AI governance is the framework of policies, processes, and oversight used to ensure AI systems are safe, effective, ethical, and compliant throughout their lifecycle, from development and deployment to ongoing monitoring and improvement. Companies may have AI specific documentation on their website, sometimes in sections with headings such as “AI safety”, “Responsible AI”, or “Trust center”.
Key considerations include:
- Does the company clearly disclose how the AI tool is intended to be used, its capabilities, and its limitations?
- Does the company provide documentation describing how the tool was developed and evaluated?
- Does the company evaluate the accuracy, reliability, and consistency of AI output?
- Has the company conducted and made available evidence regarding the tool's safety and effectiveness for its intended use?
- What kind of research has been conducted? (e.g., survey data, a real-world effectiveness study, a randomized controlled trial, etc.)
- What guardrails exist to help ensure the product functions safely and minimize any potential harm or unintended consequences?
- Is the tool subject to regulatory oversight? The FDA regulates software as a medical device, meaning software that is intended to diagnose, cure, mitigate, treat, or prevent a condition. If so, what is its regulatory status?
Bias, equity, and fairness
Algorithmic bias occurs when AI models produce unfair outcomes or systematically disadvantage particular groups. Bias can be introduced in a variety of ways, including unrepresentative or incomplete training data, as well as human judgements made during design, development, or deployment.
It is important to note that there is variability in the degree to which companies publicly share the information below. Companies may disclose some, but not all, of this information. You may wish to reach out to a company directly to inquire about questions that you were unable to answer.
Key considerations include:
- Was the data on which the AI model was trained representative of the intended user base?
- In what settings and with what populations have the tool’s performance been evaluated?
- Are there differential outcomes for specific groups?
- Does the company conduct fairness audits and document the steps taken to minimize bias?
Post-deployment
Post-deployment considerations include the mechanisms for ongoing monitoring of a tool’s performance once it is being used in a real-world clinical setting.
Key considerations include:
- Does the vendor engage in ongoing performance monitoring of the tool? If so, how?
- Is there a process for human oversight of the product’s performance over time?
- What are the incident monitoring and escalation protocols? In other words, is there a clear process to identify and respond to any AI errors or safety risks?
- Does the company notify users when significant updates are made to the AI model?
Privacy compliance
Confirm whether the company attests compliance with applicable laws and regulations, such as HIPAA, GDPR, and/or other applicable privacy and data security standards in the jurisdiction(s) where you practice. Many jurisdictions (including California, Colorado, Nevada, and Virginia), have specific state-based data privacy laws that may apply. Privacy policies often have a separate state-specific section.
If the tool creates, receives, maintains, or transmits protected health information (PHI) on a psychologist’s behalf, a signed business associate agreementopens in new window (BAA) with the company is needed.