Consent to Telehealth, Consent to Semaglutide and Tirzepatide, and HIPAA Privacy Statement
Informed Consents:
Consent to Telehealth, Consent to Semaglutide and Tirzepatide, and HIPAA Privacy Statement
Please read this consent document in its entirety. Kindly scroll down to review the consent to Semaglutide and Tirzepatide that lists all the risks and benefits of these medications.
Consent to Telehealth
Thank you for selecting Somi Health LLC to provide you with medical weight loss services via the Somi Health platform. You are viewing this form because you have chosen to engage in telemedicine visits with a Somi Health healthcare practitioner. All visits will be asynchronous (as described below), unless a real-time synchronous telemedicine visit is required by state law. Your practitioner is a board-certified Nurse Practitioner licensed in the states outlined below.
By you agreeing to Somi Heath providing care to you,” you acknowledge and agree to the following:
I acknowledge I have read and understand the terms presented below, and comprehend the risks and benefits of telemedicine, including asynchronous telemedicine. By accepting these terms of use, I hereby give my informed consent to participate in asynchronous telemedicine (or real-time synchronous video consultation if required by state law) under these terms.
What is Telemedicine?
Telemedicine involves the delivery of healthcare services, including examination, consultation, diagnosis, and treatment, through electronic communication technologies when you (the patient) are in a different location than your healthcare practitioner. Somi Health facilitates receiving treatment from a healthcare practitioner without the need to travel to another location or schedule separate appointments, thereby helping you avoid long wait times typically experienced during in-person visits.
What is Asynchronous Telemedicine?
Asynchronous telemedicine is one method of delivering telemedicine, often referred to as “store-and-forward” communication. This involves submitting and collecting data at different times. An example includes sending photos, videos, or other communications via email or text message. “Asynchronous” means “not occurring at the same time” and differs from “synchronous” telemedicine, which generally includes real-time visits conducted through audio or video means (e.g., live phone calls or video-conferencing). Healthcare practitioners may use asynchronous telemedicine to aid in diagnosis and medical consultations when live communication or face-to-face contact is not possible or necessary.
Somi Health and its medical providers offer services through the Somi Health platform, specifically allowing for the following asynchronous telemedicine services: 1) text-based healthcare practitioner-patient interactions through short message service (“SMS”) and multimedia messaging service (“MMS”) communications; and 2) secure information collection through asynchronous store-and-forward patient questionnaires.
Potential Risks of Using Telemedicine, Including Asynchronous Telemedicine
As with any medical treatment, there are potential risks associated with the use of telemedicine in general and asynchronous telemedicine specifically. Somi Health believes the likelihood of these risks materializing is low. These risks may include, but are not limited to, the following:
- Due to the lack of physical exams, certain health information may not be known, potentially affecting your care and treatment.
- Delays in medical evaluation, consultation, or treatment may occur due to deficiencies or failures of equipment or the Internet, such as poor data quality, outages, or other service interruptions. You may reschedule the visit if such interruptions occur.
- Security protocols could fail, causing a breach of personal medical information privacy.
- Somi Health does not have access to your complete medical records. If you do not disclose a full list of your medical history, including diagnoses, treatments, medications/supplements, and allergies, adverse treatment outcomes, drug interactions, allergic reactions, or other negative outcomes may occur.
Telemedicine services are NOT emergency services, and your Personal Data (as defined in the Somi Health Privacy Policy) WILL NOT BE MONITORED 24/7. If you think you are experiencing a medical emergency, CALL 911 IMMEDIATELY.
The care you receive will be at the sole discretion of the healthcare practitioner treating you, with no guarantee of diagnosis, treatment, or prescription. The healthcare practitioner will determine whether or not the condition being diagnosed and/or treated is suitable for care provided through an asynchronous or real-time telemedicine encounter via the platform.
Your Rights and Acknowledgments:
- You have the same privacy rights via telemedicine as during an in-person visit. Dissemination of any identifiable images or information from the telemedicine visit to researchers or other entities will not occur without your written consent. For more information on how we protect your privacy, please refer to the Somi Health HIPAA Privacy Statement at the bottom of this document. You acknowledge receipt of a copy of the Somi Health HIPAA Privacy Statement.
