What is HIPAA Compliance & How to Become HIPAA Certified
Understanding the pivotal role of HIPAA compliance is non-negotiable. In this blog you will not only uncover the mysteries of HIPAA, you will learn how to turn compliance into a seamless journey. Curious about the latest HIPAA updates? Eager to ace your HIPAA certification? Keep reading!
Table of Contents:
What is HIPAA Compliance?
HIPAA, or the Health Insurance Portability and Accountability Act of 1996, is a federal law that sets national standards for how your information can be used and shared. It is regulated by the Department of Health and Human Services and enforced by the Office for Civil Rights.
HIPAA compliance is more than just a set of rules. It is a cultural mindset that healthcare organizations need to adopt to keep your information safe and secure. By following these guidelines, healthcare organizations not only protect your privacy but also avoid legal and financial consequences.
In a nutshell, HIPAA is all about keeping your health information in the right hands and ensuring it's handled with care.
History of HIPAA Regulations
The history of HIPAA regulations started back in 1996 when these regulations were passed by the U.S. Congress and signed into law by President Bill Clinton. HIPAA laws have three main objectives:
Modernize the way healthcare information is managed.
Ensure the protection of personally identifiable information (PII) in the healthcare and health insurance sectors.
Tackle important issues such as healthcare insurance coverage continuation during job changes and the coverage of individuals with pre-existing conditions.
HIPAA compliance considered two key elements to ensure that these regulations are met. These elements are known as HIPAA mandated security standards, and their main goal is to protect and safeguard sensitive patient information. These regulations are overseen by the U.S. Department of Health and Human Services (HHS).
What is Protected Health Information Compliance (PHI Compliance)
Understanding what constitutes Protected Health Information is an essential part of HIPAA compliance. According to the U.S. Department of Health & Human Services, PHI is any individually identifiable health information held or transmitted by a covered entity or its business associate. This includes electronic, paper, or oral data. PHI includes medical records, billing details, treatment plans, lab results, insurance claims data, and any information related to an individual's physical or mental health.
Ensuring PHI compliance is vital for a variety of reasons, including patient privacy, data security, and compliance.
Key Elements of PHI Compliance
PHI Compliance is made up of three key elements.
Ensuring patient privacy is a crucial element of PHI compliance. Unauthorized access to personal health records can significantly damage the patient's physical and psychological well-being.
Healthcare records are one of the primary targets of cyber terrorists to commit identity theft, fraud, or other financial schemes. Ensuring your organization meets PHI compliance requirements allows you to prevent unauthorized access and mitigate potential breaches.
Failing to meet PHI compliance requirements can result in reputational damage, criminal charges, and fines of up to 1.5 million dollars every year depending on the category of the violation.
PHI Compliance Identifiers
HIPAA regulations provide clear guidance on removing 18 specific identifiers from health information to ensure it is de-identified. Let's take a look at some common examples.
Biometric Identifiers including finger and voice prints
Certification / License Numbers
Date of Birth (DOB)
Device Identifiers and serial numbers
Fingerprints or facial images
Health plan beneficiary numbers
Internet Protocol Address (IP Address)
Medical Records Numbers
Name and Address
Vehicle Identifiers and Serial Numbers
Web Universal Resource Locators (URLs)
Full-face photographic images and any comparable images
Geographic location and subdivisions
Any other unique identifying number, characteristic, or code
HIPAA Mandated Security Standards
There are two types of HIPAA mandated security standards:
HIPAA Privacy Rule
The HIPAA privacy rule establishes guidelines for how personal health information can be used or shared without a person's consent. In addition, the HIPAA Privacy Rule ensures that individuals have rights over their protected health information and the right to request corrections to their health information.
There are 12 exceptions in which your data can be shared without your or your patient's consent. Some of these exceptions include:
If you or your patient is a victim of domestic violence or assault.
If you or your patient is in the process of judicial and/or administrative proceedings.
Cadaveric organ, eye, or tissue donation.
HIPAA Security Rule
The HIPAA Security rule establishes the guidelines that covered entities must take to ensure the protection of electronic protected health information (e-PHI). This includes implementing administrative, technical, and physical safeguards that are reasonable and appropriate.
