Authorization to Release and Disclose (HIPAA Agreement)

By signing below, I am authorizing my health care provider to disclose my protected health information (PHI) to Massive Bio and its subcontractor(s). I authorize the release of all medical records, treatment history, medical data, including laboratory test results, tumor measurements, CT scans, MRIs, x-rays, and pathology results, and other clinical information relevant to my disease, other medical conditions that may affect your treatment, information on side effects (adverse events) you may experience, and how these were treated, long-term information about your general health status and the status of your disease, data that may be related to tissue and/or blood samples that may be collected from you; and numbers or codes that will identify you, such as your medical record number. I also authorize Massive Bio to retain and utilize my PHI for 1) research and 2) maintenance of the Massive Bio research database, with the exception of records relating to mental healthcare, communicable diseases, HIV or AIDS, and treatment for alcohol or drug abuse. This authorization is being requested by the undersigned individual. I understand and agree to the following:

  • This authorization is voluntary, and I may refuse to sign it without affecting (1) my ability to obtain treatment from my health care provider, (2) payment for my health care, or (3) my eligibility for health care benefits.
  • Any information disclosed pursuant to this authorization will be used and disclosed by Massive Bio for me and may be no longer protected by federal or state law. Massive Bio is not a healthcare provider and no patient-provider relationship is established through the request for any of Massive Bio services, nor by the signature of this authorization.
  • Treatment decisions are made at the discretion of the treating physician (i.e. primary oncologist) after an independent review of results. Massive Bio is not responsible or liable for these decisions or outcomes from any prescribed diagnostic or treatment interventions.

What happens if I do not sign this authorization form?

If you do not sign this authorization form, you will not be able to receive any of Massive Bio services. Signing this form is not a condition for receiving medical care, wherever you wish to pursue it.

If I sign this form, will I automatically be entered into a research study?

No, you cannot be entered into any research study without further discussion and separate consent. After discussion, you may decide to take part in the research study. At that time, you will be asked to sign a specific research consent form.

What happens if I want to withdraw or revoke (cancel) my authorization?

You can change your mind at any time and withdraw your authorization to allow your personal health information to be used in the research. If this happens, you must withdraw your authorization in writing.
Beginning on the date you withdraw your authorization; no new personal health information will be used for research. However, researchers may continue to use the health information that was provided before you withdrew your authorization.

To withdraw your authorization, please contact the person below. He/she will make sure your written request to withdraw your authorization is processed correctly.

Kristin Johnston, RN
Phone: +1 917-336-3319
Fax: +1 844-742-8837
Email: kjohnston@massivebio.com

How long will this authorization last?

If you agree by signing this form that researchers can use your personal health information, this authorization has no expiration date. However, as stated above, you can change your mind and withdraw your authorization at any time.

What are my rights regarding access to my personal health information?

You have the right to refuse to sign this authorization form. You have the right to review and/or copy records of your personal health information kept by Massive Bio. You do not have the right to review and/or copy records, analysis, results, or any other data kept by Massive Bio or other researchers associated with any research study derived from this authorization.

Signature

I agree that my personal health information may be used for any and all purposes described in this form.

By signing this HIPAA Authorization form, I have not given up any of my legal rights. I will receive a copy of the signed and dated form for my files.


Please sign below to confirm this HIPAA data release authorization for Massive Bio:


Individual's Printed Name (required)

Date of Birth (required format mm/dd/yyyy)

Individual's Signature (required)


Date



Alternatively, a legal representative for the individual may sign below:


Printed Name of Individual’s Representative

Relationship to Patient

Signature of Individual's Representative


Date



Massive Bio, Inc. Request for Virtual Tumor Board (VTB) and Clinical Trial Matching (CTM) Services

I (i.e. the Patient) understand that Massive Bio’s VTB includes these services (“Services”):

  • Contact me to obtain my medical records, treatment history, scans, and clinical information relevant to my disease, followed by review and analysis by Massive Bio’s team of experienced oncologists and researchers relevant to the specific disease subtype.
  • Provide an analysis report to my primary oncologist that helps to understand my disease, its specific genetic profile, and the latest testing and treatment options, including clinical trials.
  • Provide the same report, or the subset of the report, to me based on my primary oncologist guidance to Massive Bio.
  • Provide customer support call to me and my primary oncologist to answer any relevant questions and clarifications regarding the released analysis report. My primary oncologist chooses to present or not to present during the customer support call.
  • Finalize all customer support activities within 90 days (3 months) of the execution date of service agreement. Massive Bio’s Customer Support can be reached at support@massivebio.com or +1-917-336-3319 or +1 844-627-7246 if you have any questions.

I (i.e. the Patient) understand that Massive Bio’s CTM includes these services (“Services”):

  • Contact me to obtain my medical records, treatment history, scans, and clinical information relevant to my disease, followed by review and analysis by Massive Bio’s team of experienced oncologists and researchers relevant to the specific disease subtype.
  • Provide an analysis report to my primary oncologist that helps to understand latest clinical trials options.
  • Provide the same report, or the subset of the report, to me based on my primary oncologist guidance to Massive Bio.
  • Finalize all customer support activities within 90 days (3 months) of the execution date of service agreement. Massive Bio’s Customer Support can be reached at support@massivebio.com or +1-917-336-3319 or +1 844-627-7246 if you have any questions.

