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The Impact of Proposed Changes to the HIPAA Security Rule for Business Associates

Posted by Steve Alder

A final rule updating the HIPAA Security Rule is due for release as early as May 2026. According to HHS/OCR, the modifications to the Security Rule will improve cybersecurity in the health care sector by strengthening requirements to safeguard electronic protected health information to prevent, detect, contain, mitigate, and recover from cybersecurity threats. In Spring 2025, OCR released a timetable suggesting a May 2026 release, although the final rule will likely be delayed. If OCR opts to release a final rule implementing all changes proposed in its January 2026 Notice of Proposed Rulemaking (NPRM), it will have a major impact on business associates of HIPAA-covered entities.

For more than two decades, the HIPAA Security Rule has set a baseline for cybersecurity to safeguard electronic protected health information (ePHI). Prior to its release in 2003, there were no standards for cybersecurity, although at the time, adoption of electronic health records was far from widespread. The standards of the HIPAA Security Rule have helped to ensure that ePHI, and the systems used to store, process, and transmit that information, have appropriate safeguards to protect against unauthorized access; however, standards that were reasonable and appropriate in the early 2000s are no longer sufficient to protect against the barrage of attacks from nation-state actors and cybercriminals, the increasing sophistication of intrusion and lateral movement techniques, and the emerging threat of AI-assisted attacks.

New Mandatory Cybersecurity Rules for HIPAA Business Associates

For the past few years, more than 700 large healthcare data breaches have been reported each year, a large proportion of which occurred at business associates of HIPAA-covered entities. To address the cybersecurity weaknesses routinely being exploited by threat actors, OCR proposed two sets of voluntary healthcare-specific cybersecurity performance goals (CPGs): essential and enhanced. The CPGs consist of high-impact measures to strengthen cybersecurity, and healthcare organizations were encouraged to adopt the essential CPGs and then mature their cybersecurity programs by adopting the enhanced cybersecurity goals.

When OCR released the CPGs, it was made clear that they were a precursor to mandatory new cybersecurity measures. The NPRM- HIPAA Security Rule To Strengthen the Cybersecurity of Electronic Protected Health Information was published by OCR in the Federal Register on January 6, 2025. Since then, OCR has been reviewing the extensive feedback it received.

The Security Rule update was proposed in response to increased cyberattacks, evolving healthcare delivery environments, and the common deficiencies identified by OCR during its compliance investigations. If a final rule is issued, it will be the first major update to the HIPAA Security Rule in more than two decades. In its proposed form, business associates will be required to make substantial changes to their cybersecurity and compliance programs. Proposed rules typically have a compliance deadline of approximately 240 days (8 months). If released per OCR’s proposed timetable, compliance will likely be required as early as Q1, 2027.

There are extensive new Security Rule requirements for business associates, which will be time-consuming and potentially costly to implement. These are not changes that can be implemented overnight or in a few weeks. The changes will require extensive planning, implementation, validation, and detailed documentation. Business associates should be proactive and assess where their current security program falls short, rather than wait until the final rule is issued.

Regulated Entities Must Implement All Security Rule Implementation Specifications

Changes have been made to the language of the HIPAA Security Rule, introducing the term HIPAA-regulated entities for covered entities and business associates to improve consistency. OCR has eliminated the distinction between “addressable” and “required” implementation specifications. The removal of “addressable” implementation specifications means covered entities and business associates will be required to comply with all implementation specifications. Together with the more prescriptive cybersecurity requirements, substantial changes will need to be made to security and compliance programs.

The current HIPAA Security Rule is scalable, flexible, and technology-neutral, whereas the proposed rule is more prescriptive and testable, with operationalized cybersecurity requirements. The proposed Security Rule introduces a host of new cybersecurity requirements, and while there are limited exceptions, some requirements are risk-based and only apply to systems containing ePHI, regulated entities will have to make significant changes to their cybersecurity programs. New requirements include encryption of all ePHI at rest and in transit, multifactor authentication across all systems, continuous monitoring of systems for anomalous activity, vulnerability scanning, penetration testing, more prescriptive patch management requirements, configuration management, anti-malware protections, network segmentation, and annual testing of technical controls.

The HIPAA Security Rule requires business associates to provide security awareness training under 45 CFR § 164.308(a)(5), Standard: Security Awareness and Training. This requirement applies to all workforce members with access to IT systems, not only staff who use or disclose PHI. Security awareness training is focussed on cybersecurity training and is separate from, and in addition to, HIPAA training for Business Associates on Privacy Rule, Breach Notification Rule, and organizational policy requirements. The proposed HIPAA Security Rule changes are not expected to change the existing security awareness training requirements.