- Telemedicine may involve electronic communication of your personal medical information to healthcare practitioners in other areas, including out of state.
- You understand that anticipated benefits from telemedicine are expected, but results cannot be guaranteed or assured.
- Information submitted to Somi Health via text message and entered by your healthcare practitioner on the Somi Health platform will be part of your medical record and available to you by emailing [email protected]. This information will adhere to dissemination restrictions without your consent.
- Your healthcare practitioner’s initial text message will include their name and credentials, recorded in the Somi Health platform as part of your medical record.
- You can withdraw your consent and delete your patient profile anytime by emailing [email protected].
- Your healthcare information may be shared with other individuals per the Somi Health Privacy Policy and regulations or laws in the state or territory where you are located.
- Your healthcare information may also be shared in the following circumstances:
- When a valid court order is issued for medical records.
- Reporting suspected abuse, neglect, or domestic violence.
- Preventing or reducing a serious threat to anyone’s health or safety.
Call/Email/Text Messaging Consent:
You expressly consent to allow Somi Health LLC or its healthcare practitioners to contact you via call, email, or text messaging (SMS and/or MMS) regarding Personal Data (as defined in the Somi Health Privacy Policy), appointments, or similar matters related to your telemedicine encounters using the contact information you have provided. Calls or texts may be placed using an auto-dialer or a pre-recorded or artificial voice, even if your number is on a do-not-call list. Your phone carrier’s standard rates may apply. This consent is not a condition of purchase, and you may revoke this consent at any time by emailing us at [email protected]. This Consent to Telehealth remains valid throughout your treatment with Somi Health.
Informed Consent to Semaglutide and Tirzepatide:
The purpose of this informed consent form is to provide written information about the potential benefits, risks, and alternatives to Semaglutide and Tirzepatide prescription medications, enabling you to make an informed decision regarding your treatment. Please read this form carefully and ask any questions you may have.
During your telehealth visit, your licensed provider connected via Somi Health will perform a comprehensive evaluation of your medical history, current medications, and other pertinent medical information to determine if Semaglutide or Tirzepatide are suitable for you.
General Information:
Semaglutide:
Semaglutide is a GLP-1 receptor agonist, which mimics a hormone called glucagon-like peptide 1 (GLP-1). It helps prevent the liver from releasing excessive sugar, thus reducing blood sugar levels, and also promotes satiety by slowing digestion, leading to prolonged feelings of fullness. Ozempic® and Wegovy® contain Semaglutide and function similarly, although Wegovy® has a higher maximum dose and is FDA-approved for weight loss.
The US FDA has approved Ozempic® as an adjunct to diet and exercise for improving glycemic control in adults with type 2 diabetes mellitus and reducing the risk of major adverse cardiovascular events in adults with type 2 diabetes mellitus and established cardiovascular disease. Off-label use includes weight loss in overweight patients to improve health outcomes such as high blood pressure.
The US FDA has approved Wegovy® for chronic weight management in adults with obesity or overweight, combined with at least one weight-related condition (e.g., hypertension, type 2 diabetes, or high cholesterol), alongside a reduced-calorie diet and increased physical activity.
Both Ozempic and Wegovy are administered as once-weekly subcutaneous injections. Compounded Semaglutide has not been FDA-approved for weight loss or other conditions and is utilized on a research basis only.
Tirzepatide:
Tirzepatide is both a GIP and GLP-1 receptor agonist. By activating these receptors, Tirzepatide regulates gut hormones called incretins, which signal fullness and prevent excess sugar release by the liver, thus reducing blood sugar levels through slowed digestion.
Mounjaro®, also known as Zepbound®, is the patented brand name version of Tirzepatide injectable, recently FDA-approved for obesity management. Compounded Tirzepatide is not FDA-approved and is utilized on a research basis only.
Side Effects, Risks, and Complications:
Every treatment entails certain risks. Understanding these risks and possible complications associated with Semaglutide and Tirzepatide is crucial when deciding whether to proceed.
