Re: HIPAA & adverse event reimbursement Schoen, Alexander 28 Apr 2003 14:44 EST
Is the Sponsor subject to HIPAA? As a sponsor they have the right to the patient data and presumably they know which patient had the AE. If this is the case, why can't they send the check? Didn't they review the patients chart to asses the AE? -----Original Message----- From: Herbert B. Chermside [mailto:xxxxxx@VCU.EDU] Sent: Monday, April 28, 2003 3:08 PM To: xxxxxx@HRINET.ORG Subject: [RESADM-L] HIPAA & adverse event reimbursement We have had our first instance in which a clinical trial sponsor is willing to pay patient costs resulting from an adverse event caused by the study treatment, BUT is unwilling to reimburse the patient directly. They seem to feel that this is contrary to HIPAA regulations which require that the research must use deidentified data, and that paying the patient directly would identify him/her. So we are struggling with the question of WHO would be responsible for accepting and transmitting the company's reimbursement for the adverse event. And how to make that "agent's" activities HIPAA compliant. Anyone seen this position by any clinical trial sponsor? Any solutions to the problem? Any ideas of a way to thrust this back onto the company in a way that is HIPAA compliant? BTW, we haven't discussed with our attorneys. We're looking for advice from the list first! Chuck --- and Michael Katz Herbert B. Chermside, CRA Director, Sponsored Programs Administration Virginia Commonwealth University PO BOX 980568 Richmond, VA 23298-0568 Express Delivery Only: Biotech One, Suite 113 Virginia Biotechnology Research Park 800 East Leigh Street Richmond, VA 23219 Voice: 804-828-6772 Fax 804-828-2521 OFFICE e-mail xxxxxx@VCU.EDU Personal e-mail xxxxxx@vcu.edu http://www.research.vcu.edu/ospa.htm ====================================================================== Instructions on how to use the RESADM-L Mailing List, including subscription information and a web-searchable archive, are available via our web site at http://www.hrinet.org (click on "Listserv Lists") ====================================================================== CONFIDENTIALITY NOTICE: This transmission is intended only for the individual or entity to which it is addressed and contains information that is confidential. If you have received this communication in error, please notify the sender at the email address above and delete this email immediately. This information has been disclosed to you from confidential records and is protected by federal and state law. This information may include confidential mental health, substance abuse, alcohol abuse and/or HIV related information. Federal and state law prohibits you from making any further disclosure of this information without the specific written consent of the person to whom it pertains, or as otherwise permitted by law. Any unauthorized further disclosure in violation of the law may results in a fine or jail sentence or both. A general authorization for the release of this information may not be sufficient authorization for further disclosure. ====================================================================== Instructions on how to use the RESADM-L Mailing List, including subscription information and a web-searchable archive, are available via our web site at http://www.hrinet.org (click on "Listserv Lists") ======================================================================