More Detailed and Prescriptive Business Associate Risk Analysis Requirements

Certain requirements, such as the risk analysis, have more detailed and prescriptive requirements. Under the current regulations, business associates are required to periodically conduct a risk analysis to identify risks and vulnerabilities to ePHI, following any significant change to technology, software, hardware, or business practices, and after a security incident.

The proposed rule requires a risk analysis to be conducted at least annually. The risk analysis must identify and assess all risks and vulnerabilities to all systems, devices, applications, environments, and services that collect, receive, maintain, store, transmit, or touch ePHI. The risk analysis must cover risks associated with subcontractors, service providers, cloud environments, and integrated technologies, and must feed into contingency planning, disaster recovery, and downtime operations planning.

The risk analysis must cover all ePHI in the business associate’s possession, not just the ePHI created or received on behalf of a covered entity, including ePHI from multiple clients and ePHI maintained in shared systems. Before a HIPAA-compliant risk analysis can be conducted, the business associate must identify all systems, devices, applications, services, and environments where ePHI is created, received, maintained, or transmitted. That information must be maintained in a comprehensive, accurate, and up-to-date asset inventory.

The risk analysis must be a formal, fully documented, and repeatable process, aligned with recognised cybersecurity practices. It must be regularly updated to reflect changes in the healthcare environment, evolving threats, and new technologies, and be repeated when systems, subcontractors, business practices, technology, and threat conditions change. This update moves the risk analysis from what is often viewed, albeit incorrectly, as a one-time event to a continuous process. Everything must be documented in detail, including the methodology, identified risks, rationale for risk ratings, mitigation decisions, and residual risks, with written verification of the completeness of the risk analysis and implemented safeguards by qualified personnel.

Greater Oversight of Vendors by HIPAA-Covered Entities

Risks must be subjected to a risk management process, and while that has not changed, specific, documented mitigation plans need to be developed and prioritized for all risks, with remediation measures tracked through to completion. There will be greater oversight of business associates by covered entities. Previously, covered entities were required to obtain satisfactory assurances of HIPAA Security Rule compliance, such as by obtaining a signed business associate agreement.  The updated Security Rule requires safeguards to be verified by a covered entity through annual written verification from the business associate.

That means business associates must maintain detailed documentation of all compliance efforts, including their risk analysis methodology and results, the mitigations implemented, and the administrative, physical, and technical safeguards implemented to reduce risks to a reasonable and appropriate level, plus any residual risks that have yet to be addressed.  Safeguards must be reassessed and reverified every year.

In the event of a security incident involving ePHI, the HIPAA Breach Notification Rule requires business associates to notify each affected covered entity within 60 days; however, the updated HIPAA Security Rule requires covered entities to be notified within 24 hours of an emergency or other occurrence affecting their electronic information systems and the activation of contingency plans. Business associates must also have a plan for restoring access to critical systems. That means business associates are likely to face increased scrutiny of their breach response and will need to provide regular updates to their covered entity clients.

The expansion of requirements for business associates will require updates to current business associate agreements to include the new obligations. HIPAA-covered entities will need to incorporate the new HIPAA Security Rule requirements into their business associate templates, assess whether their current business associates meet the new requirements, and, if not, ensure that they have a viable plan to implement the required changes on time.

