Compared to the specific HIPAA safeguards of the Security Rule (the Administrative, Physical, and Technical Safeguards), most other references to safeguards in the text of HIPAA are intentionally flexible to accommodate the different types of covered entities and business associates that have to comply with them. While this flexibility means it can be easier for some organizations to comply with the HIPAA safeguards, other organizations may find the lack of direct guidance unhelpful.

To demonstrate the difference between the safeguards of the Security Rule and the safeguards of the Privacy Rule, we have provided a synopsis of the Security Rule Administrative, Physical, and Technical Safeguards to compare against the safeguards mentioned in the Privacy Rule Administrative Requirements. There is also a section relating to the Organization Requirements of the Privacy and Security Rules – both of which include further HIPAA safeguards.

HIPAA Security Rule Safeguards

The HIPAA Security Rule is dominated by the Administrative, Physical, and Technical Safeguards – the remainder of the Rule being assigned to General Rules, Organization Requirements (discussed below), Documentation Requirements, and Compliance Dates. The General Rules provide an oversight of the what the HIPAA safeguards set out to achieve and the “flexibility of approach”, and explain the difference between required and addressable implementation specifications.

Addressable implementation specifications are not as flexible as they may appear. Addressable specifications must be implemented unless they are “not reasonable or appropriate in the environment” or an alternative safeguard provides at least as much protection to ePHI as the addressable specification. In most circumstances, covered entities and business associates have no option but to implement addressable specifications in order to provide adequate protection.

HIPAA Administrative Safeguards

More than half of the Security Rule focuses on the HIPAA Administrative Safeguards (45 CFR § 164.308) – defined in the Security Rule as “administrative actions, and policies and procedures, to manage the selection, development, implementation, and maintenance of security measures to protect electronic PHI and to manage the conduct of the covered entity’s or business associate’s workforce in relation to the protection of that information”.

To achieve the objectives of the HIPAA Administrative Safeguards, covered entities and business associates must appoint a Security Officer responsible for developing a security management program that addresses access controls, incident response, and security awareness training. The Security Officer is also responsible for conducting risk assessments and implementing policies and procedures to protect ePHI from threats and vulnerabilities.

Possibly the most important standard in the HIPAA Administrative Safeguards is the requirement to implement a security awareness and training program for all members of the workforce (including management). It is important to be aware that this requirement also applies to members of the workforce with no authorized access to systems, devices, or databases containing ePHI – including agency staff, volunteers, and students.

HIPAA Physical Safeguards

The HIPAA Physical Safeguards are measures, policies, and procedures intended to protect a covered entity’s or business associate’s buildings, equipment, and information systems from unauthorized intrusion and natural or environmental hazards. Compliance with these safeguards not only involves securing buildings and controlling access to buildings, but also validating the identity of anyone with access to equipment and information systems hosting ePHI.

Compared to the Privacy Rule HIPAA Safeguards (below), the HIPAA Physical Safeguards provide direct guidance on the measures covered entities and business associates should take to (for example) govern the movement of devices and media containing ePHI, document maintenance records for facilities in which ePHI is stored, back up data before moving equipment, and properly dispose of any hardware ePHI is stored on to eliminate the possibility of unauthorized disclosures.

With regards to what members of the workforce can do to comply with the HIPAA Physical Safeguards, standard §164.310(b) requires workstation users to consider the environment in which they are using technology to access ePHI. For example, workstations used in public areas should have their screens obscured from public view, while those used to conduct telehealth consultations should be located in a private area.

HIPAA Technical Safeguards

The HIPAA Technical Safeguards relate to the technology used by covered entities and business associates, and the policies and procedures for its use and access to it. Like the HIPAA Physical Safeguards, the HIPAA Technical Safeguards include fine details on the measures that organizations should implement to protect ePHI from unauthorized access – including audit controls, user verification, and automatic log-off so ePHI cannot be accessed by unauthorized users when devices are left unattended.

Despite being the shortest of the Security Rule HIPAA Standards, the HIPAA Technical Safeguards make it clear that encryption is a significant factor in preventing unauthorized uses and disclosures. This point has been reinforced through several subsequent HHS publications – most notably a recent Fact Sheet that answers questions about ransomware and whether or not a ransomware attack is a reportable breach under the HIPAA Breach Notification Rule.

Although “passwords” are not referred to directly in the HIPAA Technical Safeguards, an effective HIPAA password policy that includes 2FA can support compliance with the standards relating to access controls, unique user identification, and person or entity authentication, so it is easier to comply with the HIPAA Technical Safeguards relating to audit controls and event logs. Indeed, an effective password policy can make it easier to comply with many of the HIPAA Security Rule Safeguards.

