Per the Balanced Budget Act of 1997, all ordering providers, including physicians, physician assistants, nurse practitioners and other laboratories, are required to submit diagnostic information to the laboratory when ordering. The information submitted on each lab order, either ICD-10 code(s)* or narrative description of diagnosis, signs/symptoms, indication, etc., should best describe the primary reason for ordering each lab test(s) and must be legibly documented (by test) in the patient’s medical record/chart.

Coding cannot be assigned based on a “rule-out” (r/o) narrative description.

All ICD-10 codes submitted must reflect the highest specificity possible.

Coding should NOT be assigned for reimbursement purposes only and should NOT reflect information available only after the lab testing is completed.

As a health care provider, you may order any test(s), including screening tests, which you believe are appropriate for the treatment of your patient. However, claims submitted for laboratory services will only be paid by Medicare or other insurance payors if the service meets the Medicare coverage criteria or insurance payor’s coverage criteria and is reasonable and necessary to treat or diagnose an individual patient. The medical necessity of each test ordered must be documented in the patient’s chart/medical record and reflect any/all coding submitted with the lab requisition.

If a ‘non-covered’ diagnosis is used the patient must be notified in advance and given the opportunity to sign the Advance Beneficiary Notice (ABN) prior to specimen collection. The ABN must be completed for any Medicare patient where claim denial is suspected based on medical necessity or frequency determinations. The signed, original ABN must be attached to the original lab order prior to submission. If an ABN is not included with such a request, the ARL client will be billed as delineated in the Client’s signed Laboratory Services Agreement (LSA).

Requesting an ABN on all Medicare beneficiaries is considered by Medicare to be an unacceptable practice.

Thoroughly completing your manual request(s) for lab tests or your electronic requests in our laboratory ordering and reporting system, ensures accurate processing and testing, efficient patient identification and registration, and timely reporting of lab results. Due to the increasing complexity of insurance billing, please attach a front/back copy of the patient’s insurance card(s) to ensure proper billing. If incomplete insurance information is submitted the patient may receive the itemized statement and may be responsible for the bill for their lab services in its entirety.

Recurring orders for an individual patient are only acceptable by Medicare in connection with extended treatment by the same ordering physician, and with the same diagnosis code(s). Recurring orders are valid for a maximum of 365 days from the original order date and must be renewed annually. One-time orders are valid for a maximum of 90 days from the original order date.

Signature stamps are NOT acceptable. Orders must include legibly-written or electronic signatures.

Statutorily, Medicare does NOT cover any lab testing for routine and/or screening purposes. However, Medicare does cover some Preventive lab tests (PSA, Glucose, Lipids, etc.) if ordered as required by Medicare.

For Preventive benefit information including test names, CPT codes required ICD-10 codes, and frequency limitations please click the following link: Medicare MPS Quick Reference

When laboratory testing is ordered for screening purposes (asymptomatic) the patient should be advised that payment may be denied by Medicare or other insurance plans. Each lab test ordered for screening purposes must have the appropriate code.

Per the Affordable Care Act, many but not all preventive lab services are available for payment if ordered as required by the patient’s insurance plan. Those tests available for coverage must be specifically ordered and coded with the appropriate code(s) as defined by the payor. Any test coded as ‘diagnostic’ rather than ‘screening’ based on the ICD-10 code submitted is not payable as a Preventive benefit.

Any laboratory test panel, whether AMA, Laboratory, or Client-developed, must only be ordered, charged, and reimbursed when ALL individual components of the panel are medically necessary as determined by specific ICD10 code(s) and documented in the patient’s medical record/chart.

Reflex Testing is additional testing (with additional cost) that is automatically performed on the basis of the initial results. All procedures that contain a reflexive pathway are identified in our test directory. Many include ‘w/reflex’ as part of the test name.

AMA and CMS have changed the description for the two major categories for drug testing.

Screens were changed to Presumptive testing and Confirmations were changed to Definitive testing. These names will be used moving forward by most payors and laboratories.

Screen = Presumptive Testing (automated Enzyme Immunoassay analyzer method)

Confirmation = Definitive Testing (Liquid Chromatography tandem Mass Spectrometry method)

Pre-authorization of certain lab testing (i.e.: Genetics, Cytogenetics, Allergy testing, Celiac testing, etc.) may be required, as defined by the patient’s insurance provider. Any pre-authorization paperwork must be completed by the ordering provider and submitted for approval prior to submission of any lab orders. Please include the pre-authorization number on the lab order along with any related documentation. If appropriate pre-authorization is not sought, the client or patient may be responsible for payment as per the signed SLA and/or the Patient Consent/Financial Responsibility Form.

Because we are a CMS provider we are prohibited from billing any federal program for testing requested by any provider excluded from participation. Lab testing ordered by any sanctioned provider should not be submitted to an ARL laboratory, and will not be accepted.

The OIG/Department of Justice takes the position that an individual who knowingly causes a false claim to be submitted may be subject to sanctions or remedies available under civil, criminal, and administrative law. The laboratory will not knowingly bill Medicare for lab testing that is non-covered, unreasonable, and/or unnecessary.

If the laboratory receives an order without any diagnosis information or is unable to bill for testing because the coding supplied doesn’t meet medical necessity requirements, we will attempt to contact the ordering provider to gather additional coding information that may have been documented in the patient’s chart but wasn’t noted on the original lab requisition. The laboratory may not assign diagnosis information on its own.

Supplies required for the collection of specimens sent to our laboratory will be provided pursuant to ARL Labs policy, which takes the average number of tests ordered by the client and provides a 5% overage to allow for damaged supplies or an increase in tests. Due to Stark II/Anti-Kickback statutes, supply volumes must reasonably match volumes of testing received.

