Healthcare Medtrade Participation Form

Healthcare Medtrade Participation Form

Participant Information

Emergency Contact

Insurance Information

Medical History

Program Description and Consent

I, the undersigned participant, consent to participate in the Medtrade program activities, which may include device demonstrations, user feedback sessions, limited device trials, surveys, photography and videography, and collection of relevant health information. Program location: . Program date(s): .

Risks and benefits: I understand participation may involve minimal to moderate risks including discomfort, allergic reaction to materials, or unforeseen device-related issues. Anticipated benefits include contributing to product improvement and receiving information about the tested device or service. No guarantee of direct medical benefit is made.

Consent to participate: I voluntarily agree to participate in the described activities. I confirm that participation is voluntary and I may withdraw at any time without penalty or loss of benefits to which I am otherwise entitled.

Authorization to photograph and record: I authorize Medtrade staff and their agents to photograph and/or record my likeness, voice and statements during program activities. I grant a perpetual, royalty-free license to use such materials for educational, promotional and procedural improvement purposes, subject to participant confidentiality protections described below.

HIPAA authorization and limited release of health information: By signing below I authorize my treating providers and any listed insurer to disclose my protected health information (PHI) necessary for participation, including diagnosis, treatment dates, relevant test results, and medication lists, to authorized Medtrade program staff, device sponsor representatives, and their designated agents for program administration, follow-up, and device evaluation. The types of information to be disclosed are limited to treatment information directly related to participation and required for device evaluation. This authorization does not authorize release of psychotherapy notes.

Authorization expiration date: . This authorization expires on the date entered above, or, if left blank, one year from the date of signature below. I understand I may revoke this authorization at any time by submitting written notice to the Medtrade program coordinator identified on the cover of this form; revocation will not apply to information already released in reliance on this authorization prior to receipt of revocation.

Sharing with sponsors and third parties: I consent to the limited sharing of my PHI with participating sponsors and contracted vendors for the specific purposes described in this form. Such recipients are required to protect my information and may not re-disclose PHI except as permitted by law.

Emergency treatment and liability: If a medical emergency occurs during program activities, I authorize Medtrade personnel to arrange or provide emergency medical care and transport. I understand that I am responsible for any costs associated with emergency care. I release and hold harmless Medtrade organizers and associated providers from liability for ordinary negligence in connection with program activities to the extent permitted by law.

Communications: I consent to be contacted regarding scheduling, follow-up, or program-related communications via phone, email or text at the contact information provided above.

Certification: I certify that the information provided on this form is true and complete to the best of my knowledge. I have read and understand the statements above, I have had the opportunity to ask questions, and all my questions have been answered to my satisfaction.

Participant Attestation

By signing below I attest that I am the participant named on this form or am the authorized guardian signing on behalf of the participant and have authority to execute this participation agreement and HIPAA authorization.

Notice: Medical information collected in connection with program participation will be used for program administration, device evaluation and quality improvement. Unless otherwise authorized, data will be retained only as necessary for program purposes and in accordance with applicable law. This form does not create a provider-patient relationship beyond activities disclosed herein and does not constitute endorsement of any device or sponsor.

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