Legal disclaimer for web application for clinical research, HIPPA compliance

[eric1988]

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.

 

[FlyingRon]

First off, it's HIPAA, not HIPPA. A disclaimer won't suffice to make something HIPAA compliant (other than one perhaps that says covered entities should NOT use your software for protected health information). In addition, HIPAA is just the tip of the iceberg. If there is any clinical use for your software, it needs to meet the FDA medical device requirements (501k). These far from trivial, and if you've not already got the proper development methods in place (something like ISO 9000-ish procedures). I had a medical imaging application that was placarded against clinical use for years. We started over for the 501k-approved modules.

 

[quincy]

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.

"Any idea where to get started on this?"

Yes. You should start by meeting with an attorney.

You will need assistance drafting the terms and conditions and disclaimer - but you should note that these alone do not protect you from any legal actions that might arise over your web application. These can only work to mitigate damages awarded against you, should someone be successful in a suit against you.

You should have adequate insurance.

And you should look to medical experts for help with your application so that you don't make errors (like calling the Health Insurance Portability and Accountability Act by the wrong acronym).

Where are you located (what country)?

 

[adjusterjack]

And you should look to medical experts for help with your application so that you don't make errors (like calling the Health Insurance Portability and Accountability Act by the wrong acronym).

Hippa is a genus of decapod crustaceans.

 

[quincy]

Hippa is a genus of decapod crustaceans.

What is semi-interesting about HIPAA's acronym is that the Accountability Act is mistakenly referred to as HIPPA so often that in a Google search for members of the Hippidae family, links to the Health Portability Act show up first.

Google assumes you erred.

 

[quincy]

Here is a link to a HIPAA compliance checklist:
https://www.google.com/amp/s/www.hipaajournal.com/hipaa-compliance-checklist/?amp

 

[eric1988]

First off, it's HIPAA, not HIPPA. A disclaimer won't suffice to make something HIPAA compliant (other than one perhaps that says covered entities should NOT use your software for protected health information). In addition, HIPAA is just the tip of the iceberg. If there is any clinical use for your software, it needs to meet the FDA medical device requirements (501k). These far from trivial, and if you've not already got the proper development methods in place (something like ISO 9000-ish procedures). I had a medical imaging application that was placarded against clinical use for years. We started over for the 501k-approved modules.

Everything else has been taken care so far except disclaimer as well as terms & condition for doctor & patient signup.

 

[eric1988]

"Any idea where to get started on this?"
You should have adequate insurance.

Except for disclaimer as well as terms & condition for doctor & patient signup, everything is taken care of including insurance.

 

[eric1988]

Hippa is a genus of decapod crustaceans.

Ok

 

[eric1988]

Here is a link to a HIPAA compliance checklist:
https://www.google.com/amp/s/www.hipaajournal.com/hipaa-compliance-checklist/?amp

Thanks or the link but all this things are taken care. We just need some one to draft disclaimer as well as terms & condition for doctor & patient signup.

 

[Just Blue]

Thanks or the link but all this things are taken care. We just need some one to draft disclaimer as well as terms & condition for doctor & patient signup.

That is beyond the scope of this forum. You need to hire an attorney.

Please read the TOS of this site so that you will better understand it's function. Thanks...

 

[quincy]

Thanks or the link but all this things are taken care. We just need some one to draft disclaimer as well as terms & condition for doctor & patient signup.

Where are you located?

There are many international law firms where you can find assistance drafting the terms and conditions and the disclaimer that will comply with US laws and with the laws of the countries where you will be marketing your web application.

Good luck.

 

[Zigner]

Everything else has been taken care so far except disclaimer as well as terms & condition for doctor & patient signup.

You've already got FDA approval?

 

[quincy]

You've already got FDA approval?

I don't see that the FDA would be involved with the web application, although the US Department of Health and Human Services perhaps could be.

 

[FlyingRon]

I don't see that the FDA would be involved with the web application, although the US Department of Health and Human Services perhaps could be.

If there is any clinical aspect, the FDA is very much interested involved. The fact that it doesn't touch the patient doesn't exempt it from being considered a medical device under the law.