Privacy Rule HIPAA Safeguards

Compared to the HIPAA security safeguards, the safeguards mentioned in the Administrative Requirements of the Privacy Rule lack direct guidance. According to 45 CFR § 164.530 a covered entity “must have in place appropriate administrative, technical, and physical safeguards to protect the privacy of Protected Health Information”. The only implementation specifications offered to support this standard are:

• A covered entity must reasonably safeguard PHI from any intentional or unintentional use or disclosure that is in violation of the standards, implementation specifications, or other requirements of this subpart.
• A covered entity must reasonably safeguard PHI to limit incidental uses or disclosures made pursuant to an otherwise permitted or required use or disclosure.

The reason the Administrative Requirements lack direct guidance is the inclusion of “other requirements of this subpart”. “This subpart” refers to the Privacy Rule; and as different covered entities develop different policies and procedures to comply with the Privacy Rule, it would be impossible to develop “one-size-fits-all” safeguards to protect the privacy of PHI in the same way as required and addressable safeguards protect the confidentiality, integrity, and availability of ePHI.

Organizational Requirements in the Privacy and Security Rules

Both the Privacy Rule and the Security Rule contain Organizational Requirements. The Organizational Requirements of the Privacy Rule (45 CFR § 164.105) apply to covered entities that are not whole units (hybrid entities) or that are not single units (affiliated entities), while the Organizational Requirements of the Security Rule (45 CFR § 164.314) relate to Business Associate contracts with subcontractors and relationships between group health plans and plan sponsors.

Additional HIPAA Safeguards for Hybrid Entities

An example of a hybrid entity is a public teaching institution that provides healthcare facilities for staff, students, and the public. The institution is a hybrid entity because the provision of healthcare for staff is a non-portable benefit (and exempt from HIPAA), the provision of healthcare for students is covered by FERPA (which pre-empts HIPAA), and only the provision of healthcare for the public is covered by HIPAA.

Hybrid entities must implement appropriate HIPAA safeguards to ensure that any PHI collected, used, and maintained by the public healthcare component of its operations is not disclosed to the other components of its operations. This includes disclosures of PHI by healthcare professionals working for a hybrid entity when the healthcare professionals assist with medical procedures for staff, students, and the public.

Additional HIPAA Safeguards for Affiliated Entities

Affiliated Entities are legally separate covered entities under the same ownership or control that designate themselves a single Affiliated Covered Entity for the purposes of HIPAA compliance. Being affiliated enables covered entities within an affiliated group to disclose ePHI to each other without the need for individual Business Associate Agreements, which increases integration and efficiency. Affiliated Entities can also use common documentation and share the same Privacy and Security Officers.

The additional HIPAA safeguards in the Organizational Requirements prevent unauthorized disclosures to other business units under the same ownership or control that do not qualify as covered entities. For example, several hospitals within a healthcare system under the same ownership can designate themselves as an Affiliated Entity; but, if the parent organization is not a covered entity, ePHI cannot be disclosed to the parent organization.

Business Associate Contracts with Subcontractors

Most covered entities and business associates are familiar with the requirement to enter into a Business Associate Agreement before ePHI is disclosed by a covered entity to a business associate, but it is not so widely known that a business associate has to enter into a Business Associate Contract before disclosing ePHI with a subcontractor or another of the covered entity´s business associates acting as a subcontractor for the primary business associate.

Originally, business associates had to ensure any subcontractors to whom they disclosed ePHI had appropriate measures in place to comply with the HIPAA Administrative Safeguards of the Security Rule. However, this requirement was changed in the Omnibus Final Rule to “ensure that any agent to whom it provides this information agrees to implement reasonable and appropriate security measures to protect the information”. Naturally, all assurances must be documented.

Relationships between Group Health Plans and Plan Sponsors

The relationship between group health plans and plans sponsors is similar to that between covered entities and business associates with the exception that there are some allowable uses and disclosures of ePHI allowed. In all other cases, group health plans must ensure the plan sponsor has implemented the administrative, physical, and technical HIPAA safeguards required by the Security Rule before disclosing further ePHI to the group sponsor.

It is Important to Comply with All Applicable HIPAA Safeguards

Covered entities and business associates must comply with all applicable HIPAA safeguards. Ignorance of the safeguards – or how to comply with them – is not a justifiable defense if an organization is audited by HHS’ Office for Civil Rights or investigated following a patient complaint or self-reported data breach. In the worst cases, substantial fines can be issued for noncompliance with HIPAA safeguards that organizations should have known about had they exercised due diligence.

