Medical Records
Collection Consent

By signing and submitting this document, I am requesting the Services from Massive Bio: I consent to Massive Bio to provide the Services to me and my healthcare provider (as required). I acknowledge that my electronic signature will result in a legally binding contract under applicable state or federal law or local laws where the Services are provided

HIPAA

This section is prepared in accordance with HIPAA (Health Insurance Portability and Accountability Act) standards to protect the privacy and security of your health information. This authorization outlines how Massive Bio may use and share the information you provide.

In addition, your health information may be used by Massive Bio to evaluate your eligibility for potential participation in clinical trials and to support you throughout the clinical trial process, ensuring that you receive the most appropriate care during and after your participation.

To Healthcare Providers, Pharmacies and Health Plans and any organization who has copies of PHI and medical records

I understand that filling in and signing this form permits you to give copies of all my health records, including complete General Practitioners records such as information about medicine, allergies, vaccinations, previous illnesses and test result s, hospital discharge summaries, appointment letters, referral letter and any hospital records relating to my cancer diagnosis, to Massive Bio, whose details are given below, for the purpose of continuity of care for my cancer diagnosis. I understand that the information used or disclosed may be subject to redisclosure by the person or class of persons or facility receiving it and would then no longer be protected by federal privacy regulations.

We are committed to complying with all applicable, federal and state laws and national and international laws regarding the retention of protected health information (PHI). While we aim to retain PHI for up to 50 years, we will adhere to the specific retention periods mandated by state laws, which may require shorter retention periods. This authorization will expire in accordance with applicable state laws and will not exceed the maximum duration permitted by those laws. Additionally, this authorization will terminate if I am no longer participating in the clinical trial matching process or upon my written revocation provided to Massive Bio (or by my legal representative). To revoke this authorization, please send a written notice to Massive Bio at [email protected].

The revocation will be effective within 30 days upon receipt by Massive Bio; however, I understand that my revocation will not be fully effective until Massive Bio has communicated the revocation to my health care providers.

Please give Massive Bio copies of my health records, in line with 21st Century Cures Act in the US within 30 days.

As per the final rule published by the US Department of Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology (ONC) and the Centers for Medicare & Medicaid Services (CMS) on July 1, 2024, healthcare providers are required to share medical records with patients or entities like Massive Bio collecting medical records on behalf of patients within 30 days to avoid penalties for information blocking. This rule, effective from July 31, 2024, ensures compliance with the 21st Century Cures Act provision.

For the UK, abiding by the rules of the Data Protection Act 2018, please give copies of my health records within a calendar month. For all other international countries, please follow the national and local rules to share the reports as soon as possible, in accordance with the legal requirements.

By signing below, I am authorizing my health care provider to disclose my protected health information to Massive Bio and its subcontractor(s) to analyze clinical trials eligibility, diagnostic options, and therapeutics (“Services”). The information released and used for these Services will include all of my medical records. This may include information about mental health, alcohol or substance abuse, HIV/AIDS, sexually transmitted diseases, and/or results of genetic testing.

The information released and used for these Services will also include:

• Hospital discharge summary
• Radiology records
• Medical history/treatment
• Medications
• Consultations
• Radiology films (like X-rays or CT scans)
• Laboratory/diagnostic tests (including genetic and genomic testing)
• EKG reports
• EEG reports
• Psychological testing
• Pathology reports
• Operative reports (about an operation)
• Pathology specimen(s) and/or slide(s)
• Diagnostic imaging reports
• Dental records

The following sensitive types of records will be accessed as noted in this consent:

• Mental health records/psychotherapy notes
• Alcohol/substance abuse
• HIV or AIDS
• Sexually transmitted diseases
• Genetic testing

The undersigned individual is requesting this authorization.

This consent form will give you information about what data of yours we would like to store and use for future opportunities so as to help you decide whether you want to authorize services and participate. It is your choice whether or not you want to be considered. Please read this form, and ask any questions you have, before agreeing. 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.
• In performance of its Services, Massive Bio is authorized to communicate with my health care providers for data/medical records collection, trial matching, biomarker testing, and drug matching purposes, report issuance and feedback. Any information disclosed under this authorization will be used and disclosed by Massive Bio to provide oncology clinical trials eligibility analysis services and may be no longer protected by federal or state law. Massive Bio is 3/5 not a healthcare provider, and no patient-provider relationship is established through the request for this service. Treatment decisions are made at the treating physician’s discretion after an independent review of results. Massive Bio is not responsible or liable for these decisions or outcomes from prescribed treatment. Able to communicate with their providers for trial matching, biomarker testing, and drug matching purposes.
• I may revoke this authorization at any time by notifying my health care provider in writing. However, my revocation will not be effective for any action my health care provider had already taken in reliance on this authorization before it was revoked.
• Massive Bio’s analysis is provided without cost to the patient or the patient’s insurance.

