Previvor Edge Patient Informed Consent

Previvor Edge is a clinical program (the “Program”) from Previvor Care, Inc. (“Previvor”) aimed at reducing cancer risks, including through early detection, that is intended to help patients understand where they are most vulnerable and what they can do to catch cancer early or reduce their chances of getting cancer.  More information about the Program is available here: https://www.previvoredge.com/patients.

This consent sets forth your agreement to participate in the Program in accordance with the terms set forth herein, as well as your understanding of the risks and limitations of your participation. 

Consent to Receive Healthcare Services; Third Party Providers

By signing below, you consent to receive services (“Services”) from Previvor and from professional corporations contracted by Previvor to provide clinical services to you as part of the Program, such as clinical appointments to develop your personal cancer risk profile and an associated care plan, including those professional corporations listed on https://www.previvoredge.com/PCs (each a “PC” and collectively referred to as the “PCs”), (Previvor and the PCs are collectively referred to as the “Providers”). This consent supplements and incorporates the Previvor Terms of Service, Privacy Policy, and the PCs’ Notices of Privacy Practices.  You understand that the Providers do not guarantee any health outcomes. You understand that you may withdraw this consent at any time and that your participation in the Program is voluntary, and that, if you withdraw your consent, the Providers will retain such information as is required by applicable law.

Additionally, the Providers will be referring and/or coordinating tests and care from third party providers, including laboratories, imaging, and other clinical specialists (collectively referred to herein as “Third Party Providers”), and you understand that the Providers are not responsible for the actions or omissions of the Third Party Providers. You understand that you may be required to sign additional consents for any medical or clinical services from Third Party Providers in order to receive such services.  

Collection and Use of Personal Information

You will allow the Providers to assess your needs and collect personal and medical information about you to provide the Services. You understand that this information will be stored and used by the Providers in accordance with the privacy policies that will be provided to you with any additional consents that you have signed or agreed to, and you will abide by the terms of use of the Provider platforms used to store and share such information. You authorize the Providers to collect any information that you make available to them, specifically including your medical history from other providers and information available on health information exchanges.  You understand that such information may include genetic information, information related to psychiatric conditions or care, and information regarding HIV status and treatment. You will immediately inform the Providers if there is any information available that you do not wish to be collected and used in connection with your care and the Program. 

Release of Information for Services and Billing 

You further hereby authorize the Providers to use and disclose your protected health information (including information relating to the diagnosis, treatment, claims payment, and health care services provided or to be provided to you and which identifies your name, address, social security number, or Member ID number) in the performance of the Services and in order to bill and/or process insurance claims in connection with the Services and for the purpose of helping you and/or the Providers to resolve claims and any health benefit coverage issues. You understand that any personal health information or other information released to the person or organization identified above may be subject to re-disclosure by such person/organization and may no longer be protected by applicable federal and state privacy laws.

Assignment of Benefits; Financial Responsibility

You agree to assign all payments, rights and claims for reimbursement of claims, costs and expenses allowable under your insurance plan(s) directly to the Providers for the Services rendered. For all such claims, you authorize payment to the Providers of all monies and/or benefits to which you may be entitled from government agencies, insurance carriers or others who are financially liable for your medical care and treatment to cover the costs of the Services. As set forth above, you hereby authorize the release of any of your medical records for the purposes of making such claims and receiving payments in connection therewith.

You agree to pay all amounts for which you are financially responsible, in accordance with the rates and terms of the Providers. You understand that, to the extent permitted by law, where insurance or other third-party benefits are insufficient, you will be responsible for the payment of any deductibles, copayments, coinsurance or other fees required by the insurer or other benefit plan. You understand that if you do not provide the Providers with accurate and current information regarding your insurance or other benefit plan/third party payor which provides you with health care coverage, you will be personally responsible for the cost of all care rendered by the Providers.  You additionally understand that you will be responsible for the payment to any Third Party Providers for medical services ordered by the Providers, including any costs associated with your insurance if you make claims associated with such services.

You certify that the information given to me in applying for payment under Medicare (if and where applicable) is correct, and you authorize any holder of medical or other information about me to release to the Social Security Administration and/or Center for Medicare and Medicaid Services, or its intermediaries or carriers, any information needed for this or a related Medicare claim. You hereby request that the payment or authorized benefits be made on your behalf to the Providers for Services provided by the Providers.