HIPAA Safeguards FAQs

Are there further references to HIPAA safeguards in the Privacy Rule?

Yes. These can be found in the section of the Privacy Rule regarding “Other Requirements Relating to Uses and Disclosures of PHI” (45 CFR § 164.514). The relevant standards relate to limited data sets of de-identified PHI and the measures Covered Entities must have in place before disclosing limited data sets.

These include safeguarding any codes or mechanisms that could be used to re-identify PHI, entering into a data use agreement with the recipient of the limited data set, and ensuring the recipient has appropriate safeguards in place to prevent the use or disclosure of data – although de-identified – other than allowed by the data use agreement.

What security awareness training should a Covered Entity provide?

According to the HIPAA Administrative Safeguards, a security and awareness training program should be implemented for all members of the workforce – including management. The content of the program should be determined by a risk assessment to establish what threats exist to the confidentiality, integrity, and availability of ePHI.

It is important to be aware that the requirement to implement a security and awareness training program differs from the training requirements of the Privacy Rule inasmuch as all members of the workforce should undergo security awareness training regardless of their roles, and the program should be ongoing – rather than a one-off training session on policies and procedures.

How is it possible to govern the movement of devices and media in community nursing?

The standard relates to governing the movement of devices and media containing ePHI. If ePHI is stored on devices used in community nursing, the devices need to be configured to comply with the technical safeguards inasmuch as they should PIN-locked, data should be encrypted and password protected, and the transmission of ePHI should be done over secure channels.

With regards to monitoring the movement of devices and media at all at times, the physical safeguards do not stipulate around-the-clock monitoring. However, many community nursing units have “check-in” procedures to ensure the safety of nursing professionals in the community, and these procedures could be adapted to increase the governance of device movement.

Is a ransomware attack reportable if data is encrypted?

This depends. According to the HHS Fact Sheet there are circumstances in which a ransomware attack is reportable even if data is unreadable, unusable, and indecipherable by the attacker due to it being encrypted. This is because some full disk encryption systems automatically decrypt data when the system is powered on, and the operating system loaded.

The Fact Sheet does make it clear that a ransomware attack on unencrypted data is a reportable offence because, at the time of the attack, the attacker was in control of unsecured data and there is no way of knowing whether it was viewed and/or extracted or not. In these circumstances, it is impossible to prove a low probability that ePHI was compromised to avoid reporting requirements.

What are the penalties for failing to comply with the HIPAA safeguards?

The penalties for failing to comply with the HIPAA safeguards vary according to the nature of the violation, the extent of the harm caused by the violation, and the organization´s previous history of HIPAA compliance. There are four tiers of violation type depending on the degree of culpability, and penalties are calculated within these tiers per violation.

It is important to be aware it is not necessary to experience a data breach in order to be issued a penalty. Eleven Covered Entities were recently investigated and fined for failing to comply with patient right of access requirements – even though no data breach had occurred. All eleven also suffered operational disruption due to the requirement to comply with a corrective action.

The post Guide to HIPAA Safeguards appeared first on HIPAA Journal.

The Health Insurance Accountability and Portability Act (HIPAA) introduced a number of HIPAA rights relating to the portability of health coverage, the continuation of health coverage between jobs, and the coverage of employees with preexisting conditions. However, many more HIPAA rights were added in the Privacy Rule, and the failure to comply with Privacy Rule HIPAA rights is one of the leading reasons for complaints to the HHS Office for Civil Rights.

When HIPAA was enacted in 1996, references to individuals’ rights mostly focused on the original purpose of the Act – to enable employees to carry forward insurance coverage from one employer to another after a break, to prevent the denial of coverage – or additional premiums for coverage – on the grounds of a pre-existing condition, and to guarantee renewability in multiemployer plans.

HIPAA Special Enrollment Rights

Possibly the most utilized of the “insurance rights” are the HIPAA special enrollment rights. These HIPAA rights allow individuals to enroll in a health plan as a result of a special enrollment event such as the loss of other health insurance coverage, the acquisition of a dependent through marriage, birth, or adoption, or becoming eligible for a Medicaid or premium assistance subsidy.

