Privacy
THIS NOTICE DESCRIBES HOW MEDICAL INFORMATION ABOUT YOU MAY BE USED AND DISCLOSED AND HOW YOU CAN GET ACCESS TO THIS INFORMATION.

PLEASE REVIEW IT CAREFULLY.

  1. Purpose: Cyberonics, Inc. and its professional staff and employees follow the privacy practices described in this Notice. Cyberonics, Inc. is required by law to maintain the privacy of your health information and to provide you with this Notice of our legal duties and privacy practices with respect to health information.
  2. How Will Cyberonics, Inc. Use My Medical Information? Your medical information that is submitted to us by your Physician may be used or disclosed, unless you ask for restrictions on a specific use or disclosure, for the following purposes:

    • Treatment purposes, including communications with your Physician.
    • Payment purposes, including disclosures to obtain insurance verification and prior authorization.
    • Health care operations purposes, including contacting your Physician and you with information about treatment alternatives you will have an opportunity to refuse to receive this information.
    • Follow up phone calls.
    • Public health activities, including disclosures to enable product replacement
    • Purposes required by law; health oversight activities (including audits); administrative and judicial proceedings (including in response to a subpoena); law enforcement (including in response to a court order); to prevent a serious threat to health or safety; lawsuit and disputes (we will attempt to provide you advance notice of a subpoena before disclosing the information); national security and intelligence activities; and to military command authorities if you are a member of the armed forces or a member of a foreign military authority.
    • To inform family members or caregivers involved in your care or questions about your treatment.

  3. Your Authorization Is Required for Other Disclosures. Except as described above, we will not use or disclose your medical information unless you authorize (permit) Cyberonics, Inc. in writing to disclose your information. You may revoke your permission, which will be effective only after the date of your written revocation.
  4. You Have Rights Regarding Your Medical Information. You have the following rights regarding your medical information, provided that you make a written request to invoke the right:

    • Right to Request Restriction. You may request limitations on your medical information we use or disclose for health care, treatment, payment, or operations (e.g., you may ask that we not disclose that you have had a particular surgery), but we are not required to agree to your request. If we agree, we will comply with your request unless the information is needed to provide you with emergency treatment.
    • Right to Confidential Communications. You may request communication in a certain way or at a certain location, but you must specify how or where you wish to be contacted.
    • Right to Inspect and Copy. You have the right to inspect and copy your medical information regarding decisions about your care; however, psychotherapy notes may not be inspected and copied. We may charge a fee for copying, mailing and supplies.
    • Right to Accounting of Disclosures. You may request a list of the disclosures of your medical information that have been made to persons or entities other than for health care treatment, payment, or operations in the past six (6) years, but not prior to April 14, 2003. After the first request, there may be a charge.
    • Right to a copy of this Notice. You may request a paper copy of this Notice at any time, even if you have been provided with an electronic copy. You may obtain an electronic copy of this Notice at our web site, http://www.cyberonics.com

  5. Requirements Regarding This Notice. Cyberonics, Inc. is required by law to provide you with this Notice upon your request. We will be governed by this Notice for as long as it is in effect. Cyberonics may change this Notice and these changes will be effective for medical information we have about you as well as any information we receive in the future.
  6. Complaints. If you believe your privacy rights have been violated, you may file a complaint with Cyberonics, Inc. or with the Secretary of the United States Department of Health and Human Services. You will not be penalized or retaliated against in any way for making a complaint to Cyberonics or the Department of Health and Human Services.

Contact: Our Cyberonics Privacy Officer at (888) 508-8082 extension 7128 or email at privacy.officer@cyberonics.com if:

  • You have a complaint
  • You have any questions about this Notice
  • You wish to request restrictions on uses and disclosures for health care treatment, payment, or operations
  • You wish to exercise your individual rights described in paragraph 4
   
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  UNITED STATES INDICATION FOR USE:
The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures, which are refractory to antiepileptic medications.

VNS Therapy (or the VNS Therapy System) is indicated for the adjunctive long-term treatment of chronic or recurrent depression for patients over the age of 18 who are experiencing a major depressive episode and have not had an adequate response to four or more adequate antidepressant treatments.