OTC AI/ML Transparency: Regulatory Compliance and HF Design

OTC AI/ML Transparency: Regulatory Compliance and HF Design

As the use of artificial intelligence (AI) and machine learning (ML) becomes increasingly common in over-the-counter (OTC) products, transparency and regulatory compliance are critical concerns for both developers and users. Incorporating human factors (HF) best practices into the design process can help ensure that the products are user-friendly. And their OTC AI/ML components are transparent and compliant with regulations.

Understanding AI/ML in OTC Products

OTC products that utilize AI/ML may include wearable devices, mobile apps, and smart health tools. These products have the potential to improve healthcare outcomes and provide users with valuable information about their health. However, as AI/ML algorithms become more complex, it becomes more challenging to ensure transparency and regulatory compliance.

Importance of Transparency and Regulatory Compliance

Regulatory agencies such as the FDA and EMA require that AI/ML components in medical products be transparent and subject to oversight. This ensures that products are safe, effective, and reliable, and that their results are trustworthy. Furthermore, transparency and regulatory compliance also help to build trust between the user and the product, which can be crucial in promoting user adoption and long-term engagement.

Applying Human Factors (HF)

Best Practices in AI/ML Design Incorporating HF best practices into the design process can help ensure that the products are user-friendly. Transparent, and compliant with regulatory requirements. HF principles can be applied at every stage of the design process. From concept to launch. For example, designers can conduct user research and use that feedback to inform product design, including the development of AI/ML algorithms. HF can also be used to evaluate the usability of the product. Making it easier for users to understand the product’s AI/ML components.

Building User Trust through Transparency

Transparency is a critical component of building user trust in AI/ML OTC products. Developers should ensure that the user understands how the product works, including its AI/ML components, and that they are aware of any limitations or potential biases in the algorithms. Providing clear and concise information about the product’s AI/ML components can help users understand how the product works. Build trust, and encourage long-term adoption and engagement.

Regulatory Compliance and Oversight

Regulatory compliance is essential for ensuring that AI/ML components in OTC products meet the requirements set forth by regulatory agencies. Developers should ensure that their products comply with regulations such as the General Data Protection Regulation (GDPR) and the FDA’s Digital Health Software Precertification Program. Additionally, products with AI/ML components should undergo rigorous testing and validation to ensure that they are safe and effective for use.

Monitoring and Adapting to User Needs

Continuous monitoring of the product for adverse events and collecting user feedback can help identify new risks or user errors . This feedback can inform changes to the product design or educational materials. Additionally, developers should regularly review and update the product to ensure that it continues to meet regulatory requirements and remains user-friendly.

  • Monitoring for Adverse Events: Developers continuously monitor their OTC products for adverse events and identify any potential risks that are not initially under detection.
  • Collecting User Feedback: User feedback can be collected through surveys, user testing. And other methods to identify areas where the product can be improved for better usability and user satisfaction.
  • Using feedback from users and monitoring adverse events allows developers to make informed changes to the product design, packaging. And labeling, ensuring that it remains safe and meets the needs of its users.
  • Regular Reviews and Updates: Developers should conduct regular reviews of their OTC products and update them as needed. To ensure that they continue to meet regulatory requirements and remain user-friendly.

The Future of OTC Products and AI/ML

The use of AI/ML in OTC products is likely to increase in the coming years. As such, it is essential that developers continue to incorporate HF best practices into the design process to ensure that products are user-friendly. And transparent, and compliant with regulatory requirements. Additionally, regulatory agencies will continue to develop guidelines and regulations for AI/ML in medical products. And developers should remain aware of these developments to ensure that their products remain compliant.


Transparency and regulatory compliance are essential for the safe and effective use of AI/ML in OTC products. Incorporating HF best practices into the design process can help ensure that products are user-friendly, transparent, and compliant with regulations.