Understanding the 5 Main HIPAA Rules

Healthcare organizations that handle protected health information (PHI) are governed by the Health Insurance Portability and Accountability Act, also known as HIPAA. The law consists of several rules that govern the privacy, security, and electronic exchange of PHI, but there are 5 main rules every healthcare professional should be aware of.

This article aims to cover the details about HIPAA’s 5 main rules, as well as answer many other frequently asked questions about the law and how it affects the healthcare industry.

5 Main HIPAA Rules

The five main components of HIPAA are as follows:

1. Privacy Rule

The HIPAA Privacy Rule sets the federal standard for protecting patient PHI. These access standards apply to both the healthcare provider and the patient as well. These privacy standards include the following:

• The patient's right to access their PHI;
• The healthcare provider's right to access patient PHI;
• The healthcare provider's right to refuse access to patient PHI and
• Minimum required standards for an individual company's HIPAA policies and release forms.

The Privacy Rule protects the PHI and medical records of individuals, with limits and conditions on the various uses and disclosures that can and cannot be made without patient authorization. This rule also gives every patient the right to inspect and obtain a copy of their records and request corrections to their file. There are specific forms that coincide with this rule: Request of Access to Protected Health Information (PHI); Notice of Privacy Practices (NPP) Form; Request for Accounting Disclosures Form; Request for Restriction of Patient HealthCare Information; Authorization for Use or Disclosure Form; and the Privacy Complaint Form.

2. Security Rule

The HIPAA Security Rule sets the federal standard for managing a patient's ePHI. It also applies to sending ePHI as well. The Security Rule addresses the physical, technical, and administrative protections for patient ePHI.

There are three safeguard levels of security. The administrative safeguards deal with the assignment of a HIPAA security compliance team. The technical safeguards deal with the encryption and authentication methods used to have control over data access. The physical safeguards deal with the protection of any electronic system, data, or equipment within your facility and organization. The risk analysis and risk management protocols for hardware, software, and transmission fall under this rule.

3. Transactions Rule

This rule deals with the transactions and code sets used in HIPAA transactions, which includes ICD-9, ICD-10, HCPCS, CPT-3, CPT-4, and NDC codes. These codes must be used correctly to ensure the safety, accuracy, and security of medical records and PHI.

4. Unique Identifiers Rule

HIPAA uses three unique identifiers for covered entities that use HIPAA-regulated administrative and financial transactions. These identifiers are a National Provider Identifier (NPI), which is a 10-digit number used for covered healthcare providers in every HIPAA administrative and financial transaction; National Health Plan Identifier (NHI), which is an identifier used to identify health plans and payers under the Center for Medicare & Medicaid Services (CMS); and the Standard Unique Employer Identifier, which identifies and employer entity in HIPAA transactions and is considered the same as the federal Employer Identification Number (EIN).

5. Enforcement Rule

The HIPAA enforcement rules address the penalties for any violations by business associates or covered entities.  This rule addresses violations in some of the following areas:

• Application of HIPAA privacy and security rules;
• Establishing mandatory security breach reporting requirements;
• Accounting disclosure requirements;
• Restrictions on marketing and sales; and
• Restrictions that apply to any business associate or covered entity contracts. These contracts must be implemented before they can transfer or share any PHI or ePHI.

This rule is derived from the ARRA HITECH ACT provisions for violations that occurred before, on, or after February 18, 2015, compliance date. This expands the rules under HIPAA Privacy and Security, increasing the penalties for any violations. This addresses five main areas in regards to covered entities and business associates: Application of HIPAA security and privacy requirements; establishment of mandatory federal privacy and security breach reporting requirements; creation of new privacy requirements and accounting disclosure requirements and restrictions on sales and marketing; establishment of new criminal and civil penalties, and enforcement methods for HIPAA non-compliance; and a stipulation that all new security requirements must be included in all Business Associate contracts.

Deep Dive: What Is the HIPAA Privacy Rule?

The HIPAA Privacy Rule is the specific rule within HIPAA Law that focuses on protecting Personal Health Information (PHI). It established national standards on how covered entities, healthcare clearinghouses, and business associates share and store PHI. It established rules to protect patients’ information used during healthcare services.