Comparison of Requirements of Current vs. Proposed Security Rule

Compliance Area Post HITECH Act – HIPAA Security Rule Requirement Proposed HIPAA Security Rule Requirement
Applicability Business associates were directly subject to the Security Rule, with certain obligations operationalized through business associate agreements. Introduction of the term “HIPAA Regulated Entities.” Obligations of business associates are identical to those of covered entities, eliminating any interpretative discrepancies.
Implementation Specifications Distinction between required and addressable implementation specifications Elimination of distinction – All implementation specifications are required for compliance.
Asset Inventory No requirement for an asset inventory. Business associates must create and maintain a comprehensive and accurate technology asset inventory, on which the risk analysis will be based, complete with network/ePHI movement maps.
Risk Analysis Business Associates required to conduct an accurate and thorough assessment of risks and vulnerabilities to ePHI. Risk assessments required periodically, and in response to material changes to systems, technology, and workflows Explicit requirements for risk analysis methodology, which must be formal, repeatable, and documented. Must cover the entire ePHI ecosystem, with specific expectations for content. Must cover risks associated with subcontractors, vendors, cloud platforms, shared systems, service providers, and supply chains. Risk analyses must be conducted at least annually, and methodologies must be updated in response to changes to systems, vendors, threat conditions, and changing operational practices. Extensive documentation requirements, including methodology, analysis, mitigations, and residual risks. The risk analysis and safeguards must be documented and performed by qualified personnel, with written verifications required.
Administrative Safeguards: Standard: Evaluation Periodic technical and nontechnical evaluation in response to environmental or operational changes affecting the security of ePHI Consistent methodology required, with an emphasis on recurring testing, technical reviews, vulnerability scanning, and documented reassessments, including in response to emerging threats and operational/environmental changes. Extensive documentation requirements for analyses and mitigations.
Technical Safeguards Technologies and configurations not specified. Left to the discretion of the business associate, with some addressable requirements. Specific cybersecurity measures mandated: Encryption of all ePHI at rest and in transit (with limited exceptions) aligned with current best practices; implementation of multi-factor authentication across all systems; continuous monitoring of systems for anomalous activity; vulnerability scanning and penetration testing; prescriptive patch management requirements and timelines; configuration management; backup restoration timing requirements; anti-malware protections, network segmentation; access control specifications; mandatory creation of audit and access logs; and periodic testing of technical controls.
Compliance Audits and Testing Perform a periodic technical and nontechnical evaluation to establish the extent to which policies and procedures meet Security Rule requirements. Annual risk analyses, verification of safeguards, testing of contingency plans, and vulnerability scanning and penetration testing.
Physical Safeguards Physical measures, policies, and procedures to protect a regulated entity’s electronic information systems and related buildings and equipment. Minor requirements for physical safeguards, including workstation management and facility access.
Workforce Access Management Ensure that all members of its workforce have appropriate access to ePHI. Flexible and technology neutral, without prescriptive standards or review frequencies. Expanded requirements for access provisioning, termination procedures, privilege management, minimum necessary access, and periodic reviews of access provisions.
Administrative Safeguards: Business associate contracts Covered entities must obtain satisfactory assurances that the business associate will appropriately safeguard ePHI, typically achieved through business associate agreements. Covered entities must verify that a business associate has implemented the required technical safeguards. The business associate must provide the necessary documentation to prove compliance.
Contingency Planning Must establish data backup, disaster recovery, and emergency operational plans. No requirement to report activation of contingency plans. Formalized incident response plans required, with defined roles and responsibilities, incident classification, response timelines, post-incident analysis, and detailed documentation requirements. Required criticality analysis, maintenance of exact backup copies, restoration testing, and restoration of critical systems and data within the specified timeframes. Business associates must report emergencies involving electronic information systems and activation of contingency plans to covered entities within 24 hours.
Documentation Policies, procedures, and analysis documentation must be retained for 6 years, with no specified requirements for format. Business associate must maintain structured, granular documentation of risk analyses, verify safeguards, risk mitigations, contingency plan reporting, cybersecurity training, third-party risk assessments, logs of system activity, and continuous monitoring. OCR will require documentation to be produced in data breach/complaint investigations and compliance reviews.
Security Incident Procedures Must identify, respond to, and mitigate harm from security incidents. Formal incident response plan required with testing requirements, and workforce reporting procedures. Adds expectation for timely notifications to appropriate regulated entities when shared systems or data are impacted.
Vendor and supply chain risk management As stipulated in business associate agreements Formal requirement for downstream vendor oversight and the assessment and management of risks associated with vendors and subcontractors. Analyses and mitigations must be fully documented for audit purposes
Business associate agreements – Business associate agreements must be updated to reference the new requirements. Covered entities require annual written verifications of technical safeguards, validated by qualified cybersecurity personnel.
CyberSecurity Training CFR § 164.308(a)(5), Standard: Security Awareness and Training. Business associated agreements can be expected to include cybersecurity training for business associates.
Enforcement There has been increased enforcement in 2026. Business associates may face increased liability for compliance failures. The proposed rule has more prescriptive standards that should aid enforcement by reducing interpretive flexibility.

When and If a Final Rule Will Be Issued

The proposed HIPAA Security Rule update significantly raises the cybersecurity bar for all HIPAA-regulated entities. Any business associate that can demonstrate that they have implemented a rigorous and well-documented risk analysis, all new safeguards, and have mitigated third-party risks will be in an ideal position to comply with the final rule when it is issued, and will be perfectly positioned to attract new healthcare clients.

