Rachel,

It is both.  The software or the vendor or the clearinghouse needs to be 
compliant.  They need to have the capability to send or receive HIPAA 
compliant transactions.  Without that capability, none of their customers can 
be compliant.

Once the capability of the software is demonstrated, each user of that 
software needs to be certified.  Why?  The two most important reasons are:

- This software is not "shrink wrap" and is customized for each site.  Even 
in the case of a clearinghouse, the transmissions between the provider or 
payer and the clearinghouse use a variety of formats, some of which may not 
have all the data necessary for compliance.

- HIPAA is a lot more than data format, it is data content.  If the required 
data content, or the situational data content, is not present, regardless of 
the software ability, the transaction is not compliant.  So, the users 
themselves need to be aware of the "situational" requirements of HIPAA that 
apply to their business.  At the end, it is the user that is the covered 
entity and needs to be in compliance, as you well said.

A vendor or clearinghouse representing that just because their software has 
the capability of producing / receiving compliant transactions, all of their 
customers will be automatically compliant with the HIPAA transactions is 
either misleading the customers or does not quite understand what is it that 
it means to comply with the transactions.  Sorry about the harsh words, but 
some people need to wake up to reality.

As you know, the system vendors are not covered entities, and most of them 
are probably not even business associates.

Just my $.02 worth.

Kepa



On Tuesday 16 April 2002 09:18 pm, Rachel Foerster wrote:
> My opinion is that it's the software that's certified, not the corporate
> entity. The software must create/process complying transactions so the
> software must be certified.
>
> In other industries and other areas of electronic commerce, many of the
> standards development organizations also create what's called "conformance"
> requirements that developers can use to validate that the software they
> develop does indeed "conform" to the standard specification.
>
> This is what HIPAA certification does.
>
> But, there's another aspect to this. That is, that software is not "HIPAA"
> compliant....it's only a tool that enables the user to process transactions
> that comply with the specifications. But, my viewpoint is that software can
> be certified as having the ability to process transactions that comply with
> the guides, but the user can mis-use or misunderstand how to configure a
> software and thus actually create non-compliant transactions.
>
> So, software can be certified, but it's the covered entity that complies
> with the law and the regulations.
>
> Rachel
> Rachel Foerster
> Principal
> Rachel Foerster & Associates, Ltd.
> Professionals in EDI & Electronic Commerce
> 39432 North Avenue
> Beach Park, IL 60099
> Phone: 847-872-8070
> Fax: 847-872-6860
> http://www.rfa-edi.com
>
>   -----Original Message-----
>   From: Natasha Farvan [mailto:[EMAIL PROTECTED]]
>   Sent: Tuesday, April 16, 2002 5:01 PM
>   To: [EMAIL PROTECTED]
>   Subject: Certification
>
>
>
>
>
>   I'm in the process of creating a TCI software vendor readiness
> questionnaire and one of my questions is if they are certified. But then it
> occurred to me does the certification apply to the entity or the
> application?
>
>   Your input is appreciated.
>
>   Natasha Farvan
>   Sr. I.S. Project Leader
>   HIPAA Transactions & Code Sets Project Manager
>   Information Technology Group
>   Oregon Health & Sciences University
>   1500 SW First Ave Ste 100B
>   Portland, OR  97201
>   Mailcode: Crown
>   Tel (503) 494-0561
>   Fax (503) 494-4626
>
>
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