How to Move the AI – Regulatory Needle

by Esther Abels, VP Regulatory & Clinical Affairs and Strategic Business Development, PathAI

The Digital Pathology Association, through the Regulatory and Standards Task Force, is working to define and clarify issues concerning the regulatory paths surrounding precision medicine, digital pathology and applied artificial intelligence, and the standardization of information formats for the sake of interoperability. 

The application of artificial intelligence in the practice of pathology has great potential to impact patient care, as well as transform the daily work of pathologists.  However, there is a lot of work to accomplish in order to define and make clear the regulatory pathways necessary to legally market such devices. To do so, we believe we will have to work collaboratively with likeminded organizations and participants to solve 3 things: 1) We’ll need to create consensus on the class of device for the applied AI, which we currently hold the opinion that they should be class II devices as long as they are informed decision making support tools to a licensed pathologist. 2) We’ll need to solve for how to regulate machine learning algorithms. At this point, we take smaller steps to ultimately move towards responsibly including algorithms that continuously learn and therefore start with clarifying general principles for validation of a locked down AI device. 3) We’ll need to include standardization and interoperability as a key component of the regulatory discussion, which also includes handling information from scanners that have been cleared for specific intended uses and to what extent that intended use can be extended to the intended use of any applied algorithm. Harmonization of terminology is one of these steps, see https://digitalpathologyassociation.org/white-papers_2.

 As we work on the above goals, one of our purposes as a taskforce is to educate the community as a whole, ensuring that we provide correct information in the most appropriate and clear manner possible.  The DPA has made FDA aware that it has the purpose to educate the community about sessions held with FDA. We have held public discussions and meetings in the past, and continue to do so in order to work towards solving regulatory issues surrounding our stated interests. While we work, learn and educate, we plan to publish our progress through regular updates on the DPA blog.  We also plan to provide in person and more in depth updates and education at Pathology Visions. To that point, please attend our informational seminars and discussions this year:

Oct 5 from noon to 5pm, see https://digitalpathologyassociation.org/dpa-mdic-fda-alliance-meeting

Oct 8 from 3:45-4:15pm Regulatory & Standards Update by Esther Abels, PathAI & Shyam Kalavar, FDA, see
https://digitalpathologyassociation.org/regulatory-standards-update

DPA Regulatory & Standards Task Force Policy: A maximum of two representatives from each company, i.e. one regulatory expert to address regulatory and one technical expert to address standards, may serve on the Task Force. Pathologist representatives may serve as deemed necessary by the Board of Directors and/or the Task Force Chair(s).

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