The events eligible for special enrollment – and the requirements for special enrollment periods – can vary according to each State’s insurance licensing laws. To explain what events are eligible for special enrollment and how long individuals have to apply for special enrollment, health plans (and, in some cases, employers) are required to provide a HIPAA Notice of Special Enrollment Rights

The HIPAA Privacy Rule Rights

The HIPAA rights most people are familiar with – the right to health information privacy and the right to access and correct health information – are mentioned in the text of HIPAA (Section 264), but only in the context of the recommendations the Secretary for Health & Human Services was tasked with preparing in the event that Congress did not pass a privacy law within three years.

As Congress did not pass a privacy law, the Privacy Rule was introduced to establish patients´ rights under HIPAA. These can be found between 45 CFR § 164.508 and 45 CFR § 164.528 in the HIPAA Administration Simplification provisions. However, as the HIPAA Administrative Simplification provisions are complex, we have provided a synopsis of the most important HIPAA Privacy Rule rights below.

Rights under the Privacy Rule

Information for which individuals have rights under the Privacy Rule is known as Protected Health Information or PHI. In addition to information relating to a patient’s past, present, or future physical or mental condition being protected – including the provision of treatment and healthcare services – past, present, or future payment information is also protected under the Privacy Rule.

45 CFR § 164.508 – Uses and disclosures of PHI for which an authorization is required

HIPAA Covered Entities and Business Associates are allowed to use or disclose PHI to carry out selected treatment, payment, or healthcare operations. All other uses and disclosures require the prior authorization of a patient. Patients have the right to request a copy of the authorization to keep, and the right to revoke the authorization at any time.

45 CFR § 164.520 – Notice of Privacy Practices for PHI

Patients have the right to receive a Notice of Privacy Practices. The Notice must explain what uses and disclosures of PHI are allowed, and when an authorization is required for other uses and disclosures. The Notice must also list the patient´s other rights, how to exercise them, and how to make a complaint if their privacy rights are violated.

45 CFR § 164.522 – Right to request privacy protection for PHI

Two of the HIPAA rights listed in the Notice of Privacy Practices are that patients can request restrictions on certain uses and disclosures of PHI – for example not informing a health plan when a patient receives treatment and pays for the treatment privately – and that they can request how Covered Entities communicate with them when a communication involves a disclosure of PHI.

45 CFR § 164.524 – Access of individuals to PHI

The right in this standard should also be included in a Notice of Privacy Practices inasmuch as it explains a patient´s right to inspect and receive a copy of their PHI within 30 days (currently under review). Patients can also stipulate how they want to receive a copy of their PHI – for example, by email, on a USB drive, or in paper format.

45 CFR § 164.526 – The right to amend PHI

Patients have the right to request corrections to their medical records if, on obtaining a copy of their PHI, it is found to be inaccurate or incomplete. There are several scenarios in which a Covered Entity can decline to comply with this request, including in these days of interoperability between Covered Entities, that the Covered Entity to whom the request is made did not create the PHI.

45 CFR § 164.528 – Accounting of disclosures of PHI

The right to access an accounting of disclosures – which explains who the patient´s PHI has been disclosed to and why over the past six years – is one of the most complicated HIPAA rights standards because there are so many exclusions allowed. It is also possible for this right to be suspended if a suspension is requested by a law enforcement officer or public health official.

The Importance of Patients’ Rights to Medical Records

Patients are encouraged to exercise their HIPAA Privacy Rule rights – especially the HIPAA patients’ rights to medical records required by 45 CFR § 164.524 – to improve their knowledge of their health and engage in their own care. The “sense of ownership” is believed to reduce misdiagnoses and medical mistakes by patients alerting healthcare providers to inaccuracies and omissions.

In addition to identifying any inaccuracies and omissions in their medical records, individuals exercising their patient rights under HIPAA can also help prevent fraud and abuse in the healthcare system by raising concerns about treatments that appear on their medical records they have not received. These indicate a third party has used the patient’s PHI to commit insurance fraud.

Rights under the Breach Notification Rule

In addition to the rights granted by the Privacy Rule, individuals also have HIPAA rights under the Breach Notification Rule – a Rule that specifies the process for reporting breaches of unsecured PHI. The Rule was extended in the Final Omnibus Rule in 2013 to include Business Associate data breaches, and further changes are being considered in response to the Safe Harbor Act 2021.

At present, patients have the right to be notified of any breach of unsecured PHI when there is reason to believe the PHI has been accessed, acquired, used, or disclosed without authorization. The notification must explain how the breach happened, the nature of the PHI that was breached, and what steps individuals should take to protect themselves from harm as a result of the breach.

In addition, Covered Entities must describe what they are doing to investigate the breach, mitigate harm to individuals, and protect against further breaches. Covered Entities must also provide contact details – which should include a toll-free number – where affected individuals can seek help or ask further questions. These procedures apply regardless of how many patients are affected.

