Terms of Service & Clinical Regulatory Disclaimer (21st Century Cures Act Exemption)
Executive Regulatory Summary
This binding Agreement governs access to and use of the SnowPoint AI Clinical Audit & Appeal Engine ('Platform') operated by SnowPoint Healthcare ('Company', 'we', 'us') at app.snowpointhealthcare.com. The Platform operates strictly as an administrative healthcare Revenue Cycle Management (RCM), clinical documentation structuring, and Non-Device Clinical Decision Support (CDS) software exempt from FDA medical device regulation under Section 3060(a) of the 21st Century Cures Act.
Scope of SaaS Administrative & Revenue Cycle Management (RCM) Services
SnowPoint Healthcare provides a specialized business-to-business (B2B) Software-as-a-Service (SaaS) platform engineered exclusively for licensed healthcare professionals, hospital revenue integrity departments, utilization review (UR) teams, clinical documentation improvement (CDI) specialists, and medical billing entities ('Authorized Subscribers').
The Platform performs administrative support, retrospective and concurrent clinical documentation auditing, interoperability data structuring into Health Level Seven Fast Healthcare Interoperability Resources (HL7 FHIR Release 4) schemas, Diagnosis-Related Group (DRG) and Current Procedural Terminology (CPT) cross-validation, and assisted drafting of administrative and medical necessity claim denial appeal dossiers (collectively, 'Revenue Cycle Management & Audit Services').
By creating an account, executing an Order Form, or uploading any de-identified clinical text to app.snowpointhealthcare.com, Subscriber agrees to be legally bound by these Terms of Service and all incorporated regulatory policies.
United States Federal Regulatory Declaration: 21st Century Cures Act Exemption (Non-Device CDS)
Under United States federal law, the SnowPoint AI Clinical Audit & Appeal Engine qualifies as 'Non-Device Clinical Decision Support (CDS) & Administrative Healthcare Software' and is expressly excluded from the statutory definition of a 'device' (and therefore exempt from U.S. Food and Drug Administration [FDA] Software as a Medical Device [SaMD] regulation) pursuant to Section 3060(a) of the 21st Century Cures Act, codified at Section 520(o)(1)(E) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 360j(o)(1)(E)), as well as the FDA Final Guidance on Clinical Decision Support Software (September 2022).
Specifically, the Platform satisfies all four mandatory statutory criteria set forth in 21 U.S.C. § 360j(o)(1)(E)(i)–(iii):
- (a) No Signal or Medical Image Acquisition [21 U.S.C. § 360j(o)(1)(E)(i)]: The Platform does NOT acquire, process, or analyze a medical image, a signal from an in vitro diagnostic (IVD) device, or a pattern/signal from a physiological signal acquisition system (such as raw ECG waveforms, continuous ICU telemetry streams, or DICOM pixel data).
- (b) Display & Analysis of Medical Information & Peer-Reviewed Literature [21 U.S.C. § 360j(o)(1)(E)(i)]: The Platform is intended solely for the purpose of displaying, analyzing, structuring, or printing de-identified medical documentation, payer clinical coverage policies (CMS NCD/LCD, commercial utilization criteria), and peer-reviewed biomedical literature indexed in the National Library of Medicine (PubMed/NCBI).
- (c) Support for Healthcare Professionals [21 U.S.C. § 360j(o)(1)(E)(ii)]: The Platform is intended solely to support or provide administrative, coding, and clinical documentation recommendations to a qualified healthcare professional regarding clinical documentation accuracy, medical necessity substantiation, and payer denial rebuttal.
- (d) Independent Review & Transparency of Basis [21 U.S.C. § 360j(o)(1)(E)(iii)]: The Platform enables the healthcare professional to independently review the complete underlying basis, clinical rationale, structured FHIR v4 data points, and verifiable bibliographic citations (PMID/DOI) for every recommendation presented, such that it is NEVER the intent that the healthcare professional rely primarily on any software output to make a clinical diagnosis, treatment decision, or formal appeal submission.
STATUTORY SAFE HARBOR NOTICE (21 U.S.C. § 360j(o)(1)(E))
SnowPoint AI outputs are transparent, citation-backed analytical drafts designed for independent evaluation by a licensed clinician. They are never autonomous clinical directives and are never intended for time-critical emergency triage.
Non-Practice of Medicine Clause & Exclusive Clinical Responsibility
SNOWPOINT HEALTHCARE DOES NOT PRACTICE MEDICINE, NURSING, OR ANY OTHER LICENSED HEALTHCARE PROFESSION. The Company does not act as a treating physician, consulting specialist, legal representative, or third-party administrator, nor does the Platform establish any physician-patient relationship.
Nothing generated, displayed, or exported by the Platform shall be construed as medical advice, a definitive clinical diagnosis, an order to initiate or withhold patient care, or a substitute for the independent professional judgment of a duly licensed physician or healthcare provider.
EXCLUSIVE RESPONSIBILITY OF SUBSCRIBER: The final review, clinical verification, modification, approval, and formal signature of any medical necessity appeal letter, peer-to-peer rebuttal brief, ICD-10/CPT/DRG coding attestation, or clinical determination submitted to any governmental payer (e.g., CMS Medicare/Medicaid), commercial health insurer, or Administrative Law Judge (ALJ) is the sole, non-delegable, and exclusive responsibility of the licensed physician or accredited healthcare institution holding the Subscriber account.
Subscriber Representations, Warranties & False Claims Act Compliance
Subscriber represents and warrants that: (i) all users accessing the Platform under Subscriber's organization are appropriately credentialed healthcare professionals, certified coders, or authorized revenue cycle personnel; (ii) Subscriber shall manually verify all clinical facts, laboratory values, timelines, and citations in any generated draft against the official medical record prior to external submission; and (iii) Subscriber shall not use the Platform to fabricate clinical findings, upcode claims, or submit false or fraudulent claims in violation of the U.S. Federal False Claims Act (31 U.S.C. §§ 3729–3733) or equivalent international healthcare fraud statutes.
Intellectual Property, Limitation of Liability & Indemnification
SnowPoint Healthcare retains all right, title, and interest in and to the Platform, its proprietary multi-agent orchestration engines, HL7 FHIR v4 mapping pipelines, and user interface. Subscriber retains full ownership of all input data and all final appeal letters exported from the Platform.
TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, THE PLATFORM IS PROVIDED 'AS IS' WITHOUT WARRANTY OF GUARANTEED PAYER REIMBURSEMENT OR APPEAL OVERTURN. In no event shall SnowPoint Healthcare's aggregate liability exceed the total subscription fees paid by Subscriber during the twelve (12) months immediately preceding the claim. Subscriber agrees to indemnify and hold harmless SnowPoint Healthcare from any third-party, payer, regulatory, or patient claims arising from Subscriber's clinical decisions or unverified submission of appeal documents.