Common side effects include nausea, vomiting, diarrhea, constipation, abdominal pain, headache, fatigue, dyspepsia, dizziness, hypotension, bloating, burping, hypoglycemia in patients with type 2 diabetes, flatulence, gastroenteritis, and gastroesophageal reflux disease. Injection site reactions such as redness or pain may occur. Rapid weight loss may result in facial thinning and hollow cheeks.
Potential Serious Side Effects and Complications include:
- Gastroparesis and chronic gastrointestinal issues (constipation/diarrhea).
- Possible thyroid tumors, including cancer. Symptoms like neck lumps/swelling, hoarseness, swallowing difficulty, or shortness of breath should be reported. Avoid use if you have a family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2.
- Vision changes in patients with type 2 diabetes (Diabetic Retinopathy). Monitor vision regularly during treatment.
- Pancreatitis. Severe abdominal pain warranting immediate medical attention.
- Gallbladder problems, including gallstones requiring surgical intervention.
- Hypoglycemia in type 2 diabetes patients. Learn to recognize and manage low blood sugar symptoms.
- Kidney problems exacerbated by dehydration from diarrhea, nausea, or vomiting.
- Serious allergic reactions necessitate immediate medical help.
- Increased heart rate at rest. Report persistent heart racing/pounding.
- Depression or suicidal thoughts. Monitor mood and behavioral changes.
This list is not exhaustive; other side effects and complications may occur or be discovered over time.
Contraindications and Additional Information Regarding Potential Risks:
Semaglutide and Tirzepatide should not be used in combination with other GLP-1 receptor agonists or other weight loss products including prescription drugs, over-the-counter drugs, and herbal products. Therefore, you must not take any other weight loss drugs, including over-the-counter weight loss products, while taking Semaglutide or Tirzepatide unless prescribed or recommended by your provider.
You should not use Semaglutide or Tirzepatide if you have multiple endocrine neoplasia type 2 (tumors in your glands), or a personal or family history of medullary thyroid cancer.
Pregnancy and Breastfeeding: You should stop using Semaglutide and Tirzepatide at least three months before you plan to get pregnant and should not use it while breastfeeding. If you are a woman, use adequate contraception to ensure you do not become pregnant while taking Semaglutide or Tirzepatide. Please tell your provider if you plan to become pregnant, and immediately contact your provider if you inadvertently become pregnant while taking Semaglutide or Tirzepatide.
Semaglutide and Tirzepatide also have warnings for the possibility of causing pancreatitis, gallbladder problems, hypoglycemia, acute kidney injury, diabetic retinopathy, increased heart rate and suicidal behavior or thinking. Therefore, Semaglutide and Tirzepatide should either not be used or should be used with caution in people with a history of pancreatitis, decreased kidney function, diabetic retinopathy or history of suicidal ideation.
This list is not complete and describes the most common side effects and risks. Symptoms may be worse after there has been a change in medication dose or when first starting the medication.
Contact your Somi Health provider or urgent care immediately if you experience any of the following while taking Semaglutide or Tirzepatide: vision changes; unusual mood changes, thoughts about self-harm; pounding heartbeats or fluttering in your chest; feeling light-headed, like you might pass out; signs of a thyroid tumor—swelling or a lump in your neck, trouble swallowing, a hoarse voice, feeling short of breath; symptoms of pancreatitis—severe persistent pain in your upper stomach spreading to your back, nausea with or without vomiting, fast heart rate; gallbladder problems—upper stomach pain, fever, clay-colored stools, jaundice (yellowing of the skin or eyes); low blood sugar—headache, hunger, weakness, sweating, confusion, irritability, dizziness, fast heart rate, or feeling jittery; kidney problems—swelling, urinating less, feeling tired or short of breath; or stomach flu symptoms—stomach cramps, vomiting, loss of appetite, diarrhea (may be watery or bloody).
Alternatives: Alternatives to Semaglutide and Tirzepatide for weight loss and blood sugar management include diet and exercise, other diabetic drugs, weight loss surgery, and natural herbal supplements. These alternatives also have potential benefits and risks to be discussed with your Somi Health provider.