Our Commitment to Privacy

This platform, defined to include any access via a web browser and any related application (collectively “Platform”), is provided, owned and managed by AMERICAN RESEARCH LABS. AMERICAN RESEARCH LABS is committed to protecting your privacy. This Platform is provided by AMERICAN RESEARCH LABS for the purposes of supporting your potential or actual participation in one or more clinical trials or other health-related research (“clinical trials”) and the accompanying use and disclosure of your personal information, either as a patient, caregiver or as a member of the study team (PI, Virtual Study Coordinator, Study Concierge, etc.). This Privacy Policy covers your full engagement with AMERICAN RESEARCH LABS current and future clinical trials and other health care-related research, from your initial interaction with the platform to the beginning of your contact with a potential trial, through participation in any trial and potential participation in other trials and additional uses of your personal information as identified in this policy to support medical research.

This Privacy Policy describes how we use, disclose and protect any personal information that we collect or receive from you or on your behalf through this Platform, whether as a potential clinical trial or healthcare research participant, patient, data subject or healthcare professional. If you are participating in a specific clinical trial as a trial participant, this Policy supplements the information you have received or will receive as part of the clinical trial’s informed consent process. The informed consent form (“ICF”) and research protocol will define how information about you will be used in connection with the clinical trial. This Policy is intended to meet applicable legal requirements globally, including in North America, Europe, Asia Pacific and other relevant jurisdictions and supplements the AMERICAN RESEARCH LABS Privacy Policy and Online Privacy Policy, which can be found at www.AMERICAN RESEARCH LABS.com.

Your Role and Responsibilities:

You should be familiar with how our Platform works and read all our policies.

You should be aware of, and have a right to know, what information is collected on this Platform, how it is stored, protected and used.

Your Rights and Choices:

You have the right to know the information collection and storage practices of this Platform.

You have the right to know how your information will be used and by whom.

You have the right to know to whom we may disclose your information.

You have the right to inquire at any time as to whether we are processing personal information about you, request access to, remove, or delete or port (transfer) your personal information, and ask that we correct or amend your personal information where it is inaccurate, consistent with the requirements of the clinical trial and the ICF.

The Information We Collect:

When you engage with this Platform, we will collect certain personal information from and about you in connection with your interest in clinical trial and other medical research activities. The personally identifiable information we may collect from you – meaning any information relating to an identified or identifiable natural person – can include your first name, last name, title and/or email address, contact telephone number(s) or other contact information, birthdate or birth year and zip or postal code that you provide to us through your use of the Platform including in any of the ways explained below. It may also include additional demographic or personal health information about you that you provide to the Platform to support your interest in clinical trial or other medical research activities. It may also include certain financial information, in connection with any expense reimbursement or other compensation related to a clinical trial or other medical research. If you are a health care professional, we may also collect financial information, and academic education and professional information (including, but not limited to, business address and business name). This information is collected through direct user input as described below (“Personally Identifiable Information”). We also may obtain information about you from other sources as described in this Privacy Policy in connection with health care research activities. We may also receive information about how you use our website through the automatic operation of “cookies” and web logs and other technologies.

This policy applies to all information received through the Platform, whether automatically, through direct user input or otherwise. For example, we receive information in any of the following ways:

Information when you register for our platform:

Registration is required for use of this Platform. To enable us to generate your log-in to the Platform, we will collect certain Personally Identifiable Information from you and you will need to create a log-in password. When you register at our platform, if you wish to learn more about current or future clinical trials, we will ask you to provide information about you that will help us identify current or future clinical trials that may be of relevance to you. This may include demographic information and (in some circumstances) certain kinds of personal health information. We will collect information from you to assist with the identification of current and/or future trials. In some circumstances we may also collect information about you from other sources to supplement this information and help us identify potential research opportunities for you.

Information as part of the clinical trial itself:

Where applicable, when you participate in a particular clinical trial (or evaluate whether to participate in a clinical trial), you will be provided with information about the trial itself and how information about you will be used in connection with the trial. This “Informed Consent” form for the clinical trial will govern how your personal information is used in connection with a specific clinical trial. This privacy policy only applies to information that is obtained through this Platform in addition to the information that is collected and used for the clinical trial (for example, your registration information for this Platform before you decide to participate in a clinical trial). The ICF will be incorporated, but not merged, into this Privacy Policy. Each ICF will include, as appropriate, the scope of the study, time line and privacy information that you agree to allow the Site personnel, AMERICAN RESEARCH LABS, and others involved in the study process, to collect and share and to whom that information can be shared. To the extent any terms or provisions of an ICF conflict with the terms and provisions of this Privacy Policy, the terms and conditions of the ICF shall control. If you are participating in a virtual trial, this Platform may be the primary means of collecting information relating to your participation in the virtual trial. In this event, we also will provide you with individual clinical trial results as set forth in the Informed Consent Form.

Web Logs:

We use standard web logs that record basic data about people who visit our websites.

The following information is contained in these logs:

The date and time of the visit

The pages of the website viewed during the visit:

The IP (Internet Protocol) address of the computer used to visit the site (computers automatically generate an IP address as they surf the internet. An IP address is a number assigned to you by your internet service provider so you can access the internet. IP addresses are also used to track new versus return visitors to the website or in connection with any questionnaire used on the website or as part of a clinical trial)

The type of web browser used to view our website

The website visited immediately before coming to this website.

We do not normally seek to identify individuals from web logs including from their IP address and we do not disclose them to others. However, web logs may be used to identify an individual who we have reason to suspect tried to damage our website or use it in an unauthorized way. If we have reason to believe that there has been a violation of computer security or related laws, we may share our web logs with law enforcement agencies.

