Summary: AAMI and CTA have signed an MOU to collaborate on creating industry standards for AI and ML in healthcare. This partnership aims to promote the safe, effective use of AI in healthcare devices and IT products, advancing AAMI’s mission of developing regulatory-ready standards.

Key Takeaways:

  • AAMI and CTA will collaborate on developing standards for AI and ML-enabled healthcare products, including post-market surveillance and evaluation criteria.
  • The partnership aims to ensure the safety, efficacy, and innovation of health technologies as they rapidly evolve.

The Association for the Advancement of Medical Instrumentation (AAMI) announced 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.

Establishing a Framework for Collaboration

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.

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

Standardization Activities and Focus Areas

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

Advancing Regulatory Standards in Healthcare

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 intended to be a continuation of that mission.

“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.”