When the HHS published its regulatory agenda for the year, the May release date was not set in stone. The proposed rule was delayed by several months, and the same may happen to the final rule, especially if the decision is made to severely cut back on its requirements. How long a delay is impossible to predict, as OCR is keeping its cards close to its chest. There is a possibility that the final rule may not be issued, as the Trump administration is pro-deregulation; however, the current state of healthcare cybersecurity and the volume of cyberattacks and data breaches being reported each month mean something needs to be done.

In my opinion, a final rule will be issued, and many of the core requirements will be retained, especially the new risk analysis requirements. It is therefore in the best interests of all business associates to start preparing for that release by reviewing their current security measures and planning, organizationally and financially, for Security Rule changes. While the final rule could differ substantially from the proposed rule, the core elements of the proposed rule are unlikely to change. The best place for business associates to start is with a gap analysis to determine how current security measures stack up against the proposed new HIPAA Security Rule standards, to ensure they can hit the ground running when the final rule is released and be fully compliant ahead of the enforcement date.

Steve Alder, Editor-in-Chief, HIPAA Journal

The post The Impact of Proposed Changes to the HIPAA Security Rule for Business Associates appeared first on The HIPAA Journal.

What is HIPAA Certification For Healthcare Vendors?

Posted by Ian

This post still to be written: HIPAA certification is the process in which an independent third party organization audits a vendor to certify and confirm that the physical, technical, and administrative safeguards required for HIPAA compliance have been met, with the award of a formal document that signals the completion of a HIPAA compliance process.

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.

Why Organizations Get Certified As Being HIPAA Compliant?

The first reason for getting certified is that, in order to achieve an accreditation, organizations will have to adopt best privacy practices and implement the administrative, technical, and physical safeguards of the HIPAA Security Rule. This in itself will reduce the likelihood of HIPAA violations and data breaches – leading to a reduction in patient complaints and OCR investigations.

If – despite achieving an accreditation – a violation still occurs that results in an OCR investigation, a certificate of HIPAA compliance demonstrates “a reasonable amount of care to abide by the HIPAA Rules”. This can be the difference between a HIPAA violation being classified as a Tier 1 violation (minimum penalty per violation $141) and a Tier 2 violation (minimum penalty per violation $1.424).

For business associates, and covered entities that act as business associates for other covered entities, HIPAA certification demonstrates an intention to operate compliantly – making an organization’s services more attractive and reducing the amount of due diligence required before a covered entity and business associate enter into a Business Associate Agreement.

HIPAA Certification Requirements for Covered Entities

In order for a covered entity to be certified as HIPAA compliant, third-party compliance experts will review seven areas of compliance:

  • Compliance with the administrative, technical, and physical safeguards of the HIPAA Security Rule. This includes (but is not limited to), an asset and device audit, an IT risk analysis questionnaire, a physical site audit, a security standards audit, a privacy standards audit, and HITECH Subtitle D privacy audit.
  • Remediation plans to address gaps identified in the above audits.
  • Policies and procedures to address HIPAA regulatory compliance and document a “good faith” effort towards compliance.
  • An employee training program that includes employee understanding of the above policies and procedures.
  • A documentation audit to ensure the documentation required by HIPAA is maintained and accessible.
  • Business Associate Agreement management and due diligence procedures.
  • Incident management procedures in the event of a data breach or reportable violation of HIPAA.

Because of the processes involved in auditing compliance with the HIPAA Security Rule, the HIPAA certification requirements cannot be fulfilled overnight. It is also impossible to put a timeframe on how long it may take to achieve HIPAA certification without knowing what gaps might be identified during the audit processes and the nature of the remediation plans required to address them.

HIPAA Certification Requirements for Business Associates

The HIPAA certification requirements for business associates are much the same as above but tailored to the nature of services provided for covered entities. One important point to note is that 45 CFR § 164.308 stipulates a security and awareness training program must be implemented for all members of the workforce – not just those involved in the provision of a service to a covered entity. It is common for potential business associates of HIPAA covered entities to undergo audits by third party HIPAA compliance companies in order to confirm that their products, services, policies, and procedures meet HIPAA standards. The audits are useful for covered entities’ peace of mind as they confirm HIPAA compliance at the time the audit was conducted.

However, for business associates unfamiliar with the far-reaching complexities of HIPAA, it is likely they will require help to become compliant. For this reason, it can be important to select a third-party HIPAA compliance company that not only offers HIPAA certification services, but also helps business associates implement effective HIPAA compliance programs.

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.

The post What is HIPAA Certification For Healthcare Vendors? appeared first on The HIPAA Journal.