Cookies and other technologies:

A cookie is a piece of data or a file that a website can send to your internet browser which may then store it on your computer. Cookies store information such as the pages you visited, the website features you used, and the amount of time you visited a particular webpage. They are also a means of keeping track of a user's preferences during a visit to a website. In order to provide persistence of a user’s preference, we store a unique identifier in a “temporary” or “session” cookie that only exists during the browser’s session with the website. When the user returns to the website, the identifier can be extracted from the session cookie and used to request detailed search information for that user from our database.

In addition, visitors clicking through to this Website from third-party services such as Facebook, Twitter, Instagram, Google, Bing or Yahoo! search engine sponsored ads will have a cookie placed on their computer for 30 days. This cookie allows Facebook, Twitter, Instagram, Google, Bing and Yahoo!, along with AMERICAN RESEARCH LABS, to measure the effectiveness of their search engine advertising.

Our uses of other technologies (“Technologies”) to automatically collect information through the website fall into the following general categories:

Operationally necessary. We may use cookies, or other similar Technologies that are necessary to the operation of our website, services, applications, and tools. This includes Technologies that allow you access to our website, services, applications, and tools; that are required to identify irregular site behavior, prevent fraudulent activity, and improve security; or that allow you to make use of our functions such as saved search, or similar functions.

Performance related. We may use cookies or other similar technologies to assess the performance of our website, applications, services, and tools, including as part of our analytic practices to help us understand how our visitors use our website, determine if you have interacted with our messaging, determine whether you have viewed an item or link, or to improve our website content, applications, services, or tools.

Functionality related. We may use cookies or other similar Technologies that allow us to offer you enhanced functionality when accessing or using our website, services, applications, or tools. This may include identifying you when you sign into our website or keeping track of your specified preferences, interests, or past items viewed so that we may enhance the presentation of content on our website.

Advertising or targeting related. We may use first-party or third-party cookies to deliver content, including advertisements relevant to your interests, on our website or on third-party sites. This includes using Technologies to understand the usefulness to you of the advertisements and content that has been delivered to you, such as whether you have clicked on an advertisement.

The following cookies may be used on our website:

Google Analytics cookie

Internal session cookies

Most browsers also allow you to block, disable and delete cookies. However, if you do that, the website may not work properly. You always have the right to refuse the storage of cookies on your computer, or to disable and/or delete cookies at any time as your browser or device permits. It is important that you understand that if you block, disable or otherwise reject our cookies, you may not be able to use the website or all of its interactive features or to use certain of its essential features. This may impact your ability to participate in a virtual clinical trial. We suggest that you accept cookies because they allow you to get the most out of your website experience (including your participation in a virtual clinical trial), and to take advantage of some of the website’s essential features.

For more information about the cookies we use, and to see what cookies have been set on your computer and how to manage, disable and delete them, visit www.allaboutcookies.org.

Device Information:

We may also collect certain information that your mobile device sends when you use our services or access our Platform, like a device identifier, user settings and the operating system of your device. Information collected about your mobile device and internet connection may include the device's unique device identifier, IMEI number, IP address, operating system, browser type, browser language, referring/exit pages and URLs, mobile network information and the device's telephone number. Tools, applications, and widgets that we enable you to download to enable you to use the services on any mobile devices, may store information on your mobile or other devices. These tools may transmit personal information to us to enable you to access your user account and to enable us to track use of these tools. Some of these tools may enable you to email reports and other information from the tool. We may use personal or non-identifiable information transmitted to us to enhance these tools, to develop new tools, for quality improvement and as otherwise described in this Privacy Policy or in other notices we provide. We may send you e-mail messages with a “click-through URL” linked to the content of our Platform. When you click onto one of these URLs, you will pass through our server before arriving at the destination webpage. We may track this click-through data to help us determine your interest in the subject matter and measure the effectiveness of our user communications. You can avoid being tracked simply by not clicking on any links or images in e-mail we send you.

The Way We Use Your Information:

We acquire, hold, use, and process your Personally Identifiable Information in order to provide, maintain and administer your login account, to provide you with information on clinical trials, other health care research or other AMERICAN RESEARCH LABS brand services, to contact you in the future with regard to any of these services (including about other clinical trials or other AMERICAN RESEARCH LABS products or services), to support your participation in the clinical trial consistent with your informed consent, to match you, based on your Personally Identifiable Information, to current or future clinical trials, other research opportunities, or other AMERICAN RESEARCH LABS services, and based on legal grounds, your explicit consent and for the legitimate business purposes outlined in this Privacy Policy.

In addition, from time to time, server logs may be reviewed for security purposes – e.g., to detect unauthorized activity on the services. In such cases, server log data containing IP addresses may be shared with law enforcement bodies in order that they may identify users in connection with their investigation of the unauthorized activities.

Use for Our Administrative Purposes:

We also may use your information for our administrative purposes, such as to measure interest in and/or develop our Platform services, ensure internal quality control, comply with regulatory requirements, including prevent potentially prohibited or illegal activities, and enforce our Terms of Use.

AMERICAN RESEARCH LABS may use Personally Identifiable Information for other purposes for which we have a legitimate interest, such as contacting you for any future clinical services, individual or market research, anti-fraud protection, or any other purpose disclosed to you at the time you provide Personally Identifiable Information or with your consent.

Aggregate Data Use and De-Identified or Anonymized Information

We combine and use non-personal information (aggregated data) from our web logs and other Technologies to study how the Platform is being used. We will periodically analyze this aggregated data and use what we learn to make improvements to our Platform. In addition, we may share this aggregated data (which does not contain any information which can identify an individual) with our clinical research partners to assist them in better designing their Platforms or clinical trials.