By you agreeing to Somi Heath providing care to you, you acknowledge and agree to the following in order to proceed with treatment with Semaglutide or Tirzepatide through the Somi Health platform:
You have read and understand all of the above statements and have been informed of potential side effects and risks that may be associated with the use of Semaglutide and Tirzepatide prescriptions. You fully understand what you are signing and hereby request and consent to treatment using Semaglutide or Tirzepatide as prescribed to you. You understand that other treatment alternatives are available for weight loss and blood sugar management.
You agree that you are, and will be, under the care of your primary medical provider for all other conditions. You understand that Somi Health providers are not providing primary care.
NO GUARANTEES: You acknowledge that there are no guarantees or assurances made with respect to weight loss or any results of taking the Semaglutide or Tirzepatide prescribed for you, and understand that it works best when combined with diet and exercise.
OFF-LABEL USE OF OZEMPIC: You understand that while Ozempic® is FDA approved for blood sugar control, it is used off-label for weight loss.
NO FDA APPROVAL FOR COMPOUNDED MEDICATIONS: You understand that compounded Semaglutide and compounded Tirzepatide are not approved by the FDA for any purpose and are formulated and used on a research basis only.
NO REFUNDS: You understand that results may vary, and that there are no refunds. You understand that your prescription is in your individual name and cannot be returned.
Complete Medical History: You understand that Semaglutide and Tirzepatide may be inappropriate and unsafe if you have certain health conditions, allergies, or take certain medications or supplements, whether prescribed or over-the-counter. For this and other reasons, you understand that it is vital that you truthfully and accurately disclose all health information requested by your Somi Health provider including allergies, medications you are taking (both prescription and over the counter), medical/surgical/social/family history, and pertinent lab results, and keep your provider updated as to any changes in your health conditions and history during treatment with Semaglutide and Tirzepatide, and there shall be no liability on the part of Somi Health or your Somi Health provider if you fail to do so. You understand that if you become pregnant or start trying for pregnancy, you must stop this medication.
Directions for use and Following Instructions:
You will be in charge of administering the medication prescribed to you. You will follow and comply with the recommended doses and methods of administration and understand this is very important for the safety of the treatment. Failure to comply with the dosage and administration instructions could alter the weight loss results and the safety of treatment.
You understand this medication must be self-injected in the subcutaneous tissue once weekly.
You will be instructed on how to administer the injections yourself, or you will need to plan to have someone assist you.
You will not adjust your medications up or down without prior instruction to do so.
You understand that the medication must be either kept frozen or refrigerated.
You will not share needles, and you will dispose of needles safely.
You agree that you will not use any medications after the Beyond Usage Date (BUD).
CERTIFICATION OF CONSENT TO PROCEED WITH TREATMENT: By you agreeing to Somi Heath providing care to you,” you acknowledge and agree to the following:
You have read this entire Informed Consent, and understand and agree to the information herein. The nature of the therapy, and the potential risks, benefits and alternatives have been explained to you, and you have had the opportunity to ask questions and all your questions have been answered to your satisfaction. You hereby freely and voluntarily accept all risks associated with Semaglutide and/or Tirzepatide and a prescribed healthy diet for the purpose of losing weight and elect and consent to proceed with treatment.
Somi Health LLC
HIPAA Privacy Statement:
Notice of Privacy Practices for Protected Health Information (PHI)
Effective Date: 3/15/2025
This Notice of Privacy Practices (“Notice”) outlines how Somi Health LLC and its affiliated licensed medical groups and healthcare providers offering medical weight loss services through the Somi Health platform (“we”, “us”, or “our”) may use and disclose your Protected Health Information (PHI) to facilitate treatment, payment, or healthcare operations, as well as other purposes permitted or required by law. This Notice also describes your rights regarding your PHI. We are legally obliged to maintain the privacy of your PHI, provide this Notice detailing our legal responsibilities and privacy practices, and adhere to the terms of this Notice.
Uses and Disclosures of PHI:
We may use and disclose your PHI for the following purposes:
Treatment: We may use and disclose your PHI to provide, coordinate, or manage your healthcare and related services. This includes communication with other healthcare providers about your treatment and coordinating your care with other providers.
