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HIPAA, Healthcare Data, and Artificial Intelligence

Posted by Steve Alder

Artificial intelligence is rapidly reshaping healthcare, offering new ways to analyze data, support clinical decisions, streamline operations, and improve patient outcomes. From predictive analytics to ambient documentation tools, AI systems are becoming embedded in everyday workflows.

Yet as these technologies evolve, the legal and ethical frameworks governing their use remain grounded in long‑standing privacy and professional standards. In addition to HIPAA, which defines the federal rules for how Protected Health Information (PHI) may be used or disclosed, healthcare organizations must also navigate evolving state AI laws, ethical obligations embedded in professional codes of conduct, and their own organizational policies governing the responsible use of technology.

These frameworks emphasize responsibilities such as safeguarding patient confidentiality, exercising independent clinical judgment, and ensuring that technology does not replace the professional duties of licensed practitioners. Understanding how compliance with HIPAA and these broader obligations apply to the use of AI is essential for healthcare organizations seeking to innovate responsibly while protecting the confidentiality of health information.

How AI Is Being Used in Healthcare

AI tools now appear across nearly every corner of the healthcare ecosystem, but not all AI functions in the same way. Understanding these distinctions helps healthcare organizations assess risks, determine when PHI may be used or disclosed, and train workforce members on the appropriate use of AI tools.

Broadly, AI in healthcare can be grouped into four categories: artificial intelligence that performs tasks autonomously, augmented intelligence that supports human decision‑making, automation software with AI capabilities, and generative AI.

  1. Autonomous AI

This category includes systems designed to carry out specific tasks without continuous human involvement. These tools operate within defined parameters and produce outputs that may be used directly in clinical or operational workflows.

Examples include:

  • Autonomous diagnostic tools that detect diabetic retinopathy without requiring a clinician to interpret the image
  • Imaging analysis systems that independently identify abnormalities on radiology scans
  • Continuous‑monitoring tools that detect patient deterioration and trigger alerts

These systems raise important questions about clinical oversight, liability, and the extent to which AI outputs can be relied upon without human review.

  1. Augmented Intelligence

Augmented intelligence is designed to enhance, not replace, human judgment. These systems provide recommendations, predictions, or insights, but a clinician or workforce member remains responsible for interpreting the output and making the final decision.

Examples include:

  • Clinical decision support tools that suggest potential diagnoses or flag medication interactions
  • Risk‑stratification models that identify patients at high risk for readmission or deterioration
  • Population health analytics that help clinicians prioritize outreach or interventions

Because humans remain in control, augmented intelligence often fits more comfortably within existing professional and ethical frameworks, but it still requires careful oversight to avoid over‑reliance on algorithmic outputs.

  1. Automation Software with AI Capabilities

Many healthcare organizations use automation software to streamline administrative and operational tasks. When these systems incorporate AI such as machine learning or natural‑language processing, they can perform more complex functions than traditional rule‑based automation.

Examples include:

  • Revenue cycle tools that extract data from clinical documentation, predict coding categories, or flag claims likely to be denied
  • Prior authorization systems that help gather required documentation or identify missing elements
  • Operational workflow tools that predict no‑shows or optimize appointment scheduling

These tools often fall under “healthcare operations” for HIPAA purposes, but they still require access and audit controls, training to prevent impermissible disclosures of PHI, and, when software is provided by a third‑party vendor, Business Associate Agreements.

  1. Generative AI

Generative AI tools create new content based on patterns learned from large datasets. In healthcare, generative AI is increasingly used to create text, summaries, images, or structured data to reduce administrative burden and support communication.

Examples include:

  • Ambient documentation tools that draft clinical notes based on recorded patient encounters
  • Drafting tools that generate patient instructions, referral letters, or summaries for care coordination
  • Chatbots that answer patient questions or help navigate services, sometimes using PHI to personalize responses
  • AI‑enabled translation tools that generate full sentences rather than translating inputs word‑for‑word

Generative AI tools can improve efficiency and accessibility, but they also raise concerns about accuracy, context, and whether PHI is transmitted to systems that lack appropriate safeguards. These risks make governance, vendor management, and workforce training especially important.

