HackerTrans
TopNewTrendsCommentsPastAskShowJobs

ware_am_i

no profile record

comments

ware_am_i
·há 4 anos·discuss
It's cool to see another FDA AI Regulatory person on HN. Drop me a note if you are interested in connecting -> [email protected]
ware_am_i
·há 4 anos·discuss
As a medical device company, establishing and documenting your approach to answer these questions can go a long way. More of a policy vs protocol approach.
ware_am_i
·há 5 anos·discuss
Hey, I’ve done dozens of similar implementations within Med device companies. Happy to chat -> [email protected]
ware_am_i
·há 5 anos·discuss
This is largely where the art of "labeling/claims" comes into play regarding how explicitly worded a "diagnosis" can be. There is a lot of room to play on the spectrum from truly diagnosing a patient with a disease (which requires the most evidence and carries the most liability) all the way down to gently prompting a healthcare provider to look at one record earlier than another one while reviewing their reading queue.