Healthcare AI systems often help with important decisions like diagnosing illnesses, making treatment plans, scheduling appointments, and managing billing. Because these AI applications affect patient health and how organizations work, they must be very accurate and reliable. According to legal advice from California Attorney General Rob Bonta in 2025, companies that develop or use AI in healthcare must make sure these systems are carefully tested, validated, and audited. This is to ensure AI follows laws about consumer protection, data privacy, civil rights, and professional licensing.
Testing and validation help developers find and fix mistakes before AI systems are used. They also help find biases that might unfairly deny care or repeat inequalities. For healthcare providers and managers, this means less risk of harm to patients and fewer legal problems. If AI systems are not properly checked, they can cause errors like misdiagnosis or wrong treatment, which can be very harmful.
Auditing AI systems is needed to make sure they keep following rules and remain clear to users. California’s Office of the Attorney General warns that AI systems may create false or biased outputs. Regular audits by independent groups can check if AI tools meet ethical standards and legal rules. Audits look at how AI is designed, how it works, where its data comes from, and its results to make sure it does not break patient rights or cause discrimination.
Healthcare organizations, like medical offices and IT departments, need to set up ways to regularly check AI’s behavior. Patients must be told how their data is used and how AI affects their care. Without audits, it is hard to confirm that AI remains safe and fair over time.
The laws about healthcare AI in the United States have been changing, especially in states like California that set many standards. California’s new AI laws, starting January 1, 2025, require transparency, limit unauthorized use of personal data or images, and stop unfair uses of AI technology. The Attorney General says that AI development and use must follow laws about consumer protection, civil rights, and data privacy.
Healthcare organizations must have strict procedures to follow these laws during the AI development and use process. Developers and managers must make sure AI systems follow these rules to avoid fines and keep patient trust. For example, providers must get consent from patients before using their data to train AI or make AI-based decisions in care.
Recent studies show that trust and data security are still big challenges with healthcare AI. More than 60% of healthcare workers are hesitant to use AI because they don’t understand how it works or worry about data safety. Data breaches, like the 2024 WotNot case, showed weak spots in AI systems. This makes strong security very important for those managing sensitive patient information and AI systems.
Bias in AI is also a big problem. AI trained on limited or unfair data can make healthcare inequalities worse. Proper testing includes checking for and fixing bias to ensure fair treatment for all patients. Ethical rules suggest teamwork among developers, doctors, ethicists, and legal experts to make AI that respects patient rights and treats people fairly.
AI can automate front-office tasks such as appointment scheduling, patient communication, and billing. Some companies, like Simbo AI, focus on phone automation for these tasks. These tools reduce the amount of routine work staff must do, letting them focus more on patient care.
But automating workflows with AI still needs careful oversight like clinical AI tools do. Mistakes in scheduling or billing can disrupt patient care and cause financial losses if not properly tested and checked. Automation must follow privacy laws and work well in different situations. Managers and IT staff should ask for proof that AI was fully tested before relying on it for patient-related tasks.
Patients should be told when AI is part of communication, and systems should be able to pass complex or sensitive matters to humans. By carefully managing these tools, healthcare providers can use AI to work more efficiently while keeping patient trust and following laws.
Explainable AI, or XAI, helps with concerns about AI being hard to understand. It shows why the AI made certain decisions. This helps doctors and managers spot errors or bias more easily. Studies show that XAI features increase trust among more than 60% of healthcare workers who were unsure about AI.
Using XAI in healthcare AI systems supports testing and auditing. Stakeholders can review how AI makes decisions. Providers should choose AI tools with explainable outputs to keep transparency and reduce risks to patient safety and legal issues.
Building and using AI in healthcare requires knowledge from medicine, technology, law, and ethics. This team approach helps handle challenges like bias, security, transparency, and following rules.
Medical administrators and IT managers should work with AI developers, compliance officers, and clinical staff to create plans for testing, validation, and auditing. This teamwork helps ensure AI tools are safe, reliable, and fit healthcare and legal standards.
Lab tests and simulations are only the first steps. AI must be tested in real healthcare settings to see how well and safely it works. This helps developers find unexpected problems and adapt AI to different patients and workflows.
Healthcare managers should require pilot programs and phased releases for new AI. This allows them to watch how AI performs, collect feedback from users, and improve the system before using it fully. Ongoing real-world testing is needed to safely and responsibly expand AI use in healthcare.
Healthcare data is very sensitive, so cybersecurity is very important when using AI. The 2024 WotNot data breach showed the risks of weak protection in AI systems. Data leaks can expose patient information, disrupt care, and harm the reputation and legal standing of healthcare providers.
Healthcare providers must have strong cybersecurity in their AI testing and validation. This includes encryption, regular security checks, access controls, and plans for handling security incidents. IT managers should ensure AI vendors follow these rules and that internal systems stay secure when connected with AI tools.
For medical administrators, healthcare owners, and IT workers, it is important to understand the need for strict testing, validation, and auditing of AI systems. The results affect patient safety, legal compliance, and how well organizations work.
California’s new legal advice sets an example, requiring healthcare AI to meet existing laws on consumer protection, civil rights, and privacy. As AI use grows across the country, these rules will likely influence national regulations.
Healthcare AI must be:
Healthcare organizations using AI, from clinical decision-making to front-office automation, must stay careful and watchful. The possible benefits—better patient outcomes, less paperwork, and fairer care—depend on their focus on safety, accuracy, and compliance. Only by thorough evaluation and following legal rules can healthcare providers in the United States use AI well for both patients and institutions.
Attorney General Rob Bonta issued two legal advisories reminding consumers and businesses, including healthcare entities, of their rights and obligations under existing and new California laws related to AI, effective January 1, 2025. These advisories cover consumer protection, civil rights, data privacy, and healthcare-specific applications of AI.
Healthcare entities must comply with California’s consumer protection, civil rights, data privacy, and professional licensing laws. They must ensure AI systems are safe, ethical, validated, and transparent about AI’s role in medical decisions and patient data usage.
AI in healthcare aids in diagnosis, treatment, scheduling, risk assessment, and billing but carries risks like discrimination, denial of care, privacy interference, and potential biases, necessitating careful testing and auditing.
Risks include discrimination, denial of needed care, misallocation of resources, interference with patient autonomy, privacy breaches, and the replication or amplification of human biases and errors.
Developers and users must test, validate, and audit AI systems to ensure they are safe, ethical, legal, and minimize errors or biases, maintaining transparency with patients about AI’s use and data training.
Existing California laws on consumer protection, civil rights, competition, data privacy, election misinformation, torts, public nuisance, environmental protection, public health, business regulation, and criminal law apply to AI development and use.
New laws include disclosure requirements for businesses using AI, prohibitions on unauthorized use of likeness, regulations on AI in election and campaign materials, and mandates related to reporting exploitative AI uses.
Providers must be transparent with patients about using their data to train AI systems and disclose how AI influences healthcare decisions, ensuring informed consent and respecting privacy laws.
California’s commitment to economic justice, workers’ rights, and competitive markets ensures AI innovation proceeds responsibly, preventing harm and ensuring accountability for decisions involving AI in healthcare.
The advisories provide guidance on current laws applicable to AI but are not comprehensive; other laws might apply, and entities are responsible for full compliance with all relevant state, federal, and local regulations.