HIPAA Compliance for Business Associates

Posted by Steve Alder

HIPAA compliance for business associates has acquired greater significance since the publication of proposals to align the HIPAA Security Rule more closely with HHS’ Healthcare Sector Cybersecurity Strategy – among which is a requirement for covered entities to obtain verifications from business associates that they have implemented measures to protect electronic Protected Health Information.

The implication of this requirement – if finalized – is that covered entities will only be permitted to contract services from business associates that can demonstrate compliance with HIPAA. However, demonstrating compliance with HIPAA is not straightforward for many business associates because what HIPAA compliance for business associates consists of can vary considerably depending on the type of service provided to or on behalf of a covered entity.

Despite the variety of compliance requirements, some areas of HIPAA compliance are common to all business associates. Business associates that can demonstrate compliance with these common areas via independent certification are likely to have a competitive advantage against other service providers to the healthcare industry. This article explains what these common areas of compliance are and what business associates need to do to comply with HIPAA.

What is a HIPAA Business Associate?

A HIPAA business associate is an organization, or a person who is not a member of a covered entity’s workforce, that provides services to or on behalf of a covered entity which enable the business associate to have “persistent access” to Protected Health Information (PHI). Examples of HIPAA business associates include medical billing service providers, software providers (including Managed Service Providers), and accreditation organizations with access to PHI.

There are exceptions to this definition of a HIPAA business associate. Some providers of healthcare and payment services, and organizations or persons for whom access to PHI is incidental or transient, do not qualify as HIPAA business associates. Researchers also do not qualify as HIPAA business associates when PHI is disclosed for research because the purpose of the disclosure is not regulated by the HIPAA Administrative Simplification Regulations.

When an organization or person qualifies as a HIPAA business associate, they are required to comply with all applicable standards, requirements, and implementation specifications of the HIPAA Administrative Simplification Regulations. Each HIPAA business associate must determine which standards, requirements, and implement specifications are applicable to the service being provided, and implement policies, procedures, and other measures as necessary.

Why HIPAA Compliance for Business Associates is Important

When the HIPAA Privacy Rule was published in 2002, covered entities were required to obtain “satisfactory assurances” HIPAA business associates would only use PHI disclosed to them for the purposes of the service being provided, would safeguard the information from misuse, and would help the covered entity comply with some of their HIPAA Privacy Rule obligations by providing a service that enabled the covered entity to carry out its functions compliantly.

However, until the passage of the HITECH Act in 2009, HIPAA business associates could not be held accountable for the failure to uphold their satisfactory assurances. The HITECH Act made HIPAA business associates and their downstream subcontractors directly liable for compliance with certain requirements of the HIPAA Rules. The direct liability of HIPAA business associates and downstream subcontractors was codified in the HIPAA Omnibus Final Rule in 2013.

“Where provided, the standards, requirements, and implementation specifications adopted under this subchapter apply to a business associate.” (§160.102(b))

More recently, The Department of Health and Human Services (HHS) published a Notice of Proposed Rulemaking in January 2025 which, when finalized, will require covered entities to obtain written verifications from their HIPAA business associates that each HIPAA business associate has deployed and is operating technical safeguards that protect the confidentiality, integrity, and availability of PHI maintained on electronic information systems.

As the Notice of Proposed Rulemaking has the objective of aligning the HIPAA Security Rule with HHS’ Cybersecurity Performance Goals, and as compliance with HHS’ Cybersecurity Performance Goals may also become a condition of participation in Medicare and Medicaid, verifiable HIPAA compliance for business associates may soon become a condition for providing services to or on behalf of covered entities in the healthcare industry.

The Responsibilities of HIPAA Business Associates

The responsibilities of HIPAA business associates are much the same as they were in 2002 – only use PHI for the purposes of the service being provided, safeguard the information from misuse, and support the covered entity’s functions by providing a HIPAA compliant service. HIPAA business associates may use PHI for internal management and administration purposes, but there must be a documented chain of custody if PHI is disclosed to downstream subcontractors.

How HIPAA business associates fulfil their responsibilities depends on their existing status. For example, a software provider that wants to break into the healthcare market may only now be starting their journey to HIPAA compliance, while a Managed Service Provider with existing healthcare clients may already be fulfilling some responsibilities of HIPAA business associates – but not all – and may need to review and revise its operations to achieve full HIPAA compliance.

For the benefit of organizations and persons starting their journeys to HIPAA compliance, this article focuses on the common areas of HIPAA compliance for business associates from start to finish. Existing HIPAA business associates can use this article to identify gaps in compliance activities, while those with additional or uncommon HIPAA compliance responsibilities should seek advice from an independent compliance professional.