HIPAA’s original intent was to ensure health insurance coverage for individuals who left their job. Since 1996, HIPAA has gone through modification and grown in scope.

HIPAA Rules and Regulations are enforced by the Office of Civil Rights (OCR) within the Health and Human Services (HHS) division of the federal government. Enforcement is ongoing, and fines of over $2 million have been issued to organizations found to be in violation of HIPAA.

HIPAA or the Health Insurance Portability and Accountability Act of 1996 is federal regulations that was established to strengthen how Personal Health Information (PHI) is stored and shared by Covered Entities and Business Associates. HIPAA regulation covers several different categories including HIPAA Privacy, HIPAA Security, HITECH and OMNIBUS Rules, and the Enforcement Rule. All Covered Entities and Business Associates must follow all HIPAA rules and regulation.

As of 2021, there are two rules, issued by the HHS Office of the National Coordinator for Health Information Technology (ONC) and Centers for Medicare & Medicaid Services (CMS), which implement interoperability and provides patient access provisions. These were issues as part of the bipartisan 21st Century Cures Act (Cures Act) and supported by President Trump's MyHealthEData initiative. MyHealthEData gives every American access to their medical information so they can make better healthcare decisions.

What Is Right of Access?

Right of access covers access to one's protected health information (PHI). The HIPAA Privacy Rule explains that patients may ask for access to their PHI from their providers. Specifically, it guarantees that patients can access records for a reasonable price and in a timely manner. These records can include medical records and billing records from a medical office, health plan information, and any other data to make decisions about an individual.

The right of access initiative also gives priority enforcement when providers or health plans deny access to information. Providers don't have to develop new information, but they do have to provide information to patients that request it. Patients should request this information from their provider. They can request specific information, so patients can get the information they need.

What Isn't Covered in the HIPAA Privacy Rule?

The HIPAA Privacy Rule omits some types of PHI from coverage under the right of access initiative. While most PHI is accessible, certain pieces aren't if providers don't use the information to make decisions about people.

Possible reasons information would fall under this category include:

• Business planning
• Patient safety activity records
• Quality assessment and improvement

As long as the provider isn't using the data to make medical decisions, it won't be part of an individual's right to access. Other types of information are also exempt from right to access.

If a provider needs to organize information for a civil or criminal proceeding, that wouldn't fall under the first category. The same is true of information used for administrative actions or proceedings.

Another exemption is when a mental healthcare provider documents or reviews the contents of an appointment. As long as they keep those records separate from a patient's file, they won't fall under right of access.

Who Does Right of Access Affect?

Right of access affects a few groups of people. When you fall into one of these groups, you should understand how right of access works. That way, you can avoid right of access violations.

These are just some of the different types of people that the right of access initiative can affect.

Patients

Of course, patients have the right to access their medical records and other files that the law allows. Patients will need to ask their healthcare provider for the information they want. This applies to patients of all ages and regardless of medical history. Patients can grant access to other people in certain cases, so they aren't the only recipients of PHI.

Representatives

Sometimes, a patient may not want to be the one to access PHI, so a representative can do so. The most common example of this is parents or guardians of patients under 18 years old. However, adults can also designate someone else to make their medical decisions. This could be a power of attorney or a healthcare proxy. While not common, a representative can be useful if a patient becomes unable to make decisions for themself.

Covered Entities

Covered entities include a few groups of people, and they're the group that will provide access to medical records. Examples of covered entities are:

• Doctors
• Nurses
• Pharmacies
• Psychologists
• Other providers
• Health insurance plans
• Government health plans

Other covered entities include healthcare clearinghouses and healthcare business associates. However, odds are, they won't be the ones dealing with patient requests for medical records. Still, it's important for these entities to follow HIPAA.

Right of Access Violations

There are a few different types of right of access violations. Like other HIPAA violations, these are serious. As a healthcare provider, you need to make sure you avoid violations. Here are a few things you can do that won't violate right of access.

• Conducting risk analyses
• Offering security awareness training to employees
• Controlling device and media access
• Encrypting electronic PHI (ePHI)
• Using a business associate agreement
• Implementing policies and procedures

Not doing these things can increase your risk of right of access violations and HIPAA violations in general. Even if you and your employees have HIPAA certification, avoiding violations is an ongoing task.

