Who must comply with the third-party audit/certification requirement for electronic CII prescriptions?

The third-party audit/certification requirement for electronic prescriptions for controlled substances (CII) is primarily directed at the application providers responsible for the systems that facilitate electronic prescribing. These application providers must demonstrate compliance with established security and regulatory standards, ensuring that the electronic prescriptions are transmitted securely and that the identity of the prescriber is verified.

Individual practitioners, pharmacies, and hospitals rely on these electronic application systems, but the audit/certification focus is on the developers and providers of the software and technology used for electronic prescription generation. This is critical because it ensures that the electronic process adheres to the rigorous standards set out for handling CII prescriptions, which are more sensitive due to their potential for misuse and abuse. Thus, the correct option reflects the primary responsibility for ensuring compliance with these requirements, emphasizing the role of technology providers in safeguarding the prescription process.