Noncompliance with HIPAA Rights

As mentioned in the introduction to this article, the failure to comply with Privacy Rule HIPAA rights is one of the leading reasons for complaints to the HHS Office for Civil Rights (OCR) and subsequent enforcement action. In recent years, complaints about patients´ rights of access have been among the top five complaints investigated by OCR that have resulted in corrective action and/or a civil penalty.

As of January 2024, OCR has issued fines or reached settlement agreements with 46 covered entities for noncompliance with the HIPAA rights. It is important to note that the settlements of up to $160,000 involved smaller practices as well as larger organizations. Therefore, it is important that every Covered Entity is aware of – and complies with – patients´ HIPAA rights.

HIPAA Rights FAQs

Why might a patient not want their health plan informed they have received treatment?

When a patient receives medical treatment and pays for it privately, the patient has the right to withhold this information from their insurance provider in case the provider subsequently increases the insurance premium, limits the benefits of the plan, or refuses future coverage. While decisions such as these are often appealed successfully, the appeal process can be particularly stressful while recovering from medical treatment.

Why does it matter how a Covered Entity communicates with a patient?

Face-to-face communications are usually exempt from this standard because they are likely to relate to the provision of treatment. However, remote communications (i.e., a telephone call to work) could be intercepted by third parties (i.e., work colleagues) who the patient may not wish to share their personal information with. This standard allows patients to request a preferred communication channel, location, and time.

Do Covered Entities have to comply with the Breach Notification Rule if a breach affects just one patient?

This depends on the outcome of a risk assessment. If the risk assessment demonstrates a low probability that unsecured PHI has been compromised due to the unauthorized access, acquisition, use, or disclosure, Covered Entities do not have to notify patients (although they may still wish to do so). In all other cases, unauthorized disclosures of unsecured PHI have to be notified to affected individuals even if only one patient is affected.

How can Covered Entities avoid penalties for noncompliance with patients´ HIPAA rights?

In many cases, noncompliance with patients´ HIPAA rights is attributable to a lack of understanding. Therefore, to mitigate the risk of noncompliance, Covered Entities should develop policies and procedures to meet the requirements of the Privacy and Breach Notification Rules, train members of the workforce on the policies and procedures, and organize periodic refresher training to maximize retention of the policies and procedures.

What exclusions apply to the accounting of disclosures right?

When a patient requests an accounting of disclosures, Covered Entities do not have to include disclosures for treatments, payments, or health care operations, any disclosures made to the patient, any disclosures previously authorized by the patient, and disclosures to law enforcement. In addition, incidental disclosures, disclosures of PHI in a limited data set, and disclosures of de-identified PHI do not have to be included in the accounting of disclosures.

How many basic rights are covered under HIPAA?

As mentioned in the introduction to this article, HIPAA introduced multiple rights – including the rights of individuals to carry forward health insurance coverage, the rights of individuals not to be discriminated against due to a pre-existing condition, and the rights of individuals to have guaranteed health insurance renewability in multiemployer plans.

With regards to the rights to health information privacy and to access and correct health information (etc.), these are not “basic rights” in the sense that they are absolute or fundamental rights. Covered Entities can disclose health information without patient authorization and deny an individual their right to access and correct health information in certain circumstances.

How many patient privacy rights are there?

Strictly speaking, there are six patient privacy rights mandated by the Privacy Rule. However, once you include patients´ rights under the Breach Notification Rule and the right to request a review if a request to access or correct health information is denied – or a request for an accounting of disclosures is denied – it could be argued that there are eight patient privacy rights.

Are all healthcare providers required to comply with the standards for HIPAA patient rights?

No, because not all healthcare providers are Covered Entities under HIPAA, and healthcare providers that do not qualify as Covered Entities are not required to comply with the HIPAA Privacy Rule and the standards for HIPAA patient rights. However, even when healthcare providers are not required to comply with the standards for HIPAA patient rights, they may be required to comply with state privacy laws that have similar requirements to HIPAA.

For the record, only healthcare providers that conduct electronic transactions for which the Department of Health and Human Services has developed standards are Covered Entities. Covered electronic transactions include patient eligibility requests, treatment authorizations, and claims for payments. Therefore, if a healthcare provider conducts these transactions non-electronically or bills patients directly, the healthcare provider is not a HIPAA Covered Entity.

Do the standards for HIPAA privacy rights apply to pharmacies?