Who Might Violate Right of Access?

Any covered entity might violate right of access, either when granting access or by denying it. Entities that have violated right of access include private practitioners, university clinics, and psychiatric offices.

A violation can occur if a provider without access to PHI tries to gain access to help a patient. Someone may also violate right to access if they give information to an unauthorized party, such as someone claiming to be a representative.

Denying access to information that a patient can access is another violation. While there are some occasions where providers can deny access, those cases aren't as common as those where a patient can access their records.

How to Prevent HIPAA Right of Access Violations

Fortunately, medical providers and other covered entities can take steps to reduce the risk of or prevent HIPAA right of access violations. Whether you work in a hospital, medical clinic, or a health insurance company, you should follow these steps. That way, you can protect yourself and anyone else involved. The steps to prevent violations are simple, so there's no reason not to implement at least some of them.

Implement Safeguards

Another great way to help reduce right of access violations is to implement certain safeguards. The HIPAA Security Rule outlines safeguards you can use to protect PHI and restrict access to authorized individuals. Safeguards can be physical, technical, or administrative. An example of a physical safeguard is to use keys or cards to limit access to a physical space with records. A technical safeguard might be using usernames and passwords to restrict access to electronic information. Administrative safeguards can include staff training or creating and using a security policy.

Verify Right of Access

Before granting access to a patient or their representative, you need to verify the person's identity. HIPAA doesn't have any specific methods for verifying access, so you can select a method that works for your office. Consider asking for a driver's license or another photo ID. When using the phone, ask the patient to verify their personal information, such as their address. Whatever you choose, make sure it's consistent across the whole team. That way, you can verify someone's right to access their records and avoid confusion amongst your team.

Use the Proper Format

When you grant access to someone, you need to provide the PHI in the format that the patient requests. They may request an electronic file or a paper file. However, HIPAA recognizes that you may not be able to provide certain formats. In that case, you will need to agree with the patient on another format, such as a paper copy. You don't need to have or use specific software to provide access to records. However, you do need to be able to produce print or electronic files for patients, and the delivery needs to be safe and secure.

Know When to Deny

While not common, there may be times when you can deny access, even to the patient directly. For example, you can deny records that will be in a legal proceeding or when a research study is in progress. If revealing the information may endanger the life of the patient or another individual, you can deny the request. The same is true if granting access could cause harm, even if it isn't life-threatening. When a federal agency controls records, complying with the Privacy Act requires denying access. And if a third party gives information to a provider confidentially, the provider can deny access to the information.

Obtain HIPAA Certification to Reduce Violations

HIPAA certification offers many benefits to covered entities, from education to assistance in reducing HIPAA violations. Whether you're a provider or work in health insurance, you should consider certification. That way, you can learn how to deal with patient information and access requests. And you can make sure you don't break the law in the process.

HIPAA violations can serve as a cautionary tale. Public disclosure of a HIPAA violation is unnerving. It can harm the standing of your organization. What's more, it can prove costly. Still, a financial penalty can serve as the least of your burdens if you're found in violation of HIPAA rules. A HIPAA Corrective Action Plan (CAP) can cost your organization even more. One example of this is the Office of Civil Rights (OCR) fining a healthcare provider $5,000 for HIPAA violations in June of 2021.

Understanding HIPAA Violations

With its passage in 1996, HIPAA changed the face of medicine. The law has had far-reaching effects. What's more, it's transformed the way that many healthcare providers operate. The most important part of the HIPAA Act states that you must keep personally identifiable patient information secure and private. This provision has made electronic health records safer for patients. However, it's also imposed several sometimes burdensome rules on healthcare providers. It's estimated that compliance with HIPAA rules costs companies about $8.3 billion every year.

The various sections of the HIPAA Act are called titles. Titles I and II are the most relevant sections of the act. Title I encompasses the portability rules of the HIPAA Act. It ensures that insurers can't deny people moving from one plan to another due to pre-existing health conditions. This is the part of the HIPAA Act that has had the most impact on consumers' lives. However, Title II is the part of the act that's had the most impact on healthcare organizations.