The Basics

Do You Qualify as a HIPAA Business Associate?

The first thing to determine is whether the service being provided qualifies you as a HIPAA business associate or subcontractor. If the service does not involve disclosures of PHI by a covered entity or upstream business associate, if disclosures of PHI are incidental or transient, or if the service is exempted under the HIPAA definition of a business associate, it is not necessary to comply with HIPAA (although other privacy and security regulations may apply).

Are disclosures of PHI involved?

Examples of when a service does not involve disclosures of PHI by a covered entity to a third party include when an organization provides email services to a healthcare provider, but the healthcare provider does not use email service to send, receive, or store PHI. Alternatively, an organization could provide software for an on-premises email server, but the organization does not have access to PHI sent, received, stored, or transmitted by the on-premises email server.

Are disclosures of PHI incidental?

Incidental disclosures of PHI are usually considered to be disclosures secondary to permitted disclosures of PHI that cannot reasonably be prevented. In the context of HIPAA compliance for business associates, incidental disclosures are when a third party whose services do not ordinarily involve uses and disclosures of PHI has unintended access to PHI. Examples could include a landscape gardener who recognizes a patient in the garden of a nursing home.

Is access to PHI transient?

Transient disclosures of PHI are disclosures to transmission-only services that do not have repeated or routine access to PHI. Example of third parties that do not qualify as a HIPAA business associate because their access to PHI is transient include the US Postal Service and other private couriers such as Fed-Ex, UPS, and DHL. Internet Service Providers also do not qualify as HIPAA business associates when they are used for transmission purposes only.

Is the service exempted?

Several types of services are exempted from qualifying as HIPAA business associates when the service being provided on behalf of a covered entity is for the treatment of a patient (i.e., medical specialists, laboratories, etc.) or for payment processing. However, the exemption for payment processing only applies to financial institutions providing their “normal” services for customers – not to developers and vendors of payment processing applications.

If You Qualify as a HIPAA Business Associate … …

If you qualify as a HIPAA business associate, there are several activities you must undertake before providing a service for or on behalf of a covered entity. The first is to appoint a HIPAA Privacy Officer and a HIPAA Security Officer. The HIPAA Privacy Officer is responsible for ensuring compliance with all applicable HIPAA Administrative Simplification Requirements, while the HIPAA Security Officer is responsible for implementing the HIPAA Security Rule Safeguards.

Both roles can be outsourced, designated to existing employees, or – in smaller organizations – designated to the same employee. However, other than in exceptional circumstances, it is important to appoint both roles. It is rare that HIPAA compliance for business associates can be accomplished complying solely with the requirements of the HIPAA Security Rule. In most cases a more holistic approach to HIPAA compliance for business associates is necessary.

Business Associate Agreements

Before any PHI is disclosed to a HIPAA business associate, upstream covered entities must enter into a HIPAA Business Associate Agreement with the business associate. The Agreement establishes the permissible uses and disclosures of PHI by the business associate, how the business associate will respond to patients exercising their HIPAA rights, and responsibility for reporting disclosures of PHI not permitted by the Agreement, security incidents, and data breaches.

If your organization (as a HIPAA business associate) is using a service provided by a third party subcontractor (i.e., Microsoft 365) in the provision of the service to the covered entity, and PHI will be disclosed to the downstream subcontractor, your organization must also enter into a Business Associate Agreement with the downstream subcontractor. Some subcontractors (i.e., Microsoft) have a standard Business Associate Agreement that your organization must agree to.

Why Business Associate Agreements are Important

Determine which standards apply

Determining which standards of HIPAA apply to a service is one of the most complicated areas of HIPAA compliance for business associates. This is because, while most business associates are aware the service has to comply with the Administrative, Physical, and Technical Safeguards of the HIPAA Security Rule, many overlook the Security Rule’s General Requirements – including the requirement to:

“Protect against any reasonably anticipated uses or disclosures [of PHI] that are not permitted or required under subpart E of this part (the HIPAA Privacy Rule).” (§164.306(a))

In addition to being aware of which uses and disclosures of PHI are permitted by the HIPAA Privacy Rule – and in what circumstances – and implementing policies and procedures to prevent violations of the HIPAA Privacy Rule, business associates may also have to prepare for individuals exercising their HIPAA rights and security incident notifications – the responsibility for which may be subject to the terms of upstream and downstream Business Associate Agreements.