AMERICAN RESEARCH LABS may use Personally Identifiable Information and other information about you to create anonymized and/or aggregated information, such as de-identified demographic information, de-identified location information, information about the computer or device from which you access AMERICAN RESEARCH LABS’s Services, this Website, or other analyses we create related to our products and services or clinical research activities. Anonymized and/or aggregated information is used for a variety of functions, including the measurement of visitors’ interest in and use of various portions or features of the Services. Anonymized and aggregated information is not Personally Identifiable Information, and we may use such information in a number of ways, including research, internal analysis, analytics, and any other legally permissible purposes. We may share this information within AMERICAN RESEARCH LABS and with third parties for our or their purposes in an anonymized or aggregated form that is designed to prevent anyone from identifying you. We may use and disclose this anonymized, de-identified and/or aggregated information in any way permitted by applicable law.

How We May Disclose Your Information

Sharing Information with Clinical Trial Support Personnel and Other Clinical Trial Health Care Providers

If you request or otherwise provide appropriate permission, we will forward your Personally Identifiable Information (such as your name, year of birth, telephone number and/or email address and zip or postal code), and your personal health information and other information to the individuals and/or entities involved in conducting the clinical trial in which you are interested in participating. This may include a study concierge, virtual study coordinator, clinical trial support personnel or other study staff or third parties involved in conducting the clinical trial in which you are interested or are participating. We also will share information about your participation, or potential participation, in a clinical trial or other research activity, with the providers, researchers and others conducting the trial, consistent with applicable law and any applicable informed consent (if any).

Vendors and Service Providers

We may share any information we receive with vendors and service providers in order to support your participation, or potential participation, in a clinical trial or other AMERICAN RESEARCH LABS activity and permit us to provide our services in connection with clinical trials or other activity. The types of service providers (processors) to whom we entrust personal information include, but are not limited to, service providers for: (i) provision of IT and related services; (ii) provision of information and services you have requested, including recruitment; (iii) payment processing; and (iv) customer service activities; and (v) in connection with the provision of the Platform. AMERICAN RESEARCH LABS has executed appropriate contracts with the service providers that prohibit them from using or sharing Personal Identifiable Information except as necessary to perform the contracted services on our behalf or to comply with applicable legal requirements.

Sharing Information with Third Parties

It is possible that we may need to disclose Personally Identifiable Information about you in response to a law enforcement or national security request or legal process such as a search warrant, subpoena, or court order or in connection with an investigation or prosecution of suspected or actual illegal activity. Disclosures may also be made to comply with the law, protect our legal rights, or yours, or those of others’ including also property, or safety, to protect the security or integrity of our Platform, to take precautions against liability, or during emergencies if physical safety is believed to be at risk, or if we, in good faith, believe that disclosure is otherwise necessary or advisable. These types of disclosures are unlikely, but they are possible and so we describe them here.

We also may need to share information with regulators or others in government who oversee clinical trial activities, as described in the ICF.

We may also share your information with personnel involved in conducting research studies and/or our affiliates.

We may also share your information in the event of a corporate merger, acquisition or other corporate transaction related to AMERICAN RESEARCH LABS.

Access, Correction, Deletion, and Removal of Personal Information

In some situations, you may access, update, correct or remove the Personally Identifiable Information you provided to us by sending an email to info@arllabs.com. Your ability to correct, remove or delete your Personal Identifiable Information will depend in most situations on the informed consent agreement and the clinical trial protocol, which may require that information be maintained.

Non-identifiable information in our databases will not be deleted. Like all responsible Platforms, we maintain backup files as a protection against natural disasters, equipment failures, or other disruptions. Backup files protect you and us because they lessen the risk of loss of valuable data. Removing a record from our principal files does not remove that record from any of the backup systems. It may take up to 6 months before all information in a backup record is completely erased through the normal recycling of backup files. In the meantime, as long as backup records exist, they receive the same privacy and security protections as our other records.

You can ask us to provide you with information about and copies of your Personally Identifiable Information that we keep by sending an email to info@arllabs.com. You may also use this contact point for any other questions you may have about your rights in connection with your Personally Identifiable Information, including the ability to request that we remove, delete or port (transfer) your personal information, and or to ask that we correct or amend any inaccurate information. Please note that these rights are not automatic or absolute and may be subject to a fee, to the extent allowed by law and consistent with the ICF.

If you have any requests concerning your personal information or have any questions or comments about privacy, please send an email to info@arllabs.com. Please include your contact information, the name of this Platform or service at issue, and a detailed description of your request or privacy concern.

PLEASE NOTE: Although we make good faith efforts to provide users with access to their Personally Identifiable Information, there may be circumstances in which we are unable to provide access or delete certain information, including but not limited to where the information: contains legally privileged information, must be maintained according to law, would compromise the integrity of the clinical study or the study data, would compromise others’ privacy or other legitimate rights, where the burden or expense of providing access would be disproportionate to the risks to the individual’s privacy in the case in question, where it is commercially proprietary or where the information must be maintained in connection with the clinical trial. If we determine that access should be restricted in any particular instance, we will provide you with an explanation of why that determination has been made and a contact point for any further inquiries. To protect your privacy, we will take commercially reasonable steps to verify your identity before granting access to or making any changes to your personal information.

All requests received from you under this Privacy Policy will be processed in line with applicable local laws.

Your Choices

You can always choose not to provide information. However, if you choose not to provide information, you will not be able to use any of the services that require you to log-in and, if applicable, you may be unable to participate in the relevant clinical trial.

