Artificial Intelligence/Machine Learning have delivered us to such a challenging time with a relatively new technology with such potential for power, for both good and bad.
With digital health startups receiving $14 billion globally and $9 billion domestically, there is a lot on the line in regards to the AI/ML based SaMD FDA Action Plan.
Engineers will wait, but what about the investors?
Last week, the FDA’s Center for Devices and Radiological Health (CDRH) released its new five-part “Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan”, in which it described the agency’s efforts to regulate products that incorporate AI.
This will be fascinating to watch the evolution, reach, and interpretation of where the regulatory oversight will begin and end.
Decision making. Do we become better informed or facilitate our own blindness?
Data. What is the level of acceptable bias?
Equitable. Who decides this and based on which parameters is equity defined?