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HIPAA (Health Insurance Portability and Accountability Act) applicability

R

RAQABJM

#1
Hi All,

Looking for a little HIPAA help.

We distribute our device through a dealer network, we are reimbursed by the dealer electronically, but we build our product directly for the patient. We get measurements and other information from the dealer/hospital and assemble a device per these measurements then ship to the dealer who sells to the patient.

1) My conclusion is that we are not a covered entity, we would be a business associate. Does this seem to be the right conclusion?

2) What do we need in place to satisfy HIPAA? We have begun with an information privacy and protection business statement and are writing up basic procedures which outline the protection of any information we do receive. Is there anything additional we would need?

Thanks for any and all help.
 
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J

Jon Nonns

#2
Hi All,

Looking for a little HIPAA help.

We distribute our device through a dealer network, we are reimbursed by the dealer electronically, but we build our product directly for the patient. We get measurements and other information from the dealer/hospital and assemble a device per these measurements then ship to the dealer who sells to the patient.

1) My conclusion is that we are not a covered entity, we would be a business associate. Does this seem to be the right conclusion?

2) What do we need in place to satisfy HIPAA? We have begun with an information privacy and protection business statement and are writing up basic procedures which outline the protection of any information we do receive. Is there anything additional we would need?

Thanks for any and all help.
Hi there. I am definitely not an expert on the HIPAA requirements or the law in grave detail. I highly recommend though that you encourage all correspondence and the delivery of specifications/measurements come with a patient identifier and not with any personally identifying information. By doing this you will maintain traceability to the patient without and infringements on personal privacy issues. Just my opinion and :2cents:.

Jon
 
R

RAQABJM

#3
Thanks Jon,

I considered trying to get dealers to use patient identifiers but I think it is common practice in my industry to put the patients name in the order when buying the device. Makes it hard to get something from them but I am going to keep pressing my dealers to try and get this though. But even if I do have patient identifiers I still have the patient information and need to protect it.

Brian
 
D

drewsky1

#4
We have a autogolous blood transfusion device that we have a label where the clinician can enter the patient's name for identification. Can anyone provide input if we are responsible if the user does not protect the patient from anyone seeing that blood container with patient's name on it? I feel it is the hospital's burden however a consultant has indicated that we would be responsible. We just provide the label on the blood container and do not know what patient's name would be entered. I could not see anything in the HIPPA policy that directs me to any specific reason why we need to remove this label.
 
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