AAMI News March 2019

Standards Spotlight: AAMI, BSI Publish Recommendations to Support Smart Use of Artificial Intelligence


The Emergence of Artificial Intelligence and Machine Learning in Healthcare: Recommendations to Support Governance and Regulation

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Artificial intelligence (AI) and machine learning are poised to transform healthcare delivery. They can provide earlier diagnosis and targeted treatments for individual patients, while driving efficiency and effectiveness in healthcare services. However, the expanded use of these algorithms is posing a challenge to healthcare regulators around the world.

To support the deployment of safe and effective AI technologies within this highly regulated sector, AAMI and the U.K. national standards body BSI published a set of recommendations in February for future standardization activities.

“The level of autonomy introduced by AI and the ability of continuous learning systems to change their output over time in response to new data introduces a new set of challenges that have not been considered in healthcare before,” said Joe Lewelling, AAMI’s vice president of emerging technologies and health IT standards. “A sustained global and proactive approached to standardization is essential to ensure these technologies are safe, effective, and scalable across the entire healthcare ecosystem.”

According to the white paper, The Emergence of Artificial Intelligence and Machine Learning in Healthcare: Recommendations to Support Governance and Regulation, the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) and the U.S. Food and Drug Administration “have a shared interest in seeing the recommendations from this report implemented, and new standards developed in the future.”

“Making sure the introduction and deployment of these tools into everyday healthcare is done safely is a priority for us as regulators. Standards will be a critical element of this,” said Mark Birse, group manager, device safety and surveillance at the MHRA, in a statement. “We were pleased to be able to initiate this important work and will continue to support both the emerging challenges, and the solutions.”

Jumpstarting Standardization Efforts

Although regulations and standards for software as a medical device (SaMD) have been developed, there are no standards that cover the definition, development, deployment, and maintenance of AI in healthcare.

The white paper recommends a phased program of standardization activities, including the development of guidelines to cover AI terminologies and validation approaches. To accomplish this goal, AAMI and BSI propose:

  • Creating an international task force to provide oversight for the direction of standardization activities related to AI in healthcare.
  • Reviewing the current standards landscape and identifying opportunities for new or modified publications.
  • Developing a scope and proposal for a standard covering terminologies and categorization for AI in healthcare.
  • Developing a scope and proposal for guidance to cover validation processes for AI in healthcare.
  • Building stakeholders’ understanding of market challenges and educating communities on the benefits of standardization.

Representatives from AAMI and BSI will discuss these recommendations in more detail during the 2019 International Conference on Medical Device Standards and Regulations, April 24–25 in Reston, VA, and will explain how they relate to other efforts being undertaken by the Consumer Technology Association, the Medical Imaging & Technology Alliance, and the International Organization for Standardization.

“AI is just one emerging technology where standards development will be crucial for ensuring the safety and efficacy of its implementation across the globe,” Lewelling said. “The International Conference on Medical Device Standards and Regulations will provide stakeholders with the opportunity to learn more about this technology, as well as other standards initiatives and new regulatory approaches.”

For more information about this conference, including a tentative program, visit www.aami.org/InternationalStandards. If you are unable to attend the event and would like to provide feedback on the white paper, contact Lewelling at jlewelling@aami.org.