Legal disclaimer for web application for clinical research, HIPPA compliance

[quincy]

Perhaps.

Here is a link to what the FDA regulates: https://www.fda.gov/medicaldevices/digitalhealth/mobilemedicalapplications/default.htm

 

[xylene]

Let's be blunt. The lawyers telling you everything is good to go need to write or at least authorize the disclaimer, since only they seem to matter.

 

[quincy]

Let's be blunt. The lawyers telling you everything is good to go need to write or at least authorize the disclaimer, since only they seem to matter.

I have a sneaking suspicion that no lawyers have been involved yet, hence the search for answers here.

An attorney should be involved, however, and not only for the drafting of the terms and disclaimer but to ensure the web application complies with all applicable laws.

 

[eric1988]

no lawyers have been involved yet

True

An attorney should be involved, however, and not only for the drafting of the terms and disclaimer but to ensure the web application complies with all applicable laws.

Agreed & the quest for attorney brought us here.

 

[eric1988]

Perhaps.

Here is a link to what the FDA regulates: https://www.fda.gov/medicaldevices/digitalhealth/mobilemedicalapplications/default.htm

Thanks for the link, the technical aspect including encryption & data security has been taken care. But we do not have lawyer so the only thing left before production deployment is disclaimer etc. Hence here searching for someone who can help us.

 

[FlyingRon]

There are darned few attorneys here and none of the ones who are here are qualified to advise you on HIPAA or medical device compliance.
This is a very specialized area. When I was the Vice President of a medical software company, we had both specialized attorneys and medical device consultants (ours was an MD who was involved in that area).

The forum doesn't do lawyer referrals either. There are some "referal" links eleswhere on this site or you can try https://www.martindale.com/

ut we do not have lawyer so the only thing left before production deployment is disclaimer etc. Hence here searching for someone who can help us.

If you haven't previously had an attorney involved, you're not at the "last step." Disclaimers don't mean anything. As I stated earlier on, you can't fix the HIPAA and FDA deficiencies with a disclaimer (other than telling people you aren't compliant and they shouldn't use it).

 

[eric1988]

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.

FDA is involved (Title 21 CFR Part 11).

 

[quincy]

... Agreed & the quest for attorney brought us here.

Good. Now your quest should take you to a law firm in your country that handles international law. We cannot assist with drafting your disclaimer or the terms and conditions of use as that falls outside the scope of this forum.

I had been thinking your app would come under one of the Appendix A applications that are not regulated. It is good that you checked.

You are smart to be getting the legalities dealt with before the launch of your web app. I wish you success with it.

 

[eric1988]

There are darned few attorneys here and none of the ones who are here are qualified to advise you on HIPAA or medical device compliance.
This is a very specialized area. When I was the Vice President of a medical software company, we had both specialized attorneys and medical device consultants (ours was an MD who was involved in that area).

The forum doesn't do lawyer referrals either. There are some "referal" links eleswhere on this site or you can try https://www.martindale.com/


If you haven't previously had an attorney involved, you're not at the "last step." Disclaimers don't mean anything. As I stated earlier on, you can't fix the HIPAA and FDA deficiencies with a disclaimer (other than telling people you aren't compliant and they shouldn't use it).

Understood, thanks for the response.

 

[eric1988]

Good. Now your quest should take you to a law firm in your country that handles international law. We cannot assist with drafting your disclaimer or the terms and conditions of use as that falls outside the scope of this forum.

I had been thinking your app would come under one of the Appendix A applications that are not regulated. It is good that you checked.

You are smart to be getting the legalities dealt with before the launch of your web app. I wish you success with it.

Understood, thanks for the response.

 

[quincy]

Understood, thanks for the response.

We all appreciate the thanks, Eric.