Cybersecurity certification of Artificial Intelligence: a missed opportunity to coordinate between the Artificial Intelligence Act and the Cybersecurity Act

2022 ◽  
Author(s):  
Federica Casarosa
Keyword(s):  
Artificial Intelligence ◽  
Missed Opportunity

scholarly journals Conflicting information from the Food and Drug Administration: Missed opportunity to lead standards for safe and effective medical artificial intelligence solutions

2021 ◽  
Author(s):  
Tina Hernandez-Boussard ◽  
Matthew P Lundgren ◽  
Nigam Shah
Keyword(s):  
Artificial Intelligence ◽  
Medical Device ◽  
Drug Administration ◽  
Cost Savings ◽  
Clinical Decision ◽  
The Public ◽  
Decision Tools ◽  
Conflicting Information ◽  
Emerging Issues ◽  
Missed Opportunity

Abstract The Food & Drug Administration (FDA) is considering the permanent exemption of premarket notification requirements for several Class I and II medical device products, including several artificial Intelligence (AI)–driven devices. The exemption is based on the need to rapidly more quickly disseminate devices to the public, estimated cost-savings, a lack of documented adverse events reported to the FDA’s database. However, this ignores emerging issues related to AI-based devices, including utility, reproducibility and bias that may not only affect an individual but entire populations. We urge the FDA to reinforce the messaging on safety and effectiveness regulations of AI-based Software as a Medical Device products to better promote fair AI-driven clinical decision tools and for preventing harm to the patients we serve.

Artificial Intelligence

2009 ◽  
Author(s):  
David L. Poole ◽  
Alan K. Mackworth
Keyword(s):  
Artificial Intelligence

Suicidology in Ireland—A Missed Opportunity

Crisis ◽  
2000 ◽  
Vol 21 (3) ◽  
pp. 102-104
Author(s):  
John F. Connolly
Keyword(s):  
Missed Opportunity
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