As AI-Based Diagnostics Proliferate, Stakeholders Strive for Regulation Without Stifling Innovation
In this article:
- The surge in artificial intelligence-based tests is prompting a focus on how to regulate these tools to balance innovation and patient health protection.
- Attention is on regulating in vitro diagnostic (IVD) tests and platforms that use continually updating algorithms versus those with stable algorithms.
- US and European regulators are working on frameworks to assess IVDs with updating algorithms.
- Developers need to demonstrate their ability to maintain product safety and prevent their models from drifting in unpredictable ways.
- AI-based tools entering the market today are used for various applications, such as:
- Quickly identifying aberrant cells
- Identifying biomarker combinations linked with disease or disease risk
- Conducting multimodal analyses across test results and medical records to identify patient-specific risk factors
- Currently, all AI-based diagnostic tests and platforms on the market use stable, or locked, algorithms because they are easier to validate and bring to market quickly.
- As the market evolves, more diagnostic tools will use continually updating algorithms.
- Regulators will need to develop frameworks to allow these continually updating AI products to be marketed and sold.