Map the flow of PHI in all formats

One of the factors that can affect which standards of HIPAA apply is how PHI is created, received, maintained, or transmitted by the organization. For example, if PHI is received verbally, written down, and then transferred to an electronic system for storage, it will be necessary to have procedures in place to compliantly dispose of the media on which the PHI was written down as well as the final disposition of PHI stored on the electronic system.

Mapping the flow of PHI in all formats will also enable HIPAA business associates to determine when an individual’s consent or authorization is required prior to further disclosing PHI (for example, Substance Use Disorder records), or when an attestation is required from the recipient of PHI that the information will not be used to investigate or impose liability on any person for the mere act of seeking, obtaining, providing, or facilitating lawful reproductive health care.

Conduct Risk Analyses

Determining which HIPAA standards apply and mapping how PHI flows through the organization will help HIPAA business associates better prepare for a risk analysis – a process required by the HIPAA Security Rule, but also potentially necessary for PHI in all formats depending on the nature of the service(s) being provided to a covered entity. HIPAA risk analyses should be based on guidance published by HHS and adjusted as necessary to accommodate uncommon circumstances.

Identify and document potential vulnerabilities and threats to PHI

Business associates are required to identify and document vulnerabilities which, if triggered by a reasonably anticipated threat, would create a risk of unauthorized access to – or disclosure of – PHI. All vulnerabilities and reasonably anticipated threats from both internal and external sources must be documented.

Assess the capabilities of existing policies and security measures

Most organizations will already have some policies and security measures in place to support HIPAA compliance for business associates. However, business associates should assess whether the existing policies and security measures are sufficient to reduce identified vulnerabilities and risks to a reasonable and appropriate level.

Determine the likelihood and impact of a threat occurrence

It is not possible to eliminate all risks to the confidentiality, integrity, and availability of PHI, but by determining the likelihood and impact of a threat occurrence, HIPAA business associates should be able to prioritize which vulnerabilities should be addressed either by implementing additional technical safeguards or the provision of workforce training.

Determine the level of risk and potential consequences

Determining the level of risk to PHI and the potential consequences of a data breach will help HIPAA business associates with the development of contingency plans, data backup plans, and emergency mode operation plans (as required by the Administrative Safeguards) to ensure the availability of covered entities’ PHI during a HIPAA security incident

Implement additional policies and security measures as required

If existing policies and security measures are not sufficient to reduce identified vulnerabilities and risks to a reasonable and appropriate level, business associates are required to implement additional policies and security measures as required, and document the reasons for them based on the previous steps in the risk analysis process.

Reassess periodically and in response to a regulatory or operational change

A risk analysis is required every time there is a change in regulations or work practices, and when new technology is implemented. If none of these events occur, HIPAA business associates must still perform a periodic technical and non-technical evaluation to ensure policies and security measures remain effective and in compliance with HIPAA.

Common Safeguards

Because business associates must implement administrative, physical, and technical safeguards based on the outcome of a risk analysis, there is no one-size-fits-all guidance for what safeguards must be implemented in order to accomplish HIPAA compliance for business associates. Nonetheless, there are several common safeguards that must be implemented in order for HIPAA business associates to comply with HIPAA.

Physical security

Secure locations in which PHI in all formats is stored and restrict physical access to systems on which PHI is maintained. It may also be necessary to secure workstations and other devices or media which can access PHI depending on whether PHI is stored locally on the workstations, devices, and media, and what other technical safeguards exist to prevent unauthorized access.

Unique user IDs

Although HIPAA does not stipulate password requirements, business associates are required to assign unique user IDs for all members of the workforce. If user IDs consist of a username and password, it is important to enforce the use of strong passwords and be conscious that the mandatory use of MFA is included in the proposed update to the HIPAA Security Rule.

Minimum Necessary

Other than in exempted circumstances, uses and disclosures of PHI must be limited to the minimum necessary to fulfil the purpose of a use or disclosure. This means assigning different access permissions to systems depending on their functions, and different access permissions to workforce members depending on their roles.

Maintain audit logs

One of the purposes of assigning unique user IDs is to create audit logs and monitor access to PHI by workforce members. For this reason, it is important workforce members are instructed not to share login credentials with other members of the workforce. The audit logs should also monitor access to PHI by applications and be configured to flag anomalies that could indicate unauthorized access.

Workforce training

A common issue with HIPAA compliance for business associates is that the security awareness training provided by business associates is generic. According to the General Requirements of the HIPAA Security Rule, workforce training must be designed to protect against reasonably anticipated uses or disclosures of PHI not required or permitted by the HIPAA Privacy Rule.