The Purpose Of HIPAA

Healthcare organizations must comply with Title II. It states that covered entities must maintain reasonable and appropriate safeguards to protect patient information. In part, those safeguards must include administrative measures. These kinds of measures include workforce training and risk analyses.

They also include physical safeguards. Physical safeguards include measures such as access control. It also includes technical deployments such as cybersecurity software. In general, Title II says that organizations must ensure the confidentiality, integrity, and availability of all patient information. Organizations must also protect against anticipated security threats. Furthermore, they must protect against impermissible uses and disclosure of patient information.

In addition, the HIPAA Act requires that healthcare providers ensure compliance in the workplace. At the same time, it doesn't mandate specific measures. In this regard, the act offers some flexibility. Here, organizations are free to decide how to comply with HIPAA guidelines.

At the same time, this flexibility creates ambiguity. Accordingly, it can prove challenging to figure out how to meet HIPAA standards. In part, a brief example might shed light on the matter.

As previously noted, in June of 2021, the HHS Office for Civil Rights (OCR) fined a healthcare provider $5,000 for HIPAA violations. Here's a closer look at that event.

Current HIPAA Violations

In May of 2023, the OCR issued its 19th action involving a patient's right to access. The covered entity in question was a small specialty medical practice.

The fine was the office's response to the care provider's failure to provide a parent with timely access to the medical records of her child. In the end, the OCR issued a financial fine and recommended a supervised corrective action plan.

The Diabetes, Endocrinology & Biology Center Inc. of West Virginia agreed to the OCR's terms. The care provider will pay the $5,000 fine. They'll also comply with the OCR's corrective action plan to prevent future violations of HIPAA regulations.

According to the OCR, the case began with a complaint filed in August 2019. It alleged that the center failed to respond to a parent's record access request in July 2019.

In response to the complaint, the OCR launched an investigation. The investigation determined that, indeed, the center failed to comply with the timely access provision. As a result, it made a ruling that the Diabetes, Endocrinology & Biology Center was in violation of HIPAA policies.

Top Causes of HIPAA Violations

Occasionally, the Office for Civil Rights conducts HIPAA compliance audits. Recently, for instance, the OCR audited 166 healthcare providers and 41 business associates. The purpose of the audits is to check for compliance with HIPAA rules.

HIPAA violations might occur due to ignorance or negligence. In either case, a resulting violation can accompany massive fines. The fines can range from hundreds of thousands of dollars to millions of dollars. The OCR establishes the fine amount based on the severity of the infraction. The OCR may impose fines per violation. Alternatively, they may apply a single fine for a series of violations. The fines might also accompany corrective action plans.

There are a few common types of HIPAA violations that arise during audits. For instance, the OCR may find that an organization allowed unauthorized access to patient health information. Alternatively, the office may learn that an organization is not performing organization-wide risk analyses. The OCR may also find that a healthcare provider does not participate in HIPAA-compliant business associate agreements as required. A healthcare provider may also face an OCR fine for failing to encrypt patient information stored on mobile devices. Finally, audits also frequently reveal that organizations do not dispose of patient information properly.

Other HIPAA violations come to light after a cyber breach.

Types of HIPAA Breaches

There are two primary classifications of HIPAA breaches. If a violation doesn't result in the use or disclosure of patient information, the OCR ranks it as "not a breach."

Still, the OCR must make another assessment when a violation involves patient information. They must define whether the violation was intentional or unintentional.

Accidental disclosure is still a breach. However, it comes with much less severe penalties.

Alternatively, the OCR considers a deliberate disclosure very serious. Resultantly, they levy much heavier fines for this kind of breach.

After a breach, the OCR typically finds that the breach occurred in one of several common areas.

Lack of a Valid Risk Assessment

Risk analysis is an important element of the HIPAA Act. The purpose of this assessment is to identify risks to patient information. It's the first step that a healthcare provider should take in meeting compliance.

Sharing Patient Information

Here, a healthcare provider might share information intentionally or unintentionally. In either case, a healthcare provider should never provide patient information to an unauthorized recipient. An unauthorized recipient could include coworkers, the media, or a patient's unauthorized family member.

