Contraindications for UBI and Ozone

We advise not to administer ozone if your patient has the following

1. All cases with Blood Coagulation Failure

2. Bleeding Organs

3. Thrombocytopenia

4. Hemorrhagic or Apoplectic Stroke

5. Recent Myocardial Infarction

6. Alcohol Intoxication

7. Significant G6PD deficiency (favism)/ acute hemolytic anemia

8. Hyperthyroidism if not controlled

9. Leukemia

10. Pregnancy – First trimester only and medical-legal reasons

11. Photosensitivity

12. Sulfa Drugs

CONDITIONS OF TREATMENT AND INFORMED CONSENT TO TREAT

This document is a binding agreement (the “Agreement”) between Tru Functional Health (“We” or “Us”), and the individual patient whose name and signature appears below (“You” or “Your”). In consideration of the health care services provided to You by Us at the present and at all times in the future, You agree as follows (Your agreement indicated by placing Your initials on the lines next to each section and by signing in the space provided):

IV Infusion and Injection Consent Form

This form outlines that you understand that a peripheral intravenous catheter will be inserted into a vein in your body, and you will have fluids, vitamins, minerals, nutrient, and/or medications infused directly into your body. This is considered “IV Infusion Therapy.” If you are having injection therapy, then you understand that a vitamin, mineral, nutritional compound, and/or medication will be injected directly into the subcutaneous fat or muscle of your body. This is considered “Injection Therapy.”

PLEASE READ & INITIAL BELOW:

I understand that IV infusion and injection therapy at Tru Functional Health is not intended to diagnose or treat a specific medical condition.

I understand that IV infusion and injection therapy will not prevent, treat, or cure and medical condition or disease. Furthermore, I understand that I am here seeking IV infusion and/or injection therapy voluntarily to assist with certain symptoms or ailments I may be experience.

I have informed Tru Functional Health, of all the medications, supplements, and allergies that I have. I understand that serious adverse events could happen if I do not disclose all of my drug/food/vitamin/and additional allergies and medications/supplements that I am currently taking.

I understand that IV and injectable therapy and any claims made about these treatments have not been evaluated by the US Food and Drug Administration (FDA) and are not intended to diagnose, treat, cure, or prevent any medical disease. I understand that these treatments are not FDA approved for any given indications of treatment and are not considered a medical necessity.

I understand that I have been informed of the procedure involving IV infusion and injections, the alternative treatment options, and the risks and benefits of the mutually agreed upon treatment.

I understand that the procedure involves inserting a needle into a vein or having a solution injected into my muscle or body fat.

I understand that common risks involved with IV and injection therapies include, but are not limited to, irritation, pain, discomfort, bruising, and bleeding at the site of the IV insertion or injection.

I understand that less common risks involved with IV and injection therapies include, but are not limited to, infection at the site of the IV insertion or injection, injury to the tissue, phlebitis, low blood pressure, fainting, fluid volume overload, medication interactions, and drops in blood sugar levels.

I understand that rare side risks involved with IV and injection therapies include, but are not limited to, sepsis, severe allergic reactions, severe medication/supplement interactions, anaphylaxis, blood clots, shock, cardiac arrest, and death.

I understand that the benefits of IV and injection therapies include, but are not limited to, enhanced absorption of vitamins and minerals as they bypass the digestive tract, increased total body hydration, alleviation of certain symptoms, increased total body nutrient density, and improved performance/recovery.

I affirm that I am voluntarily seeking IV infusion and injection therapies at Tru Functional Health, and have not been coerced into doing so.

I understand the risks and benefits of the procedure, IV infusion therapy, and injection therapy and have had all my questions answered to my full satisfaction.

I understand that unforeseeable complications can arise when an IV is placed and medications/fluids/minerals/vitamins are infused into the body.

I understand that I have the right refuse any treatments or treatment recommendations at any time.

Voluntary Nature of Treatment and Alternative Therapies

Treatment with IV and injectable vitamins/hydration/nutritional/mineral and/or medications offered at Tru Functional Health is completely voluntary in nature. Alternative therapy for the symptoms you are seeking IV infusion and injectable therapy for include, not are not limited to, ongoing treatment by your primary care provider and/or specialty provider, oral supplementation, and dietary/lifestyle modifications.

I acknowledge that IV infusion and injection therapy provided at Tru Functional Health is voluntary in nature and that I am seeking out this therapy on my own or from the recommendation of my referring provider. I acknowledge that I have also notified my medical and/or mental health provider about my decision to undergo IV and injectable vitamin/hydration/nutritional/mineral therapy. I acknowledge the alternative treatment options and have voluntarily decided to pursue IV and injectable therapy.

