HIPAA Privacy Policy for the Study Participants in the United States (including Puerto Rico)

This privacy notice describes how  personal identifiable information about you may be used and disclosed and how you can get access to this information. Please review it carefully.

Your Rights

You have the right to: 

  • Get a copy of your electronic records from this Study’s website
  • Correct your electronic record on this Study’s website
  • Request for confidential communication with AI and/or your Study Site related to this Study’s website.
  • Ask AI Software, Inc. to limit the information we share as described in this privacy policy
  • Get a list of those with whom we have shared your personal identifiable information
  • Get a copy of this privacy notice for your own records.
  • Choose someone to act for you. If you choose to do this, please discuss with your Study Doctor who is acting on your behalf and how, as this Study’s webpages is about self-injecting your Study Drug, while you are on the Study.
  • File a complaint if you believe your privacy rights have been violated

Our Uses and Disclosures

AI Software, Inc. may use and share your information  for the following reasons: 

  • To run our business
  • Help with public health and safety issues
  • Do research as required per the Study
  • Comply with the law
  • Work with your study doctor 
  • Address law enforcement, and other government requests related to the Study
  • Respond to lawsuits and legal actions related to the Study
  • May need to provide information to your Study Site, Study Doctor, Study staff about your activity related to the Study’s webpages.
  • May need to provide anonymous / coded data to the clinical research organiszation Medpace and/or the Sponsor so they can be made aware of how many Study subjects are accessing the portal for compliance purposes.

Your Rights

When it comes to your  personal identifiable information, you have certain rights. This section explains your rights and some of our responsibilities to help you.

Get an electronic record 

  • You can ask to see or get an electronic copy of records and other personal identifiable information we have about you. 
  • AI Software, Inc. will provide a copy or a summary of your personal identifiable information, usually within thirty (30) days of your request. We may charge a reasonable, cost-based fee for this request.

Ask us to correct your record

  • You can ask us to correct information about you that you think is incorrect or incomplete. 
  • We may say “no” to your request, but we will tell you why in writing within thirty (30) days.

Request confidential communications

  • You can ask AI Software, Inc. to contact you in a specific way (for example, home or office phone) or to send e-mail to a different email address. 
  • We will say “yes” to all reasonable requests.

Ask us to limit what we use or share

  • You can ask us not to use or share certain personal identifiable information for treatment or our operations. We are not required to agree to your request, and we may say “no” if it would affect your care.

Get a list of those with whom we’ve shared information

  • You can ask for a list (accounting) of the times we have shared your personal identifiable information for six (6) years prior to the date you ask, who we shared it with, and why.
  • AI Software, Inc. will include all the disclosures except for those about treatment, and operations, and certain other disclosures (such as any you asked us to make). We’ll provide one (1) accounting per year for free, but will charge a reasonable, cost-based fee if you ask more than one (1) time within twelve (12) months.

Get a copy of this privacy notice

  • You can ask for a paper copy of this notice at any time, even if you have agreed to receive the notice electronically. We will provide you with a paper copy promptly, as long as you provide your full mailing address.

Choose someone to act for you

  • If you have given someone medical power of attorney or if someone is your legal guardian, that person can exercise your rights and make choices about your personal identifiable information.
  • AI Software, Inc. will make sure the person has this authority and can act for you before we take any action.

File a complaint if you feel your rights are violated

  • You can complain if you feel AI Software, Inc. have violated your rights by contacting at info@aisoftware.us .
  • You can file a complaint with the U.S. Department of Health and Human Services Office for Civil Rights by sending a letter to 200 Independence Avenue, S.W., Washington, D.C. 20201, calling 1-877-696-6775, or visiting www.hhs.gov/ocr/privacy/hipaa/complaints/.
  • AI Software, Inc. will not retaliate against you for filing a complaint.

 

Your Choices

For certain personal identifiable information, you can tell us your choices about what we share. If you have a clear preference for how we share your information in the situations described below, talk to us. Tell us what you want us to do, and we will follow your instructions.

In these cases, you have both the right and choice to tell us to:

  • Share information with your family, close friends, or others involved in your care
  • Share information in a disaster relief situation

If you are not able to tell us your preference, for example if you are unconscious, we may go ahead and share your information if we believe it is in your best interest. We may also share your information when needed to lessen a serious and imminent threat to health or safety.

In these cases we never share your information unless you give us written permission:

  • Marketing purposes
  • Sale of your information

 

Our Uses and Disclosures

How does AI Software, Inc. typically use or share your personal identifiable information? 

We typically use or share your  personal identifiable information in the following ways.

Treat you

We can use your  personal identifiable information and share it with professionals who are treating you.

Example: Your Study doctor treating you for your illness.

Run our organisation

We can use and share your personal  identifiable information to run our practice, improve your care regarding the instructional video on our webpages, and contact you when necessary.

Example: We may use personal identifiable information about you to manage your services related to the Study. 

How else can AI Software, Inc. use or share your  personal identifiable information? 

We are allowed or required to share your information in other ways – usually in ways that contribute to the public good, such as public health and research for the purpose of the Study. We have to meet many conditions in the law before we can share your information for these purposes. For more information see: www.hhs.gov/ocr/privacy/hipaa/understanding/consumers/index.html.

Help with public health and safety issues

We can share  personal identifiable  information about you for certain situations such as: 

  • Preventing disease
  • Helping with Study Drug recalls
  • Reporting adverse reactions to  the Study Drug 
  • Preventing or reducing a serious threat to anyone’s health or safety

Do research

We can use or share your information for health research for the purpose of this Study.

 

Comply with the law

AI Software, Inc. will share information about you if state or federal laws require it, including with the Department of Health and Human Services if it wants to see that we are complying with the federal privacy law, as applicable.

Work with your Study Doctor 

AI Software, Inc. can share health information with your Study Doctor, Study staff and/or Study site.

Address workers’ compensation, law enforcement, and other government requests

AI Software, Inc. can use or share personal identifiable information about you:

  • For law enforcement purposes or with a law enforcement official
  • With health oversight agencies for activities authorised by law
  • For special government functions related to the Study 

Respond to lawsuits and legal actions

We can share personal identifiable information about you in response to a court or administrative order, or in response to a subpoena.

AI Software, Inc.’s Responsibilities

  • We are required by law to maintain the privacy and security of your protected personal identifiable information. 
  • We will let you know promptly if a breach occurs that may have compromised the privacy or security of your information.
  • We must follow the duties and privacy practices described in this notice and give you a copy of it. 
  • We will not use or share your information other than as described here unless you tell us we can in writing. If you tell us we can, you may change your mind at any time. Let us know in writing if you change your mind. 

For more information see: www.hhs.gov/ocr/privacy/hipaa/understanding/consumers/noticepp.html.

Changes to the Terms of this Notice

AI Software, Inc. can change the terms of this notice through permission of the clinical research organisation Medpace and the Sponsor of the study, NGM Biopharmaceuticals, and the changes will apply to all information we have about you. The new notice will be available to view on this Study website and your study site will provide you a notice of these updates.

 

Effective Date of this Notice : 09-21-2020