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A predicate rule is any requirement set forth in the Federal Food, Drug and Cosmetic Act, the Public Health Service Act, or any FDA regulation other than Part 11. [3] The rule also applies to submissions made to the FDA in electronic format (e.g., a New Drug Application) but not to paper submissions by electronic methods (i.e., faxes). It ...
With the development and implementation of electronic technologies in Russian healthcare system, electronic prescription became part of the project called EMIAS. EMIAS is the digital system designed to increase the quality and access of the medical aid in the public health facility. The project was designed and being implemented as part of ...
Medical and health care providers experienced 767 security breaches resulting in the compromised confidential health information of 23,625,933 patients during the period of 2006–2012. [78] One major issue that has risen on the privacy of the US network for electronic health records is the strategy to secure the privacy of patients. Former US ...
The electronic health record (EHR) is a more longitudinal collection of the electronic health information of individual patients or populations. The EMR, in contrast, is the patient record created by providers for specific encounters in hospitals and ambulatory environments and can serve as a data source for an EHR.
An electronic signature, or e-signature, is data that is logically associated with other data and which is used by the signatory to sign the associated data. [1] [2] [3] This type of signature has the same legal standing as a handwritten signature as long as it adheres to the requirements of the specific regulation under which it was created (e.g., eIDAS in the European Union, NIST-DSS in the ...
(8) Electronic signature - means an electronic sound, symbol, or process attached to or logically associated with a record and executed or adopted by a person with the intent to sign the record. Another important aspect of this definition lies in the necessity that the electronic signature be linked or logically associated with the record.