High-Risk AI Systems in Healthcare: Disclosure Requirements and Risk Management Under Colorado’s SB 24-205

Colorado’s SB 24-205 defines “high-risk” AI systems as AI technologies that make or strongly influence important decisions. These decisions often have legal or serious effects, especially in areas like healthcare. In healthcare, high-risk AI may help with things like patient diagnosis, planning treatments, deciding insurance coverage, and clinical evaluations.

High-risk AI systems need more careful checking because mistakes or unfairness in these systems can cause big problems. For example, if an AI tool recommends whether a patient’s insurance claim should be approved, it’s high-risk because it affects access to care.

Developers and Deployers: Two Key Groups Under SB 24-205

SB 24-205 gives rules for two groups: developers and deployers of AI systems.

• Developers are the people who create or make big changes to AI technology.
• Deployers are those who use the AI systems in real work, like hospitals, clinics, or insurance companies.

Both groups must follow the law, but their jobs are different.

Disclosure Requirements for High-Risk AI in Healthcare

One main rule in SB 24-205 is transparency. Developers and deployers must share clear information about AI systems that affect patient care. This helps patients, medical staff, and regulators know when AI is used and how it might affect decisions.

• Consumer Notices: Deployers must tell patients when a high-risk AI system affects decisions about their care. For example, if an AI tool helps decide treatment options or insurance coverage, patients must be told.
• Opt-out Rights: Patients should get the chance to refuse certain AI-based profiling if it is possible. They should also have a way to appeal decisions influenced by AI. This supports fairness and choice.
• Disclosures About AI Functionality: Healthcare groups using high-risk AI must explain what the AI does, what data it uses, and any risks or limits. This helps patients understand and trust the system better.
• Reporting to the State: Developers and deployers must tell the Colorado Attorney General about any known or suspected risks of unfair treatment by the AI within 90 days. Unfair treatment means the AI system hurts patients unfairly based on race, gender, or other protected traits.

Risk Management and Impact Assessments

SB 24-205 asks healthcare groups that use high-risk AI to have strong programs to manage risks. These programs check and lower possible problems caused by AI.

Key Risk Management Parts:

• Risk Management Policies: Deployers must have policies that explain how they find, check, and handle risks. These policies should be updated often based on how the AI is used, what it does, and the data it handles.
• Annual Impact Assessments: Groups must review each year what the AI system’s purpose is, what data it uses and gives out, how accurate and safe it is, and if it is fair. They must check again after big updates to the AI.
• Documentation: All reviews and risk actions must be written down and kept for at least three years. This proves accountability and helps regulators check compliance.
• Monitoring and Transparency: Deployers must watch how the AI system works all the time. They should look for new risks, especially for unfair treatment or bias.

The law points to guides like the National Institute of Standards and Technology (NIST) AI Risk Management Framework to help make good policies. Following these guides can also help providers protect themselves from legal problems by managing risks well.

Impact of SB 24-205 on Healthcare Providers and Organizations in Colorado

Healthcare leaders and IT managers in Colorado need to carefully check how SB 24-205 affects their work. If they don’t follow the law, the Colorado Attorney General can take action. The violations can be treated as unfair or misleading business practices. Mistakes in handling AI could lead to legal problems and hurt reputations.

Some important points for healthcare providers are:

• Assessment of Current AI Use: Groups should list all AI tools they use and find out which ones are high-risk and must follow the law.
• Training and Governance: Staff who use AI must learn about SB 24-205 rules. Creating groups or roles in charge of AI governance can help oversee compliance.
• Vendor Oversight: Providers working with AI creators should ask for clear information and papers from suppliers to show they are following rules.
• Patient Communication: Providers should plan clear and simple ways to tell patients about AI use. This meets the law’s notice and disclosure rules.

Small healthcare offices with fewer than 50 employees may have some exceptions, mostly if they don’t use protected data to train AI. But they should check these exceptions carefully since they are limited.

Workflow Automation in Healthcare AI: Enhancing Efficiency While Managing Compliance

Automation tools are common in healthcare offices for tasks like answering phones and scheduling appointments. AI tools like Simbo AI provide automatic answering services that help make these tasks run smoother and easier for patients.

Since AI front-office tools are used more, it is important to know how they fit with laws like SB 24-205. Usually, these tools don’t count as “high-risk” because they do routine jobs and don’t make major clinical decisions. However, providers must still follow rules about being clear and protecting data when using AI for communication.

Benefits of AI Automation in Healthcare Workflows:

• Improved Patient Access: Automated phone systems can handle many calls, cut down waiting, and offer basic patient help 24/7.
• Reduced Administrative Burden: Automation lets staff focus on harder tasks that need human judgment.
• Consistent Patient Interaction: AI can give standard replies that lower human mistakes in communication.

Compliance Considerations:

• If AI generates patient communication, some states like California (with AB 3030) require telling patients that AI was used. Colorado providers should watch for similar laws about transparency.
• Healthcare groups should get documents from AI service providers explaining how the AI works and what data it uses, especially if AI content affects what patients understand or decide.
• Organizations should set up rules to watch and manage risks tied to AI automation and keep following state and federal laws.

Broader Context: AI Regulations Beyond Colorado

While Colorado’s SB 24-205 is a detailed state law about high-risk AI, other states like California and Utah have made laws about AI transparency and bias in healthcare.

• California’s AB 3030 makes health providers tell patients when messages are AI-generated without doctor review, starting January 1, 2025.
• Utah’s Artificial Intelligence Policy Act requires revealing AI use in regulated jobs like healthcare, effective May 1, 2024.

Federal agencies also regulate AI in healthcare. For example, the Centers for Medicare & Medicaid Services (CMS) allow AI to help with coverage decisions but require checks that consider each patient’s situation.

Healthcare leaders and IT managers working across states should keep up with these changing laws to stay following rules and use AI safely.

How Healthcare Organizations Can Prepare for SB 24-205 and Future AI Laws

Healthcare groups can use these ideas to meet rules:

• Create AI Governance Structures: Set up committees or teams to manage AI use, look at risk assessments, and handle legal needs.
• Conduct Comprehensive AI Audits: List and review AI systems, especially those with big impacts, to check risks and law readiness.
• Engage with AI Vendors: Ask AI suppliers for detailed information, risk reports, and proof they reduce bias following laws.
• Develop Patient Communication Policies: Make clear messages to explain AI use, patient rights to refuse certain AI uses, and appeal rules.
• Train Staff on AI and Compliance: Teach staff about how AI works, its limits, and new legal duties.
• Monitor Legislative Updates: AI law rules will change. Watching updates helps stay legal and avoid problems.

Summary for Medical Practice Administrators, Owners, and IT Managers in Colorado

Colorado’s SB 24-205 gives new rules for developers and users of AI systems that affect healthcare decisions. This includes requirements for clear disclosure, strong risk management, and reports to the state Attorney General. High-risk AI systems used in clinical support, insurance review, and other important healthcare tasks must follow these rules closely.

Healthcare leaders and IT managers should check their AI tools, set up governance, keep communication clear with patients, and work closely with AI developers to follow these standards. Meeting these requirements can take time and effort but aims to lower unfair AI bias, build patient trust, and keep care quality safe.

As AI grows in medical use, staying up-to-date on laws and preparing for changes will help healthcare groups serve their communities well and stay within the law.

Final Note on AI in Healthcare Operations

By using tools like Simbo AI for front-office automation along with following rules for high-risk AI, healthcare providers in Colorado and other places can make work more efficient and improve how patients are helped. Balancing these goals with law compliance is important as AI keeps changing healthcare delivery in the United States.