Department of Health and Human Services July 10, 2012 – Federal Register Recent Federal Regulation Documents

The Office of the National Coordinator for Health Information Technology (ONC) announces the launch of the What's In Your Health Record Video Challenge. This challenge is an open call for the public to create and submit short, compelling videos sharing how getting access to your health record and checking the information can help make sure you or your loved one get the best care. Having access to your health record is fundamental to your ability to participate in your health care. Patients and their families have a legal right under the HIPAA Privacy Rule to request to see and get a copy of their health record (``right to access'') from most doctors, hospitals and other health care providers, such as pharmacies and nursing homes, as well as from their health plans. Patients can use that information to better understand their health, to coordinate their care with other health care providers or to help identify possible errors or omissions in their medical records. Patients can get access to their health information through a patient portal, or a personal health record (PHR) or by email. This is the third in a series of Health IT video contests that will occur throughout 2012. The video contests are one way to crowd source stories from the public about how they are benefiting from health information technology (health IT). This is one way ONC is working to motivate and inspire individuals to play a more active role in their health. Each video contest will be a call to action for members of the public to create a short video clip [2 minutes or less] on a particular topic, and will award cash prizes to winners in several categories.

The Food and Drug Administration (FDA) is proposing to establish a unique device identification system to implement the requirement added to the Federal Food, Drug, and Cosmetic Act (FD&C Act) by section 226 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), Section 226 of FDAAA amended the FD&C Act to add new section 519(f), which directs FDA to promulgate regulations establishing a unique device identification system for medical devices. The system established by this rule would require the label of medical devices and device packages to include a unique device identifier (UDI), except where the rule provides for alternative placement of the UDI or provides an exception for a particular device or type of device such as devices sold over-the-counter and low risk devices. Each UDI would have to be provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology. The UDI would also be required to be directly marked on the device itself for certain categories of devices for which the labeling requirement may not be sufficient, for example, those that remain in use for an extended period of time and devices that are likely to become separated from their labeling. The rule would require the submission of information concerning each device to a database that FDA intends to make public, to ensure that the UDI can be used to adequately identify the device through its distribution and use.