The debate over how the FDA should regulate the emerging solutions that use AI for healthcare applications is one that is attracting opposite but truly equally valid points of view.   Baku Patel, former head...

Before any new diagnostic or therapeutic, or technology can be used in the practice of healthcare, it has to be deemed safe and effective by certain regulatory bodies. US, EU, Japan, and others have robust...

Evidence-based AI is not exclusive to showing that AI algorithms will improve patient outcomes, improve clinical workflows, or lower the cost of care.  Currently there is a great deal of variability in risk-mitigating AI development...

My discussions with many of the experts in AI in Healthcare has highlighted the fact that well-designed, large-scale, multi-center trials have not been done so far. These types of trials would establish the efficacy and...

According to a survey of over 12,000 participants conducted by the consultancy PwC, lack of trust and a need for the human element were the biggest hurdles to using AI in healthcare.  Another survey by KPMG in...