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Clinical documentation improvement (CDI), also known as "clinical documentation integrity", is the best practices, processes, technology, people, and joint effort between providers and billers that advocates the completeness, precision, and validity of provider documentation inherent to transaction code sets (e.g. ICD-10-CM, ICD-10-PCS, CPT, HCPCS) sanctioned by the Health Insurance ...
EHNAC grew out of the 1993 Workgroup for Electronic Data Interchange (WEDI) meeting, sponsored by the Network Architecture and Accreditation Technical Advisory Group. The healthcare transactions industry agreed there was a need for a self-governing body to develop standards for the industry, and the Association for Electronic Health Care Transactions (AFEHCT) championed the cause by sponsoring ...
This guidance supersedes the guidance of the same name dated April 1999; and supplements the guidance for industry on Part 11, Electronic Records; Electronic Signatures — Scope and Application and the Agency's international harmonization efforts when applying these guidances to source data generated at clinical study sites.
Good clinical data management practice (GCDMP) is the current industry standards for clinical data management that consist of best business practice and acceptable regulatory standards. In all phases of clinical trials , clinical and laboratory information must be collected and converted to digital form for analysis and reporting purposes.
The rules are intended to eliminate certain C coding practices which make code difficult to review or statically analyze. These rules are a complement to the MISRA C guidelines and have been incorporated into the greater set of JPL coding standards .
Guidances for statistics in regulatory affairs refers to specific documents or guidelines that provide instructions, recommendations, and standards pertaining to the application of statistical methodologies and practices within the regulatory framework of industries such as pharmaceuticals and medical devices. These guidances serve as a ...
Data retention laws and regulations ask data owners and other service providers to retain extensive records of user activity beyond the time necessary for normal business operations. These requirements have been called into question by privacy rights advocates. [35] Compliance in this area is becoming very difficult.
An example of a data-integrity mechanism is the parent-and-child relationship of related records. If a parent record owns one or more related child records all of the referential integrity processes are handled by the database itself, which automatically ensures the accuracy and integrity of the data so that no child record can exist without a parent (also called being orphaned) and that no ...