Clara Subscription Terms

About these terms

These Clara Subscription Terms ("Subscription Terms") govern your access to and use of Clara, the clinical decision support software service ("Clara" or the "Service") operated by Mosaic Biodata Inc. ("Mosaic," "we," or "us"). They supplement, and for Clara control over, our general Terms of Service in the event of a conflict for your use of Clara. By creating a Clara account, clicking "I agree," or using the Service, you agree to these Subscription Terms, the Clara Clinical Use Notice, and, because Clara is used with protected health information, the mandatory Clara Business Associate Agreement ("BAA"), which is executed at signup and controls the handling of PHI.

These Subscription Terms are the "Subscription Terms" referenced in the Mosaic Terms of Service.

Definitions

• "Clara" / "Service": Mosaic's software that displays and analyzes medical information and provides non-directive recommendations and options to support a licensed health care professional's clinical decision-making.
• "HCP" / "you": the licensed health care professional (or the professional entity) that subscribes to and uses Clara.
• "PHI": Protected Health Information as defined by HIPAA (45 CFR 160.103).
• "Output": the information, recommendations, options, summaries, and other results Clara generates.
• "Credits": the usage units consumed by certain Clara features, as described in the Subscription, credits, and billing section.
• "HIPAA": the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations, as amended.

Eligibility: licensed health care professionals only

Clara is intended solely for use by licensed health care professionals acting within their scope of practice. By subscribing, you represent that you are a licensed HCP (or are authorized to contract on behalf of one), are at least 18 years old, and will provide accurate registration information, including professional and licensure details. We may, but are not obligated to, verify your credentials, and we make no guarantee as to any user's identity, professional credentials, or licensure status. Access is personal to you and your authorized users and may not be shared. Clara is not intended for, and may not be used by, patients or consumers for self-diagnosis or self-treatment.

Subscription, credits, and billing

Clara is offered on a subscription basis at $25 per month per provider seat. Each seat includes 250 Credits per month; these monthly Credits do not roll over and expire at the end of each one-month billing cycle. Additional Credits may be purchased in blocks of 100 Credits for $10 (each Credit is $0.10); purchased Credits expire twelve (12) months after purchase. Additional Credits may be purchased only while you have an active subscription, but any remaining purchased Credits may still be used after cancellation until they expire. When you add a provider seat mid-cycle, the charge is prorated to your current billing cycle and billed immediately. All fees are billed through our payment processor and are stated in U.S. dollars, are exclusive of applicable taxes, and, except as required by law or expressly stated here, are non-refundable, including for unused Credits. Credits are non-transferable between practices. Subscriptions renew automatically each billing period until cancelled. We may change fees or Credit pricing prospectively on reasonable prior notice; your continued use after the change takes effect constitutes acceptance. We do not store your full payment card details.

Cancellation, pause, and deactivation

You may cancel or pause your subscription at any time through your account; cancellation or pause takes effect at the end of the then-current billing period, and you keep access and that period's monthly Credits until then. Cancelling or pausing your subscription is not the same as closing your account. After cancellation, you keep access to spend any remaining purchased Credits until they expire, but you cannot purchase additional Credits without an active subscription and no new monthly Credits are granted. If you take no further action, an inactive account is retained and then permanently deleted after twelve (12) months of inactivity. You may close your account at any time, in which case your account and all associated data are deleted at that point and any remaining Credits are forfeited without refund. We may suspend or deactivate access for non-payment, breach of these Subscription Terms, absence of an effective BAA, or as needed to comply with law or protect the Service or its users. PHI is handled as provided in the BAA; the BAA remains in effect for as long as your account can access or hold PHI, including after a subscription is cancelled or paused, until the account is closed and all PHI is returned or destroyed.

What Clara is: non-device clinical decision support

Clara is designed to operate as non-device clinical decision support under section 520(o)(1)(E) of the Federal Food, Drug, and Cosmetic Act (as added by the 21st Century Cures Act). Consistent with that framework, Clara:

1. is not intended to acquire, process, or analyze a medical image, a signal from an in vitro diagnostic device, or a pattern or signal from a signal-acquisition system;
2. is intended to display, analyze, or present medical information about a patient and other medical information (such as peer-reviewed clinical studies and practice guidelines);
3. is intended to support or provide recommendations and options to you about the prevention, diagnosis, or treatment of a disease or condition, not to provide a specific directive diagnostic or treatment output; and
4. is intended to enable you to independently review the basis for any recommendation, including the inputs, the underlying logic, and the supporting evidence, so that you do not rely primarily on Clara to make a clinical diagnosis or treatment decision.

