The Association for the Advancement of Medical Instrumentation (AAMI) has entered into a partnership with the Consumer Technology Association (CTA) to develop new standards for the integration of artificial intelligence and machine learning in healthcare.
This collaboration was formalized through a memorandum of understanding (MOU) between the two organizations, aimed at promoting patient safety and best practices in AI-enabled healthcare tools.
The agreement sets the stage for AAMI and CTA to work together on creating standards and guidelines for the use of AI and ML in healthcare products, particularly for medical device manufacturers and health IT. The effort will focus on areas such as post-market surveillance for over-the-counter health devices and evaluation criteria for AI-based medical tools.
Pat Baird, senior regulatory specialist at Philips, and longtime member of both associations said, “Standards are a great way to share good practices and warn about common pitfalls for a particular topic; I’m happy that AAMI and CTA are starting down a path where even more people can share their perspectives, experiences, and ideas of what good looks like.”
The MOU states that AAMI and CTA intend to coordinate standardization activities related to digital health products and solutions that have AI or ML capabilities. This may include:
Post-market surveillance methodology for over-the-counter (OTC) health devices
Evaluation and assessment criteria for AI- and ML-enabled products
Other activities such as mutual recognition of standards, information sharing, and workshops
The potential for additional collaborative projects
“As health technologies develop at an unprecedented rate, industry-driven standards will be crucial to ensuring the efficacy, safety, and innovation of these products and services,” said Kerri Haresign, senior director of Technology and Standards at CTA. “For CTA, collaborating with AAMI marks an important step in creating the standards needed to guide the responsible development of AI in healthcare."