Telehealth Disclaimer and Consent

You understand that you will be receiving, and you consent to receive, certain Services via telehealth, in addition to those communications as set forth in the Previvor Privacy Policy (to which you have separately agreed to). The details of your telehealth interaction, which may include oral, visual, and electronic communications between you and your health care provider, may become part of your medical records, as such details would for any other type of face-to-face interaction with a health care provider.  

While telehealth may improve access to care and lead to more efficient diagnosis, treatment, and care management, there are potential risks associated with telehealth, as there are with any medical treatment or procedure. The potential risks associated with telehealth include, but are not limited to: insufficient transmission of information that does not allow for appropriate decision-making and diagnosis by the health care provider; delays in diagnosis, consultation, and/or communication due to deficiencies or failures of equipment or systems; failure of security protocols, resulting in a breach of privacy of personal health information; or adverse results or reactions due to lack of access to complete medical records. Under certain circumstances, telehealth may not be as appropriate as face-to- face interaction, and your genetic counselor may refer you to another provider for follow-up or additional care.

Consent to Phone, Email and Text Communications

Consent to Call:  You consent to receiving communications from the Providers by phone if you provide us with a phone number, including automated or pre-recorded communications to your cell phone.  

Consent to Text and Message:  You also authorize the Providers to communicate with you via text messaging (or similar technology, such as iMessage, WhatsApp, etc.) on such phone line regarding your “protected health information” (“PHI”) (as that term is defined in the Health Insurance Portability and Accountability Act (“HIPAA”) of 1996 and its implementing regulations) and agree and acknowledge that:

• Text messaging is not a secure medium for sending or receiving PHI because these messages are not encrypted and may be addressed to the wrong person or accessed improperly while in storage or during transmission, such as being intercepted on public Wi-Fi networks; and 
• If you communicate with us via text message, you consent to our responding via text, despite the risks stated above.

Consent to Email: You additionally authorize and consent to receiving communications from the Providers via email if you provide us with an email, including electronic statements from the Providers.  You agree and understand that such communications will include PHI and that:

• E-mail is not a completely secure medium for sending or receiving PHI because these messages may be addressed to the wrong person or accessed improperly while in storage or during transmission;
• we cannot assure or guarantee the confidentiality of e-mail communications, although we will make reasonable efforts to keep e-mail communications confidential and secure; and
• We are not liable to Individual for any loss, cost, injury, or expense caused by, or resulting from, a delay in responding to you as a result of technical failures.

Genetic Counseling Consent

Your Services may include Genetic counseling, which is the process of discussing genetic information and concerns, including personal and family history, genetic disease concerns, and the benefits and limitations of both genetic testing and potential test results, with a trained clinical genetics professional. During a genetic counseling session, you and your clinician may:

• Review your personal health history and family history.
• Discuss questions you have about possible genetic conditions or the risk of a genetic condition in you or your family.
• Explore genetic testing options by helping you understand what tests are available and what testing can and cannot tell you, and provide guidance to help you decide if you would like to pursue genetic testing.
• Discuss the risks and benefits of genetic testing related to prevention or therapeutic medical treatment to reduce the risk of disease, including the potential psychological and social impact of genetic conditions or genetic test results.
• Explain results of any genetic testing you have had and what the results mean for you and your family.
• Discuss the Genetic Information Nondiscrimination Act (GINA) of 2008 that prohibits discrimination based on genetic testing from health insurance and employment with some exceptions. Your clinician can clarify any concerns you have about genetic testing (ginahelp.org).

Genetic counseling is voluntary. You are seeking genetic counseling either based on your own interest, or because your healthcare provider recommended you do so. Some insurance companies may require genetic counseling before they cover the cost of genetic testing.

You should share complete and accurate medical history and details regarding any conditions you may have or may be aware of in your family. You will also need to provide access to your medical records and any genetic test results. The recommendations from your genetic consultation will depend on the accuracy of your family history. Issues of non-paternity (for example, named father is not the biological father) will affect the evaluation of your family history. We may request that you obtain genetic test results or medical records from a family member.