I understand that it is my responsibility to pay Massive Bio for the services provided to me and agree to Massive Bio’s refund policy.

  • Pricing options:
    • 3 Physician Analysis Supervision, including Clinical Trials Matching: $3000.00. Translation fees are not included. If the patient wishes to use Massive Bio’s translation services, then fees start at $250.
    • Clinical Trial Matching: $750. Translation fees are not included. If the patient wishes to use Massive Bio’s translation services, then fees start at $250.
  • Refund policy:
    • If the person who is receiving Massive Bio’s services, makes the payment for the services but passes away before Massive Bio receives medical records, the family member of the client is entitled to a full refund. If needed, a faxed or scanned soft copy of the death certificate and proof of document relation to the client will be sent to Massive Bio. After 30 days of Massive Bio’s initial request for documentation, the patient or family is no longer entitled to a refund.
    • Once medical records are collected by Massive Bio, no refunds will be issued to the patient.
    • If medical records are not obtained within 30 consecutive days after the payment was received by Massive Bio, the client may request a full refund.
    • Once the analysis report is delivered to the requestor, he/she is no longer entitled to a refund. Should the patient succumb to his/her illness pre- or post- delivery of the analysis, no refunds will be given.
    • No other refund requests will be accepted if the patient does not fall under one of the previous categories.


I also understand the following disclaimers and limitations of the Services:

  • Massive Bio is not practicing medicine and is not licensed, registered, certified, and/or otherwise qualified to practice medicine or deliver medical services in any of the United States of America.
  • Massive Bio is not a health care provider and no patient-provider relationship is established by this request for services from Massive Bio.
  • Massive Bio disclaims all express and implied warranties, including implied warranties of merchantability and fitness for a particular purpose. Massive Bio does not make any absolute claims or representations regarding accuracy, completeness, or reliability of its report.
  • Massive Bio does not provide medical advice or opinions and our reports are advisory, for educational and informational purposes only.
  • Massive Bio is a healthcare data analytics firm that acts as a vendor to healthcare providers for evaluation of their patient’s existing clinical information and data to provide observations and information about the patient’s disease subtype.
  • Massive Bio does not physically observe or examine me, test my blood or tissue samples, or take any anatomical images for diagnostic or therapeutic purposes.
  • I represent that the medical records and clinical information provided by me or my healthcare providers are accurate and complete and Massive Bio is not responsible for, or liable to, anyone for incorrect or incomplete reporting due to inaccurate, incomplete, or unreadable clinical information received from my healthcare providers or me.
  • Massive Bio will first issue its reports to my primary oncologist, and only after their review and approval, will present the report to me.
  • My primary oncologist, in his/her sole discretion, may choose to utilize or disregard the observations and information in Massive Bio’s reports.
  • It is my responsibility to work with my primary oncologist to decide on clinical trials, prepare documents, and apply to clinical trials. After the report is released, if there is a specific clinical trial that I would like to enroll in, I will need to apply to the institution for the clinical trial. I will only be accepted for the clinical trial if I am eligible and my condition is suitable. Massive Bio does not guarantee the acceptance or enrollment in clinical trials. Massive Bio may answer my questions regarding clinical trials and help prepare documentation as a part of customer support, but I will clearly communicate what I need from Massive Bio and Massive Bio will discuss timing and additional payment requirements (if applicable).
  • Prior to engaging in customer support call, I shall confirm my identity (name, date of birth, and zip code for identification and security purposes), and shall verbally agree to a disclaimer statement in order to proceed with the call.
  • Massive Bio’s report is the product of a proprietary knowledge base and top expert medical oncologists’ input on my anonymized clinical data. Due to proprietary and confidentiality agreements, Massive Bio reserves the right not to disclose the names of the specialists who reviewed my anonymized clinical data.
  • After an initial review of my clinical information, if Massive Bio concludes, in its sole discretion, that the Services would not be useful to my primary oncologist or me, Massive Bio may decline to process my request and refund payment.
  • Massive Bio will retain and use my protected health information after the Services for research and maintenance of the Massive Bio research database.
  • This Request for Services constitutes the entire agreement between Massive Bio and me with respect to this subject matter and shall be construed under the laws of the United States of America and the State of Delaware. All disputes shall be resolved exclusively by binding arbitration held in New York City.

By signing below, I am requesting the Services from Massive Bio; I give my informed consent to Massive Bio to provide the Services to my healthcare provider.


Individual's Printed Name (required)

Date of Birth (required format mm/dd/yyyy)


Please sign below to confirm your request for the Services:

Individual's Signature


Date



Address


Provider's Information

Please fill out as much of the information as possible. The more details we have, the easier it will be for us to gather all of your medical records.


Oncologist (First and Last Name)

Hospital Affiliation




Provider's City

Provider's State

Provider's Phone Number



Insurance Provider


By signing and submitting this document, I acknowledge that my electronic signature used will result in a legally binding contract under applicable state or federal law.


Please call 844-627-7246 with any questions

Please fax to 844-742-8837