Where you have consented to our processing of your Personally Identifiable Information, you may withdraw that consent at any time and opt out of further processing by following the instructions in this Privacy Policy. This will not have an impact on information that has been collected, used or disclosed previously. Even if you opt out, we may still collect and use non-personal information regarding your activities on our website.

IMPORTANT NOTE: If you desire to correct, amend or delete Personally Identifiable Information that was provided to us by third parties (and not directly by you), you may contact us to access, correct or remove your information from our files. However, we also recommend that you contact the third-party website operators or other entities to whom you have provided such information under such third parties' privacy policies, as we do not control and are not responsible for those practices or privacy policies.

If you receive automated email messages or other emails that you prefer not to receive, please send an email to info@arllabs.com for further assistance. Alternatively, if you receive an unwanted email from us, you can use the unsubscribe link found at the bottom of the email to opt out of receiving future emails. We will process your request within a reasonable time after receipt. Note that you will continue to receive transaction-related emails regarding services you have requested. We may also send you certain communications regarding our services and you will not be able to opt out of those communications (e.g., communications regarding updates to our Terms of Use or this Privacy Policy).

We maintain “do-not-call” and “do-not-mail” lists as mandated by law. We process requests to be placed on do-not-mail, do-not-phone and do-not-contact lists within 60 days after receipt, or such shorter time as may be required by applicable law.

Do Not Track

Do Not Track (“DNT”) is a privacy preference that users can set in certain web browsers. DNT is a way for users to inform websites and services that they do not want certain information about their webpage visits collected over time and across websites or online services. Please note that we do not respond to or honor DNT signals or similar mechanisms transmitted by web browsers.

International Transfers

While some aspects of this platform may be hosted in the European Union or other countries, much of this Platform and its services are provided from the United States of America. Accordingly, any personal information we receive through direct user input may be stored on our servers located in the United States of America. By choosing to visit the Platform, utilize the services, or otherwise provide information to us, you agree and consent to this storage in the US-located servers and that personal information you provide may also be transferred to and processed by persons operating outside the US and/or the European Economic Area who work for us and/or service vendors who are engaged to help provide the services. You should be aware that not all countries offer the same standards of data protection and personal information privacy as those that may apply where you reside. However, your personal information will always be treated and used by us in accordance with this Platform Privacy Policy. In addition, AMERICAN RESEARCH LABS participates in the EU-U.S. and Swiss-U.S. Privacy Shield Frameworks that have been implemented by the Department of Commerce. These principles help to demonstrate our commitment to the protection of personal information received from or about individuals protected by these Principles and the EU General Data Protection Regulation.

Information Security

Processing Personally Identifiable Information in a secure manner is essential to our business and for your protection as a user. Maintaining a secure network and server system is in the best interests of our users and our research partners. We process and store Personally Identifiable Information using industry standard physical, technical, and administrative safeguards to secure such personal information against foreseeable risks such as unauthorized use, access, disclosure, destruction, and modification. Such security safeguards include use of encryption, password protection and user authenticated access rights. While we will use reasonable efforts to create a secure, safe and reliable Platform, the confidentiality of any communication or material transmitted to or from the Platform over the internet cannot be guaranteed.

The security of your Personally Identifiable Information is also, in part, your responsibility. When you register through the Platform, you should select passwords that are hard to guess and you must keep your passwords private and confidential. You should not share your password with anyone and should not store it in an unprotected format, such as taped to your computer or saved in your email. We do not accept liability for unintentional disclosure.

By using the Platform or providing Personally Identifiable Information to us, you agree that we may communicate with you electronically regarding security, privacy, and administrative issues relating to your use of the Platform. If we learn of a security system’s breach, we may attempt to notify you electronically by posting a notice on the Platform or sending an e-mail to you. You may have a legal right to receive this notice in writing.

Children's Privacy

Protecting the privacy of the very young is especially important. This Platform is not intended for or designed to attract minors. Users under the age of 18 or the age of legal majority in their country should not submit information to our Platform, and we do not collect, receive or knowingly keep information from any user we know or have reason to believe is a child under the age of 18 or age of legal majority, unless the information is provided by a parent or guardian. If a child has provided us with Personally Identifiable Information, the parent or guardian of that child should contact us if they want this information deleted from our files.

Users that are participating in pediatric trials will be asked to enter a date of birth. If the date of birth is under the age of 18 or legal majority in their country, the user will not be allowed to continue and submit the information unless that information is submitted by a parent or guardian.

Data Retention

The information you provide to us may be archived or stored periodically by us according to backup processes and will only be retained for as long as is required for the purposes for which it was collected, to provide our products and services to you, to support your participation in clinical trial activity, resolve disputes, establish legal defenses, conduct audits, pursue legitimate business purposes, enforce our agreements, and comply with applicable laws.

Accountability/Compliance and How to Contact Us

We are committed to protecting the privacy of our Platform users. We have posted this Privacy Policy to communicate the specifics of this commitment.

If you wish to access, correct, update or request removal of any of your information you provided to us or if you have any questions regarding this Privacy Policy or would like more information on our privacy practices, please contact us at: info@arllabs.com. We will address your concerns and attempt to resolve any privacy issues in a timely manner.

In addition, we will address any complaints or questions that our users may have regarding this policy or its implementation. If you have a complaint or question about our Privacy Policy, please email to info@arllabs.com. We will respond to your comments or concerns as soon as possible following receipt of your inquiry.

If any request remains unresolved, you may contact: AMERICAN RESEARCH LABS’s Privacy Office at info@arllabs.com or mail us at 5511 S Congress Ave Ste 125 Atlantis FL 33462.