Some Key Elements of the HIPAA security rule include:
Protect sensitive health information.
Ensure your information is only used and disclosed as intended.
Make sure your team is certified and committed to compliance.
HIPAA Breach Notification Rule
The HIPAA Breach Notification Rule requires both HIPAA covered entities and their business associates to let people know if there has been a breach of their personal health information that was not properly protected.
This rule also applies to vendors of personal health records and their service providers, according to a law called the HITECH Act. Plus, the Federal Trade Commission enforces similar breach notification provisions.
Do I Need to Be HIPAA Compliant?
There are two primary types of organizations that need to adhere to HIPAA regulations: covered entities and business associates.
Covered Entities (CE) are all those organizations involved in administering or providing healthcare services. Some examples of covered entities that need to comply with HIPAA regulations include:
Medical Practitioners: All providers administering or delivering professional care such as doctors, physicists, pharmacists, nurses, etc.
Health Plans: All organizations that offer health insurance services including health maintenance organizations (HMOs), preferred provider organizations (PPOs), Medicaid/Medicare programs, employer-sponsored health plans, and more.
Healthcare clearinghouses: Organizations that process non-standard protected health information into a standard format for electronic transmission.
Bas, or business associates, are every organization that has access to PHI information while performing services on behalf of covered entities, these organizations include:
IT service providers
Consultants and Auditors
Covered entities and business associates must HIPAA compliance is being achieved, especially when managing protected health information (PHI). These measures include adhering to the HIPAA Privacy Rule, the HIPAA Security Rule, PHI compliance rules, and other relevant guidelines established by the U.S. Department of Health & Human Services (HHS).
How do I Become HIPAA Compliant
The HHS Office of Inspector General (OIG) developed the Seven Elements of an Effective Compliance Program. These are the essential components that organizations should consider when evaluating compliance solutions or creating their own programs.
An effective compliance program needs to meet the minimum requirements outlined in the Seven Elements. It should also be able to address all the necessary HIPAA Privacy and Security standards.
By focusing on these components, organizations can ensure a comprehensive and successful HIPAA compliance program.
Follow The 7 Key Elements of HIPAA Compliance
Following these 7 steps will ensure that you have an effective HIPAA compliance program within your organization.
Implement policies, procedures, and standards that fit your organization's needs and objectives.
Ensure there is a compliance officer and a compliance committee within your organization.
Make sure your team has the appropriate training and education.
Create appropriate lines of communication.
Conduct audits and assessments regularly.
Create effective disciplinary guidelines to promote and enforce compliance.
Create a plan of action to effectively respond to and mitigate problems.
During an OCR (Office for Civil Rights) HIPAA investigation, federal auditors evaluate how well an organization's compliance program meets the Seven Elements to determine its effectiveness in addressing a violation.
Ensure Your Physical and Technical Safeguards and Policies Follow HIPAA Compliance Guidelines
To comply with HIPAA regulations, organizations must establish a comprehensive system that combines both physical and technical safeguards, along with clearly defined policies. By implementing these measures, the security of PHI compliance can be effectively ensured.
Access Control: By establishing procedures to limit access to areas containing PHI, you can ensure the security of your data. Consider implementing security systems like access control cards, surveillance cameras, or biometric authentication to take things up a notch.
Workstation and Use Security: When it comes to managing sensitive data, ensuring the security of workstations is of the utmost importance. Unauthorized access is a no-go. That's why it's crucial for employees to adhere to our guidelines on workstation usage. We recommend you go the extra mile to protect your data by strategically positioning your monitors to keep them out of plain sight and the use of privacy screens.
Device & Media Controls: Managing electronic media containing PHI is crucial. To ensure data security, organizations must have policies for securely disposing or reusing devices. It is vital that data is wiped clean before disposal or reuse.
Data Encryption: Data Encryption: Safeguard your information from unauthorized access on networks and devices. Utilize SSL/TLS certificates for secure transmission and storage.