Unauthorized Viewing of Patient Information

Reviewing patient information for administrative purposes or delivering care is acceptable. However, it's a violation of the HIPAA Act to view patient records outside of these two purposes. Personnel cannot view patient records unless they are doing so for a specific reason that's related to the delivery of treatment.

Improper Disposal of Patient Information

The HIPAA Act mandates the secure disposal of patient information. Complying with this rule might include the appropriate destruction of data, hard disks, or backups. It also includes destroying data on stolen devices. In addition, it covers the destruction of hardcopy patient information.

Lack of Patient Access Controls

According to HIPAA rules, healthcare providers must control access to patient information. For example, your organization could deploy multi-factor authentication. Multi-factor authentication is an excellent place to start if you want to ensure that only authorized personnel accesses patient records.

Lack of Encryption

This violation usually occurs when a care provider doesn't encrypt patient information that's shared over a network. Tools such as VPNs, TSL certificates, and security ciphers enable you to encrypt patient information digitally. It's also a good idea to encrypt patient information that you're not transmitting.

Breach Notification Compliance

Failure to notify the OCR of a breach is a violation of HIPAA policy. Furthermore, you must do so within 60 days of the breach. If not, you've violated this part of the HIPAA Act.

Improper Handling of Patient Information

Care providers must share patient information using official channels. Staff members cannot email patient information using personal accounts. They also shouldn't print patient information and take it off-site. Either act is a HIPAA offense.

Unauthorized Information Disclosure

Your staff members should never release patient information to unauthorized individuals. Doing so is considered a breach. However, the OCR did relax this part of the HIPAA regulations during the pandemic.

Limited Access Logging

Organizations must maintain detailed records of who accesses patient information. They must also track changes and updates to patient information.

You never know when your practice or organization could face an audit. If so, the OCR will want to see information about who accesses what patient information on specific dates. If you cannot provide this information, the OCR will consider you in violation of HIPAA rules. Here, however, the OCR has also relaxed the rules. They're offering some leniency in the data logging of COVID test stations. There are many more ways to violate HIPAA regulations. Fortunately, your organization can stay clear of violations with the right HIPAA training.

Healthcare professionals must have HIPAA training. The HIPAA Act requires training for doctors, nurses, and anyone who comes in contact with sensitive patient information. Understanding the many HIPAA rules can prove challenging. In many cases, they're vague and confusing.

HIPAA training is a critical part of compliance for this reason. Proper training will ensure that all employees are up-to-date on what it takes to maintain the privacy and security of patient information. With training, your staff will learn the many details of complying with the HIPAA Act. More importantly, they'll understand their role in HIPAA compliance.

It's important to provide HIPAA training for medical employees. Without it, you place your organization at risk. For example, your organization could face considerable fines due to a violation. The smallest fine for an intentional violation is $50,000. In a worst-case scenario, the OCR could levy a $250,000 fine on an individual for a criminal offense. Furthermore, the court could find your organization liable for paying restitution to the victim of the crime.

What is HIPAA Certification?

With HIPAA certification, you can prove that your staff members know how to comply with HIPAA regulations. Today, earning HIPAA certification is a part of due diligence.

HIPAA compliance rules change continually. As a result, there's no official path to HIPAA certification. If a training provider advertises that their course is endorsed by the Department of Health & Human Services, it's a falsehood.

Nevertheless, you can claim that your organization is certified HIPAA compliant. The statement simply means that you've completed third-party HIPAA compliance training. It also means that you've taken measures to comply with HIPAA regulations. Here, however, it's vital to find a trusted HIPAA training partner.

What Is Considered Protected Health Information (PHI)?

PHI is the information that identifies an individual patient or client. Examples of protected health information include a name, social security number, or phone number. It can also include a home address or credit card information as well.

Health-related data is considered PHI if it includes those records that are used or disclosed during the course of medical care.  Health data that are regulated by HIPAA can range from MRI scans to blood test results. When this information is available in digital format, it's called "electronically protected health information" or ePHI. Any form of ePHI that's stored, accessed, or transmitted falls under HIPAA guidelines.

HIPAA is designed to protect not only electronic records themselves but the equipment that's used to store these records.  HIPAA applies to personal computers, internal hard drives, and USB drives used to store ePHI.  HIPAA regulations also apply to smartphones or PDAs that store or read ePHI as well.

