Minimum Necessary Standard
• A covered entity must try to limit the use or disclosure of
PHI to the minimum necessary to achieve the research
purpose.
• This standard applies to the following:
– Research pursuant to a waiver
– Use/disclosure of decedent’s PHI
– Uses preparatory to research
– Limited Data Sets
• Minimum Necessary Standard does not apply to the
following:
– Treatment disclosures or requests
– Use or disclosure made with an authorization
– Disclosures to the individual
– Disclosures to DHHS for compliance
– Disclosures required by law