FICS® ACCEPTABLE USE POLICY

Last Modified: October 18, 2024

Introductions

Pi Health Inc. or any of its affiliates, including but not limited to Pi Health USA, LLC; Pi Health Aus Pty; Pi Health Brasil Consultoria Ltda.; B10 Health Technologies Private Limited; Pi Health Technologies Private Limited; and Pi Health Hong Kong Limited (collectively, “Pi Health”, “we”, “us”, or “our”) provides access to our Front-End Interoperable Capture Software (“FICS”) clinical trial platform, including the software, products, and services we may provide from time to time as part of FICS (collectively, the “Service(s)”), to companies, institutes, organizations, and other entities who have entered into an applicable subscription services agreement or other similar agreement (“Terms & Conditions”) with us.

Your employer or other entity on whose behalf or for whose benefit you are using the Services (your “Organization”) is providing you access to the Services through its FICS subscription pursuant to the Terms & Conditions, subject to your agreement and compliance with this FICS Acceptable Use Policy (“FICS AUP”) and, as between us and your Organization, the other applicable terms and conditions of the Terms & Conditions. This FICS AUP supplements the Terms & Conditions in accordance with the terms thereof and nothing in this FICS AUP shall limit any other obligations of your Organization thereunder.

BY USING THE SERVICES, YOU ACCEPT AND AGREE TO BE BOUND AND ABIDE BY THIS FICS AUP. IF YOU DO NOT AGREE TO THIS FICS AUP, YOU ARE NOT GRANTED ACCESS TO ANY OF THE SERVICES AND YOU MUST NOT ACCESS OR USE ANY OF THE SERVICES.


Changes

The date of last revision of this FICS AUP is indicated at the top of this document. Pi Health reserves the right to amend, alter, or modify this FICS AUP at any time and will use commercially reasonable efforts to notify you of such changes (such as by posting a notice on our website available at www.pihealth.ai (the “Site”), or if you have provided us with your email, we may send you an email notification, or we may notify your Organization or use such other method as may be required by or permitted pursuant to this FICS AUP or the Terms & Conditions).


Your Responsibilities Generally

When using the Services, it is your responsibility to:

  • Comply with this FICS AUP
  • Comply with the then-current documentation made generally available by us to our customers regarding the Services, including as may be made available by us from time to time at the Site and/or on or through the Services, or provided to you by your Organization (the “Documentation”).
  • Ensure that you are adhering to all applicable laws, rules, and regulations, and (to the extent not inconsistent with this FICS AUP, the Documentation, or the Terms & Conditions) the commonly accepted practices of the healthcare community with respect to the conduct of clinical trials and use of clinical trial-related technology services that are like the Services. Without limiting the generality of the foregoing, you are responsible for understanding and complying with all laws applicable or related to the retention of medical records, patient access to information, and any patient authorization to release data. You must have all necessary patient consents prior to using the Services and must apply settings and operational controls to exclude information from availability as necessary to comply with applicable laws. Any patient data you provide through the Services is covered under your Organization's “HIPAA Notice of Privacy Practices” (or similar written policy) and privacy policy, as each is made available to you by your Organization. Please review your Organization's privacy notices and policies prior to using the Services.

YOUR RESPONSIBILITIES DESCRIBED ABOVE ARE REGARDING YOUR CONDUCT GENERALLY, AND THE PROHIBITED USES DESCRIBED BELOW ARE INTENDED ONLY AS GUIDELINES REGARDING IMPROPER AND INAPPROPRIATE CONDUCT. NEITHER SHOULD BE INTERPRETED AS AN EXHAUSTIVE LIST.


Intended Uses of the Services

FICS is a single-solution software designed to connect life science sponsors and clinical trial sites by enabling the collection of regulatory standard data during patient care.

Intended uses of FICS include:

  • Storing, indexing, managing, and making available data to your Organization's designated End Users and any authorized external user that your Organization provides with access to such data (in accordance with the Terms & Conditions and Documentation).
  • Retrieving, viewing, processing, and/or sharing by an End User of the content that the End User has created and/or migrated and which is stored on FICS or another part of the Services.
  • Viewing, downloading, modifying, and transmitting by your Organization of reports and other compiled data stored and/or generated on or through FICS or another part of the Services.
  • Administration by your Organization (i.e., by an authorized End User of your Organization's organization who is given such responsibility) of your Organization's account(s) relating to FICS or another part of the Services and/or of information relating to your Organization's data stored on FICS or another part of the Services, including information management policies, metadata, access rights, configuration settings, and other such options and features as set forth in the Documentation or as may be made available through the Services.

THE SERVICES ARE NOT PROVIDED AS AN IMPROPER INDUCEMENT FOR REFERRALS OF ANY ITEM OR SERVICE REIMBURSED BY A FEDERAL HEALTHCARE PROGRAM AND ARE NOT INTENDED TO INFLUENCE OR USURP THE SOLE RESPONSIBILITY OF A HEALTHCARE PROVIDER FOR CLINICAL DECISION-MAKING AND DETERMINATIONS OF MEDICAL NECESSITY RELATED TO ANY INDIVIDUAL PATIENT RECEIVING TREATMENT FROM SUCH HEALTHCARE PROVIDER.

