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AI in Healthcare

6 min

Top HIPAA Risks When Using AI in Healthcare and How to Mitigate Them

Keragon Team
August 26, 2025
August 26, 2025
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Hospitals are racing to bring AI into everything from radiology scans to patient scheduling. The results look impressive on the surface: faster decisions, lighter workloads, and more data-driven care. But behind that efficiency, there’s a quieter risk taking shape. Every time an algorithm touches patient information, the chance of a HIPAA violation grows.

Last year alone, healthcare data breaches exposed over 275 million records, costing organizations an average of $10.22 million each (HIPAA Journal). Add to that the fact that 71 percent of healthcare workers use personal AI tools at work, and it’s easy to see why compliance officers are uneasy.

HIPAA was never written with algorithms in mind, and that gap has created new risks for providers, payers, and tech partners. This article looks at the biggest HIPAA risks AI brings into healthcare and what leaders can do to stay ahead of them.

Understanding HIPAA in the Context of AI

HIPAA was written long before machine learning and generative AI entered healthcare. At its core, the law protects Protected Health Information (PHI) through three main rules:

  • Privacy Rule – limits who can access or share PHI.
  • Security Rule – requires safeguards like encryption and access controls.
  • Breach Notification Rule – mandates that patients and regulators are informed when data is compromised.

On paper, these rules are straightforward. In practice, AI makes them harder to follow. Training a model often requires massive datasets, which increases the risk of PHI slipping through. Even when data is “de-identified,” modern AI tools can sometimes re-identify individuals by finding patterns across datasets.

AI systems also rely heavily on third-party vendors and cloud platforms. That creates more points of exposure and puts responsibility not only on healthcare providers but also on the partners building or hosting the AI. A single weak link can lead to a compliance failure that affects everyone involved.

The challenge isn’t that HIPAA no longer applies. It’s that AI introduces new ways for organizations to unintentionally break the rules. To use these tools responsibly, healthcare leaders need to understand where the risks show up most often and how to close those gaps before they become violations.

Top HIPAA Risks When Using AI in Healthcare and How to Mitigate Them

1. Data Privacy Violations

AI models often need enormous datasets to perform well. In healthcare, that usually means working with PHI.

Even if data is de-identified, advanced algorithms can sometimes re-identify patients by linking different pieces of information. Sharing datasets with third-party vendors or using them in open AI tools adds another layer of risk.

How to mitigate:

  • Limit data exposure from the start. Use strong de-identification techniques, but also adopt data minimization practices so models only train on what’s absolutely necessary.
  • Whenever possible, work with synthetic data to reduce reliance on sensitive records.
  • For external partners, ensure Business Associate Agreements (BAAs) are in place and enforce strict contractual safeguards around PHI use.

2. Weak Data Security

AI systems are often cloud-based, which means sensitive patient data can move outside traditional hospital servers.

If encryption is weak or access controls are loose, that data becomes a target for breaches. Hackers don’t just go after providers anymore; they target AI vendors and cloud platforms as well.

How to mitigate:

  • Apply security at every layer.
  • End-to-end encryption, role-based access, and regular penetration testing should be non-negotiable.
  • Use vendors that meet HIPAA security standards and perform independent audits.
  • Internally, conduct routine risk assessments so new AI tools don’t create blind spots in your security posture.

3. Algorithmic Bias and Inaccuracies

AI tools are only as good as the data they’re trained on. If the training data is incomplete or unbalanced, the system can generate biased results. In healthcare, that can translate into misdiagnoses, unequal treatment recommendations, or overlooked conditions in certain patient groups. 

Beyond patient safety concerns, these outcomes can open the door to compliance violations if PHI is mishandled or if patients are treated unfairly.

This is one of the biggest challenges in healthcare software development, where algorithms must be carefully designed to support clinical decisions without introducing bias.

How to mitigate:

  • Audit algorithms regularly. Use diverse, representative datasets during training and validate outputs against clinical standards.
  • Bring in cross-disciplinary review teams — clinicians, data scientists, and compliance officers — to identify blind spots before models go live.
  • Bias detection should be part of ongoing monitoring, not a one-time check.

4. Lack of Transparency and Auditability

Healthcare providers often depend on third-party AI vendors for tools and infrastructure. If a vendor doesn’t follow HIPAA rules, the healthcare organization is still liable for any violations. 

This creates shared responsibility, and one weak partner can put the entire compliance framework at risk.

Choosing the right technology partner is critical, especially when outsourcing custom healthcare software solutions that directly handle PHI.

How to mitigate:

  • Prioritize explainable AI tools where possible.
  • Maintain detailed documentation on how models are trained, what data they use, and how decisions are generated.
  • Keep audit logs that track every AI interaction involving PHI.
  • Transparency not only supports compliance but also builds trust with patients and regulators.

5. Vendor Compliance Gaps

Healthcare providers often depend on third-party AI vendors for tools and infrastructure. If a vendor doesn’t follow HIPAA rules, the healthcare organization is still liable for any violations. This creates shared responsibility, and one weak partner can put the entire compliance framework at risk.

How to mitigate:

  • Conduct due diligence before signing with vendors.
  • Verify HIPAA compliance certifications, review security practices, and confirm whether they’re willing to sign a BAA.
  • Reassess vendors regularly to ensure they’re keeping up with evolving security and privacy standards.
  • Treat vendor management as an ongoing compliance function, not a one-time contract review.

6. Poor Access Controls and Identity Management

Unauthorized access is a recurring cause of healthcare breaches. With AI systems, the risk grows because multiple users — from clinicians to data scientists — may need access to sensitive datasets or model outputs. Without strong controls, it becomes easy for credentials to be misused or for staff to see information they don’t need.

How to mitigate: Implement strict role-based access controls. Require multi-factor authentication for all AI platforms handling PHI. Regularly review user permissions to ensure access is limited to current job functions. Monitor system activity for unusual behavior and respond quickly to anomalies.

7. Inadequate Employee Training

Even the most advanced AI system can be compromised by human error. Staff may feed sensitive details into unapproved AI tools, use weak passwords, or mishandle PHI when prompted by AI assistants. Without clear training, employees can unintentionally bypass HIPAA safeguards.

How to mitigate:

  • Provide ongoing, scenario-based training that addresses both HIPAA rules and safe AI usage.
  • Teach employees what they can and cannot enter into AI systems, and why.
  • Refresh training regularly as new AI tools are introduced, so staff stay aligned with compliance practices.

Conclusion

AI is already reshaping how hospitals, clinics, and insurers deliver care. The benefits are undeniable, but so are the compliance challenges. Each of the risks we’ve covered, from privacy violations to vendor missteps, shows how quickly innovation can collide with HIPAA if the right safeguards are not in place.

The good news is that healthcare leaders do not have to choose between progress and compliance. By minimizing data exposure, investing in stronger security, monitoring algorithms for bias, and holding vendors accountable, organizations can protect patient trust while still reaping the rewards of AI.

Training staff and keeping compliance front of mind ensures these safeguards exist not only on paper but also in everyday practice.

Ultimately, the future of AI in healthcare compliance depends on treating HIPAA not as a barrier but as a framework that pushes technology toward safer and smarter use.

Healthcare organizations that strike that balance will not only stay out of trouble with regulators but also set the standard for responsible, patient-first innovation.

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Keragon Team
August 26, 2025
August 26, 2025
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