HIPAA’s Role in Governing AI Use

HIPAA does not contain AI‑specific provisions because the HIPAA Security Rule is designed to be technology‑neutral. As a result, HIPAA’s existing Privacy, Security, and Breach Notification Rules govern how PHI may be used or disclosed to AI tools. These requirements apply regardless of whether PHI is handled by a human, a traditional software system, or an advanced AI model.

Under HIPAA, the starting point is whether a use or disclosure of PHI is permissible. PHI may be shared with an AI system for treatment, payment, and healthcare operations without patient authorization. When PHI is used for operational purposes, HIPAA requires organizations to limit the information disclosed to the minimum necessary to achieve the purpose of the disclosure.

The HIPAA Security Rule’s administrative, physical, and technical safeguards also apply in full. These safeguards require organizations to assess risks, implement appropriate controls, and ensure the confidentiality, integrity, and availability of PHI, regardless of whether information is processed by humans or algorithms.

When an AI tool is provided by a third‑party vendor, HIPAA’s business associate requirements come into play. A Business Associate Agreement is required whenever a vendor creates, receives, maintains, or transmits PHI on behalf of a covered entity, including when the vendor uses AI to perform regulated functions.

If PHI is disclosed to a third‑party AI tool without a Business Associate Agreement in place, or if de‑identified information is re‑identified by a vendor’s AI system, the incident qualifies as a notifiable breach under the HIPAA Breach Notification Rule. Other events may also trigger breach notification obligations – for example, if an AI‑generated output includes more than the minimum necessary information and is then shared (even permissibly) with a third party without being validated for HIPAA compliance.

In other words, AI does not sit outside HIPAA. It is simply another mechanism through which PHI may be used or disclosed, and the same HIPAA compliance obligations apply. What changes with AI is not the legal framework, but the operational risks and the need for organizations to understand how these tools function so they can apply HIPAA’s requirements appropriately.

State Laws with Stricter Requirements

While HIPAA provides the federal baseline for privacy and security, multiple states have enacted more stringent laws governing disclosures to AI tools or automated decision‑making systems. Some states (i.e., Texas) have enacted multiple laws that impact the use of AI in different areas of healthcare.

These laws vary widely in scope and applicability but often include requirements such as explicit consent before sensitive information can be used for automated processing, restrictions on secondary uses of data (including model training), and transparency obligations requiring organizations to inform individuals when AI is used in their care. Several prohibit sharing sensitive categories of information with AI tools, such as mental health, reproductive health, substance use disorder, or genetic data.

For organizations operating across multiple states, these variations create a complex compliance landscape. Workforce training must reflect not only HIPAA but also the most protective state‑level requirements that apply to the organization’s operations.

The Risks of Using AI in Healthcare and How to Avoid Them

AI introduces new categories of risk that extend beyond traditional privacy and security concerns. Some risks arise from how AI systems process information, while others stem from how workforce members interact with these tools. Understanding these risks, and implementing safeguards to mitigate them, is essential for using AI in a manner that complies with HIPAA and protects the confidentiality of health information.

One of the most common risks is the inadvertent disclosure of PHI when workforce members enter identifiable information into public or non‑HIPAA‑compliant AI tools. Even when an AI tool is approved, staff may unintentionally disclose more than the minimum necessary, especially when copying AI‑generated outputs into emails, referral notes, or other communications.

AI systems also carry operational and clinical risks due to confabulations. Confabulations occur when an AI tool combines unrelated or partially related data elements into a single, inaccurate output. These errors can lead to incorrect summaries, misaligned recommendations, or misleading documentation if they are relied on without verification. AI tools may also behave unpredictably when encountering unusual inputs, edge cases, or ambiguous information.

To manage these risks, organizations should implement mechanisms that allow workforce members to report anomalies, unexpected behaviors, and inaccurate outputs. These reports help identify patterns, support continuous improvement, and ensure that AI tools are used safely. They can also support the development of standardized prompts, helping organizations determine whether inaccuracies stem from the tool itself or from the way a question is phrased or input.

Logging AI interactions is equally important. Audit logs allow organizations to review how AI tools were used, assess the accuracy of outputs, and investigate potential privacy incidents or operational errors. Logging also supports quality assurance, model monitoring, and compliance reviews.

