New FDA Policies Could Limit the Full Value of AI in Medicine 

The rapid advancement of artificial intelligence (AI) in medicine is paving the way for the potential development of artificial general intelligence (AGI), a revolutionary technology capable of understanding and solving complex medical problems with human-like proficiency. However, regulatory challenges, particularly...

We Need More Robust Post-Market Surveillance For Health Care AI

As AI and machine learning (ML) continue to transform health care, the importance of effective post-market surveillance mechanisms becomes clear. With nearly 1,000 AI-enabled medical devices approved as of 2024, ranging from predictive glucose monitors to AI-equipped smartwatches, there is...

Decentralized Clinical Trials: Bust or Breakthrough?

While the life science industry began piloting decentralized clinical trials (DCTs) more than 15 years ago, the COVID 19 pandemic led to tremendous growth, primarily out of necessity.  As the world shut down, DCTs became the only viable option for...

Pathways to Governing AI Technologies in Healthcare

As AI technologies in healthcare grow, professionals in the field are worried about the regulations needed to support its increased use. With growing aspirations of how AI can be used to improve the patient and provider experience, regulations must be...

AI governance through the patient’s lens

As artificial intelligence (AI) widens its influence across a variety of industries around the world, healthcare is no exception. While feelings are mixed, many patients are expressing their concerns surrounding the use of AI in their continuum of care. Older...