Hello,
I am wondering what effect indirect influences of software error have on assigning correct software safety class in case of screening test.
If we take NIPT (non-invasive prenatal test) test for pregnant women. The false positive result of software happens when an error occurs, and a test falsely shows there is a high risk of trisomy in the foetus. A doctor can suggest amniocentesis to the pregnant woman or not (based on the other information he has). If the woman decides on amniocentesis, it is an invasive procedure that has a 1% possibility of miscarriage.
What would be your thoughts on which safety class this SW fall into? Sure, it can lead to death, but the test itself is screening, and there are external factors which must be met to lead to the worst case (doctor recommends a diagnostic test, a woman decides to go, the procedure is one of 1% that can lead to death). Do this "indirect" consequences influence the class?
I am wondering what effect indirect influences of software error have on assigning correct software safety class in case of screening test.
If we take NIPT (non-invasive prenatal test) test for pregnant women. The false positive result of software happens when an error occurs, and a test falsely shows there is a high risk of trisomy in the foetus. A doctor can suggest amniocentesis to the pregnant woman or not (based on the other information he has). If the woman decides on amniocentesis, it is an invasive procedure that has a 1% possibility of miscarriage.
What would be your thoughts on which safety class this SW fall into? Sure, it can lead to death, but the test itself is screening, and there are external factors which must be met to lead to the worst case (doctor recommends a diagnostic test, a woman decides to go, the procedure is one of 1% that can lead to death). Do this "indirect" consequences influence the class?