Indemnification Clause

agree to indemnify, defend, protect, and hold harmless the medical providers employed by Tru Functional Health; and their respective officers, directors, employees, stockholders, assigns, successors and affiliates (Indemnified Parties) from, against and in respect of all liabilities, losses, claims, damages, judgements, settlement payments, deficiencies, penalties, fines, interest and costs, expenses suffered, sustained, incurred or paid by the indemnified parties, in connection with, results from or arising out of, directly or indirectly, the medical providers employed by Tru Functional Health; rendering medical care, services, advice, and/or treatment, my failure to disclose all relevant information regarding my medical and physical condition, acts or omissions, the medical providers employed by Tru Functional Health harm or injury resulting from medical care or pharmaceuticals provided directly or indirectly by the medical providers employed by Tru Functional Health. I am aware of the potential side effects associated with IV infusion and injectable therapies provided by Tru Functional Health, accept all the risks involved with IV infusion and injectable therapies, and will not seek indemnification or damages from the indemnified parties.

Final patient consent for treatment

I have had the nature of the procedure and/or treatment, the benefits of treatment, the risks of treatment, the side effects, the alternative therapies for my medical condition or symptoms I am seeking treatment for, and the chances of treatment success explained to me. I have had all my questions and concerns answered to my satisfaction. I acknowledge that I have been given sufficient information about IV hydration/vitamin/mineral/nutrient infusion and injection therapy and all its associated risks and benefits upon which to make an informed decision about treatment.

I acknowledge that there are no guarantees regarding the results of treatment and its effect on my presenting condition.

I give my consent for the use of emergency intervention if required during treatment.

I certify that I am of sound mind and body to make medical decisions and to consent for treatment.

I certify I will continue to remain under the care a licensed and qualified primary care provider and/or mental health provider as IV infusion and injection therapy is considered an adjunctive and non-medically necessary treatment option, not a complete one.

I release the administering provider/nurse at Tru Functional Health and all the medical staff from all liabilities for any complications or damages associated with IV infusion and injection therapy.

I have read this consent and fully understand the information within it and I voluntarily authorize and consent to the treatment options, including but not limited to IV infusion therapy, provided to me at Tru Functional Health.

I herby acknowledge that I understand that my insurance coverage may not pay for this non- covered service, and that all services ancillary to this treatment may be also non-covered services and non-reimbursable. I agree to be responsible for payment at the time of services, including non-covered services.

Patient Directed INFORMED CONSENT for BioPhotonic Therapy

I hereby give my consent to THIS CLINIC to administer BioPhotonic Therapy (BPT) often referred to as Ultraviolet Blood Irradiation (UBI ). I have been informed and understand that this method involves removing a small volume of my own blood (from 30 cc to a maximum of 250ccs) under sterile conditions, briefly exposing that blood to selected frequencies of Ultraviolet Light and re-infusing the blood back into the body. The blood may also be treated with a very small amount of temporary acting anti-coagulant (heparin).

I understand that BPT is used clinically as both a specific (ie psoriasis, lymph cancer) and non-specific (chronic infections, chronic fatigue, auto-immune diseases, scleroderma, etc.) immune modulating therapy. Certain forms of auto-immune diseases, infections and tissue transplant rejection have all been published as benefiting from Biophotoinc - UBI therapy. Although there are many positive medical studies and testimonies, I realize that this alternative treatment is not guaranteed to cure or improve my condition.

I understand that the nonspecific use of BPT is "alternative" and is therefore NOT COVERED BY MEDICARE OR MEDICAID and MAY NOT BE COVERED by private insurance. I understand that BPT therapy is usually administered once or twice weekly for a series (4-15) of treatments, depending on the condition being treated. I understand that the side effects of BPT therapy include minor bruising at the injection site, potential minor bleeding from the heparin, mild temporary "healing reactions" (low grade fever, minor muscle aches or joint aches, possible prescription drug - BPT interaction (ie sulfa drugs, tetracyclines, phenothiazines) and the rare possibility of photoallergy in the case of allergy to sunlight. Other side effects although not listed in the literature may also be possible.

I have notified the clinical director/staff of ALL PRESCRIPTION MEDICATIONS I am currently taking prior to UVBI therapy being administered. I also understand that in the event of any adverse reaction after the first treatment that I am to contact this clinic for further instructions. If it is an emergency call 911.

I understand that this is a patient directed therapy and I am directing this Clinic to perform the above procedure and that in doing so I, and any and all parties that may represent me or my estate, hold harmless the staff and all other controlling or involved entities or manufacturers. In the event of a dispute, I and/or my above representative parties agree to binding arbitration that follows the rules of the American Arbitration Association.

I have READ, UNDERSTAND AND CONSENT to the above.

