1) Ultraflex is not a patient care facility for Medicare or Medicaid
patients, does not bill electronically, and therefore is not covered
by HIPAA's patient facility requirements.
2) By policy, Ultraflex does not accept Protected Health Information
(PHI) as defined by HIPAA, and, therefore, each customer does not
need a business associates agreement with Ultraflex.
3) Even if PHI is sent for custom fabrication instructions, Ultraflex
is not a business associate as defined by HIPAA, since this is normal
and customary clinical information exchange, necessary to deliver
4) Ultraflex does ask that each order include the patients initials
or a PO number to reference and additional information needed to
review diagnosis, prognosis and orthometry to assure all potential
indications, precautions and contra-indications are reviewed, so
technology and orthoses design is optimized. All such information,
while not PHI, will still be held in the strictest confidence and
only be used for ordering, design and fabrication processes.
However, recognizing different potential interpretations
of the regulation, Ultraflex will sign any reasonable Business Associate
Agreement upon customer request.
Our ABC accredited onsite research facility fully adheres to HIPAA regulations.