Comment on FR Doc # 2010-16718

As a healthcare consumer I am requesting that the proposal prohibit disclosure of PHI for research purposes unless the consumer (subject?) provides informed consent (opt-in). I do not believe that all research organizations have the financial means to comply with Privacy and Security Rules. Therefore, I consider my protected health information at risk. Additionally, an Institutional Review Board or Privacy Board should not be able to authorize the access a consumers’ PHI or medical information without obtaining informed consent (opt-in) and providing an understanding of the scope of the research study and data handling (1. where and how obtained, 2. where it is held, 3. How it will be used (how, length of time, etc.), and 4. how and when it will be disposed). I believe that consumers own their medical information and would like to have the option to donate their de-identified medical information for research purposes without restriction(s). Finally, thank you ONC for your contributions to improving healthcare.