The following individuals and organizations may receive or use my identifiable health and non-health information:

• Massive Bio staff and agents who carry out activities and purposes permitted by this form for Massive Bio.
• Any vendor, partner, or sub-contractor of Massive Bio, including but not limited to next generation sequencing vendors, clinical, pathology and/or genomic laboratories, contract research organizations, pharmaceutical, diagnostic, real-world evidence, and data companies.
• Clinical Trial Sites.

I understand that Massive Bio will perform these services at no cost. I agree that I had the opportunity to review this agreement and clarify all questions before its signature.

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

• Massive Bio is not practicing medicine and is not licensed, registered, certified, and otherwise qualified to practice medicine or deliver medical services in any world jurisdiction or country.
• 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 absolute claims or representations regarding its report’s accuracy, completeness, or reliability.
• 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 and other stakeholders to evaluate their patient’s existing clinical information and data to provide observations and information about the patient’s disease subtype. This includes analytics of clinical trial potential eligibility options, diagnostic options including biomarkers, and prior, existing, and future therapeutic options based on such analysis.
• Massive Bio does not physically observe or examine me, assess 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 my healthcare providers or me 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 issue its reports to myself, my primary oncologist, and other entities and/or individuals I authorize in writing.
• My primary oncologist may choose to utilize or disregard the observations and information in Massive Bio’s reports at their discretion.
• After the report is released to me as the patient, 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 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.
• 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 or data sources who contributed to the Deep Learning Clinical Trial Matching System (DLCTMS) development.
• After an initial review of my clinical information, if Massive Bio concludes, in its sole discretion, that the Services would not apply to my primary oncologist or me, Massive Bio may decline to process my request to analyze my anonymized clinical data through DLCTMS.
• Massive Bio will retain and use my protected health information in anonymized, aggregated form after the Services for research and maintenance of the Massive Bio research database, including the creation of Real-World Data, Deidentified Data and Derivative Materials therefrom, and disclose such aggregated Real-World Data, De-Identified Data, and Derivative Materials for any and all purposes (commercial, research, datasets) to its health data sharing partners. In European Union Countries, Massive Bio will store the data for a minimum of ten (10) years. This Request for Services constitutes the entire agreement between Massive Bio and me concerning 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, United States of America.

Frequently Asked Questions

What happens if I do not sign this AUTHORIZATION form?

Your consent is required for us to access your records and provide Massive Bio’s services. Without this authorization, we are unable to offer our services.

Without further discussion and separate consent, you cannot be entered into any research study. After the meeting, you may decide to participate in the research study; you will be asked to sign a specific research consent form.

What information will be collected?

The main risk of this participation is a loss of confidentiality. This means that someone outside Massive BIO could get access to your medical information collected.

What are the risks of taking part?

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

How will my information be used?

The study matching team will collect information about you from your medical records. This information, some of which may identify you, may be used for research-related, commercial and/or purposes. This may include making sure you meet the criteria to be a particular study, gathering medical information about you to be stored in Massive Bio database repository, determining diagnostic and therapeutic options at the point of care and elsewhere, or to inspect and/or copy such medical records for quality assurance and data analysis and reporting to Massive Bio and its partners.

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

After reviewing this form and having your questions answered, you may decide to sign this form and participate. Or you may choose not to participate. This decision is up to you. If you choose not to participate or change your mind after signing this document, it will not affect your usual medical care or treatment or relationship with Massive Bio. You can change your mind and withdraw your authorization at any time to allow your personal health information to be used by Massive Bio and its partners. If this happens, you must withdraw your cancellation in writing. Beginning on the date, you withdraw the authorization; no new personal health information will be used for research. Even if you withdraw your permission, your personal data collected before receiving your written request may have been used already. If you withdraw your permission to use your personal data, you will also be withdrawn from the Services, and no new information will be collected. Further, if any data was shared with partners/vendors/etc., we would do the notify such parties to have it removed and no longer utilized per your request. To withdraw your consent, please get in touch with the person below. They will make sure your written request to withdraw your authorization is processed correctly.

• Contact information of the Data Protection Officer: Cagatay M. Culcuoglu, [email protected].
• You can exercise the rights above by sending an email to: [email protected]
• Contact phone: +1-844-627-7246
• Contact fax: +1-844-742-883

How long will this AUTHORIZATION last?

If you agree by signing this form that Massive Bio can use your personal health information, this authorization has no expiration date. In the European Union, it has an expiration date of ten (10) years past services. However, you can change your mind and withdraw your authorization, as stated above.

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

• You can exercise the rights above by sending an email to: [email protected]
• Contact phone +1-844-627-7246
• Contact Fax: +1-844-742-883

Additionally, you can access your medical records from Massive Bio’s Patient Connect solution at any time upon request

Individuals will not receive any form of remuneration for the use of their Protected Health Information (PHI).

How will my information be stored and protected?

Every effort will be made to keep your personal information confidential, but we cannot guarantee absolute confidentiality. Your information is stored on a platform developed with human subject protection and data security as a top priority. Our privacy policy is on our website: Privacy Policy .

PATIENT’S CONSENT

In consideration of all the above, I agree to participate in these services. I will be given a copy of this document to keep for my records.

Signature

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