William,
thanks for the 140 suggestion. That looks like it would work now I'll just
have to find out why
it isn't being used other than it is another transaction for a hospital to
implement. The FDA actually
requires the manufacturers of medical devices to make a good faith effort to
keep track of patients that
have their devices implanted, the doctors and hospitals are off the hook on
this part. Any recall notice goes
to the patient. The FDA does auditing to make sure these companies make
this good faith effort and
that they do have procedures in place for a potential recall.
The other interesting area is if the HIPAA regulations for security and
privacy are going to cover
these patient registries. The FDA mandates these registries but to my
knowledge does not have any
of the requirements for security and privacy like HIPAA. HIPAA is not
supposed to supersede any
other government jurisdiction like the FDA but I wonder what happens in a
situation like this where
there would be another layer on top of existing regulations that don't
appear to conflict.
Thanks for your help.
Dave Frenkel
----- Original Message -----
From: William J. Kammerer <[EMAIL PROTECTED]>
To: <[EMAIL PROTECTED]>
Sent: Friday, February 23, 2001 5:12 AM
Subject: Re: HIPAA - Patient registration
> Dave Frenkel wrote: "Does anybody have any suggestions for a transaction
> to do patient registration for tracking medical devices. The FDA
> requires medical devices like pacemakers to be tracked by the
> manufacturers for things like recalls. It is common for patient
> information to be on hospital purchase orders (850) but under HIPAA
> privacy regulations this will probably not be allowed, accounting has no
> need to know patient info since it is the hospital usually being
> billed."
>
> Rachel Foerster "[doesn't] believe there is a requirement to
> track/report to the FDA UNLESS there is an adverse event or the device
> is explanted. Thus, again I don't believe there is a standard
> transactions for this purpose." She suggests that Dave "...may wish to
> look at the 275 Patient Information transaction to see if it will meet
> your needs."
>
> Dear Rachel:
>
> Dave said that the "FDA requires medical devices like pacemakers to be
> tracked by the manufacturers," not anything about reporting to the FDA -
> you're reading far too much into the question.
>
> Thus, somehow the hospital - which was responsible for implanting the
> device - needs to tell the manufacturer who the thing was stuck into.
> Presumably the manufacturer would like to capture not only the patient
> details, but also record stuff like the surgeon and hospital, so it can
> get in contact with the relevant parties if a ticker is later determined
> to have a likelihood of a problem. This doesn't sound too much
> different from product recalls of automobiles or tires - it's the
> manufacturer that collects the information, not some government
> authority.
>
> It's a product being registered in this case, not the patient, and
> something like the X12 140 - Product Registration - transaction set
> might be more appropriate than your suggestion of the 275 Patient
> Information transaction set. And when the product is recalled, its
> sister transaction - the X12 143 Product Service Notification - can be
> sent to the hospitals (or the surgeons) who then would notify the
> individual patients in a discreet, expeditious and sensitive manner:
> "Hey pal, you're dead meat unless you get your ass in here, pronto."
>
> Though the 140 and 143 are not HIPAA standard transactions, there's no
> law that says they couldn't be used in this context, assuming the
> transactions are securely transferred between hospitals and
> manufacturers.
>
> William J. Kammerer
> FORESIGHT Corp.
> 4950 Blazer Pkwy.
> Dublin, OH USA 43017-3305
> +1 614 791-1600
>
> Visit FORESIGHT Corp. at http://www.foresightcorp.com/
> "accelerating time-to-trade"
>
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