Terms of Service

Last updated: June 5, 2026. Effective: June 5, 2026.

Clinical disclaimer (read first): PPHrisk is a clinical decision-support tool intended to assist licensed healthcare professionals. It is not a diagnostic device. It does not provide medical advice or treatment. The output is informational only — clinical judgment, the patient's clinical picture, and institutional protocols always supersede the score. PPHrisk does not diagnose, treat, cure, or prevent any disease. Use of PPHrisk does not establish any duty of care between Epigenuity and a patient.

1. Acceptance

By accessing or using PPHrisk at pphrisk.com (the "Service"), you ("User", "you") agree to these Terms of Service ("Terms"). If you do not agree, do not use the Service.

The Service is provided by Epigenuity LLC ("Epigenuity", "we", "us"), a Delaware limited liability company. These Terms form a binding agreement between you and Epigenuity.

2. Intended audience

The Service is intended for use by licensed healthcare professionals — physicians, advanced practice providers, registered nurses, midwives, and other clinicians authorized to provide obstetric care in their jurisdiction. It is not intended for use by patients, family members, or the general public.

3. Clinical use disclaimer

The Service implements published risk-stratification frameworks (CMQCC V3, AWHONN, ACOG Safe Motherhood Initiative) for postpartum hemorrhage. While we make reasonable efforts to align the Service with current published guidance, you acknowledge:

The output is a calculated category or numeric score derived from the inputs you provide; errors in input will produce errors in output
The Service does not substitute for clinical judgment or institutional policy
The Service does not diagnose, treat, or recommend specific treatment; it identifies risk categories aligned with published bundles
The Service may contain errors, including in the implementation of scoring rules; you are responsible for verifying outputs against institutional protocols before acting on them
The Service is not a substitute for advanced fetal monitoring, laboratory studies, or clinician assessment

4. FDA non-device determination

Epigenuity has determined that PPHrisk qualifies as Clinical Decision Support (CDS) software exempt from FDA device regulation under Section 3060(a) of the 21st Century Cures Act (Pub. L. 114-255), which amended Section 520(o)(1)(E) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j). PPHrisk meets all four statutory criteria:

It does not acquire, process, or analyze medical images, IVD signals, or signal-acquisition patterns; it analyzes user-entered structured inputs or, in SMART-on-FHIR sessions, discrete coded clinical data from the EHR
It is intended to display and analyze medical information about a patient
It is intended to support a healthcare professional's prevention and assessment of postpartum hemorrhage
It enables the user to independently review the basis for its recommendation — every risk factor selected and every framework rule applied is displayed in the output, and the user can verify each component before relying on it

FDA guidance: "Clinical Decision Support Software" (September 2022; superseded by current guidance January 2026). This determination is made by Epigenuity LLC.

5. License to use

Subject to your compliance with these Terms, Epigenuity grants you a personal, non-exclusive, non-transferable, revocable license to use the Service for your professional clinical practice. You may not:

Sublicense, sell, lease, or transfer access
Reverse-engineer, decompile, or disassemble the Service
Use the Service in a manner that violates HIPAA, your institutional policies, or any applicable law
Use the Service to provide medical advice to patients without independent clinical judgment
Use automated systems (scrapers, crawlers, bots) to access the Service without prior written consent
Attempt to access systems or data you are not authorized to access
Use the Service to develop a competing product

6. Account and access

Some features (team feed, compliance report, simulation drill log, SMART-on-FHIR) require sign-in. You are responsible for the accuracy of information you provide at sign-in and for activity that occurs under your account. Do not share your account.

Access to team features is gated by your institutional email domain. We may revoke access if your institution requests it or if we detect misuse.

7. Patient data and PHI

You are solely responsible for ensuring that any data you input into the Service complies with HIPAA, your institutional policies, and any applicable patient consent. Specifically:

You will not enter direct patient identifiers (name, MRN, date of birth, address, phone) in any field on PPHrisk. Use bed numbers, room labels, or other de-identifying labels only.
Patient health information read via SMART-on-FHIR from an EHR remains within your browser session. We do not persist it. See the Privacy Policy for details.
You will not use the Service to circumvent your institution's documentation or authorization controls.

8. No warranty

THE SERVICE IS PROVIDED "AS IS" AND "AS AVAILABLE" WITHOUT WARRANTY OF ANY KIND. EPIGENUITY DISCLAIMS ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NON-INFRINGEMENT, AND ANY WARRANTY ARISING FROM COURSE OF DEALING OR USAGE OF TRADE.

WE DO NOT WARRANT THAT THE SERVICE WILL BE UNINTERRUPTED, ERROR-FREE, OR THAT DEFECTS WILL BE CORRECTED.

9. Limitation of liability

TO THE MAXIMUM EXTENT PERMITTED BY LAW, EPIGENUITY AND ITS OFFICERS, MEMBERS, EMPLOYEES, AND AGENTS WILL NOT BE LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, OR PUNITIVE DAMAGES, INCLUDING DAMAGES FOR LOST PROFITS, LOST DATA, OR BUSINESS INTERRUPTION, ARISING FROM YOUR USE OF OR INABILITY TO USE THE SERVICE.

OUR AGGREGATE LIABILITY FOR ANY CLAIM ARISING FROM OR RELATED TO THE SERVICE WILL NOT EXCEED THE GREATER OF (A) THE AMOUNT YOU PAID TO US FOR THE SERVICE IN THE 12 MONTHS PRECEDING THE CLAIM (CURRENTLY ZERO; THE SERVICE IS PROVIDED FREE OF CHARGE) OR (B) USD $100.

Nothing in these Terms excludes or limits liability that cannot be excluded or limited by law.

10. Indemnification

You agree to indemnify and hold harmless Epigenuity from any claim arising out of (a) your use of the Service, (b) your violation of these Terms, (c) your violation of applicable law, or (d) your violation of any third party's rights, including patient rights.

11. Intellectual property

The Service, including all text, graphics, code, and design, is the property of Epigenuity LLC or its licensors and is protected by copyright, trademark, and other laws. "Epigenuity" is a registered trademark of Epigenuity LLC. "PPHrisk" is a trademark of Epigenuity LLC. All rights not expressly granted are reserved.

12. Modifications

We may modify these Terms from time to time. If the change is material, we will update the "Last updated" date and, for signed-in users, send notice via email. Continued use after the effective date constitutes acceptance.

13. Termination

We may suspend or terminate your access to the Service at any time, with or without notice, for any reason, including violation of these Terms. You may stop using the Service at any time. Sections 7 through 16 of these Terms survive termination.

14. Governing law and dispute resolution

These Terms are governed by the laws of the State of Arizona, USA, without regard to its conflict-of-laws principles. Any dispute arising from or related to these Terms or the Service will be resolved exclusively in the state or federal courts located in Pima County, Arizona, and you consent to personal jurisdiction in those courts.

15. Forward-looking statements

Marketing material on the Service, including descriptions of forthcoming features (such as multi-tenant SMART support, additional EHR vendor integrations, or expanded reporting), reflects our current intentions and may change. We undertake no obligation to deliver any specific feature on any specific timeline.

16. Miscellaneous

These Terms, together with the Privacy Policy and any institutional agreement we may sign with your employer, constitute the entire agreement between you and Epigenuity regarding the Service
If any provision is held unenforceable, the remaining provisions remain in force
Our failure to enforce a provision is not a waiver of that provision
You may not assign these Terms; we may assign them in connection with a merger, acquisition, or sale of assets

17. Contact

Epigenuity LLC
Tucson, Arizona
General: hello@pphrisk.com
Legal: legal@pphrisk.com

PPHrisk is a product of Epigenuity LLC.