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# Takeaways from FDA AI/ML Transparency Workshop
- URL: https://www.fdaweb.com/takeaways-from-fda-ai-ml-transparency-workshop/
- Published: 2021-10-28T12:00:00.000Z
- Updated: 2026-09-14T17:20:39.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5150472

Two Morrison Foerster attorneys say an FDA 10/14 virtual public workshop focused on the role of transparency in enhancing the safe and effective use of AI/ML (artificial intelligence/machine learning) technology in the medical device space, with an emphasis on information-sharing methods for patients, caregivers, and providers. The attorneys [list](https://lifesciences.mofo.com/topics/five-key-takeaways-from-FDAs-transparency-of-AIML-enabled-medical-devices-virtual-workshop.html?ref=fdaweb.com) these five workshop takeaways: 

- cultivating user awareness for both patients and healthcare providers will be a key area of focus for AI/ML-enabled device manufacturers and regulators going forward;
- transparency and effective communication of AI/ML medical device labeling will be important to consider for all user types;
- bias and systemic discrimination remain persistent issues in the AI/ML space;
- inequality, from both a patient and a manufacturer perspective, was a key workshop conversation topic; and
- transparency surrounding tracking and reporting of device errors or malfunctions will be an important discussion topic as AI/ML-enabled devices are made available.