If you are a resident of the European Union or Switzerland and feel that any request or complaint remains unresolved, you may contact your national data protection authority for your EU Member State which can be located through the following European Commission website: https://ec.europa.eu/info/law/law-topic/data-protection/reform/what-are-data-protection-authorities-dpas_en.

As this Privacy Policy explains, we are responsible for determining the purposes and means for the handling and processing of personal information subject to this Privacy Policy. In most cases AMERICAN RESEARCH LABS is the “controller” of your personal information collected through this Platform for purposes of compliance with the Data Protection Law of the European Union. If AMERICAN RESEARCH LABS is acting on behalf of a clinical trial sponsor, then that sponsor may instead be contacted by the controller of such Personally Identifiable Information.

Links to Other Websites

Our website may contain links to other third-party websites. You should carefully review the privacy policies or notices and practices of other websites, as we cannot control or be responsible for their privacy policies, notices or practices. For links to other company web properties, please review those privacy terms as well as they may differ from those on this website.

Notification of Changes

As we provide more information and services on our Platform and as privacy laws and regulations change, we may need to revise or update our Privacy Policy from time to time. We will always change the “Last Updated” date on the Privacy Policy to reflect when it was last revised. If we make a meaningful change to the Privacy Policy, we will notify you here, by email or by means of a notice on the Platform home page. However, we will always continue to protect your Personally Identifiable Information according to the law and as described by our current Privacy Policy.

Additionally, before we use Personally Identifiable Information for any new purpose not originally authorized by you, we will endeavor to provide information regarding the new purpose and give you the opportunity to opt out. Where your consent for the processing of Personally Identifiable Information is otherwise required by law or contract, we will endeavor to comply with the law or contract.

This Privacy Policy was last updated on December 15, 2020

1. Acceptance of Terms of Use

By accessing, using, or registering with the Website or any of the Services, you agree to all of these terms and conditions of use (the "Terms of Use") in full. If you do not agree to all of the Terms of Use, you are not permitted to use this Website! AMERICAN RESEARCH LABS does not provide warranties for the Website or Services and these Terms of Use include limits on AMERICAN RESEARCH LABS’s liability – you should read sections 9 and 10 carefully.

2. Changes to Terms of Use

AMERICAN RESEARCH LABS reserves the right to modify these Terms of Use at any time. If we make a material change to the Terms of Use, we will notify you here, by email, or by a notice posted on our Website home page. Your continued use of the Website and/or the Services after the Terms of Use have been modified will mean you accept such changes. If you disagree with the changes to the Terms of Use, you may cancel your registration in the Website at any time by using the “Contact Us” form or by clicking the Unsubscribe link that is included at the bottom of automated Service email messages. The following Terms of Use will continue, even after you cancel your registration: #4 Your Responsibilities, #7 Additional Terms, #8 Use of Website/Service/Content, #9 Limitation of Liability, #10 Disclaimer of Warranties, #12 Trademarks, #13 Copyright, and #14 Digital Millennium Copyright Act. In addition, de-identified or non-identifiable information that you provided prior to cancellation will still be used, in accordance with our Privacy Policy. We encourage you to review the Terms of Use on a regular basis.

3. Registration and Personally Identifiable Information

In order to offer personalized Services to our members, upon registration for any Services we will ask for certain personally identifiable information from you such as your first and last names, an email address, year of birth, gender, ZIP or postal code, contact telephone numbers, country/language preference, medical conditions of interest, education, qualifications, and organization (your “Profile”). You are responsible for keeping your Profile complete and up to date. AMERICAN RESEARCH LABS is not responsible for any part of your Profile, including its correctness or completeness.

AMERICAN RESEARCH LABS is committed to protecting your privacy; more information on our information practices is explained in the Privacy Policy. By using or registering with the Website, you consent to our collecting, receiving, storing, using, releasing, and keeping this information for the operation of the Website and the Services and in accordance with our Privacy Policy, which is incorporated by reference and made a part of this Agreement. You also agree that AMERICAN RESEARCH LABS may use your User Details and Profile to provide you with personalized Services and information.

4. Your Responsibilities

You are responsible for your use of the Website and Services and for taking reasonable steps to make sure that no unapproved person can access your User Details.

You may use the Website and Services for lawful, non-commercial purposes only. You may not use the Website in any way that could harm our Website or Services and you may not attempt to gain unapproved access to any information on the Website or the Services or the support networks. You may not use the Website or Services in any way that harms the lawful enjoyment by, or the rights of, any Website or Service user.

You are not entitled to use the content of the Website for commercial purposes under any circumstances.

5. Changes to/Termination of Services

We may from time to time add new Services, replace an existing Service with a new Service, or stop offering an existing Service. Information about new Services will be included on the Website, and these Terms of Use will apply to your use of new Services. Where we plan to stop offering an existing Service, we will make an effort to give you prior notice by posting details on the Website before we make any change.

We may end and/or suspend your registration without notice for any reason, such as if there has been a violation of policies posted on the Website or these Terms of Use by you or someone else using your User Details. Once your registration is cancelled, your Profile will be unavailable. You may cancel your registration in the Website at any time by using the “Contact Us” form or by clicking the Unsubscribe link that is included at the bottom of automated Service email messages.

6. Cookies and Third-Party Materials

This Website stores cookies and uses them in various ways as per our Privacy Policy. Please consult our Privacy Policy for detailed information about which cookies we use and how we use them.

