Legal disclaimer for web application for clinical research, HIPPA compliance

[eric1988]

Jurisdiction

Florida

We have new web application that deals with doctor & patient data, which comes under HIPPA. So before we go live we need to add appropriate disclaimer, terms of user, general terms etc. Any idea where to get started for this? As we are more focused on tech side rather then legal. Any one can help paid or otherwise?

PS: The application will be deployed in USA.

 

[cbg]

If you're going to do anything with HIPAA you might learn to spell it right first.

A disclaimer is not going to do it and this is not a DIY project. You need an attorney.

 

[adjusterjack]

which comes under HIPPA

HIPAA - Health Insurance Portability and Accountability Act

Hippa is a genus of decapod crustaceans.

Any idea where to get started for this?

A lawyer's office.

Any one can help?

A lawyer.

Bottom line: You need to read the Act, understand it, and obey it.

Health Insurance Portability and Accountability Act - Wikipedia

There are training classes that you and your employees can take.

 

[flyingron]

You don't make HIPAA compliance by putting in a disclaimer. About the only disclaimer that you can add that would be meaningful would be to tell covered entities it is NOT suitable to use for PHI.

HIPAA is only one aspect. If there is going to be clinical use of the software it needs 501k compliance as well, and that's way more involved than HIPAA's requirements.

Not only do you need an attorney, you need a consultant that is well versed in medical product development issues.

 

[eric1988]

You need an attorney.

I guess that why we are posting this in a law / legal forum?

PS : Apologies for the typo.

 

[eric1988]

A lawyer.

Everything else including insurance has been taken care of. And we are posting this in this in a law / legal forum so someone having knowledge in this can approach us.

 

[eric1988]

You don't make HIPAA compliance by putting in a disclaimer. About the only disclaimer that you can add that would be meaningful would be to tell covered entities it is NOT suitable to use for PHI.

HIPAA is only one aspect. If there is going to be clinical use of the software it needs 501k compliance as well, and that's way more involved than HIPAA's requirements.

Not only do you need an attorney, you need a consultant that is well versed in medical product development issues.

Thanks for the input & yes we have taken care of above. Only thing remains is
disclaimer as well as terms & condition for doctor & patient signup.

 

[cbg]

What you are looking for is far beyond the scope of a message board.

 

[ElleMD]

Attorneys do not use the boards to search for business. There is a find a lawyer button at the top of the page you can use to seek out an appropriate attorney.