule:
establishes federal guidelines for patients’ rights to PHI. The HIPAA Privacy Rule includes several requirements, such as those relating to patients’ access rights to PHI, health care providers’ access rights to PHI, the information that Use and Disclosure HIPAA release forms and Notices of Privacy Practices must contain, among others.
HIPAA Security Rule
The HIPAA Security Rule establishes federal requirements for the safe storage, processing, and transmission of ePHI. Due to the potential sharing of ePHI, both covered entities and business partners are subject to the HIPAA Security Rule. The Security Rule specifies requirements for the integrity and security of ePHI, including administrative, technical, and administrative measures that must be in place in every health care institution.
HIPAA Breach Notification Rule
In the case of a data breach involving PHI or ePHI, covered entities and business partners are required to comply with a set of rules known as the HIPAA Breach Notification Rule. Depending on the scale and severity of the breach, the Rule specifies various breach reporting obligations. Regardless of their size, breaches must be reported to HHS OCR by organizations, although the reporting procedures vary depending on the nature of the breach.
HIPAA Omnibus Rule
The HIPAA Omnibus Rule was created as an extension to the HIPAA regulation to extend its coverage to business associates as well as covered companies. The HIPAA Omnibus Rule specifies the requirements for Business Associate Agreements and mandates that business associates comply with HIPAA.
HIPAA compliance checklist:
- Putting into practice stated standards of conduct, regulations, and procedures.
- Establishing a committee and compliance officer.
- Conducting efficient education and training.
- Establishing efficient channels of communication.
- Carrying out internal audits and monitoring.
- Enforcing standards via widely known disciplinary policies.
- Taking immediate corrective action after discovering infractions.
HIPAA auditors will assess the efficiency of your organization’s compliance program during a HIPAA investigation in response to a HIPAA violation by comparing it to this checklist.