How Does the Executive Order for AI Affect Digital Health Products?
(Thursday, November 2, 2023)
With a wide-ranging and far-reaching Executive Order signed this week by President Biden, the administration is implementing several requirements from developers of products containing Artificial Intelligence (AI) technologies that would affect digital health products, somewhat. The order is primarily focused on the safety and privacy of the information used to train AI algorithms but also addresses the impact these technologies could have on health equity, job replacements, and other issues. Overall, most of the requirements specified in the Executive Order are already required by the FDA for medical devices, including those containing AI technology, that require a 510k clearance or a PMA approval. However, it adds emphasis on issues that have not been addressed adequately so far.
Some provisions in the Order were already included, in principle, in the existing regulations such as the requirement that the developers must notify the federal government prior to training the model and share the results of the tests to demonstrate that the product is safe, secure, and reliable before release. These are already covered in the IDE and 510k/PMA requirements for AI devices deemed high-risk and categorized as Class 3 devices. Similarly, the requirement for robust cybersecurity, addressing concerns for privacy protection, and inclusion of diverse populations for evaluation and use of the product have already been discussed in the existing regulations. For the non-regulated devices, the devices are deemed low risk so the Executive Order will likely not apply.
Some interesting new provisions in the Executive Order are that the government, likely through the FDA and NIH, will propose robust new standards for screening biological molecules designed using AI, and federally funded programs will require that these standards be enforced as a condition for federal funding.
The Executive Order aims to balance innovation and risk by modernizing federal laws to include AI. It announces that the government will issue new guidance documents for AI products.
Overall, the Executive Order will have minimal direct impact on AI-based healthcare products that already require FDA approval. It is primarily designed to address consumer products currently not regulated.
Dr. Mukesh Kumar
Founder & CEO, FDAMap
Linkedin: Mukesh Kumar, PhD, RAC