Privacy/Disclaimer

Disclaimer:  This program does not endorse any specific brand of diabetes medication, supply, or device.  Our providers utilize their knowledge and your insurance plan’s formulary to determine the most effective medication for you both physically and financially.  Any information on this website that is from a specific manufacturer is used because of it’s beneficial, informative content and is not an endorsement of that company’s product.

AUTHORIZATION OF USE AND DISCLOSE PROTECTED HEALTH INFORMATION FOR RESEARCH PURPOSES

The privacy law, Health Insurance Portability & accountability Act (HIPAA), protects your individually identifiable health information (protected health information).  The privacy law requires you to sign an authorization (or agreement) in order for researchers to be able to use or disclose your protected health information for research purposes in the study entitled Related Aspects of the “About the Patient” Diabetes Disease State Management Program.  Please read the information below to see if you agree to allow the use of your protected health information for this study.

Who will have access to your protected health information related to your participation in this research study?

Only the principal investigators, their assistants, you health benefit provider, Blue Cross Blue Shield of North Dakota, and your provider will have access to study information that is identifiable as yours.

What protected health information will be used or disclosed?

Health information that will be used for this study, but reported anonymously, includes: age, sex, weight, laboratory results, Hemoglobin A1c (where applicable), cholesterol (where applicable), blood pressure (where applicable), and the responses to condition specific questionnaires that provide medical history, symptoms, list of medications, and health related behaviors (nutrition, activity, smoking history).  In addition, data on the cost of health care for the study group will be tracked and reported. 

What will your protected health information be used for?

This information will be used to determine if an employer sponsored wellness program that provides improved access to medication, education, and frequent follow-up with a care manager will result in clinical improvement and lower overall health care costs.

Who will the researchers share your protected health information with?

The Institutional Review Board.

Government representatives, such as the Food and Drug Administration and the Office of Human Research Protections when required by law.

This information may be shared with your physician or health educator.

Individual, but unidentifiable, information will be shared with statisticians for statistical analysis of the study group.

When laboratory testing is done it will be necessary for laboratory personnel to know who the individuals are that are being tested.

Information on the group outcomes, but not individual outcomes may be reported in medical and/or pharmaceutical journals.

Once your health information has been disclosed to anyone outside of this study, the information may no longer be protected under this authorization.  Therefore, the researchers agree to protect your health information by using and disclosing it only as permitted by you in this Authorization and as directed by state and federal law.

You do not have to sign this Authorization.  If you decide not to sign the Authorization:

It will not affect your treatment, payment or enrollment in any health plans or affect your eligibility for benefits.

You may not be allowed to participate in this disease state management research study.

After signing the Authorization, you can change your mind and:

Not let the researchers disclose or use your protected health information (revoke the Authorization).

If you revoke the Authorization, you must send a written letter to the Clinical Coordinator to inform him of your decision.

If you revoke this Authorization, researchers may only use and disclose the protected health information already collected for this research study.

If you revoke this Authorization your protected health information may still be used and disclosed should you have an adverse event (a bad effect).

If you change your mind and withdraw the Authorization, you may not be allowed to continue to participate in this study.

You may not be allowed to review the information collated for the research until after the study is completed.  When the study is over, you will have the right to access the information again.

This Authorization does not have an expiration date.

If you have not already received a copy of the Privacy Notice, you may request one.  If you have any questions or concerns about your privacy rights in this research study, you should contact the Clinical Coordinator at 1-877-364-3932 or by writing Clinical Coordinator, Frontier Pharmacy Services, 3306 Sheyenne St, Suite 218, West Fargo, ND  58078.