This Website may display, include, or make available third-party content (including data, information, applications, and other products, services, and/or materials) or provide links to third-party websites or services, including through third-party advertising (“Third-Party Materials”). You acknowledge and agree that AMERICAN RESEARCH LABS is not responsible for Third-Party Materials, including their accuracy, completeness, timeliness, validity, copyright compliance, legality, decency, quality, or any other aspect thereof. AMERICAN RESEARCH LABS does not assume and will not have any liability or responsibility to you or any other person or entity for any Third-Party Materials. Third-Party Materials and links thereto are provided solely as a convenience to you, and you access and use them entirely at your own risk and subject to such third parties' terms and conditions.

7. Additional Terms

Certain Services on the Website may have additional terms or we may provide special offers including, but not limited to clinical trials, market research, disease education, or contests. If you choose to register for any such Service or special offer, you will be presented with any additional terms and conditions that apply at that time. By using those Services, you agree to obey such terms and conditions. AMERICAN RESEARCH LABS may use non-identifiable data for research purposes to improve research knowledge. In addition, and in line with our business model, we will make non-identifiable information available to qualified commercial and non-commercial researchers for research studies, such as clinical trials, market research, and outcomes research.

8. Use of Website/Service/Content

The Website and Services are provided for visitors and registrants. All rights, title and interest (including intellectual property rights) in and to the Website, its content (“Content”) and the Services is owned by AMERICAN RESEARCH LABS, its affiliates, its partners, and/or its licensors, and is protected by copyrights, trademarks, patents, trade secret laws, and other intellectual property and proprietary rights.

You may use the Website, Content, and Services for lawful, personal, non-commercial purposes only as described in these Terms of Use. You agree not to alter, copy, distribute, sell, resell, transmit, derive another work from any Content obtained from the Website, or abuse our Website, Content, and/or Services for any commercial purpose.

In the event that you gain any right, title, or interest (including intellectual property rights) in or to the Website, the Content, or the Services (whether by operation of law or otherwise) you will do all things and execute all documents that we reasonably require in order to assign such right, title, and interest to us.

9. Limitation of Liability

IN NO EVENT WILL AMERICAN RESEARCH LABS BE LIABLE FOR ANY DAMAGES WHATSOEVER, INCLUDING, BUT NOT LIMITED TO ANY DIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL, EXEMPLARY, OR OTHER INDIRECT DAMAGES ARISING OUT OF: (I) THE USE OF OR INABILITY TO USE THE WEBSITE OR THE CONTENT; (II) ANY TRANSACTION CONDUCTED THROUGH OR FACILITATED BY THE WEBSITE; (III) ANY CLAIM ATTRIBUTABLE TO ERRORS, OMISSIONS, OR OTHER INACCURACIES IN THE WEBSITE, THE SERVICE, AND/OR THE CONTENT; (IV) UNAUTHORIZED ACCESS TO OR ALTERATION OF YOUR TRANSMISSIONS OR DATA; OR (V) ANY OTHER MATTER RELATING TO THE WEBSITE, OR THE CONTENT, EVEN IF AMERICAN RESEARCH LABS HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. IF YOU ARE DISSATISFIED WITH THE WEBSITE, THE CONTENT, OR WITH THE TERMS OF USE, YOUR SOLE AND EXCLUSIVE REMEDY IS TO DISCONTINUE USING THE WEBSITE.

BECAUSE SOME STATES DO NOT ALLOW THE EXCLUSION OR LIMITATION OF LIABILITY FOR CONSEQUENTIAL OR INCIDENTAL DAMAGES, SOME OF THE ABOVE LIMITATIONS MAY NOT APPLY TO YOU. IN SUCH STATES, AMERICAN RESEARCH LABS'S LIABILITY IS LIMITED AND WARRANTIES ARE EXCLUDED TO THE GREATEST EXTENT PERMITTED BY LAW, BUT SHALL, IN NO EVENT, EXCEED THE GREATER OF $100 OR THE ACTUAL AMOUNT PAID BY YOU FOR USE OF THE WEBSITE.

ALL SITE CONTENT AND SERVICES ARE FOR EDUCATIONAL AND INFORMATIONAL PURPOSES ONLY. USE CAUTION AND SEEK THE ADVICE OF A MEDICAL PROFESSIONAL IF YOU HAVE ANY QUESTIONS OR IF YOU NEED MEDICAL HELP. IF YOU NEED EMERGENCY MEDICAL HELP, YOU SHOULD IMMEDIATELY CALL YOUR LOCAL EMERGENCY HELPLINE.

IF YOU ARE DISSATISFIED WITH THE WEBSITE OR SERVICE FOR ANY REASON, YOUR ONLY REMEDY IS TO STOP USING THE WEBSITE AND SERVICES. IF YOU DO NOT AGREE WITH THESE TERMS OF SERVICE, YOU MAY CANCEL YOUR REGISTRATION AT ANY TIME BY CONTACTING US OR BY CLICKING THE UNSUBSCRIBE LINK THAT IS INCLUDED AT THE BOTTOM OF AUTOMATED SERVICE EMAIL MESSAGES.

