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Press Release
PRIM&R Responds to FDA, "Proposed Regulatory Framework for Modifications to AI/ML-Based Software as a Medical Device”
June 10, 2019
Boston, MA— On April 2, the FDA published a Discussion Paper: "Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD).” In our June 2019 response, PRIM&R expresses appreciation to the FDA for rethinking its regulatory framework for devices as the use of adaptive AI/ML-based technologies become increasingly prevalent in the health and wellness space.
At the same time, PRIM&R asks the FDA, as it determines appropriate oversight of adaptive AI/ML-based technologies, to consider the ethical impact of generating training data and optimizing algorithmic models through data that comes from interactions with human beings in real time. PRIM&R raises these concerns in light of the tech sector’s increasing use of algorithms that may be based on human subject research to develop health and wellness products. The FDA’s review of these issues is especially important given the lack of federal oversight of private sector software and social media companies that depend on not just observing, but at times perturbing human beings’ engagement with software to develop their products and services. Increasingly, these observations are taking place in real time on an almost continuous basis with companies frequently pulling source material not only from the user but also from those they are in contact with, such as friends and acquaintances.
The response also describes four human research protection issues the FDA should consider as they craft a new regulatory framework, which should begin to extend to certain health products produced that are not currently considered as medical devices:
- Honoring people's wishes regarding the use of, and access to, their information
- Privacy risks, including risks of re-identification of anonymized data
- Transparency
- Understandability
Read PRIM&R's Full Response
About PRIM&R
Since 1974, PRIM&R has advanced the highest ethical standards in the conduct of research. We accomplish this mission through education, membership services, professional certification, public policy initiatives, and community building. PRIM&R is a 501(c)3 nonprofit. Find out more at www.primr.org
Media Contact:
Daniel McLean
Public Engagement Manager
Public Responsibility in Medicine and Research (PRIM&R)
Direct: 617-303-1877
dmclean@primr.org
www.primr.org