YOU AND YOUR ORGANIZATION ARE SOLELY RESPONSIBLE FOR VERIFYING THE ACCURACY OF CUSTOMER DATA AND ALL PATIENT DATA INCLUDED THEREIN, FOR OBTAINING ANY PATIENT'S CONSENT TO USE THE SERVICES, AND FOR ALL OF YOUR AND YOUR ORGANIZATION'S DECISIONS AND ACTIONS WITH RESPECT TO MEDICAL CARE, TREATMENT, AND WELL-BEING OF YOUR AND YOUR ORGANIZATION'S PATIENTS, INCLUDING ALL OF YOUR AND YOUR ORGANIZATION'S ACTS OR OMISSIONS. YOU AND YOUR ORGANIZATION ASSUME ALL RISKS ASSOCIATED WITH YOUR AND YOUR ORGANIZATION'S CLINICAL USE OF THE SERVICES FOR THE TREATMENT OF PATIENTS.


Prohibited Uses

You may use the Services only for lawful purposes and in accordance with this FICS AUP. You agree not to use the Services:

  • In any way that violates any applicable federal, state, local, or international law or regulation (including any laws regarding the export of data or software to and from the US or other countries, and any laws regarding the retention of medical records, patient access to information, and patient authorization to release data)
  • To exploit, harm, or attempt to exploit or harm, minors in any way by exposing them to inappropriate content, asking for personally identifiable information, or otherwise.
  • To send, knowingly receive, upload, download, use, or re-use any material which violates the rights of any individual or entity established in any jurisdiction.
  • To transmit, or procure the sending of, any advertising or promotional material, including any “junk mail”, “chain letter”, “spam”, or any other similar solicitation.
  • To impersonate or attempt to impersonate Pi Health, a Pi Health employee, another user, or any other person or entity (including by using e-mail addresses or user names associated with any of the foregoing).
  • To engage in any other conduct that restricts or inhibits anyone's use or enjoyment of the Services, or which, as determined by us, may harm Pi Health or users of the Services or expose us or them to liability.

Additionally, you agree not to:

  • Share with anyone else your user name, password, or any other unique access credentials assigned to or used by you for accessing the Services (other than sharing certain information with us, and only if requested by us, to the extent necessary to facilitate your access to the Services).
  • Use the Services in any manner that could disable, overburden, damage, or impair the Services or interfere with any other party's use of the Services, including their ability to engage in real time activities through the Services.
  • Use any robot, spider, or other automatic device, process, or means to access the Services for any purpose, including monitoring or copying any of the Services traffic or resources available on the Services.
  • Use any manual process to monitor or copy any of the Services traffic or resources available on the Services or for any other unauthorized purpose without our prior written consent.
  • Use any device, software, or routine that interferes with the proper working of the Services.
  • Introduce any viruses, trojan horses, worms, logic bombs, or other software or material which is malicious or technologically harmful.
  • Attempt to gain unauthorized access to, interfere with, damage, or disrupt any parts of the Services or any server, computer, database, or other resource or element connected to the Services.
  • Violate, attempt to violate, or knowingly facilitate the violation of the security or integrity of the Services.
  • Use the Services in any manner that could allow you, Customer, or third parties to unfairly compete with us, including to develop software, products, or services that compete with us or any features of the Services.
  • Otherwise attempt to interfere with the proper working of the Services.

Content Standards

You agree not to use the Services to send, knowingly receive, upload, download, use, or re-use any material which:

  • Contains any material that is defamatory, obscene, indecent, abusive, offensive, harassing, violent, hateful, inflammatory, or otherwise objectionable.
  • Promotes sexually explicit or pornographic material, violence, or discrimination based on race, sex, religion, nationality, disability, sexual orientation, or age.
  • Infringes any patent, trademark, trade secret, copyright, or other intellectual property or other rights of any other person.
  • Violates the legal rights (including the rights of publicity and privacy) of others or contains any material that could give rise to any civil or criminal liability under applicable laws or regulations.
  • Is likely to deceive any person.
  • Promotes any illegal activity, or advocates, promotes, or assists any unlawful act.
  • Causes annoyance, inconvenience, or needless anxiety or is likely to upset, embarrass, alarm, or annoy any other person.
  • Impersonates any person, or misrepresents your identity or affiliation with any person or organization.
  • Involves commercial activities or sales, such as contests, sweepstakes, and other sales promotions, barter, or advertising.
  • Gives the impression that they emanate from or are endorsed by us or your Organization, or any other person or entity, if this is not the case.

Monitoring and Enforcement

We, in our sole discretion, will determine whether your conduct complies with this FICS AUP. We have the right to:

  • Monitor your use of the Services for any purpose in our sole discretion and as we see fit.
  • Take any action we deem necessary or appropriate in our sole discretion if we believe your or any other user’s conduct violates this FICS AUP, infringes any intellectual property right or other right of any person or entity, threatens the personal safety of users of the Services or the public, or could create liability for us.
  • Disclose your identity or other information about you to any third party who claims that material posted by you violates their rights, including their intellectual property rights or their right to privacy.
  • Take appropriate legal action, including referral to law enforcement, for any illegal or unauthorized use of the Services.
  • Terminate or suspend your access to all or part of the Services for any or no reason, including any violation of this FICS AUP.

Without limiting the foregoing, we have the right to fully cooperate with any law enforcement authorities or court order requesting or directing us to disclose the identity or other information of anyone who accesses or uses the Services. YOU WAIVE AND HOLD HARMLESS PI HEALTH AND ITS LICENSEES AND SERVICE PROVIDERS FROM ANY AND ALL CLAIMS RESULTING FROM ANY ACTION TAKEN BY ANY OF THE FOREGOING PARTIES DURING, OR TAKEN AS A CONSEQUENCE OF, INVESTIGATIONS BY ANY SUCH PARTIES OR LAW ENFORCEMENT AUTHORITIES.


Notification of Violation

If you become aware of any violation of this FICS AUP by any person or entity, including End Users and other third parties, you must immediately notify us via a representative of your Organization.

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