Payment: We may use and disclose your PHI to obtain payment for healthcare services provided to you. This may involve sharing PHI with other healthcare providers, pharmacies, or collection agencies.
Healthcare Operations: We may use and disclose your PHI for healthcare operations, including quality assessment, improvement activities, case management, accreditation, licensing, credentialing, and conducting or arranging for medical reviews, audits, or legal services.
As Required by Law: We may use and disclose your PHI when mandated by federal, state, or local law.
Public Health and Safety: We may use and disclose your PHI to prevent or control disease, injury, or disability; report child abuse or neglect; report reactions to medications or issues with products; and notify individuals who may have been exposed to a communicable disease or may be at risk of spreading a disease or condition.
Health Oversight Activities: We may disclose your PHI to health oversight agencies for activities authorized by law, such as audits, investigations, inspections, and licensure.
Judicial and Administrative Proceedings: We may disclose your PHI in response to a court or administrative order, subpoena, discovery request, or other lawful process.
Law Enforcement: We may disclose your PHI for law enforcement purposes, such as reporting certain types of wounds or injuries, or complying with a court order, warrant, or other legal process.
Research: We may use and disclose your PHI for research purposes when the research has been approved by an institutional review board and privacy protections are established.
Organ and Tissue Donation: If you are an organ donor, we may disclose your PHI to organizations responsible for organ procurement, transplantation, or donation.
Workers’ Compensation: We may disclose your PHI in compliance with workers’ compensation or similar programs that provide benefits for work-related injuries or illnesses.
Military and Veterans: If you are a member of the armed forces, we may disclose your PHI as required by military authorities.
Inmates: If you are an inmate, we may disclose your PHI to the correctional institution or law enforcement official having custody of you.
Your Rights Regarding PHI:
You possess the following rights concerning your PHI:
Right to Inspect and Copy: You have the right to inspect and copy your PHI maintained by us, with certain exceptions. To request access, submit a written request to our Privacy Officer. We may charge a reasonable fee for costs associated with copying, mailing, or other supplies related to your request.
Right to Amend: You have the right to request an amendment to your PHI if you believe it is inaccurate or incomplete. To request an amendment, submit a written request to our Privacy Officer, specifying the information you believe is incorrect and the reasons why. We may deny your request if we believe the information is accurate and complete or if we did not create the information.
Right to an Accounting of Disclosures: You have the right to request an accounting of disclosures of your PHI made by us in the past six years, excluding disclosures made for treatment, payment, or healthcare operations, and certain other disclosures. To request an accounting, submit a written request to our Privacy Officer.
Right to Request Restrictions: You have the right to request a restriction on our use or disclosure of your PHI for treatment, payment, or healthcare operations. Although we are not obligated to agree to your request, we will consider it. To request a restriction, submit a written request to our Privacy Officer, specifying the restriction and to whom it applies.
Right to Request Confidential Communications: You have the right to request that we communicate with you about your PHI in a specific manner or at a particular location. To request confidential communications, submit a written request to our Privacy Officer, indicating how or where you wish to be contacted.
Right to a Paper Copy of This Notice: You have the right to receive a paper copy of this Notice, even if you agreed to receive it electronically. To obtain a paper copy, contact our Privacy Officer.
Right to be Notified of a Breach: You have the right to be notified if we discover a breach of your PHI.
Transmission of PHI:
We are dedicated to protecting the privacy of your PHI and will ensure that any electronic transmission of PHI adheres to the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule (45 CFR 164). This includes using Secure-Socket Layer (SSL) or equivalent technology for transmitting PHI and adhering to all applicable security standards for online transmissions of PHI.
Changes to This Notice:
We reserve the right to revise this Notice, and any changes will apply to PHI we already have about you and any future information we receive. We will display a copy of the current Notice in our office and on our website. The Notice will include the effective date on the first page.
Complaints:
If you believe your privacy rights have been violated, you may file a complaint with our Privacy Officer or the Secretary of the Department of Health and Human Services. There will be no retaliation for filing a complaint.
