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The Unique Device Identification (UDI) System is intended to assign a unique identifier to medical devices within the United States, Europe, China, South Korea, Saudi Arabia and Taiwan. [1] It was signed into law in the US on September 27, 2007, as part of the Food and Drug Administration Amendments Act (Section 226) of 2007.
1. The removal of 18 specific identifiers listed above (Safe Harbor Method) 2. Obtain the expertise of an experienced statistical expert to validate and document the statistical risk of re-identification is very small (Statistical Method). [4] [5] De-identified data is coded, with a link to the original, fully identified data set kept by an ...
Such systems are part of an overall information system and may interact with the person's electronic health record, [1] where information specific to the person is stored, the system used by radiology departments to track patients as well as the system storing medical images, the pathology laboratory information management system, as well as ...
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Patient safety work product includes any data, reports, records, memoranda, analyses (such as root cause analyses), or written or oral statements (or copies of any of this material), which are assembled or developed by a provider for reporting to a PSO and are reported to a PSO; or are developed by a patient safety organization for the conduct ...
Obtain consent from individuals if the company intends to collect or disclose their personal biometric identifiers. Destroy biometric identifiers in a timely manner. Securely store biometric identifiers. [6] A key area of focus is that an entity must use a "reasonable standard of care" [7] in managing biometric information and identifiers.
Health Insurance Portability and Accountability Act of 1996; Other short titles: Kassebaum–Kennedy Act, Kennedy–Kassebaum Act: Long title: An Act To amend the Internal Revenue Code of 1986 to improve portability and continuity of health insurance coverage in the group and individual markets, to combat waste, fraud, and abuse in health insurance and health care delivery, to promote the use ...
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