Although you might not think of a pharmacy as a healthcare provider, the HIPAA Administrative Simplification Regulations define health care as including “the sale or dispensing of a drug, device, equipment, or other item in accordance with a prescription.”

Consequently, provided the pharmacy conducts electronic transactions for which the Department of Health and Human Services has published standards and it sells or dispenses drugs in accordance with a prescription, it is a Covered Entity and the standards for HIPAA privacy rights apply.

One grey area relates to marijuana dispensaries. Strictly speaking, they are not Covered Entities under HIPAA because – unless they use a third-party service provider to conduct transactions on their behalf – they do not conduct covered transactions.

However, because of the sensitive nature of PHI collected by marijuana dispensaries, the Department for Health and Human Services has taken an interest in how HIPAA privacy rights are applied – notwithstanding that state privacy and security laws may also dictate whether privacy rights similar to those stipulated by HIPAA apply to marijuana dispensaries.

The post HIPAA Rights appeared first on HIPAA Journal.

HIPAA certification for individuals is certified HIPAA training combined with testing to verify awareness of HIPAA compliance requirements, typically conducted on an annual basis. Successful trainees receive a HIPAA compliance certificate.

HIPAA Certification Requirements for Healthcare Professionals and Administrators

Certifying that an organization’s workforce is HIPAA compliant can have similar benefits to those discussed above inasmuch as a compliant workforce is less likely to violate HIPAA or make mistakes that could result in data breaches. Similarly achieving workforce HIPAA certification demonstrates a reasonable amount of care to abide by the HIPAA Rules in the event of an OCR investigation or audit.

For individual members of the workforce, HIPAA certification can help foster patient trust, support applications for promotion, and increase prospects in the job market. However, it is what workforce members learn during a certification program that can have the biggest impact on their professional lives, as this can help prevent unintentional violations that can have significant consequences.

Unintentional violations of HIPAA can be attributable to a lack of knowledge, shortcuts being taken “to get the job done”, or because a cultural norm of noncompliance has been allowed to develop. Whatever the reason, violations of HIPAA can result in sanctions ranging from written warnings to loss of professional accreditation – sanctions that can be avoided by applying the information learned during a certification program.

HIPAA training is not optional and “a covered entity must train all members of its workforce on policies and procedures […] as necessary and appropriate for the members of the workforce to carry out their functions within the covered entity” as stated in §164.530(b)(1) of the HIPAA Privacy Rule. All HIPAA covered entities must  “implement a security awareness and training program for all members of its workforce including management” as stated in §164.308(a)(5) of the HIPAA Security Rule.

Who Needs HIPAA Certification?

Anyone who creates, views, sends, or stores protected health information (PHI) needs HIPAA certification.

HIPAA Certification for Clinicians and Clinical Support Staff

Physicians, nurses, advanced practice providers, therapists, pharmacists, techs, and medical assistants touch PHI all day long. The risks are not abstract, they show up in small, routine activities:

• Clicking into the wrong chart when the waiting room is busy

• Talking through a case a little too loudly at the nurses’ station

• Leaving imaging results open on a workstation during a handoff

Certification for this group should reinforce habits that protect patients even on hectic days: using the minimum necessary information, double-checking patient identity before discussing results, logging out of shared devices, and knowing when a “quick favor” (for example, sharing results with a family member) actually needs an authorization.

HIPAA Certification for Administrative and Front-Office Staff

Front-desk and administrative teams often see PHI before a clinician does. They manage check-in, intake forms, insurance cards, and a constant stream of phone calls and portal messages.

Administrative roles here include:

• Practice managers and office administrators

• Reception and scheduling staff

• Medical records and health information management teams

The risks are practical: reading a full diagnosis out loud at the front desk, sending an appointment reminder to the wrong number, or handing a packet of records to the wrong person in a busy waiting room. HIPAA certification should give these staff clear scripts and workflows, how to verify identity over the phone, what can and can’t go in a voicemail, how to handle walk-in record requests, and when to escalate a request to the privacy office.

Billing, Coding, and Revenue Cycle Personnel

Billing and coding teams live in the details of claims, remits, and patient balances. They may not be in the exam room, but they regularly work with diagnoses, procedures, and sensitive financial information.

The types of roles requiring HIPAA certification include:

• Coders and charge entry staff

• Billing and collections teams

• Payment posting and follow-up staff

HIPAA Certification for IT, IT Security, and other Technical Staff

IT and security teams may never open a chart for treatment, but they often have broad access to systems that store PHI. A misstep in this group, like a misconfigured database or shared admin account—can expose far more data than a single wrong fax.