Sanctions Policy

Business associates are required to apply sanctions against workforce members for any violation of the HIPAA Privacy Rule or for any violation of a policy implemented by the business associate to comply with the HIPAA Security Rule. Business associates that do not have, do not explain, or do not enforce a sanctions policy are themselves in violation of HIPAA.

Incident Management Preparation

According to §164.304 of the HIPAA Security Rule, the definition of a HIPAA security incident is any “attempted or successful unauthorized access, use, disclosure, modification, or destruction of information or interference with system operations in an information system.” The reason that unsuccessful security incidents must be monitored is to identify trends in failed access attempts in order to identify future potential risks to the security of PHI.

System configurations

In order to monitor unsuccessful security incidents, systems should be configured where it is possible to automatically detect and log events such as unsuccessful brute force attacks on log-in credentials, pings, and scans looking for undefended network ports. Anti-virus software and email systems should also be monitored for increasing volumes of detected malware and spam emails.

Reporting procedures

Procedures should also be developed for members of the workforce to report incidents that have evaded detection by security software or that have resulted from their own actions. In some cases, it can be beneficial to implement a system that facilitates anonymous reports to ensure that workforce members report an incident before it develops into a more serious event.

Incident management plan

Business associates must develop an incident management plan that includes incident monitoring, tracking, handling, and response for each type of incident. The plan must be documented and include the procedures for determining whether an incident is notifiable to an upstream covered entity. This can depend on the content of the Business Associate Agreement.

Incident preparedness testing

The incident management plan must be tested periodically for each type of incident and revised as necessary if vulnerabilities are discovered or if an analysis of detected unsuccessful security incidents identifies an increasing incident type. It may also be necessary to test workforce members on their abilities to identify and report incidents using a safe or sandboxed environment.

Procedures for receiving notifications

If a HIPAA business associate uses services provided by a downstream subcontractor, and the Business Associate Agreement with the downstream subcontractor specifies the business associate must be notified of security incidents and data breaches, the business associate must have procedures in place for receiving notifications (i.e., a point of contact, the method of notification, etc.).

Procedures for making notifications

Procedures must also be in place for notifying upstream covered entities when a HIPAA security incident or data breach occurs. Depending on the content of the Business Associate Agreement with the upstream covered entity, it may also be necessary to have procedures in place to notify affected individuals and HHS’ Office for Civil Rights in the event of a data breach.

Documentation and Reviews

One of the most important elements of HIPAA compliance for business associates is documentation. The accurate documentation of how PHI flows through the organization, risk analyses, and policies and procedures to support HIPAA compliance are essential. It is also important that all HIPAA training is documented as well as any sanctions imposed for violations of HIPAA. Business Associate Agreements and breach notifications must also be documented.

Organized documentation implies operational efficiency, which can help build trust in upstream covered entities. Organized documentation also makes it easier to keep on top of periodic reviews and evaluations. In addition, although documentation alone will not absolve a business associate from liability in the event of an avoidable HIPAA violation, organized documentation provides visible evidence of a business associate’s good faith effort to be HIPAA compliant.

It is important for certain documents to be reviewed periodically (risk analyses, incident management plans, etc.). However, HIPAA documentation is not the only regulatory requirements business associates may have to comply with and it is advisable to implement a policy management platform that not only manages HIPAA documentation and reviews, but also other documentation required by other federal and state agencies (i.e., OSHA, CMS, etc.).

The Strategic Advantage of HIPAA Compliance for Business Associates

HIPAA compliance is often seen as a legal obligation, but for business associates, it can also serve as a strategic advantage. By embracing HIPAA standards, demonstrating a commitment to safeguarding PHI via independent certification, and aligning HIPAA compliance activities with broader privacy and security frameworks, business associates not only fulfill their HIPAA compliance responsibilities but can also enhance their reputation and unlock growth opportunities.

Demonstrating compliance with applicable HIPAA Administrative Simplification Regulations via white papers, case studies, and independent certifications positions HIPAA business associates as reliable and attractive partners. This can serve as a differentiator in the healthcare industry when a compliance-certified HIPAA business associate is compared to other vendors and service providers  – opening doors to business opportunities, contracts, and collaborations.

Business associates that invest in HIPAA compliance are better positioned to adapt to new laws and industry standards. The processes and systems established for HIPAA compliance often lay the groundwork for meeting future regulatory requirements, ensuring long-term sustainability and success. For those willing to embrace the challenges and opportunities of HIPAA compliance for business associates, the rewards extend far beyond meeting regulatory requirements – they lead to lasting business growth and innovation.

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