Patient Bill of Rights

Right to informed consent

Before any prescription is written, you have the right to receive a clear, plain-language explanation of:

• What the medication is and how it is intended to work
• What benefits the published research supports (with specific clinical-trial data when available)
• What known and reasonably foreseeable risks and side effects have been reported
• What alternative treatments exist, including the option to do nothing
• How long treatment is expected to continue and what monitoring is required
• The FDA status of the medication (see Right #2)

You have the right to ask any question and receive an honest answer before consenting. Consent must be documented in writing or via an audited electronic signature. You can withdraw consent at any time.

Right to know FDA status

You have the right to know, before any prescription is dispensed, the specific FDA regulatory status of every medication you may receive. We classify every peptide we discuss into one of three categories:

Right to understand off-label prescribing

"Off-label" means a physician is prescribing a medication for a condition, dose, or patient population for which the FDA has not specifically approved that medication. Off-label prescribing is legal in the United States and is common across many specialties; it is the basis for most compounded peptide therapy.

You have the right to know whether your prescription is off-label, why your physician believes it is appropriate for you specifically, and what published evidence supports that decision. For most compounded peptides, the evidence base is preclinical (animal studies); for some it includes limited human clinical data; for none does it match the rigor of FDA-approved branded indications. We will tell you this honestly before you decide.

Right to a real physician evaluation

You have the right to a real evaluation by a US-licensed physician before any prescription is issued. This includes:

• A documented video consultation (not a form-only review)
• A complete medical history review, including current medications and allergies
• Relevant lab work review when clinically indicated (HbA1c, IGF-1, lipid panel, thyroid function, etc.)
• Identification of contraindications and risk factors
• A clear medical rationale for the prescription, documented in your chart

You have the right to know the name, state of licensure, and NPI of the physician evaluating you. Irvine Health affiliated physicians must be licensed in the state where you reside.

Right to refuse or stop treatment

You have the absolute right to refuse any prescribed treatment, to stop a treatment at any time, and to switch to a different protocol. You do not need to justify your decision. If stopping a medication abruptly is medically inadvisable (e.g., taper required), your physician will explain a safe discontinuation plan, but the final decision remains yours.

Refusal of any one treatment will not affect your access to other treatments or your standing as a patient.

Right to access your medical records

Under HIPAA, you have the right to request, review, and receive copies of your complete medical records held by Irvine Health, including:

• Consultation notes and physician chart entries
• Prescriptions issued and any modifications
• Lab orders and results we have on file
• Billing records
• Identity of healthcare providers who have accessed your records

Records will be provided within 30 days of a written request (extendable once by 30 days under HIPAA). You have the right to receive records in the format you request when reasonably available (electronic, paper, or specific file format). You also have the right to request corrections to any information you believe is incorrect.

Right to privacy (HIPAA)

Your protected health information (PHI) is private. Irvine Health does not sell, rent, or share your PHI for marketing without your written authorization. PHI is shared with:

• Your prescribing physician and their direct clinical team
• The licensed 503A compounding pharmacy that fills your prescription
• Payment processors only for the data necessary to complete the transaction
• Government authorities when legally compelled (court order, subpoena, public health reporting)

All vendors that receive your PHI operate under a Business Associate Agreement (BAA). You have the right to request a list of disclosures of your PHI over the prior six years. See our Notice of Privacy Practices for full details.

Right to know your pharmacy

You have the right to know the name, state license, and accreditation status of the compounding pharmacy that will prepare your medication. You may request:

• The pharmacy's state license number
• Their accreditation (e.g., PCAB)
• Whether they operate under 503A or 503B framework
• Whether they hold a non-resident pharmacy license in your state
• The source of the active pharmaceutical ingredient and the certificate of analysis when available
• Sterility and potency testing results for injectables

Right to transparent pricing

You have the right to know the full price of any treatment before you commit. This includes:

• The consultation fee
• The medication cost
• Shipping costs
• Any required lab work fees
• The cost of follow-up visits
• Recurring/subscription billing terms, if any

You have the right to a written itemized statement of every charge. We do not bill in advance of services and we do not charge cancellation fees prior to physician evaluation.

Right to a second opinion

You have the right to seek a second opinion from any other licensed healthcare provider at any time and to share your Irvine Health records with that provider at no cost. We will not delay or interfere with your access to other providers.

Right to non-discriminatory care

Irvine Health does not discriminate in clinical evaluation or treatment decisions on the basis of race, color, national origin, religion, sex, gender identity, sexual orientation, age, disability, marital status, or veteran status. Clinical decisions are based solely on medical appropriateness, evidence, and patient goals.

Right to raise concerns

You have the right to raise any concern about your care, your privacy, your bill, or your physician without fear of retaliation. Concerns will be:

• Acknowledged in writing within two business days
• Investigated and substantively addressed within five business days when possible
• Escalated to clinical leadership when appropriate
• Documented in our compliance log

If you are not satisfied with our internal response, you have the right to escalate to:

• Your state medical board (oversight of the prescribing physician)
• Your state pharmacy board (oversight of the dispensing pharmacy)
• The HHS Office for Civil Rights for HIPAA concerns: hhs.gov/hipaa/filing-a-complaint
• The FTC for advertising or business practice concerns

Right to report adverse events

If you experience a side effect, unexpected reaction, or any harm you believe is related to a medication, you have the right to report it. You should:

• Contact us immediately at [email protected] or your physician portal so we can document the event, advise you, and update your protocol
• If symptoms are severe or life-threatening, call 911 or go to the nearest emergency department first; report to us as soon as you can
• Report directly to FDA MedWatch at accessdata.fda.gov/scripts/medwatch or by phone at 1-800-FDA-1088

We are required to record adverse events in our compliance log and may be required to report certain events to FDA or state authorities. We will tell you when we do so. Reporting an adverse event will not affect your standing as a patient.

Right to data portability and deletion

You have the right to receive a portable electronic copy of your data (clinical records, billing history, treatment history) on request. Once a treatment relationship has ended and the legal retention period for medical records has elapsed (typically 7–10 years per state law), you may request deletion of personal information held outside of legally required retention.

Right to interpretation services

If English is not your primary language, you have the right to request interpretation services at no cost during your physician consultation. The Irvine Health platform is available in English and Spanish. Additional language support can be arranged on request.