10. Disclaimer of Warranties

AMERICAN RESEARCH LABS MAKES NO EXPRESS OR IMPLIED WARRANTIES, REPRESENTATIONS OR ENDORSEMENTS WHATSOEVER WITH RESPECT TO THE WEBSITE OR THE CONTENT. AMERICAN RESEARCH LABS EXPRESSLY DISCLAIMS ALL WARRANTIES OF ANY KIND, EXPRESS, IMPLIED, STATUTORY, OR OTHERWISE, INCLUDING, BUT NOT LIMITED TO, IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE AND NON-INFRINGEMENT, WITH REGARD TO THE WEBSITE, THE CONTENT, AND ANY PRODUCT OR SERVICE FURNISHED OR TO BE FURNISHED VIA THE WEBSITE. AMERICAN RESEARCH LABS DOES NOT WARRANT THAT THE FUNCTIONS PERFORMED BY THE WEBSITE WILL BE UNINTERRUPTED, TIMELY, SECURE, OR ERROR FREE, OR THAT DEFECTS IN THE WEBSITE WILL BE CORRECTED. AMERICAN RESEARCH LABS DOES NOT WARRANT THE ACCURACY OR COMPLETENESS OF THE CONTENT, OR THAT ANY ERRORS IN THE CONTENT WILL BE CORRECTED. THE WEBSITE AND THE CONTENT ARE PROVIDED ON AN “AS IS” AND “AS AVAILABLE” BASIS.

11. Electronic Communications

When you register for Services, or send an email to us, you are communicating with us electronically. Accordingly, you explicitly consent to receive communications or information from us and our service providers electronically. We will communicate with you by email or by posting notices on this Website. You agree that all agreements, notices, disclosures, and other communications that we provide to you electronically satisfy any legal requirement that such communications be in writing. In order to access the Website, Content, and Services, you must have a computer connected to a communications source; Java script; full implementation of cascading style sheets; and a more recent version of one of the following Internet browsers: Internet Explorer, Firefox, Opera, or Safari.

12. Trademarks

The trademarks, logos, service marks, brand identities, title, characters, trade names, graphics, designs, and other properties (collectively the “Trademarks”) displayed on the AMERICAN RESEARCH LABS Website are protected intellectual properties that are registered and unregistered trademarks of AMERICAN RESEARCH LABS, its affiliates, and others. Nothing contained on the AMERICAN RESEARCH LABS Website should be construed as granting, by implication or otherwise, any license or right to use any Trademark displayed on this Website without the written permission of AMERICAN RESEARCH LABS or such third party that may own the Trademark displayed on AMERICAN RESEARCH LABS’s Website. Your misuse of the Trademarks displayed on AMERICAN RESEARCH LABS’s Website, or any other content on AMERICAN RESEARCH LABS’s Website, except as provided herein, is strictly prohibited.

13. Copyright

AMERICAN RESEARCH LABS, its suppliers, or the original creator of the Content own all copyrights to Content on the Website and all other intellectual property rights related to the Website. To the extent that AMERICAN RESEARCH LABS has the right to do so without compensation to third parties and except for Content specifically provided under other terms, AMERICAN RESEARCH LABS grants you permission to copy Content on the Website solely for your non-commercial use in support of AMERICAN RESEARCH LABS products. You agree that any copies of the Content shall retain all copyright and other proprietary notices in the same form and manner as the original. You may not, without AMERICAN RESEARCH LABS’s permission, “mirror” any Content contained on the Website or any other server. Except as specified above, nothing contained herein shall be construed as conferring by implication, estoppel, or otherwise any license or right under any trademark, patent, copyright, or any other intellectual property right of AMERICAN RESEARCH LABS or any third party.

14. Digital Millennium Copyright Act

AMERICAN RESEARCH LABS is committed to complying with US copyright law and to responding to claims of copyright infringement. AMERICAN RESEARCH LABS will promptly process and investigate notices of alleged infringement and will take appropriate actions under the Digital Millennium Copyright Act, Title 17, United States Code, Section 512(c) (“DMCA”).

Pursuant to Title 17, United States Code, Section 512(c)(2), notifications of claimed copyright infringement should be sent to AMERICAN RESEARCH LABS’s Designated Agent. See Copyright Infringement Notification.

15. Entire Agreement

These Terms of Use and all other legal notices, additional terms, policies, rules, and guidelines posted on the Website and the Services constitute the entire agreement between you and AMERICAN RESEARCH LABS and supersede all previous written or oral agreements.

16. Assignment

We may assign this Agreement at any time to any of our AMERICAN RESEARCH LABS companies, or as part of the sale to, merger with, or other transfer of our company to another entity. We will post a notice on the Website and may send you an email about any change of ownership so that you have the option to stop using the Website or cancel your registration if you do not wish to continue to use the Website and Services under the new ownership. You may not assign this agreement to anyone else.

17. Indemnification

You agree to indemnify, defend, and hold harmless AMERICAN RESEARCH LABS and its officers, directors, employees, agents, affiliates, successors, and assigns from and against any and all losses, damages, liabilities, deficiencies, claims, actions, judgments, settlements, interest, awards, penalties, fines, costs, or expenses of whatever kind, including attorneys' fees, arising from or relating to your use or misuse of the Website or your breach of this Agreement. Furthermore, you agree that AMERICAN RESEARCH LABS assumes no responsibility for the content you submit or make available through this Website.

18. Governing Law

This Agreement is governed by and construed in accordance with the internal laws of the State of Florida without giving effect to any choice or conflict of law provision or rule. Any legal suit, action, or proceeding arising out of or related to this Agreement or the Application shall be instituted exclusively in the federal courts of the United States or the courts of the State of Florida. You waive any and all objections to the exercise of jurisdiction over you by such courts and to venue in such courts.

19. Severability

If any provision of this Agreement is illegal or unenforceable under applicable law, the remainder of the provision will be amended to achieve as closely as possible the effect of the original term, and all other provisions of this Agreement will continue in full force and effect.

20. Waiver

No failure to exercise, and no delay in exercising, on the part of either party, any right or any power hereunder shall operate as a waiver thereof, nor shall any single or partial exercise of any right or power hereunder preclude further exercise of that or any other right hereunder. In the event of a conflict between this Agreement and any other applicable terms, the terms of this Agreement shall govern.

Last Updated: December 15, 2020