Hospital entities are not required to have a signed Business Associate Agreement with us because the services provided by California Transplant Services, Inc. are exempt from HIPAA authorization requirements under HHS Regulations:

Uses and Disclosures – 45 §164.512 for the following purposes:

To track FDA-regulated products (b) (iii a-d),

To enable product recalls, repairs, or replacement, or look back (including locating and notifying individuals who have received products that have been recalled, withdrawn, or are the subject of look back) (c),

To conduct post marketing surveillance (d)

and for Organ, Eye or Tissue Donation Purposes (h).

If you would like a copy of the Federal Regulation 45 §164.512 in a PDF format click here.

For an article discussing the regulation 45 §164.512 in a PDF format click here.

If you have any questions about this please call us at 760-804-6890 during business hours.