1. Nature of This Tool — Not a Medical Device
This software application ("System") is a clinical decision support tool designed to assist licensed healthcare professionals in organizing clinical information and referencing institutional trauma protocols. This System is not a medical device as defined under Section 520(o)(1) of the Federal Food, Drug, and Cosmetic Act, as amended by Section 3060 of the 21st Century Cures Act (Pub. L. 114-255). Consistent with FDA Final Guidance on Clinical Decision Support Software (March 2026), this System is intended to display and organize medical information and enable the healthcare professional ("User") to independently review the basis for any recommendations presented. No output of this System is intended to replace, override, or serve as the primary basis for clinical diagnosis or treatment decisions.
2. No Replacement for Clinical Judgment
All suggestions, recommendations, alerts, and decision pathways generated by this System are intended solely to assist with — not replace — the independent medical judgment of the treating provider. The User acknowledges and agrees that all final clinical decisions, including but not limited to diagnosis, treatment, admission, transfer, and discharge decisions, remain the sole responsibility of the attending physician or authorized healthcare provider. This System does not practice medicine and no output should be interpreted as a medical order, directive, or prescription.
3. Standard of Care
The User acknowledges that the standard of care applicable to the treatment of any patient is determined by the clinical circumstances of each individual case and the professional judgment of the treating provider, not by any algorithm, protocol, or recommendation generated by this System. Clinical protocols referenced within this System, including but not limited to those derived from the Advanced Trauma Life Support (ATLS) 10th Edition and institution-specific algorithms, represent general guidelines and are not a substitute for individualized clinical assessment. Deviation from any protocol or recommendation presented by this System may be medically appropriate based on patient-specific factors.
4. No Doctor-Patient Relationship
Use of this System does not create a doctor-patient, provider-patient, or therapeutic relationship between the developers, operators, or licensors of this System and any patient. No duty of care to any patient arises from the development, maintenance, distribution, or operation of this System by its developers or operators.
5. No Warranty of Accuracy
While this System incorporates clinical references, evidence-based protocols, and peer-reviewed guidelines, the developers and operators make no representation or warranty, express or implied, regarding the accuracy, completeness, timeliness, or clinical reliability of any information, recommendation, or output generated by this System. Clinical medicine evolves continuously. The User is responsible for verifying all clinical information against current authoritative sources before applying it to patient care.
6. Limitation of Liability
To the maximum extent permitted by applicable law, including North Carolina General Statutes, the developers, operators, licensors, and affiliated institutions of this System shall not be liable for any direct, indirect, incidental, special, consequential, or punitive damages, including but not limited to damages arising from misdiagnosis, delayed diagnosis, inappropriate treatment, patient injury, or death, that arise from or relate to the use of, reliance upon, or inability to use this System or any information or recommendation it provides. This limitation applies regardless of the legal theory upon which the claim is based, including negligence, strict liability, breach of warranty, or any other theory.
7. Indemnification
The User agrees to defend, indemnify, and hold harmless the developers, operators, and licensors of this System, and their respective officers, directors, employees, and agents, from and against any and all claims, damages, obligations, losses, liabilities, costs, and expenses (including reasonable attorney fees) arising from the User's use of this System in connection with patient care, the User's violation of this Agreement, or the User's violation of any applicable law or regulation.
8. Compliance with Applicable Law
The User is solely responsible for ensuring that their use of this System complies with all applicable federal, state, and local laws and regulations, including but not limited to: the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and its implementing regulations (45 C.F.R. Parts 160 and 164); the Health Information Technology for Economic and Clinical Health (HITECH) Act; applicable provisions of the Federal Food, Drug, and Cosmetic Act as amended by the 21st Century Cures Act; North Carolina Medical Practice Act (N.C.G.S. Chapter 90); and all applicable state and institutional policies governing clinical practice, documentation, and scope of practice. The User acknowledges that this System does not collect, store, or transmit Protected Health Information (PHI) as defined under HIPAA. No patient-identifiable data is entered into, processed by, or retained by this System.
9. Institutional Responsibility
The User's employing institution or healthcare facility is responsible for evaluating this System's appropriateness for use within its clinical environment, for training its staff on the proper use and limitations of the System, and for establishing institutional policies governing its use. Institutional adoption of this System does not transfer any clinical liability to the System's developers or operators.
10. Acknowledgment of Risk
The User acknowledges that clinical decision support systems, including this System, may contain errors, may not account for all patient-specific variables, and may produce recommendations that are clinically inappropriate for a given patient. The User accepts full professional responsibility for all clinical decisions made in connection with or following the use of this System.
11. Modification and Termination
The developers and operators reserve the right to modify, update, or discontinue this System at any time without prior notice. Continued use of the System following any modification constitutes acceptance of the modified terms.
12. Governing Law and Jurisdiction
This Agreement shall be governed by and construed in accordance with the laws of the State of North Carolina, without regard to its conflict of laws provisions. Any dispute arising under or in connection with this Agreement shall be subject to the exclusive jurisdiction of the state and federal courts located in the State of North Carolina.
13. Severability
If any provision of this Agreement is held to be invalid or unenforceable, the remaining provisions shall continue in full force and effect.
14. Entire Agreement
This Agreement constitutes the entire agreement between the User and the developers/operators of this System with respect to its subject matter and supersedes all prior or contemporaneous communications, representations, or agreements, whether oral or written.