User authentication: To ensure the traceability of your system and protect your sensitive data, you need all users to have their own identification credentials. This includes a unique username and password combination, as well as additional authentication options such as tokens or biometrics.
Audit Controls: To protect sensitive information, it is crucial for organizations to establish effective mechanisms that record and verify activity on systems that store or utilize protected health information (PHI). These audits play a vital role in not only identifying potential security incidents but also monitoring user access and ensuring adherence to established policies. By implementing robust audit controls, you can proactively identify and address any vulnerabilities, ensuring the utmost security for your organization and the individuals it serves.
Policies & Procedures
Risk Analysis: Identifying any vulnerabilities, whether they are physical or technical is crucial for your organization's well-being. Conducting risk assessments on a regular basis will allow you to mitigate and prevent any threats while staying compliant with HIPAA regulations.
Training Programs: Everyone who oversees PHI must receive regular training on HIPAA regulations and best practices for data privacy. Train your employees regularly to ensure that they are up to date with the latest compliance requirements and regulations.
Breach Notification Policy: If unsecured PHI is breached, organizations are legally obligated to promptly inform affected individuals. A well-defined policy ensures a swift response and limits unauthorized disclosure of sensitive information.
HIPAA Compliance Requirements
To meet HIPAA compliance requirements, all covered entities and business associates in the United States who oversee both PHI and ePHI must take the following steps:
Administrative Safeguards: creating clear policies and procedures for protecting patient data, designating a privacy and security officer, training staff on HIPAA regulations, and managing risks.
Physical Safeguards: ensures that access to places where patient information is stored is carefully controlled. This includes limiting entry to authorized personnel, using security cameras and other measures, and properly disposing of devices or media containing patient information.
Technical Safeguards: protecting electronic patient information by using access controls like unique user IDs and passwords, encrypting data both at rest and in transit, keeping security software up to date, and monitoring network activity for any unauthorized access or breaches.
Breach Notification: Organizations must follow specific procedures to notify affected individuals and the appropriate health department in case of data breach.
Business Associate Agreements: creating business associate agreements allows you to ensure that those who work with covered entities also follow HIPAA regulations. These agreements outline the obligations and responsibilities of business associates.
Complying with the Privacy Rule: organizations must have policies and procedures in place to obtain individual consent, implement safeguards, and provide individuals with access to their own information.
Complying with the Security Rule: serves as a general requirement for covered entities and associates to implement administrative, physical, and technical safeguards to protect electronic patient information from unauthorized access, use, or disclosure.
By following these safeguards and regulations, organizations can protect patient data and maintain HIPAA compliance.
HIPAA Compliance Violations
Violating HIPAA compliance regulations can seriously impact your organization and those involved. The consequences can be severe, including major fines, damage to your reputation, and even legal trouble. In this section, we'll dig into the specifics of what can happen if you don't comply with HIPAA and give you real-life examples to drive the point home.
Types of HIPAA Compliance Violations
An organization or individual can violate HIPAA rules in several ways. Common violations include:
Unauthorized access or disclosure: Accessing or disclosing protected health information (PHI) without proper authorization.
Breach notification failure: Failing to notify affected individuals and authorities within the required timeframe after discovering a PHI breach.
Lack of safeguards: Not implementing appropriate physical, technical, and administrative safeguards to protect PHI.
Poor training: Inadequate employee training on handling PHI consistent with HIPAA requirements could lead to violations due to negligence or mistakes.
Types of HIPAA Penalties
The Office for Civil Rights (OCR) is responsible for enforcing HIPAA regulations. They categorize violations into four tiers based on how serious they are. The penalties can range from $100 per violation all the way up to a whopping $1.5 million per year for each provision that is violated.
Covered entities are unaware of any violations.
From $100 to $50,000 per violation.
Covered entities should have detected the violation but they did not act with willful neglect.
From $1000 to $50,000 per violation
Willful Neglect (Corrected)
The covered entity acted with willful neglect but corrected any problems within 30 days
From $10,000 to $50,000
Willful Neglect (Not corrected)
The covered entity acted with willful neglect and failed to fix all issues within 30 days.
