5 key rules of HIPAA compliance

Content Writer
COO & Co-Founder

Did you know that the Health Insurance Portability and Accountability Act (HIPAA) is a US law that requires the protection and confidential handling of ‘individually identifiable health information’ — anything that can identify the patient? 

All businesses should comply with the law to avoid criminal charges and monetary fines. You should analyze every aspect of your business to ensure your organization complies with HIPAA. Then you can specify the areas that require work. This article discusses the five main rules of comprehensive HIPAA compliance and gives some advice.

What HIPAA stands for?

HIPAA stands for health insurance portability and accountability act and was implemented in 1996 by congress. HIPAA legislation was updated in 2009 with the HITECH and then again in 2013 with the Omnibus Act. HIPAA allows the federal government to maintain how covered entities store, receive, and transmit PHI.

To comply with HIPAA, all healthcare organizations need to implement comprehensive privacy and security policies and procedures and train employees. Moreover, they should conduct risk assessments to identify and address vulnerabilities in their systems and processes. It’s also essential they work with their business associates to ensure they are HIPAA-compliant.

Why is HIPAA compliance important?

HIPAA compliance is important for legal and ethical reasons and the overall quality of healthcare delivery. It ensures patient data is handled securely and responsibly, leading to better patient outcomes and improved patient satisfaction. It also helps foster a culture of privacy and security within healthcare organizations, which is essential, especially as cyber threats are becoming increasingly common.

Suppose healthcare providers, software vendors, and other PHI entities want to implement HIPAA compliance standards. In that case, they must take necessary steps to secure any information and prevent unauthorized access, use, or disclosure. Omitting HIPAA regulations can result in serious consequences, including hefty fines, legal liabilities, loss of reputation, and damaged relationships with patients and customers.

1. HIPAA Privacy Rule

The Privacy Rule sets standards for protecting individually identifiable health information, including how it is used, disclosed, and safeguarded. The purpose of HIPAA privacy is

  • to protect patients by providing them access to their protected health information (PHI) and the ability to control and use their PHI disclosure
  • to improve the efficiency of healthcare delivery in the US by creating a national framework for the healthcare privacy
  • to restore public trust in the healthcare system 

2. HIPAA Security Role

The Security Rule establishes standards for protecting electronically protected health information (ePHI). It requires healthcare organizations to implement administrative, physical, and technical safeguards ensuring the confidentiality, integrity, and availability of ePHI.

HIPAA Security Plan Goals

Everyone must have a HIPAA security plan and understand its goals. It is based on ensuring confidentiality, integrity, and availability of the ePHI that the organization creates, receives, maintains, or transmits.


Data or information shouldn’t be available or disclosed to unauthorized persons or processes. Protect against any anticipated threats or hazards involving the security or integrity of such information, e.g., loss of patient electronic information due to human error.


Ensure that your workforce is compliant and trained – the basis of a HIPAA security plan.


Protect against any reasonably anticipated uses/disclosures of such information that are not permitted or required by the Privacy Rule, e.g., by using passwords of authorized users.

Address the three different safeguards in HIPAA security

18 HIPAA standards cover the requirements for securely handling Protected Health Information (PHI) and protecting patients’ privacy rights. These standards are broken down into three categories: Administrative Safeguards, Physical Safeguards, and Technical Safeguards. Here is a list of the 18 HIPAA standards:

Administrative safeguards – your policies and procedures

  1. Security Management Process
  2. Assigned Security Responsibility
  3. Workforce Security
  4. Information Access Management
  5. Security Awareness and Training
  6. Security Incident Procedures
  7. Contingency Planning
  8. Evaluation

Physical safeguards – controls and measurements to prevent unauthorized access to the facility or your workstations

  1. Facility Access Controls
  2. Workstation Use and Security
  3. Device and Media Controls

Technical safeguards – your information technology and your configurations, such as access controls, firewalls, VPNs, and encryption

  1. Access Control
  2. Audit Controls
  3. Integrity
  4. Person or Entity Authentication
  5. Transmission Security
  6. Encryption and Decryption
  7. Unique User Identification

For more about technical standards that meet HIPAA rules in software development, you can discover more in the article below.