Other risks include data leakage, model drift, and over‑reliance on automation. For example, if an AI model is trained on outdated data, its outputs may become less accurate over time. Similarly, workforce members may assume that AI‑generated content is always correct, leading to reduced vigilance and missed errors.

Organizations can avoid these risks by using only AI tools that support HIPAA compliance, configuring the tools to mitigate the risk of a HUIPAA violation, and maintaining clear policies on what staff may and may not input into AI systems. Strong governance structures are also essential to evaluate new AI tools, monitor performance, and ensure that safeguards remain effective over time.

Training the Workforce to Use AI in Compliance with HIPAA

As AI tools become part of everyday workflows, workforce members must understand how to use them in a way that protects patient privacy and complies with HIPAA. HIPAA AI training for healthcare staff should give staff a clear understanding of the risks associated with AI, the safeguards the organization has put in place, and the practical steps each person must take to ensure PHI is handled appropriately.

AI introduces several risks that staff need to be aware of. These include the inadvertent disclosure of PHI when information is entered into public or non‑HIPAA‑compliant tools, the possibility of confabulations that combine unrelated data into inaccurate outputs, and the risk of over‑reliance on AI‑generated content. AI tools may also behave unpredictably when encountering unusual inputs or ambiguous information, and outputs may contain more than the minimum necessary if not carefully reviewed.

As part of training, organizations should clearly identify which AI tools have been authorized and configured to support HIPAA compliance. Staff should be instructed to use only these approved platforms and to avoid entering PHI into any unapproved or public AI system. Training should also explain that approved tools have been evaluated for security, contractual protections, and appropriate safeguards, but that these protections do not eliminate the need for human oversight.

Training should also cover state‑specific requirements. Some states impose stricter consent rules, especially for sensitive categories of information such as mental health, reproductive health, substance use disorder, or genetic data. Workforce members must understand when consent is required before using AI tools and how these state‑level rules interact with HIPAA’s permissible uses and disclosures.

In addition, training should address operational workflows. Staff need to know how to use ambient documentation tools, clinical decision support systems, and revenue cycle automation platforms safely and appropriately. This includes understanding what information may be entered into these tools, how to review outputs, and when to escalate concerns. Training should also reflect role‑based access controls so that staff understand which AI tools they are permitted to use.

To support the compliant use of AI, workforce training should include the following best practices:

  • Only use approved AI platforms. Do not enter PHI into any tool that has not been authorized by the organization.
  • Fully de‑identify PHI before AI input whenever possible. Remove names, dates, contact information, and any other identifiers unless the task requires identifiable data.
  • In all other cases, standardize minimum‑necessary inputs. Provide only the information needed for the task and avoid including extraneous details.
  • Ensure you obtain consent when required. Some state laws or organizational policies require explicit consent before using AI for certain types of information or processing.
  • Log AI interactions for auditing. Follow organizational procedures for documenting how AI tools are used so that outputs can be reviewed and any issues investigated.
  • Always review and validate AI outputs before use. Never assume an AI‑generated summary, recommendation, or explanation is correct without checking it against the source information.
  • Document decisions influenced by AI. When AI contributes to a clinical or operational decision, record what prompts were used, what outputs were generated, and how the outputs were validated.
  • Flag anomalies, unexpected behaviors, and inaccurate outputs. Reporting these issues helps the organization identify patterns, improve tools, and prevent future errors.
  • Never use AI to answer a HIPAA compliance question. Compliance questions must be directed to the organization’s privacy or compliance team, not to an AI system.

HIPAA AI training for healthcare staff should be scenario‑based, practical, and relevant to workforce members’ roles. Staff need to understand not only the rules but also the real‑world situations where errors occur. Organizations should provide concrete examples of how AI tools can produce incorrect, misleading, or incomplete outputs.

Seeing how AI gets it wrong in realistic scenarios reinforces the importance of validating AI‑generated content and encourages the vigilance needed to use these tools safely. Training should also be updated as AI tools evolve so that staff remain familiar with new features, changes in workflows, and updated organizational policies.

The post HIPAA, Healthcare Data, and Artificial Intelligence 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.