Up to $1.5 million for each provision violated annually.
Recent HIPAA Compliance Updates
Over the past few years, the U.S. Department of Health and Human Services has been taking action to address new cybersecurity threats and advancements in technology by updating HIPAA regulations. To stay compliant with these changes, it is important for covered entities and business associates to stay informed and up to date.
Information Blocking Rule: Improving Data Sharing in Healthcare
As of April 5, 2021, the Information Blocking Rule is now in effect, revolutionizing the way electronic health record systems communicate with each other and giving patients easier access to their health information.
Under this rule, hospitals, doctors' offices, and other covered entities have a crucial role to play. Not only must they comply with HIPAA regulations, but they must also avoid any practices that could hinder the flow of information – known as "information blocking."
Failure to comply with the Information Blocking Rule could lead to penalties and other enforcement actions by HHS.
OCR's Right of Access Initiative: Ensuring You Get Your Medical Records without Hassle.
The Office for Civil Rights (OCR) has taken a stand for your rights to access your medical records promptly and without unreasonable barriers. With their Right of Access Initiative, OCR is cracking down on healthcare providers who fail to provide timely access or overcharge for recorded copies.
Ransomware Attacks: New Guidance from OCR.
Keeping your data safe from ransomware attacks is crucial, and OCR wants to help. They released a comprehensive fact sheet in June 2021, highlighting the importance of a strong cybersecurity program. This guide stresses regular risk assessments, employee training, data backups, and incident response plans.
Telehealth Flexibilities: Convenient and Secure Healthcare during COVID-19 and beyond.
When the pandemic hit, HHS made temporary changes to HIPAA regulations for telehealth. This allowed healthcare providers to use non-public-facing communication technologies without worrying about HIPAA violations. While these flexibilities are still in effect in 2023, it is essential for organizations using telehealth services to stay updated on any future changes.
Looking for a HIPAA Service Provider?
Here at BTI, we have more than 35+ years of experience with all kinds of business associates and covered entities. It does not matter how complex or big your operations are, if you want to ensure that your organization is up to date with HIPAA compliance regulations, you are in the right place!
You are one click away from complying with HIPAA regulations, contact us today and start your journey towards compliance without complications and for the best price!
Who needs to meet HIPAA compliance requirements?
To ensure the security and privacy of patient information, healthcare providers and those who assist them must comply with HIPAA regulations. This includes both covered entities, like hospitals and clinics, as well as business associates who have access to patient data and provide support in areas such as treatment, payment, or operations.
What are the 3 main rules of HIPAA compliance?
1.- The Privacy Rule.
2.- The Security Rule.
3.- The Breach Notification Rule.
What does HIPAA not cover?
HIPPA focuses specifically on keeping Personal Health Information (PHI) and Electronic Personal Health Information (ePHI) secure. This means that means other types of data, like login credentials for social media sites, employer records about employees, or student health records held by schools, are not covered by HIPAA.
However, there are some exceptions to this rule. For example, if a university provides medical care to its students, they would be subject to HIPAA regulations. It's important to understand what is and isn't covered to ensure the privacy and security of sensitive information.
What are HIPAA compliance requirements?
If you wish to comply with HIPPA regulations in the U.S., you must adhere to the HIPAA Security, Privacy, and Breach Notification Rules. These rules require you to implement administrative, physical, and technical safeguards to ensure the protection of PHI and ePHI.
What are the most common HIPAA compliance violations?
Here are some of the most common HIPAA violations to be aware of:
1.- Not providing proper training to employees on HIPAA compliance.
2.- Experiencing security breaches that expose electronic protected health information (ePHI).
3.- Sharing protected health information (PHI) with colleagues without proper authorization.
4.- Losing a laptop or mobile device that contains unencrypted ePHI.
5.- Incorrectly disposing of ePHI, allowing unauthorized users to access it.
Does HIPAA applies to foreigners?
HIPAA focuses on the protection of health information rather than the individual. This means that any personally identifiable health information (PHI) collected and kept for an undocumented immigrant is indeed covered and safeguarded by HIPAA.