Resources
Three primary-source pages to check this module’s reasoning yourself. All three were curl-verified (curl -s -o /dev/null -w "%{http_code}" -L <url>) and returned 200 at the time this page was written.
45 CFR 164.506, eCFR — the treatment/payment/health care operations permission this module leans on hardest. Read paragraph (c), which this module’s excerpt didn’t quote, if you want the full list of what counts as a TPO disclosure beyond the standard in (a).
45 CFR 164.512, eCFR — the full public-health-activities section that paragraph (b)(1)(iii) (the FDA-regulated-product exception quoted in full above) sits inside. Useful if you ever need one of 164.512’s other paragraphs (judicial/law-enforcement disclosures, decedents, research) — none of which this module quotes or relies on.
45 CFR 164.514, eCFR — the full minimum-necessary section, including paragraphs (a)-(c) and (e)-(g) this module’s excerpt deliberately left out (de-identification methodology, limited data sets, and research/marketing-adjacent provisions). Read (d)(4) and (d)(5) here if you want the rest of the minimum-necessary implementation specifications beyond (d)(1)-(3).