Clara is not a medical device, is not FDA-cleared or FDA-approved, and is not intended to support time-critical decision-making. You agree to use Clara consistent with this intended use.

Clinical responsibility and no medical advice

Clara supports, and does not replace or direct, your professional judgment. You are the final decision-maker and are solely responsible for evaluating and independently verifying all Output and for all clinical decisions, diagnoses, and treatment. Clara does not practice medicine, is not a health care provider, and does not create a physician-patient (or any provider-patient) relationship. Output may contain errors or omissions and is generated by artificial intelligence. Clara is not for use in medical emergencies. Nothing in Clara is a substitute for your evaluation of an individual patient.

Output is not a medical record. Clara's Output is clinical decision support only; it is not, and does not create, a medical record, a legal record of care, or a diagnosis, and Clara does not maintain any patient's medical record. The medical or designated record set remains the responsibility of you and your covered entity. A Clara Output becomes part of a patient's medical record only if and when you exercise your independent clinical judgment to enter or incorporate it, an act that is yours alone. If you adopt, act on, sign, share, distribute, or incorporate a Clara Output into a patient record, communication, or report, that material becomes your own clinical work product and professional determination, for which you are solely responsible; once adopted or shared it is no longer a Clara decision-support output, and Mosaic is not responsible for it or for any downstream use, distribution, or reliance.

Acceptable use

You agree to use Clara lawfully and within your scope of practice; keep your credentials confidential; not share access; not attempt to reverse engineer, scrape, or misuse the Service; and not use Clara to make a directive clinical decision without your independent review. You are responsible for your authorized users' compliance.

Protected health information and the mandatory BAA

Because you may input PHI into Clara, Mosaic acts as your Business Associate and you (or the covered entity you represent) act as the Covered Entity. The Clara BAA is mandatory, executed at signup, and cannot be skipped; it controls all creation, receipt, maintenance, and transmission of PHI through Clara and prevails over any conflicting term in these Subscription Terms or the Privacy Policy with respect to PHI. Absent an effective BAA, you must not input PHI into Clara.

Data use

PHI is governed exclusively by the BAA and is walled off from Mosaic's consumer Privacy Policy. Mosaic does not use your data, PHI or de-identified, to train or improve AI models, and its service providers are contractually prohibited from using it to train theirs. Mosaic does not sell PHI and does not use PHI for third-party advertising.

Intellectual property

Clara and all associated software, content, and materials are owned by Mosaic or its licensors and are protected by intellectual property laws. We grant you a limited, non-exclusive, non-transferable, revocable license to access and use Clara for your own professional use during your subscription. As between the parties and subject to the BAA, you retain your rights in the patient data you input and in the Output; Mosaic owns and retains all rights in the Clara service, software, and underlying models.

Disclaimers

Clara is provided on an "AS IS" and "AS AVAILABLE" basis, without warranties of any kind, express or implied, to the fullest extent permitted by law, including the implied warranties of merchantability, fitness for a particular purpose, and non-infringement. We do not warrant that Clara will be uninterrupted, error-free, or that any Output is accurate, complete, or current.

Limitation of liability

To the maximum extent permitted by law, Mosaic and its affiliates, licensors, and suppliers will not be liable for any indirect, incidental, special, consequential, or punitive damages, or for lost profits or data, arising from or relating to Clara. Our total aggregate liability for any claim relating to Clara will not exceed US $500. Some jurisdictions do not allow certain limitations; some may not apply to you.

Indemnification

You will defend, indemnify, and hold harmless Mosaic and its affiliates from and against any claims, damages, and expenses arising out of your use of Clara, your clinical decisions, your breach of these Subscription Terms or the BAA, or your violation of law or any third-party right.

Term, changes, and termination

These Subscription Terms apply while you have a Clara account. We may update them from time to time; material changes will be posted with a revised date and, where required, communicated to subscribers, and continued use constitutes acceptance. Either party may terminate as described in the Cancellation, pause, and deactivation section. Provisions that by their nature should survive termination do so, including those on clinical responsibility, protected health information and the BAA, data use, intellectual property, disclaimers, limitation of liability, indemnification, and governing law and dispute resolution.

Governing law and dispute resolution

These Subscription Terms are governed by the laws of the State of Texas, without regard to conflict-of-laws principles, and are subject to the dispute-resolution provisions of the Mosaic Terms of Service (informal resolution followed by binding arbitration before JAMS in Travis County, Texas, with a class-action waiver and a 30-day opt-out), which are incorporated by reference. To the extent any dispute concerns PHI, the BAA's terms also apply.

Contact

Questions about these Subscription Terms: support@mosaicbio.io.