Home > radiation safety > NRC Exploring E-Signatures in Written Directives

NRC Exploring E-Signatures in Written Directives

During its September 22-23 business meeting, the U.S. Nuclear Regulatory Commission’s (NRC) Advisory Committee on the Medical Uses of Isotopes (ACMUI) discussed the issue of identifying electronic signature standards for written directives.  The discussion, a continuation of the dialog started by NRC back in October 2010, was intended to inform NRC staff as they write guidance for regional investigators on the requisite characteristics of acceptable e-signatures.

NRC staff presented their preliminary thoughts on potential characteristics of acceptable e-signatures, particularly the need for:

  • Unique identification
  • Authentication
  • Non-repudiation
  • Data integrity assurance

Members of the ACMUI mentioned that other federal agencies and programs deal with electronic standards and NRC should be careful not to conflict with things such as standards, implementation specifications, and certification criteria for EHR technology.  The guidance must also be flexible enough to be suitable for licensees with low or no levels of HIT adoption; for example, any licensees that store written directives electronically but do not use EHR technology to do so.

Ultimately, ACMUI members decided to form a subcommittee to report back with a recommended approach for how NRC might be able to gather the information they need to develop good guidance.

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Categories: radiation safety
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