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HIPAA Compliance

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 custom orthoses.

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.

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