Artificial intelligence (AI) has rapidly entered the healthcare world—powering diagnostic tools, predicting diseases, and even recommending treatments. While these systems have revolutionized efficiency and accessibility, they also introduce new risks. What happens when an AI-powered diagnosis goes wrong, leading to serious injury, delayed treatment, or even death? Can patients hold someone legally accountable when the “doctor” is a machine?
At Alan Ripka & Associates, we believe that technological innovation should never come at the expense of patient safety. As AI becomes more integrated into medical care, questions of liability, negligence, and accountability are becoming increasingly urgent. In this blog, we’ll explore whether AI misdiagnosis can lead to a personal injury lawsuit—and what you can do if it happens to you.
The Role of AI in Modern Healthcare
AI tools are designed to assist doctors, not replace them—at least for now. They analyze vast amounts of medical data, from imaging scans to lab results, and generate predictions or diagnostic suggestions. Common applications include:
- AI radiology systems that detect tumors or fractures.
- Predictive algorithms that forecast heart disease or stroke risk.
- Chatbots and symptom checkers that recommend next steps for patients.
- Automated diagnostic systems used by telehealth platforms.
While these tools promise faster results and reduced human error, they are not infallible. In some cases, flawed programming, incomplete data, or biased algorithms can lead to devastating consequences.
When an AI System Gets It Wrong
AI systems depend on training data and human oversight. If either is inadequate, the results can be catastrophic. Examples of potential AI-related medical errors include:
- Missed diagnosis: An AI fails to detect a life-threatening condition, such as cancer, visible in medical imaging.
- False positives: The system identifies a disease that isn’t there, leading to unnecessary treatments or surgeries.
- Algorithmic bias: The AI underperforms for certain demographics, such as women or minorities, due to underrepresentation in training data.
- Software malfunction: Coding or integration errors cause the system to deliver incorrect outputs or fail entirely.
In these cases, the harm to patients is very real—even if the “decision-maker” was a machine. The challenge lies in determining who is legally responsible.
Who Can Be Held Liable for an AI Misdiagnosis?
AI does not operate in a vacuum. Even if a machine makes the error, there are always human actors or entities behind its use and development. Liability in an AI misdiagnosis case can potentially fall on several parties:
1. The Healthcare Provider
Doctors and hospitals have a duty to verify AI results. If a physician relies solely on an AI system without exercising independent judgment, and that reliance leads to harm, they can still be held accountable for negligence.
2. The AI Software Developer
If the misdiagnosis resulted from a flaw in the algorithm or design, the developer or manufacturer may be liable under product liability law. This is similar to how a medical device company can be held responsible for a defective product.
3. The Hospital or Institution
Hospitals that implement AI systems without proper testing, staff training, or oversight may share responsibility. They are also responsible for ensuring the tools meet regulatory and safety standards before use.
4. Telehealth and Digital Health Platforms
If you received an AI-generated diagnosis through a remote app or online platform, liability could extend to the company providing the service, especially if it failed to disclose the limitations or accuracy rate of its AI tools.
Can AI Error Be Considered Medical Negligence?
The short answer: yes, but proving it is complex.
A successful medical negligence or personal injury claim requires proving four key elements:
- Duty of Care – The healthcare provider or institution owed you a legal duty to deliver competent care.
- Breach of Duty – They failed to meet the accepted medical standard—by over-relying on AI, ignoring warning signs, or using unverified systems.
- Causation – The AI-related error directly caused your injury, delayed treatment, or worsened condition.
- Damages – You suffered measurable harm, such as additional medical bills, lost wages, pain and suffering, or disability.
If these elements can be established, the involvement of AI does not shield a provider or manufacturer from liability.
The Legal Challenges of AI-Related Injury Claims
Because AI systems are relatively new, courts are still defining how to handle them under existing medical malpractice and product liability laws. Some of the most pressing challenges include:
- Proving human oversight failure – Was the doctor negligent for trusting the AI?
- Understanding proprietary algorithms – Many AI systems are “black boxes,” meaning developers won’t reveal how the system reached its conclusions.
- Jurisdictional confusion – Who is liable when the software developer is in another state—or another country?
- Determining regulatory compliance – Was the AI approved or cleared by the FDA before use in clinical care?
These complexities make it essential to work with an attorney who understands both medical malpractice and emerging AI technology law.
What to Do If You’ve Been Harmed by an AI Misdiagnosis
1. Seek Immediate Medical Attention
Your health comes first. Get a second opinion or emergency care to address any worsening conditions or delayed diagnoses.
2. Gather Evidence
Document everything:
- Medical records, lab results, and diagnostic reports.
- The name and manufacturer of the AI software used.
- Communication with doctors, hospitals, or telehealth platforms.
- Emails or reports explaining how your diagnosis was determined.
3. Speak to a Qualified Attorney
AI-related medical malpractice claims require careful technical investigation. A skilled attorney can consult with medical and software experts to determine how the error occurred—and who is at fault.
At Alan Ripka & Associates, we work with forensic specialists and medical professionals to reconstruct every detail of your case.
Can You Sue an AI Company Directly?
Yes—under certain circumstances. If the harm stems from a defective algorithm, poor programming, or misleading claims about accuracy, the developer or distributor could face product liability or negligence claims.
For example, if an AI tool marketed as “clinically validated” failed to detect a condition it claimed to identify with high accuracy, and that failure caused injury, the manufacturer could be held accountable.
In some cases, your claim might involve both medical malpractice and product liability, especially when human oversight and software design both contributed to the error.
The Future of AI and Medical Accountability
Regulatory bodies like the U.S. Food and Drug Administration (FDA) are now developing frameworks to evaluate AI-driven medical tools. But as these systems evolve, the law is still catching up.
For now, the legal principle remains clear: patients deserve competent, transparent, and safe care—whether that care is provided by a doctor, a nurse, or an algorithm. When AI systems fail to meet that standard, injured patients have the right to pursue justice.
Conclusion: Protecting Patients in the Age of Artificial Intelligence
AI may be transforming healthcare, but it does not eliminate responsibility. When an AI misdiagnosis leads to preventable harm, someone is still accountable—be it the provider, the hospital, or the software developer.
At Alan Ripka & Associates, we combine decades of experience in personal injury and medical malpractice law with a deep understanding of emerging technologies. Our team investigates every layer of liability—from the hospital’s decision to use AI tools to the developer’s coding flaws—to ensure our clients receive the justice and compensation they deserve.
If you believe an AI-assisted diagnosis or algorithmic error caused you harm, don’t stay silent.
Call Alan Ripka & Associates today for a free consultation. Let’s discuss your case, evaluate your legal options, and hold the right parties accountable.
📞 Call (212) 661-7010 or visit AlanRipka.com to schedule your consultation.
Because technology may be changing medicine—but your right to safe, responsible care never will.