Privacy/HIPPA Policy

OUR LEGAL RESPONSIBILITIES

We are required by law to give you this notice. It provides you on how we may use and disclose protected health information about you and describes your rights and our obligations regarding the use and disclosure of that information. We shall maintain the privacy of protected health information and provide you with notice of our legal duties and privacy practices with respect to your protected health information.

We have the right to change these policies at any time. If we change our privacy policies, we will notify you of these changes immediately. This current policy is in effect unless stated otherwise. If the policy is changed, it will apply to all your current and past health information.

You may request a copy of our notice any time. You may contact Tru Functional Health at 16 North Goodman Street, Suite 110 Rochester, NY 14607 at any time to request a copy of this privacy policy.

HOW WE MAY USE OR DISCLOSE YOUR PROTECTED HEALTH INFORMATION

The following examples describe ways that we may use your protected health information for your treatment, payments, healthcare operations etc. but please be advised that not every use or disclosure in a particular category will be listed.

Treatment: We may use and disclose your protected health information to provide you treatment. This includes disclosing your protected health information to other medical providers, trainees, therapists, medical staff, and office staff that are involved in your health care.

For example, your medical provider might need to consult with another provider to coordinate your care. Also, the office staff may need to use and disclose your protected health information to other individuals outside of our office such as the pharmacy when a prescription is called in.

Payment: Your protected health information may also be used to obtain payment from an insurance company or another third part. This may include providing an insurance company your protected health information for a preauthorization for a medication we prescribed.

Health Care Operations: We may use or disclose your protected health information in order to operate this medical practice. These activities include training students, reviewing cases with employees, utilizing your information to improve the quality of care, and contacting you be telephone, email, or text to remind you of your appointments.

If we have to share your protected health information to third party “business associates” such as a billing service, if so, we will have a written contract that contains terms that will protect the privacy of your protected health information.

We may also use and disclose your protected health information for marketing activities. For example, we might send you a thank you card in the mail with a coupon for specialized services or products. We may also send you information about products or services that might be of interest to you. You can contact us at any point to stop receiving this information.

We will not use or disclose your protected health information for any purpose other than those identified in this policy without your specific, written Authorization. You may give us written authorization to use your protected health information or to disclose it to anyone for any purpose. You can revoke this authorization at any time but will not affect the protected health information that was shared while the authorization was in effect.

Appointment reminders: We may contact you as a reminder that you have an appointment for your initial visit, follow up visit, or lab work via text, phone or email.

Others Involved in Your Health Care: We may disclose protected health information about you to your family members or friends if we obtain your verbal agreement to do so, or if we give you an opportunity to object to such a disclosure and you do not raise an objection. For example, we may assume that if your spouse or friend is present during your evaluation, that we can disclose protected professional information to this person. If you are unable to agree or object to such a disclosure, we may disclose such information as necessary if we determine that it is in your best interest based on our professional judgment if there is an urgent or emergent need.

Research: We will not use or disclose your health information for research purposes unless you give us authorization to do so.

Organ Donation: If you are an organ donor, we may release protected health information to organizations that handle organ procurement or organ, eye or tissue transplantation if it is necessary to facilitate this process.

Public Health Risks: We may disclose your protected health information, if necessary, in order to prevent or control disease, report adverse events from medications or products, prevent injury, disability or death. This information may be disclosed to healthcare systems, government agencies, or public health authorities. We may have to disclose your protected health information to the Food and Drug Administration to report adverse events, defects, problems, enable recalls etc. if required by FDA regulation.

Health Oversight Activities: We may disclose protected health information to health oversight agencies for audits, investigations, inspections or licensing purposes. These disclosures might be necessary for state and federal agencies to monitor healthcare systems and compliance with civil law.

Required by Law: We will disclose protected health information about you when required to do so by federal, state and/or local law.

Workman’s compensation: We may disclose your protected health information to workman’s comp or similar programs.

Lawsuits: We may disclose your protected health information in response to a court action, administrative action, or a subpoena.

Law Enforcement: We may release protected health information to a law enforcement official in response to a court order, subpoena, warrant, subject to all applicable legal requirements.

YOUR RIGHTS REGARDING YOUR PROTECTED HEALTH INFORMATION

Access to medical records: You have the right to access and receive copies of your protected health information that we use to make decisions about your care. You must submit a written request to obtain your protected health information to the individual listed at the end of this privacy policy. We reserve the right to charge you a fee for the time it takes to obtain and copy the protected health information and provide it to you.

Amendment: If you believe the protected health information, we have about you is incorrect or incomplete, you may ask us to amend the information You will need to submit a written request on why you feel the health information should be amended. We may deny your request to amend if you did not send a written request or give a reason on why it should be amended. If we deny your request, we will provide you a written explanation. We may deny your request if we believe the protected health information is accurate and complete.