The IT roles that may require HIPAA certification include:

• Network and system administrators

• EHR and practice management system admins

• Helpdesk and desktop support staff

• Cybersecurity, infrastructure, and cloud teams

HIPAA Certification for Business Associate Staff

Many organizations that never see a patient face-to-face still qualify as HIPAA Business Associates because they handle PHI for a HIPAA Covered Entity. Some common examples of HIPAA Business Associates include:

• Cloud hosting providers and EHR vendors

• Billing and collection agencies

• Transcription and dictation services

• Analytics, reporting, and population health vendors

A Business Associate Agreement (BAA) sets the contract terms and should include HIPAA training and HIPAA certification for the people doing the work. Individual staff at these companies need HIPAA certification that addresses:

• What the contract allows them to do with PHI and what’s outside scope

• When to de-identify data and how to do it correctly

• How to respond if they receive more PHI than they expected, or PHI from the wrong client

• How and when they must notify their client about a potential incident or breach

Without that HIPAA training, even a well-written BAA can be undermined by day-to-day shortcuts by staff.

HIPAA Certification for Healthcare Students

Healthcare students handle PHI during clinical rotations, practicums, and administrative internships.

• Medical, nursing, and allied health students

• Health information management and coding students

• Administrative and health management interns

Healthcare sector students, both clinical and administrative, should receive comprehensive HIPAA training and HIPAA certification that covers the everything they need to know about HIPAA but also covers the special circumstances of students such as using PHI in student reports.

Benefits of HIPAA Certification

IPAA certification gives employees a stronger résumé signal and marketability by showing they can handle PHI correctly, applying the HIPAA Minimum Necessary Rule, HIPAA Security Rule, and HIPAA Privacy Rule. It builds credibility with peers and employers. HIPAA certification gives employees a competitive edge for promotions. HIPAA certification gives employees peace of mind by clarifying what to do, how to document and escalate, and which safeguards to apply, so everyday decisions are confident and defensible.

HIPAA Certification FAQs

Why is HIPAA certification described as a “point in time” accreditation?

HIPAA certification is described as a “point in time” accreditation because HIPAA compliance is an on-going progress. A HIPAA certified organization may have passed a third-party company’s HIPAA compliance program and implemented mechanisms to maintain compliance, but that is no guarantee the organization will remain compliant in the future. HIPAA certification should be considered an initial objective and then an ongoing task.

Can software be certified as HIPAA compliant?

Software cannot be certified as HIPAA compliant because, while it is possible for software to have HIPAA-compliant capabilities, the way the capabilities are used determines compliance with the HIPAA Rules. It is also important to note the distinction between HIPAA compliant software and HIPAA compliance software.

What does HHS say about HIPAA certification?

What HHS says about HIPAA certification is that there is no requirement in HIPAA for a covered entity or business associate or healthcare worker to be certified as compliant. The Department warns organizations to be aware of misleading marketing claims suggesting compliance programs or material is endorsed by HHS or the Office for Civil Rights (OCR).

What is the difference between a third party audit and an HHS audit?

The difference between a third party audit and an HHS audit is that a third party audit checks a covered entity´s HIPAA compliance and, if lapses in compliance are found, the covered entity has an opportunity to address them. If lapses in compliance are found during an HHS audit, the covered entity may be fined – even if there has been no unauthorized use or disclosure of PHI. Because of the risk of a financial penalty for non-compliance, the cost of a third party audit can be a sound investment.

What is the cost of a third party compliance audit?

The cost of a third party compliance audit depends on the size of the covered entity or business associate and the nature of activities. For example, the cost of a third party audit for a major healthcare group is going to be significantly more than the cost to a sole-trader insurance broker who handles a limited number of healthcare claims each year.

How long does HIPAA certification for covered entities and business associates last?

HIPAA certification for covered entities and business associates does not “last”. A HIPAA certification indicates that a covered entity or business associate has passed a third-party company´s HIPAA compliance program and “at that point in time” was HIPAA compliant. As soon as that point in time has passed, a HIPAA certification is no guarantee of compliance. As a result, HIPAA certification has no lifespan and it is a best practice is to conduct regular compliance audits.

How long does HIPAA certification for healthcare workers last?

How long HIPAA certification for healthcare workers lasts depends on whether the certification has been achieved independently or as part of an employer’s training program. If the former, the “point in time” principle applies. If the latter, the certification should be retained for six years in compliance with the HIPAA documentation requirements. It is also recommended refresher training is provided at least annually.

How does HIPAA certification help foster patient trust?