Contact Information:
To exercise any of your rights, or if you have questions about this Notice or our privacy practices, please contact the Somi Health Privacy Officer at: [email protected]
This Notice is provided in accordance with the Notice of Privacy Practices for Protected Health Information from the Department of Health and Human Services’ Model and is applicable across all US states.
Rights Specific to Jurisdictions within the US:
Certain states may offer additional privacy protections applicable to your PHI. Below are examples of specific rights within California. If you reside in a state with additional privacy protections, you may have extra rights related to your PHI.
Notice of Privacy Practices for Protected Health Information (PHI) – State-Specific Provisions:
In addition to the privacy practices outlined here, we comply with applicable state-specific privacy laws concerning PHI.
Examples of states with additional privacy protections include:
California:
For residents of California, we adhere to the Confidentiality of Medical Information Act (CMIA) and California’s specific privacy laws regarding marketing, sale of PHI, and minors’ rights. Written consent will be obtained before disclosing certain information, adhering to additional privacy protections required by California law.
Right to Access: Besides the rights described above, California residents may request access to their PHI in an electronically usable format, along with any additional information required by California law. Submit a written request to our Privacy Officer to request access.
Right to Restrict Certain Disclosures: California residents may request restrictions on certain disclosures of their PHI to health plans if they paid out-of-pocket for specific healthcare items or services in full. To request such a restriction, submit a written request to our Privacy Officer.
Confidentiality of Medical Information Act (CMIA): California residents receive additional privacy protections under the CMIA. Compliance with CMIA is required in addition to HIPAA.
Marketing and Sale of PHI: California residents can request that their PHI not be used for marketing purposes or sold to third parties without authorization. To restrict the use or sale of your PHI, submit a written request to our Privacy Officer.
Minor’s Rights: Minors (under 18 years old) may request that certain information related to sensitive services—such as reproductive health, mental health, or substance use disorder treatment—not be disclosed to parents or guardians without consent. Submit a written request to our Privacy Officer to restrict such information.
Other States:
For residents of other states, consult specific privacy laws for information about additional rights regarding your PHI. You may also contact our Privacy Officer for more information about your rights under specific state laws.
New York:
For New York residents, we comply with the New York State Confidentiality of Information Law, which provides additional privacy protections for HIV-related information, mental health records, and genetic testing results. Written consent will be obtained prior to disclosing such information, even for treatment, payment, or healthcare operations.
Texas:
For Texas residents, we comply with the Texas Medical Privacy Act, offering privacy protections beyond HIPAA, including requiring consent for certain PHI disclosures, additional safeguards for electronic PHI, and specific requirements for PHI destruction. Texas privacy protections for mental health records and substance use treatment records are also followed.
Florida:
For Florida residents, we comply with Florida’s privacy laws, providing additional protections for mental health records, HIV/AIDS-related information, and substance abuse treatment records. Written consent will be obtained before disclosing such information, even for treatment, payment, or healthcare operations. Specific security measures to protect electronic PHI as required by Florida law are implemented.
Illinois:
For Illinois residents, we comply with Illinois’s privacy laws concerning mental health records, HIV/AIDS-related information, and genetic testing results. Written consent will be obtained before disclosing such information, even for treatment, payment, or healthcare operations. Patients will be notified of any unauthorized access to electronic PHI as required by Illinois law.
Massachusetts:
For Massachusetts residents, we comply with Massachusetts’s privacy laws concerning mental health records, HIV/AIDS-related information, and genetic testing results. Written consent will be obtained before disclosing such information, even for treatment, payment, or healthcare operations. Specific security measures to protect electronic PHI as required by Massachusetts law are enforced.
By you agreeing to Somi Heath providing care to you,” you acknowledge and agree that I shall be present in the following states outlined below where Somi Health is licensed to deliver telehealth services:
Current State Licenses:
Arizona
Colorado
Connecticut
Florida
Georgia
Iowa
Kentucky
Minnesota
New Jersey
North Carolina
Oklahoma
Tennessee
Texas
Washington
Washington DC