Accounting of Disclosures: You have the right to receive a list of instances in which we disclosed your personal health information unless the disclosure was used for treatment, payment, healthcare operations, was pursuant to a valid authorization and as otherwise provided in applicable federal and state laws and regulations. You must submit a written request to obtain this “accounting of disclosures” to the individual listed at the bottom of this policy. After your request has been approved, we will provide you the dates of the disclosure, the name of the individual or entity we disclosed the information to, a description of the information that was disclosed, the reason why it was disclosed, and any additional pertinent information. This information may not be longer than (STATUTE OF LIMITATIONS) years ago prior to the date the accounting is requested. We reserve the right to charge a reasonable fee for this process.

Restriction Requests: You have the right to request a restriction or limitation on the protected health information we use or disclose about you for treatment, payment, or healthcare operations. We shall accommodate your request except where the disclosure is required by law. We require this be a written request submitted to the individual at the end of this policy.

Confidential Communication: You have the right to request that we communicate with you about healthcare matters in a certain way and at a certain location. We must accommodate your request if it is reasonable and allows us to continue to collect payments and bill you.

Paper copy of this notice: You may request a hard copy of this practice policy if you reviewed and signed it via electronic means. To obtain this copy, contact the individual at the end of this privacy policy.

Complaints: If you believe your privacy rights have been violated, you may file a complaint with our office. You also file a complaint with the U.S. Department of Health and Human Services. We will provide you with the address to file your complaint with the U.S. Department of Health and Human Services upon request.

PRIVACY/HIPPA POLICY Name of Contact Person: Tru Functional Health Craig Danehy Trufunctionalhealth@gmail.com

Please sign and date indicating you have read and understand you’re Patient Rights.

Blood Draw ~ INFORMED CONSENT

do hereby consent to the drawing of a blood sample for the purpose of performing laboratory testing to help guide treatment recommendations. I have had the opportunity to read and consider Tru Functional Health Privacy Practices Notice to my satisfaction prior to consent.

I understand that the risks involved with blood draws include, but are not limited to, discomfort at the site of the blood draw, possible bruising, redness and swelling around the site, bleeding at the sight, feeling of lightheadedness when blood is being drawn, and rarely, an infection at the site of the blood draw.

I understand and accept that data derived from this blood draw is considered preliminary only and does not constitute any kind of diagnosis. It is my responsibility for initiating a follow-up examination to confirm results and obtain professional advice and medical treatment that may be required by my primary care provider.

Tru Functional Health will keep my results confidential and will only release information to other organizations with my consent.

I have read this consent form. All of the questions I have asked have been answered to my satisfaction. I agree with this procedure.

Intravenous Vitamin C~ Informed Consent

Ozone and UBI is not approved by the United States Food and Drug Administration to treat any medical condition including cancer. Ozone and UBI is not a cure for cancer, and it has not been proven to slow the rate of cancer progression. You should continue ongoing care with your regular oncologist and treating physicians.

I have been informed that while Ozone and UBI has shown favorable results in laboratory studies, animal studies, and in some clinical cases for improving outcomes with cancer, there is no definitive proof that it has an impact on life expectancy in the face of cancer.

Although I understand this therapy is anticipated to improve my health, I acknowledge my understanding that this therapy is considered controversial and may be deemed an alternative, adjunctive, complementary or unconventional therapy by a majority of conventional physicians in the allopathic medical community because it has not yet been shown to be “safe”, “effective” or “usual, customary, and reasonable”. Further, I have been informed that other treatment approaches have been used in treating these conditions, including, without limitation, conventional drug therapy and surgery and these alternatives have been explained to me to my full satisfaction. I understand that the benefits of this therapy are much greater if I follow a healthy lifestyle, such as non-smoking, weight control, proper exercise, proper diet, and nutritional supplementation.

Risks associated with intravenous Ozone and UBI include, without limitation, infection, bleeding, bruising, blood clots in the vein, possible adverse effect on kidney function, and possible increased risk of kidney stones. Low blood sugar reactions (tremor, thirst, weakness) can occur.

This list is not meant to be inclusive of all possible risks associated with intravenous Ozone and UBI treatments as there are both known and unknown side effects associated with any medication or procedure.

I understand that I have the right to consent to or refuse any proposed treatment at any time prior to its performance.

I understand and agree that all services rendered to me are charged directly to me and that I am personally responsible for payment. I further agree in the event of non-payment, to bear the cost of collection, and/or court cost and reasonable legal fees, should this be required.

By signing below, I acknowledge that I have read the foregoing informed consent and agree to the treatment with its associated risks. I hereby give consent to perform this and all subsequent intravenous Ozone and UBI treatments with the above understood.