Who Must Comply With HIPAA?

HIPAA's protection of health information rests on the shoulders of two different kinds of organizations. HIPAA calls these groups business associates or covered entities. Here’s a closer look at these two groups:

Covered Entities

A covered entity is an organization that collects, creates, and sends PHI records. Covered entities are businesses that have direct contact with the patient. Covered entities include health care providers (i.e., dentists, therapists, doctors, etc.) primarily.

These businesses must comply with HIPAA when they send a patient's health information in any format. The patient's PHI might be sent as referrals to other specialists.  It could also be sent to an insurance provider for payment.

Business Associates

Business associates don't see patients directly. Instead, they create, receive, or transmit a patient's PHI.  Examples of business associates can range from medical transcription companies to attorneys.

Other examples of a business associate include the following:

• Accountants;
• Cloud storage businesses;
• Email hosting providers;
• Faxing service companies;
• Medical billing firms;
• A monolithic power system;
• Physical storage companies; and
• Professional shredding companies.

Why Breached PHI Is Valuable

It's a common newspaper headline all around the world. Hacking and other cyber threats cause a majority of today's PHI breaches.  But why is PHI so attractive to today's data thieves?

One way to understand this draw is to compare stolen PHI data to stolen banking data.  Stolen banking or financial data is worth a little over $5.00 on today's black market. Compromised PHI records are worth more than $250 on today's black market.

Stolen banking data must be used quickly by cybercriminals. Victims will usually notice if their bank or credit cards are missing immediately.  When this happens, the victim can cancel their card right away, leaving the criminals very little time to make their illegal purchases.

PHI data has a higher value due to its longevity and limited ability to change over long periods of time. PHI data breaches take longer to detect, and victims usually can't change their stored medical information.

Other valuable information such as addresses, dates of birth, and social security numbers are vulnerable to identity theft.  Sometimes cybercriminals will use this information to get prescription drugs or receive medical attention using the victim's name. All of these perks make it more attractive to cyber vandals to pirate PHI data.

Best Way To Protect PHI

Perhaps the best way to head off breaches to your ePHI and PHI is to have rock-solid HIPAA compliance in place.  Some components of your HIPAA compliance program should include the following:

Written Procedures for Policies, Standards, and Conduct

HIPAA protection begins when business associates or covered entities compile their own written policies and practices. These policies can range from employee conduct records to disaster recovery efforts. Any policies you create should be focused on the future. Invite your staff to provide their input on any changes. When you request their feedback, your team will have more buy-in while your company grows.

Identify a Compliance Body

Hire a compliance professional to be in charge of your protection program. You can choose to either assign responsibility to an individual or a committee.

Access to Information, Resources, and Training

HIPAA protection doesn't mean a thing if your team doesn't know anything about it. When new employees join the company, have your compliance manager train them on HIPAA concerns. Give your team access to the policies and forms they'll need to keep your ePHI and PHI data safe. Team training should be a continuous process that ensures employees are always updated. 

Audit and Monitor

Compare these tasks to the same way you address your own personal vehicle's ongoing maintenance. Your car needs regular maintenance. So does your HIPAA compliance program. Regular program review helps make sure it's relevant and effective. Decide what frequency you want to audit your work site. Then you can create a follow-up plan that details your next steps after your audit.

Automated systems can also help you plan for updates further down the road. You can use automated notifications to remind you that you need to update or renew your policies. Allow your compliance officer or compliance group to access these same systems.

Enforcement

HIPAA requires organizations to identify their specific steps to enforce their compliance program. Let your employees know how you will distribute your company's appropriate policies. Tell them when training is coming available for any procedures. Send automatic notifications to team members when your business publishes a new policy. That's the perfect time to ask for their input on the new policy.

Quick Response and Corrective Action Plan

A comprehensive HIPAA compliance program should also address your corrective actions that can correct any HIPAA violations. Your company's action plan should spell out how you identify, address, and handle any compliance violations. Who do you need to contact? What are the disciplinary actions we need to follow?

The primary purpose of this exercise is to correct the problem. Fix your current strategy where it's necessary so that more problems don't occur further down the road.

For information on how to stay HIPAA compliant, sign up for one of our HIPAA courses.