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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 ...
One of the considerations in support of this move to electronic prescriptions was the view that using electronic prescriptions in lieu of written or oral prescriptions could reduce medical errors that occur because handwriting is illegible or phoned-in prescriptions are misunderstood as a result of similar-sounding medication names.
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 ...
An electronic trial master file (eTMF) is a trial master file in electronic (digital content) format.It is a type of content management system for the pharmaceutical industry, providing a formalized means of organizing and storing documents, images, and other digital content for pharmaceutical clinical trials that may be required for compliance with government regulatory agencies.
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 ...
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