Each of these standards contains specific requirements that business associates must comply with to protect PHI.

3. Breach Notification Rule

This Rule requires healthcare organizations should notify patients and the Department of Health and Human Services (HHS) if there is an unsecured PHI breach. A breach occurs when PHI is improperly used or disclosed, compromising security or privacy. For example, if a healthcare organization accidentally emails PHI to the wrong recipient, that is considered a breach.

When a breach occurs, what are healthcare organizations required to do?

  • Provide notification to affected individuals without unreasonable delay within 60 calendar days after discovering the breach.  In a written notice there should be included specific information about the breach, the types of PHI involved, and steps individuals can take to protect themselves from potential harm.
  • Notify prominent media outlets serving the affected state or jurisdiction (if a breach affects more than 500 individuals). In addition, the healthcare organization must report the violation to the HHS Secretary, who may post the breach on the HHS website.

In case of a breach notification failure, individuals affected by the breach might be able to pursue civil fines and legal action.

4. Enforcement Rule

The Enforcement Rule outlines the penalties and consequences for violations of HIPAA rules. Civil penalties can range from $100 to $50,000 per violation, up to a maximum of $1.5 million per year for each type of violation. Up to 31.01.2023, The Office for Civil Rights (OCR) has settled or imposed civil money penalties in 130 cases, totaling $134,828,772.00.

As hhs.gov informs from the compliance date to the present, the compliance issues most often alleged in complaints are compiled cumulatively, in order of frequency:

  • Impermissible uses and disclosures of protected health information
  • Lack of safeguards for protected health information
  • Lack of patient access to their protected health information
  • Lack of administrative safeguards for electronically protected health information
  • Use or disclosure of more than the minimum necessary secure health information

5. Omnibus Rule

The Omnibus Rule strengthens and expands HIPAA’s privacy and security protections. It was finalized in January 2013 and went into effect on March 26, 2013. The goal was to improve patient privacy protections, give individuals new rights to their health information, and strengthen the government’s ability to enforce the law.

As HHS OCR Director Leon Rodriguez described, “This final Omnibus Rule marks the most sweeping changes to the HIPAA Privacy and Security Rules since they were first implemented.”

The Omnibus Rule is a set of regulations added to HIPAA in 2013 to strengthen and expand the privacy and security protections for individuals’ health information. It is also known as the HIPAA Final Rule.

What steps can you take to comply with the Privacy and Omnibus Rule?

  1. Analyze the potential risks and vulnerabilities to electronically protected health information (ePHI).
  2. Document policies and procedures in place to safeguard ePHI. These policies and procedures should cover all aspects of HIPAA compliance, including privacy, security, and breach notification.
  3. Train employees on the policies and procedures related to ePHI. This training should cover handling ePHI, recognizing potential security risks, and reporting suspected breaches.
  4. Conduct regular audits of their business associates, ensuring they comply with HIPAA regulations.
  5. Develop breach processes to notify affected individuals, the Department of Health and Human Services, and the media (if necessary).
  6. Protect ePHI by implementing technical safeguards through access controls, encryption, and backups.
  7. Conduct regular evaluations of HIPAA regulations and make any necessary updates to policies and procedures.

By following these steps, you will develop a comprehensive compliance program that meets the requirements of the Omnibus Rule and helps safeguard ePHI. It’s important to note that compliance with HIPAA is an ongoing process, and your business must remain vigilant and proactive in protecting patient privacy and security.

5_HIPAA_compliance rulesObey HIPAA compliance rules

If you run a business in the healthcare industry, it’s essential to obey HIPAA rules to protect sensitive patient health information from unauthorized access. HIPAA compliance provides a legal framework for protecting patient health information and imposes penalties for noncompliance, like fines, reputational damage, and legal action.

Taking HIPAA compliance seriously is essential to protect patient privacy, maintain patient trust, avoid penalties, and ensure business continuity. If your business obeys HIPAA guidelines in the software development process, you will get an important step in meeting these goals.

It’s important to consider the organization environment in which you operate to determine reasonable and appropriate security measures. If you need assistance to ensure compliance while maintaining business growth, we can help you meet HIPAA objectives in your software. Talk to us about how we can help you breeze through your HIPAA compliance.

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