The privacy of your report is protected under the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule. HIPAA specifically permits covered entities (such as pharmacists, physicians or hospitals) to voluntarily report adverse events and other information related to the quality, effectiveness and safety of FDA-regulated products both to the manufacturers and directly to FDA.
For more information, please go to the MedWatch HIPAA Compliance page.
FDA recognizes that confidentiality is an important concern in the context of adverse event reporting. The patient's identity is held in strict confidence by FDA and protected to the fullest extent of the law. However, to allow for timely follow-up in serious cases, the reporter's identity may be shared with the manufacturer unless specifically requested otherwise. The FDA will not disclose the reporter's identity in response to a request from the public, pursuant to the Freedom of Information Act.