Important Notice: If you participated in the “Fetal Intrapartum Heart Rate FHR/ECG Study” at Akron City Hospital between the dates of March 2013 and February 2014 we have important information for you. Please see below and contact us at 330.375.3000 for additional information.
The research study you agreed to participate in is called the “Fetal Intrapartum Heart Rate FHR/ECG Study.” To participate in this study, you should have been asked to sign a form called an “HIPAA Authorization” giving the study researchers your permission to use and disclose you and your baby’s health information. When Summa officials recently reviewed the research records for this study they found that you were not asked to sign the Authorization form — only the informed consent document.
Once you completed your participation in the study, you and your baby’s health information was shared (disclosed) to the sponsor of the research study in accordance with the approved study plan. However, sharing your information was only allowed if you had signed the Authorization form to give your permission.
HIPAA (Health Insurance Portability and Accountability Act) requires that Summa Health System now notify you in writing that this disclosure occurred without your written Authorization, even though you voluntarily agreed to participate in this research study.
Please understand that the health information that was shared with the sponsor does not contain your name, social security number, address, medical record number, or financial information. Therefore, it would be very difficult for anyone outside of Summa Health System to know that the information is about you or your baby. We have taken steps with the sponsor to restrict disclosure of your information and have tightened the research process regarding completion of the authorization form.
Summa takes seriously its obligation to protect your health information. Please contact us at 330.375.3000 for additional information.