The information provided by genetic counselors is not intended to replace the medical advice and recommendations of your existing healthcare team who are responsible for your overall care. If you have non-genetic concerns about a current health condition, you should consult your local healthcare provider.

Consent for Genetic Testing

If genetic testing is ordered by the Providers, you acknowledge that you have requested the performance of the genetic test ordered as part of the Program. More information about the tests to be performed will be made available to you, including on the website of the laboratory performing the testing. You will be asked to provide a blood, cheek swab, or saliva specimen in accordance with specified collection procedures. You will also be asked to provide certain health and other personal information, such as name, address, DOB, and certain medical history. you acknowledge that your submission of this information and or a specimen to be tested is voluntary, and agree that, insofar as you provide it, it will be true and complete and done to the best of your knowledge.

You understand that the purpose of this genetic testing is to look for mutations or genetic characteristics known to be associated with certain genetic diseases, conditions, or pharmaceutical therapies. You acknowledge that you have reviewed information specific to the genetic tests that are ordered for you and that you understand these tests’ risks, benefits, and limitations, including that the test may or may not help your healthcare provider better understand your health and treatment options, that types of variants that could cause a specific disease or disorder may not be detected by the test, and that the test has technical limitations that may prevent detection of some rare gene variants, or may give an inaccurate result.

You acknowledge that you have been provided with information about obtaining genetic counseling prior to giving your consent, and you understand that you may seek consultation with a geneticist, genetic counselor, and/or physician after testing. You hereby acknowledge that genetic test results may have implications for your biological family members and unexpected family relationships may be identified through genomic testing.

You understand that your specimen, along with your other personal information, will be sent for analysis by the testing laboratory, and that the testing laboratory will use this information in accordance with its privacy policy. Genetic information will be extracted from the specimen, and certain markers within regions of your genome relevant to the relevant genetic test(s) will be sequenced (or otherwise generated) and analyzed. Upon successful completion of the Test, the results will be sent to the Providers and any other authorized person. No other tests will be performed using the specimen except as authorized by you and as permitted by applicable law.

Genetic information is protected under the federal Genetic Information Nondiscrimination Act (GINA), which generally prohibits health insurers and employers from discriminating against you based on your genetic information. However, you should be aware current federal laws do not specifically prohibit genetic discrimination in life insurance, long-term care insurance and disability insurance. More information about GINA and its limitations is available at ginahelp.org.

These genetic tests analyze specific gene regions based on currently available information in the medical literature and scientific databases, which may be subject to change. As such, new information may replace or add to the information that was used to analyze your results that may impact the interpretation of results. As with any genetic test, there is a possibility of error, such as the chance of a false positive or a false negative result. A false positive result means a relevant marker or variant is incorrectly reported as present. A false negative result means that a variant of interest is not identified when it is in fact present and within the reportable range. Other sources of error, while rare, include specimen mix-up, poor specimen quality or contamination, inherent DNA sequence properties, and technical errors in the testing laboratory. In addition, if you have certain rare biological conditions or have had certain bone marrow, kidney, liver or heart transplants, transfusions, or hematologic malignancies, these conditions may limit the accuracy or relevance of the results or prevent the Test from being completed. 

You understand that the laboratory’s use of your sample and health information outside of the specific test(s) you have consented to are governed by the laboratory’s internal policies, and you understand that the laboratory, and not the Providers, is solely responsible for compliance with such policies. 

Questions and additional information

If you have any additional questions about the Program or require any additional information before signing this consent, please contact support@previvoredge.com.

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Signature and Agreement

By agreeing to this Consent, I hereby agree that:

• I am of legal age to request the Services and Participate in the Program and I have the capacity and authority to enter into this consent.
• I have read, or had read to me, and understand the above information.
• The decision to consent to, or to refuse, participation in the Program is voluntary and entirely mine.
• I understand that my health information will be accessed, used, retained, and disclosed as set forth above.
• I understand that my insurance may be billed as set forth above and that I have financial responsibility for the Services.
• I understand that the Providers and the Program make no guarantees about my current or future health state or diagnoses.
• I have all the information I require, and all of my questions have been satisfactorily answered.