Relating to the sale, design, and manufacture of orthodontic devices.

Contracts

• MSAs with Dentists: Manufacturers and labs must amend agreements to require dentist-partners to provide "written or electronic confirmation" of the in-person exam and x-ray review.
• Indemnification: Strengthen clauses to protect the manufacturer/lab if a provider falsifies the clinical verification.
• Teledentistry Networks: Contracts must explicitly assign responsibility for the *in-person* exam and physical record retention to the provider.

Hiring/Training

• Sales & Support: Staff must be retrained on the new "hard stop" workflow. No order can move to manufacturing or billing without the verified clinical data packet.
• Compliance Officers: Designate personnel responsible for auditing the "confirmation" files to ensure they meet the 7-year retention standard.

Reporting & Record-Keeping

• 7-Year Retention: You must upgrade data storage to retain dentist confirmations and patient acknowledgments for seven years post-sale.
• New Intake Forms: Update patient portals to capture specific dates of in-person exams and x-ray reviews.
• Patient Acknowledgment: Implement a mandatory form where the patient signs verifying they received counsel on treatment options and risks.

Fees & Costs

• Data Storage: Budget for increased costs associated with long-term secure document retention.
• Revenue Impact: Anticipate a drop in conversion rates due to the friction of mandatory in-person visits for previously remote-eligible patients.