Healthcare Non-Medical Device Statement

HEALTHCARE NON-MEDICAL DEVICE STATEMENT

Facility Name:

Patient Information

Insurance Information (if applicable)

Medical History (summary)

Device Information (Non-Medical Device Brought by Patient)

Device Category (select all that apply):

Wearable sensor (e.g., activity tracker)
Assistive device (e.g., mobility aid, brace)
Consumer electronics (e.g., smartphone, tablet)
Personal monitoring device (non-diagnostic)
Other

Acknowledgements, Risks, and Responsibilities

I acknowledge that the device identified above is not provided, maintained, or certified by the facility as a medical device. The device has not been evaluated for safety, effectiveness, or compatibility with clinical equipment by the facility. I understand that the device is brought for my personal use and I assume full responsibility for its condition, operation, and any outcomes arising from its use while on facility premises.

I further acknowledge and agree that the facility and its staff have no obligation to monitor data produced by the device or to rely upon that data for clinical decision-making. The facility disclaims any warranty, express or implied, concerning the device. To the extent permitted by law, I release and indemnify the facility, its employees, agents, and contractors from any claims, losses, liabilities, or damages arising from the presence or use of this device.

The facility reserves the right to restrict, disconnect, or remove any device that interferes with care, jeopardizes safety, or poses a risk to clinical equipment. In such circumstances, facility staff will make reasonable efforts to notify me prior to action when feasible.

Infection Control and Maintenance: I accept responsibility for ensuring the device is clean and maintained according to manufacturer recommendations. I acknowledge that the facility may require cleaning or isolation of a device before staff handle it and that I am responsible for any costs associated with cleaning or special handling.

Data and Privacy: I understand the device may collect, store, or transmit personal health information. The facility is not responsible for data retained or transmitted by the device. I consent to the facility's limited handling of the device as necessary for safety or clinical care but do not confer any ownership of data to the facility.

By signing below, I certify that the information provided is accurate to the best of my knowledge and that I have had the opportunity to ask questions about risks, responsibilities, and alternatives. I understand I may withdraw this statement in writing at any time, subject to any action already taken by the facility in reliance on this document.

Consent for Staff Handling (check if consented):

I authorize facility staff to handle or temporarily remove the device for reasons of safety, clinical care, or infection control.

I authorize facility staff to power down or disconnect the device if it interferes with clinical equipment.

I acknowledge that the facility is not responsible for collecting, storing, or interpreting data generated by my device.

Privacy Notice Acknowledgment

By checking the box below I acknowledge that I have received or been offered a notice of privacy practices from the facility and understand how the facility may use or disclose protected health information in the course of care.

I acknowledge receipt or offer of the facility's privacy notice.

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