AAMI, CTA to Collaborate on AI Standards

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As artificial intelligence (AI) becomes more integrated into the healthcare sector, there is a pressing need for industry standards that will protect patients and promote best practices.

The Association for the Advancement of Medical Instrumentation (AAMI) is pleased to announce that it has signed a memorandum of understanding with the Consumer Technology Association (CTA) that will enable the production of new industry standards related to the use of AI and machine learning (ML) in healthcare products.

The new MOU establishes a framework for AAMI and CTA to collaborate on efforts like the production of new standards documents. Any forthcoming projects will promote the safe, effective use of AI and ML-enabled tools and are expected to impact medical device manufacturers and end users, and the health IT field.

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:

1. Post-market surveillance methodology for over the counter (OTC) health devices
2. Evaluation and assessment criteria for AI and ML-enabled products
3. Other activities such as mutual recognition of standards, information sharing, and workshops
4. The potential for additional collaborative projects

Collaboration with CTA and its members is an opportunity for AAMI to advance its core mission of producing regulatory ready standards. Since 1967, AAMI has used its voluntary industry standards to ensure medical devices and products promote optimal patient outcomes. This new relationship with CTA is a continuation of that mission.

According to Matt Williams, Vice President of Standards at AAMI, “This MOU with CTA is a major milestone in AAMI’s ongoing work related to artificial intelligence. I look forward to the opportunities that this joint endeavor will bring to both our organizations in the future.”

“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, Sr. 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."

AAMI members interested in the specifics of the new relationship can learn more by reaching out at standards@aami.org. Journalists who have questions about forthcoming projects from AAMI and CTA are welcome to reach out to AAMI’s media team at dvisnovsky@aami.org.