PHI (Protected Health Information)
Definition
Protected Health Information (PHI) is any individually identifiable health information that is created, received, maintained, or transmitted by a covered entity or its business associates in connection with health care operations. PHI includes information about an individual’s past, present, or future physical or mental health condition, the provision of health care, or the payment for health care.
In the 340B context, PHI includes patient prescription records, eligibility data, dispensing records, and claims information used to administer the program. This data flows between the covered entity, its EHR system, split-billing software, TPAs, and contract pharmacies—all of which must handle it in compliance with HIPAA.
PHI must be protected through appropriate administrative, physical, and technical safeguards. Access must be limited to those with a legitimate need. Any sharing of PHI with vendors must be governed by a Business Associate Agreement.
Frequently Asked Questions
Why PHI (Protected Health Information) Matters
340B program operations involve extensive handling and sharing of PHI. Inadequate PHI protections expose covered entities to HIPAA enforcement risk and undermine patient trust. HRSA also expects covered entities to have appropriate data security practices as part of overall program management.
How Virtue 340B Uses It
Virtue 340B ensures that our data handling practices comply with HIPAA and that we have appropriate BAAs in place with all covered entity clients. We also help clients assess whether their vendor relationships include proper PHI protections.