Healthcare Equipment Evaluation Agreement

Healthcare Equipment Evaluation Agreement

Parties and Patient Information

Patient Name:

Insurance Information

Medical History

Equipment Evaluation Details

Equipment Name:

Purpose of Evaluation:

Provider/Company Supplying Equipment:

Device supplied by (check all that apply): Manufacturer Healthcare Provider Third Party Supplier

Consent, Risks, Benefits and Data

I, the undersigned patient or legal representative, authorize the provider to place the equipment described above for the purpose of clinical evaluation and trial use. I understand that the equipment is being provided for short-term evaluation and is not a permanent medical device assignment.

Risks and Benefits: I have been informed of the intended benefits of the equipment and reasonably foreseeable risks, which may include device malfunction, skin irritation, discomfort, and need for additional clinical monitoring. I acknowledge that there may be unknown risks associated with evaluation use. I have had the opportunity to ask questions and to have those questions answered to my satisfaction.

Right to Withdraw: I understand I may discontinue the evaluation at any time and request removal of the equipment. Withdrawal will not affect my right to continue receiving healthcare services from the provider.

Data Collection and Use: The device may collect physiological or usage data. I authorize collection of device data for clinical assessment, device performance evaluation, quality assurance, and, if applicable, de-identified research or product improvement. I understand that identifying health information will be treated in accordance with applicable privacy and confidentiality policies.

I consent to the collection and limited use of my device data as described above: I consent I decline

Equipment Handling; Liability; Insurance

Care and Use: I agree to follow all instructions regarding safe use, maintenance, storage, and cleaning of the equipment. I will not modify the equipment or permit others to use it without prior authorization from the supplying party. I will notify provider promptly of any malfunction, damage, or adverse event.

Loss or Damage: I accept responsibility for loss or damage to the equipment while in my possession due to misuse or negligence, and will reimburse reasonable repair or replacement costs, except to the extent caused by ordinary wear or manufacturer defect.

Insurance and Liability: The supplying party represents that it maintains appropriate insurance for equipment demonstration and testing. To the maximum extent permitted by law, I release and hold harmless the provider and supplying party from liability for injuries arising solely from the evaluation use except for wilful misconduct or gross negligence.

Return, Inspection and Ownership

Ownership: I acknowledge that title to the equipment remains with the supplying party. The equipment shall be returned by me or the provider to the supplying party at the conclusion of the evaluation or upon earlier request.

Inspection: The supplying party may inspect equipment condition upon return. Any discrepancy in condition will be documented and may be the basis for assessment of repair or replacement charges as described above.

Authorization and Expiration

This authorization for evaluation and data collection will expire on:

If no date is provided above, this authorization will remain in effect for the duration of the stated evaluation period unless revoked earlier in writing. Revocation of this authorization does not affect disclosures already made in reliance on this authorization.

HIPAA / Privacy Acknowledgment

I acknowledge that I have been informed of how my protected health information may be used or disclosed in connection with the equipment evaluation, and that the provider has provided a written notice of privacy practices describing those uses and disclosures.

Acknowledgment: I acknowledge receipt of the privacy notice

Representations, Indemnification and Governing Law

Representations: I represent that the information I have provided in this agreement is true and complete to the best of my knowledge and that I have authority to enter into this agreement.

Indemnification: To the extent permitted by law, I agree to indemnify and hold harmless the provider and supplying party from any third-party claims, losses, or damages arising from my breach of this agreement, negligent use of the equipment, or unauthorized modifications or alterations.

Governing Law: This agreement shall be governed by the laws of the jurisdiction in which the provider maintains its principal place of business, without regard to conflict-of-law principles.

Miscellaneous

Entire Agreement: This document constitutes the entire agreement regarding the evaluation equipment between the parties and supersedes all prior oral and written agreements on this subject.

Amendment: Any amendment to this agreement must be in writing and signed by the patient or the patient's authorized representative and an authorized representative of the supplying party.

Copies: Electronic or facsimile copies of this agreement are effective as originals for all purposes.

Patient Certification

By signing below I certify that I have read and understand this Healthcare Equipment Evaluation Agreement, that my questions have been answered, and that I consent to the evaluation and any authorized data collection described herein.

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