HIPAA certification helps foster patient trust because one of the most important elements of a patient/healthcare professional relationship is trust. When patients are confident their privacy is being respected, this will help foster trust – which contributes to the delivery of better care in order to achieve optimal health outcomes. Better patient outcomes raise the morale of healthcare professionals and result in more rewarding work experience.

Why might a healthcare professional lack knowledge of HIPAA?

A healthcare professional might lack knowledge of HIPAA because covered entities are only required to provide training relevant to a healthcare professional’s role. When a healthcare professional transfers to a new role – or is asked to substitute for a colleague in a different role – they may not immediately have the level of HIPAA knowledge relevant to the role they are performing, potentially resulting in unintentional HIPAA violations.

How are cultural norms of noncompliance allowed to develop?

Cultural norms of non-compliance are allowed to develop in the workplace because many covered entities lack the resources to monitor HIPAA compliance 24/7. It is not unusual for busy healthcare workers to take shortcuts with HIPAA compliance “to get the job done”; and, if the shortcuts become a regular occurrence, they develop into a cultural norm of noncompliance. This is why it is important for covered entities to provide refresher HIPAA training at least annually.

What does HIPAA certification signify?

HIPAA certification signifies that an organization has passed a HIPAA compliance audit. Although this may only be a point in time accreditation, the certification demonstrates the organization has effectively implemented HIPAA’s privacy provisions and security standards. Alternatively, a HIPAA certification for an individual can signify that a member of the workforce has achieved the level of HIPAA knowledge required to comply with the organization’s policies and procedures.

Is certification a requirement of HIPAA?

Certification is not a requirement of HIPAA. It is a voluntary process that organizations can undertake to validate their understanding and implementation of HIPAA’s regulations. Indeed, preparing for certification can help organizations fine-tune risk analyses to better identify gaps in compliance and make better informed decisions about how to fill the gaps.

What are the benefits of becoming HIPAA certified?

The benefits of becoming HIPAA certified include that the process of certification can help organizations adopt best privacy practices and implement the safeguards required by the HIPAA Security Rule. This can reduce the likelihood of HIPAA violations and data breaches. Also, if a violation does occur, certification may demonstrate “a reasonable amount of care” to abide by the rules, which could impact the severity of penalties.

How can HIPAA certification affect the penalties for HIPAA violations?

HIPAA certification can impact the penalties for HIPAA violations significantly if – for example – an organization that is certified experiences a HIPAA violation, and HHS’ Office for Civil Rights investigates the violation. A HIPAA certification demonstrates a good faith effort to comply with HIPAA. This could influence the decision about whether a violation is classified as a Tier 1 or Tier 2 violation, affecting the minimum penalty per violation – if a penalty is imposed at all.

Why might business associates find it beneficial to obtain HIPAA certification?

Business associates might find it beneficial to obtain HIPAA certification to demonstrate the intention to operate compliantly, making their services more appealing to prospective covered entities in a crowded marketplace. Also, if a business associate has achieved HIPAA certification, it may reduce the amount of due diligence required before a covered entity will enter into a Business Associate Agreement.

What are the key areas of compliance that are reviewed for a covered entity to be certified as HIPAA compliant?

The key areas of compliance that are reviewed for a covered entity to be certified as HIPAA compliant include adherence to the HIPAA Security Rule’s administrative, technical, and physical safeguards; remediation plans for gaps identified in audits; policies and procedures for regulatory compliance; employee training; documentation management; Business Associate Agreement management; and incident management procedures for data breaches or violations.

How do HIPAA certification requirements differ for business associates compared to covered entities?

HIPAA certification requirements differ for business associates compared to covered entities by being tailored to the services being offered to or on behalf of covered entities. A key point is that business associates must implement a security and awareness training program for all members of the workforce, not just those involved in services being offered to or on behalf of covered entities.

What are the benefits of HIPAA certification for healthcare workers?

The benefits of HIPAA certification for healthcare workers are that healthcare workers achieve a deeper understanding of HIPAA beyond the basic “policy and procedure” training provided by employers. This comprehensive education covers frequently violated standards like patients’ rights, the minimum necessary standard, and allowable uses and disclosures – helping to prevent unintentional violations due to lack of knowledge.

How long does it take to achieve HIPAA certification?

The length of time it takes to achieve HIPAA certification can vary widely and is difficult to predict without knowing the level of knowledge that each organization or individual is starting from, the gaps that might be identified during audit processes and the nature of the remediation plans required to address them. The process involves thorough several audits and tests, and cannot be completed overnight.

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