HIPAA and Informed Consent Forms
Informed Consent Forms and HIPAA
Last update: 11/10/2025
Informed 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:
Purpose:
Under HIPAA and the 21st Century Cures Act (45 CFR §171), providers must release records within 30 days of a patient request or the patient’s authorized agent (such as Massive Bio) to avoid information-blocking penalties. This authorization allows Massive Bio and its subcontractor(s) to access and use protected health information (PHI) to analyze clinical-trial eligibility, diagnostic options, and therapeutic optimization for the purpose of continuity of care for my cancer diagnosis or any other disease diagnosis.
Authorized Recipients:
Massive Bio and its subcontractors operate as Business Associates under HIPAA and are bound by Business Associate Agreements (BAAs) to safeguard PHI. The following information may be disclosed and used for these Services: complete medical records, hospital discharge summaries, diagnostic tests, genetic and genomic testing, mental health records/psychotherapy notes, alcohol or substance abuse records, HIV/AIDS information, sexually transmitted diseases, and other sensitive health data.
De-Identification and Real-World Evidence:
Anonymized and aggregated PHI created by Massive Bio is no longer subject to HIPAA and may be used for analytics, AI training, and real-world evidence research to improve clinical-trial matching, diagnostics, and therapeutic options.
Right to Access:
You have the right to refuse to sign this authorization without affecting your ability to obtain treatment, payment, or eligibility for benefits. You have the right to review and copy your PHI held by Massive Bio, including electronic copies under 45 CFR §164.524(c)(2).
Withdrawal:
You may revoke this authorization at any time by submitting a written or electronic notice to [email protected]. Revocation becomes effective within 30 days of acknowledgment and halts new processing of identifiable PHI. Information already used or disclosed may continue to be used as required by law or scientific integrity.
Information to Be Released and Used
I authorize my health-care providers and facilities to release all medical records necessary for Massive Bio to perform its Services, including information relevant to my diagnosis, treatment, and clinical history. This may include, as applicable:
- Hospital discharge summaries, consultation notes, and treatment history
- Laboratory and pathology results (including genetic or genomic tests)
- Radiology and diagnostic imaging records (e.g., X-rays, CT or MRI scans)
- Medication and procedure records, operative or surgical reports, and related documentation
Sensitive Information: I understand these records may include information regarding mental-health treatment or psychotherapy notes, alcohol or substance-use disorder treatment, HIV/AIDS status, sexually transmitted diseases, or results of genetic testing. I specifically authorize release of such information to Massive Bio for the purposes described in this authorization. Psychotherapy notes, as defined by HIPAA, will only be obtained or disclosed if specifically requested and separately authorized.
Purpose of Disclosure
The information described above will be used and disclosed by Massive Bio and its authorized subcontractors to provide oncology and/or other disease clinical-trial eligibility analyses, biomarker and drug-matching services, clinical-trial navigation, coordination of trial appointments, and related communications with my health-care providers.
Voluntary Authorization
- This authorization is voluntary. I may refuse to sign it without affecting (1) my ability to obtain treatment, (2) payment for my health care, or (3) my eligibility for health-care benefits.
- In performing its Services, Massive Bio may communicate with my providers to collect records, verify biomarker testing, schedule appointments with clinical research sites, and facilitate referrals to clinical-trial investigators on my behalf with my authorization.
Right to Revoke
I may revoke this authorization at any time by notifying my health-care provider and Massive Bio in writing at [email protected]. Revocation will not affect disclosures made before receipt of the written notice.
Communication and Security Safeguards
Massive Bio may use HIPAA-compliant secure methods—encrypted email, secure file-sharing systems, patient portals, HIPAA-compliant video or voice calls, and fax—to ensure confidentiality of my PHI when coordinating care and appointments.
Recipients of Information
- Massive Bio staff and agents who carry out activities permitted by this form
- Vendors and subcontractors (such as laboratories, pathology or genomic testing facilities, CROs, pharmaceutical and diagnostic companies, and real-world-data partners)
- Clinical-trial research sites, investigators, sub-investigators, and research staff involved in screening or scheduling appointments
Disclaimer and Limitations of Services
Massive Bio is not a licensed health-care provider and does not practice medicine. Its reports are for educational and informational purposes only. Treatment decisions are made solely by my treating physician. Massive Bio is not liable for any clinical outcomes arising from such decisions.
Trial Enrollment Disclaimer: Clinical-trial participation is determined solely by the trial sponsor or investigator. Massive Bio provides eligibility-matching and navigation support but does not control enrollment decisions or guarantee acceptance.
Proprietary and Confidential Analytics: Massive Bio’s analytics and reports are produced using proprietary algorithms and expert input. The specific data sources and contributing specialists are confidential and not publicly disclosed.
Retention and Use of Information
Massive Bio may retain and use my PHI in anonymized and aggregated form after Services to support research and database maintenance, including creation of Real-World Data and Derivative Materials. Anonymized data are not subject to HIPAA restrictions. This authorization remains valid for ten (10) years from the date of signature unless revoked earlier.
Disclosure of Sponsor Support
In certain situations, the sponsor of a clinical trial (for example, a pharmaceutical or biotechnology company) may provide financial support to Massive Bio, Inc. to cover concierge, navigation, or last-mile coordination services that assist you and/or your treating physician once a decision has been made to pursue participation in a specific eligible trial. This financial support is provided directly to Massive Bio to enable these services and does not affect your rights, the cost of your care, or your eligibility for any clinical trial. Massive Bio remains an independent organization, and your treating physician retains full clinical responsibility and decision-making authority. These services are offered solely to facilitate access, coordination, and communication related to trial participation.
Patient Rights and Contact Information
You may request an electronic copy of your PHI or contact Massive Bio to exercise your rights of access, amendment, or restriction by emailing [email protected]
Phone: +1-844-627-7246 Fax: +1-844-742-8837
Data Protection Officer: Cagatay M. Culcuoglu ([email protected])
PATIENT’S CONSENT
By signing below, I authorize my healthcare provider to disclose my protected health information to Massive Bio and its subcontractor(s) for clinical-trial eligibility analysis, diagnostic options, and therapeutic optimization.