Many health care providers still find it hard to know precisely what they need to do to ensure HIPAA compliance. The HIPAA Law implemented by the federal law mandates the patient-protection approach. It is the protection of health data of patients across the nation. Nonetheless, this blog covers .
As stipulated by the HHS, there are five main guidelines under HIPAA compliance. Each rule is directed at a particular area of operations of covered entities involving PHI.
The 5 HIPAA Compliance Rules You Must Know
The Privacy Rule
The Privacy Rule is the primary patient data safeguard under HIPAA. The rule specifies national standards regarding the use and disclosure of PHI by covered entities. For instance, the rule outlines specific situations where sharing of patient information does not require patient authorization.
- Some of the permitted actions without patient authorization are:
- Treatment, payment, and healthcare operations
- Activities related to public safety and health
- Mandatory disclosures
- HHS compliance investigations
For any other case, patient consent must be obtained. Additionally, the Privacy Rule provides patients with different rights, including access to their PHI, correction of incorrect information, and limitation of its usage.
Lastly, the Privacy Rule requires covered organizations to adhere to the minimum necessary rule, making sure that as little PHI as possible is released.
The Security Rule
While the Privacy Rule applies to all PHI, the HIPAA Security Rule targets ePHI specifically. Covered entities are required to have three safeguard categories:
- Administrative Safeguards: Policies and Procedures for Risk Analysis, Workforce Training, Access Control Policy
- Physical Safeguards: Facility Access Controls, Workstation Security, Equipment Disposal
- Technical Safeguards: Encryption, Audit Controls, Automatic Logoff, User Authentication
Significantly, the OCR at HHS proposes major Security Rule amendments. These amendments mandate MFA and advanced cybersecurity safeguards. By 2026, the OCR has finalized its regulatory agenda for the amendments. Currently, the Security Rule is entirely enforceable while the amendments are being processed.
Thus, businesses need to adhere to the existing regulation while anticipating future changes.
The Breach Notification Rule
Breach is defined as any use or disclosure of unsecured PHI without authorization. In case of a breach, HIPAA compliance entails certain actions and fast notification.
Covered entities should be required to inform:
- Individuals: within 60 days after finding out about the breach
- Secretary of Health and Human Services: immediately in case of 500+ affected individuals, or once per year for those with less than 500 affected individuals
- Local news media: in case of 500+ affected individuals in that state or jurisdiction
The business associate shall promptly inform the covered entity about a discovered breach. Failure to report a breach, including unintentional failure to report, is considered very seriously in the HIPAA act.
Additionally, in the case of an encrypted PHI, which satisfies the HIPAA criteria for safe harbor, the need for reporting will disappear altogether.
The Enforcement Rule
Enforcement of violations includes an investigation and imposition of CMPs in accordance with the HIPAA Enforcement Rule, which stipulates the process for reviews and hearings.
Penalties for violations include the following four tiers:
- Tier 1: Violation without knowledge, minimum $137 penalty per violation
- Tier 2: Violation with reasonable cause but not willful neglect, minimum $1,379 penalty per violation
- Tier 3: Violation due to willful neglect that was corrected, minimum $13,785 penalty per violation
- Tier 4: Violation due to willful neglect that was not corrected, minimum $68,928 penalty per violation
The OCR announced 21 settlements and CMPs just for the year 2025. Consequently, there is enforcement, and it is increasing. Ignorance of HIPAA law cannot be used as an excuse.
The Omnibus Rule
The HIPAA Omnibus Rule of 2013 made many important changes that greatly enhanced HIPAA regulations. There were more stringent provisions with regard to protecting patient privacy in the Privacy, Security, and Breach Notification Rules, and business associates were held responsible as well.
Prior to the implementation of this regulation, business associates had limited liability. With its enactment, business associates became liable even if there was no written agreement involved.
New features of the HIPAA Omnibus Rule are:
- More stringent regulations regarding the use of PHI in marketing and fundraising activities
- Right to limit disclosure of PHI to health plans for payment of out-of-pocket payments
- Strict guidelines regarding the Business Associate Agreement (BAA)
- Expanded definition of PHI by adding genetic information
In other words, this regulation effectively plugged many loopholes in the previous HIPAA laws.
Common HIPAA Violations to Avoid
Knowledge of the 5 rules also implies understanding when those rules are violated. The following are the most frequent HIPAA violations that OCR pursues:
- Access to patient information without authorization
- Inadequate or inaccurate risk analysis
- Failure to conduct HIPAA training for the workforce
- Use of an unencrypted device containing ePHI
- Absence of Business Associate Agreement (BAA)
- Late breach reporting
What is the common denominator in most violations? Inadequate risk management. Those covered entities that neglect annual risk assessments always end up as defendants in OCR cases.
2026 Compliance Date Reminder: Covered Entities have until February 16, 2026, to amend their Notice of Privacy Practices (NPP). This obligation arises out of the recent final rule amendments regarding Part 2. Effective immediately, the federal appeals court in June 2025 upheld the rule.
Where HIPAA Compliance Is Heading in 2026
Learning the five primary HIPAA compliance requirements is necessary for all providers and covered entities working in 2026. After many years since HIPAA was implemented, the violation of some of its provisions still leads to expensive OCR fines for healthcare organizations. CMS has deemed it mandatory to comply with the mentioned requirements to ensure a streamlined procedure.
The specialists of Rhode Island Medical Billing will provide you with comprehensive assistance in ensuring your compliance. By doing the correct documentation, providing training to your workforce, and following all the HIPAA guidelines, you will be able to avoid penalties and ensure stable functioning.
FAQ
What are the 5 main HIPAA rules?
The 5 main HIPAA rules are the Privacy Rule, the Security Rule, the Breach Notification Rule, the Enforcement Rule, and the Omnibus Rule.
What is the compliance of HIPAA?
HIPAA compliance means covered entities and business associates follow all federal standards set by HHS to protect patient health information from unauthorized use or disclosure.
What are the examples of HIPAA violations?
Common examples include unauthorized access to patient records, missing Business Associate Agreements, unencrypted devices containing ePHI, and failure to report a breach on time.
What is the common cause of HIPAA violations?
The most common cause of HIPAA violations is inadequate risk management, particularly the failure to conduct and document an annual risk analysis.