Regulatory framework
Psychiatric practices operate under HIPAA as covered entities through standard electronic transactions — claims, eligibility, e-prescribing including controlled substances under DEA EPCS. 42 CFR Part 2 applies separately to programs treating substance use disorder under federal-assistance criteria. State mental health confidentiality laws apply on top, frequently with stricter standards than HIPAA. Section 164.524(a)(1)(i) creates a specific protection for psychotherapy notes when maintained separately from the general record. State pharmacy boards govern controlled-substance prescribing. State medical boards impose practice and supervision rules.

