Comment: One commenter stated the proposed rule dramatically changed the definition of standard. The commenter stated the new definition implies that any and all standards promulgated by an ANSI SSO or HHS automatically become a standard, whereas under the Act, only the Secretary can specify, establish, or adopt standards. The commenter recommended the definition under the Act stay the same.
Response: We agree that only the Secretary may adopt a standard under the Act. Because the statutory definition of the term “standard” is ambiguous, we are adopting a broader definition to accommodate the varying functions of the specific standards proposed in the other HIPAA regulations. We have revised the definition in §160.103 to clarify this, and have also added a definition for standard transaction in §162.103 for further clarification.