NIST Urges Federal Commitment to Development of AI Standards

Posted August 20, 2019

Getting Smarter

The March/April issue of BI&T, AAMI’s peer-reviewed and award-winning journal, features a cover story on artificial intelligence. It details how the burgeoning AI revolution is set to alter the development of medical devices and infuse the healthcare technology field with new tools for optimizing all manner of device management activities. Get the details at

Working with BSI, AAMI also has released a position paper on artificial intelligence and machine learning, looking at the role of standardization. The paper is complimentary and available to download.

The AAMI Podcast also covers artificial intelligence in episode 29.

The National Institute of Standards and Technology (NIST) is calling for a federal commitment to standards development for artificial intelligence (AI) in order to intensify the pace of “reliable, robust, and trustworthy” technology on that front.

NIST’s ideas are detailed in a final report released Aug. 9 by the organization.

“The federal government can help the U.S. maintain its leadership in AI by working closely with our experts in industry and academia, investing in research, and engaging with the international standards community,” said Walter G. Copan, under secretary of commerce for standards and technology and director of NIST, in a statement. “This plan provides a path to ensure the federal government supports AI standards that are flexible and inclusive—and suited for a world of rapidly changing technologies and applications.”

The report was issued in response to a February 2019 executive order by President Trump. The objectives set forth in the executive order included promoting "sustained investment in AI R&D in collaboration with industry, academia, international partners and allies, and other non-federal entities to generate technological breakthroughs in AI and related technologies." The executive order noted that AI could “contribute to our economic and national security" and that technical standards could “minimize vulnerability to attacks from malicious actors."

Joe Lewelling, vice president of standards strategy and emerging technologies at AAMI, applauded the report’s call for robust federal engagement in AI standards.

“When AI systems include machine learning, then the outputs of those systems can change frequently, but the rationale for those changes is not always easy for clinicians to understand or to explain to patients,” Lewelling said. “Current medical device regulations are not are ideal for handling adaptive change or inexplicability. This report, and the executive order behind it, are welcome reinforcement of the federal government’s commitment to help develop globally relevant consensus standards address this issue.”

The NIST plan states that AI standards development activities should be driven by four key themes:

  1. Maximizing effectiveness and efficiency by bolstering "knowledge, leadership, and coordination among Federal agencies to "in relation to AI standards
  2. Promoting research aimed at improving understanding of "how aspects of trustworthiness can be practically incorporated within standards and standards-related tools"
  3. Fostering public-private partnerships in support of the standards and related tools
  4. Engaging on an international level "to advance AI standards for U.S. economic and national security needs"

“Public trust, security and privacy considerations remain critical components of our approach to setting AI technical standards," said Michael Kratsios, chief technology officer of the United States, in the news release. "As put forward by NIST, federal guidance for AI standards development will ensure AI is created and applied for the benefit of the American people.”

The final report was developed by NIST with public and private sector engagement, including a workshop held in May. In July, NIST released a draft document for public commenting. Additional information is available at the NIST's AI Standards webpage.

AAMI and the U.K. national standards organization BSI, with the involvement of the Food and Drug Administration and the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) have been working on the issues surrounding AI standardization since late last year through expert workshops.

Earlier this year, AAMI and BSI published a set of recommendations for future AI standards activities and are currently working on a white paper that will identify where standards and regulations may need to be modified or supplemented to address machine learning technologies.