Right now, AI rules for healthcare are still being made. There are only a few laws that directly focus on AI. The federal government is working on setting standards and how to watch over AI use. For example, an Executive Order (No. 14110) tells us to follow clear rules like being open about AI, avoiding discrimination, having good management, and improving cybersecurity when using AI in healthcare and other areas. The Department of Health and Human Services (HHS) plans to regulate AI by 2025 and has made an AI Task Force to guide this work.
The National Institute of Standards and Technology (NIST) gave out a Risk Management Framework in 2023. This helps groups follow good practices to handle AI risks. This framework is advice, not a law, but healthcare organizations find it useful for planning AI programs carefully.
The Federal Trade Commission (FTC) can hold healthcare groups responsible under Section 5 of the FTC Act if AI is used in unfair or tricky ways, especially with personal information. Also, new laws like the Artificial Intelligence Research, Innovation, and Accountability Act of 2023 ask for required disclosures about how AI is used and how it affects patient care.
Healthcare groups must keep up with these new rules and check what AI they use now to make sure they follow the law. Since rules about AI change fast, compliance programs must also change and update often.
One big challenge is making sure AI follows the Health Insurance Portability and Accountability Act (HIPAA). HIPAA has strict rules on using, sharing, and protecting private health information. Since AI systems often use large amounts of patient data, keeping this data private is very important.
AI also causes other privacy problems. For example, biometric data like face scans or fingerprints used by AI can cause permanent privacy issues if leaked. Unlike passwords, biometric info cannot be changed once it is stolen. Also, some AI systems collect data without clear permission, like using browser fingerprinting or hidden tracking, which brings legal and ethical problems.
Another big issue is algorithmic bias. When AI is trained on biased or incomplete data, it might treat patients unfairly or make wrong decisions. This is not just wrong but can cause legal problems if some groups of patients are treated worse than others.
In 2021, a big healthcare AI company had a data breach that exposed millions of health records. This event showed why patient trust is fragile and why protecting privacy and following rules must be top priorities when using AI in healthcare.
Healthcare groups need to make full risk maps. They should list all the spots AI is used, check what happens if it fails, see how much risk is okay, and figure out how well they can find and fix AI problems.
Using AI without good management can hurt healthcare providers. An example is the “Grok incident,” where an AI gave harmful instructions. This caused bad publicity and changes in leadership. Healthcare groups should not think AI is always safe or that vendors watch it closely enough.
Having humans check AI decisions is still very important. The “human in the loop” method means a qualified person reviews any AI-based clinical choices before actions happen. This helps find mistakes and bias that AI might miss on its own.
Healthcare groups need plans that can change with new info. They should monitor how AI works all the time and have clear rules for stopping AI if needed. These steps help make AI use safer and keep groups following laws like HIPAA.
AI is also changing front-office work in healthcare. Companies like Simbo AI use AI to automate phone systems and answering services. This technology can free workers from doing the same tasks over and over, like scheduling appointments, directing calls, and giving basic info to patients.
Automated call systems help in many ways. They shorten how long patients wait, work all day and night, and reduce human mistakes in sharing information. From the office side, automating calls can make work run smoother, reduce staff stress, and let offices handle more patients without hiring more people.
But adding AI to workflows must follow rules. Since these systems talk with patients and may handle health info, HIPAA rules apply. AI must keep patient data safe, encrypt sensitive info, and get proper permission when needed.
Also, AI automation can help with better record-keeping and data logging. This makes it easier to check compliance and get ready for audits. AI systems should be set up to treat everyone fairly and avoid bias or mistakes when talking to patients. This matches Executive Order rules about non-discrimination.
Healthcare IT managers should carefully check AI tools for security and privacy risks before using them. They should look for vendor honesty about data use, following NIST’s Risk Management Framework, and strong controls for managing data.
Healthcare groups in the U.S. face quickly changing AI rules. Because these rules will keep changing, leaders must keep learning and prepare for future compliance needs.
Healthcare providers should also watch the HHS AI Task Force guidance, follow new laws like the AI Research, Innovation, and Accountability Act, and get ready for future rules on transparency and AI content labeling.
Adding AI tools means more cybersecurity work. Hackers try to attack AI by poisoning data or changing AI models. These attacks can let hackers see patient records or mess up AI decisions.
Compliance programs must treat AI risks seriously, not just as software tools. Security should include always watching AI systems, fixing problems quickly, and making sure only the right people can access AI data and settings.
Healthcare groups should also check AI vendors for safe software development, good encryption, and following federal cybersecurity rules.
Medical practice administrators, owners, and IT managers in the United States need a strong understanding and good rules around AI in healthcare. The law is changing fast, with federal agencies focusing on being clear, keeping privacy, fairness, and good cybersecurity. Successful compliance means checking technical, operational, and healthcare-specific risks.
AI in front-office work, like call automation by companies such as Simbo AI, offers benefits but also needs careful checking to protect patient data and follow HIPAA and new rules.
By focusing on ongoing learning, keeping track of AI tools, risk checking, human oversight, and cybersecurity, healthcare groups can use AI responsibly and avoid legal and reputation problems. Staying updated about groups like the HHS AI Task Force and changing laws will help healthcare providers stay within the rules as AI grows more common in healthcare.
AI regulations in healthcare are in early stages, with limited laws. However, executive orders and emerging legislation are shaping compliance standards for healthcare entities.
The HHS AI Task Force will oversee AI regulation according to executive order principles, aimed at managing AI-related legal risks in healthcare by 2025.
HIPAA restricts the use and disclosure of protected health information (PHI), requiring healthcare entities to ensure that AI tools comply with existing privacy standards.
The Executive Order emphasizes confidentiality, transparency, governance, non-discrimination, and addresses AI-enhanced cybersecurity threats.
Healthcare entities should inventory current AI use, conduct risk assessments, and integrate AI standards into their compliance programs to mitigate legal risks.
AI can introduce software vulnerabilities and is exploited by bad actors. Compliance programs must adapt to recognize AI as a significant cybersecurity risk.
NIST’s Risk Management Framework provides goals to help organizations manage AI tools’ risks and includes actionable recommendations for compliance.
Section 5 may hold healthcare entities liable for using AI in ways deemed unfair or deceptive, especially if it mishandles personally identifiable information.
Pending bills include requirements for transparency reports, mandatory compliance with NIST standards, and labeling of AI-generated content.
Healthcare entities should stay updated on AI guidance from executive orders and HHS and be ready to adapt their compliance plans accordingly.