Telehealth Informed Consent
Telehealth Informed Consent
January 24, 2022
OUR PROVIDERS DO NOT ADDRESS MEDICAL EMERGENCIES. IF YOU BELIEVE YOU ARE EXPERIENCING A MEDICAL EMERGENCY, YOU SHOULD DIAL 9-1-1 AND/OR GO TO THE NEAREST EMERGENCY ROOM AND SHOULD NOT PROCEED WITH CLINICAL SERVICES USING THE HEALTHSPAN PLATFORM.IF YOU ARE CONTEMPLATING SUICIDE, CONTACT 911 OR THE NATIONAL SUICIDE PREVENTION LINE AT 1-88-273-TALK (8255).
By creating an account, starting a consult, clicking “I consent to telehealth,” checking a related box to signify your acceptance or using any other acceptance protocol presented through the Healthspan Platform you indicate that you have reviewed the risks as described herein of receiving services utilizing telehealth technologies and consent to receiving the services. A record of this Telehealth Informed Consent is maintained in the files and records of the applicable Provider delivering your services, and your on-going participation in services by your medical providers using telehealth technologies serves as an on-going acknowledgement of your acceptance of this Telehealth Informed Consent and updates at such time the representations you provide herein.
Purpose: The purpose of this consent form (“Consent”) is to provide you with information about telehealth and to obtain your informed consent to the use of telehealth in the delivery of healthcare services to you by physicians, physician assistants and nurse practitioners (“Providers”) using the online platforms owned and operated by ZenPatient, Inc (Doing Business as Healthspan) (the “Service”).
Use of Telehealth: Telehealth involves the delivery of healthcare services using electronic communications, information technology or other means between a healthcare provider and a patient who are not in the same physical location. Telehealth may be used for diagnosis, treatment, follow-up and/or patient education, and may include, but is not limited to, one or more of the following: electronic transmission of medical records, photo images, personal health information or other data between a patient and a healthcare provider; interactions between a patient and healthcare provider via audio, video and/or data communications (such as secure messaging); use of output data from medical devices, sound and video files. Alternative methods of care may be available to you, such as in-person services, and you may choose an alternative at any time. Always discuss alternative options with your Provider.
Anticipated Benefits: **The use of telehealth may have the following possible benefits: Making it easier and more efficient for you to access medical care and treatment for the conditions treated by your Provider(s); allowing you to obtain medical care and treatment by Provider(s) at times that are convenient for you; and enabling you to interact with Provider(s) without the necessity of an in-office appointment.
Potential Risks: While the use of telehealth in the delivery of care can provide potential benefits for you, there are also potential risks associated with the use of telehealth and other technology. These risks include, but may not be limited to the following: the quality, accuracy or effectiveness of the services you receive from your Provider could be limited’ technology, including the Service, may contain bugs or other errors, including ones which may limit functionality, produce erroneous results, render part or all of such technology, including the Service, unavailable or inoperable, produce incorrect records, transmissions, data or content, or cause records, transmissions, data or content to be corrupted or lost; failures of technology may also impact your Provider(s) ability to correctly diagnose or treat your medical condition; the inability of your Provider(s) to conduct certain tests or assess vital signs in-person may in some cases prevent the Provider(s) from providing a diagnosis or treatment or from identifying the need for emergency medical care or treatment for you; your Provider(s) may not able to provide medical treatment for your particular condition and you may be required to seek alternative healthcare or emergency care services; delays in medical evaluation/treatment could occur due to unavailability of your Provider(s) or deficiencies or failures of the technology or electronic equipment used; the electronic systems or other security protocols or safeguards used could fail, causing a breach of privacy of your medical or other information; given regulatory requirements in certain jurisdictions, your Provider(s) diagnosis and/or treatment options, especially pertaining to certain prescriptions, may be limited; a lack of access to all of your medical records may result in adverse drug interactions or allergic reactions or other judgment errors.
Informed Consent of Off-Label Treatment
FDA Approval Status
The treatment you will be receiving may have not been approved by the FDA to treat my condition.
Off Label and No Label
When a drug or device is approved for medical use by the Food and Drug Administration (FDA), the manufacturer produces a “label” to explain its use. Once a device/medication is approved by the FDA, physicians may use it “off-label” for other purposes if they are well informed about the product, base its use on firm scientific method and sound medical evidence, and maintain records of its use and effects.
Off-Label Use of Rapamycin (Sirolimus)
Rapamycin (also known as Sirolimus) is an experimental mTOR inhibitor used as geroprotective therapy. Many of the geroprotective benefits of rapamycin are derived from animal studies and may not translate to humans. The dosing and long-term effects of rapamycin at low doses are unknown. The optimal dosing regimen is not known and the protocol determined by your Provider is experimental. Blood tests administered by your Provider can help guide your treatment and provide more context for optimal dosing, but long-term trials have not been conducted to establish such a dosing regimen.
Known Risks of Rapamycin:
- May impair fertility. Ovarian cysts, amenorrhea, menorrhagia, azoospermia, or oligospermia have been observed following the use of oral rapamycin. Sperm banking prior to rapamycin treatment may be considered.
- Immunosuppressive agents, including rapamycin, may be associated with the development of lymphoma and other malignancies, including an increased risk of skin cancer; limit sun and ultraviolet light exposure; use appropriate sun protection.
- Can interfere with immune response when receiving vaccines.
- Patients who could become pregnant should use highly effective contraception prior to initiation of rapamycin, during treatment, and for 12 weeks after rapamycin is discontinued.
Since rapamycin is an immunosuppressant you are required to inform all current healthcare providers of your rapamycin treatment. It is required that you notify your current healthcare providers of your usage of rapamycin in the case that your provider wishes to prescribe you anotherimmunosuppressant.
While rapamycin treatment is administered, patients are to be monitored for know side effects of rapamycin which include: stomatitis/mucositis, anemia, thrombopenia, leukopenia, edema, and pneumonitis. Providers are responsible for prescribing bloodwork to monitor for these side effects and reviewed the results of these tests during your monthly consultations.
By agreeing to the informed consent policy you understand that rapamycin was approved by the FDA as an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients over 13 years of age. Understanding the known risks and off-label designation of the treatment you are willing to accept the potential risks of taking rapamycin. You acknowledge that there may be other, unknown risks and the long-term effects and risks of rapamycin are not known.
Follow Up Care; Emergency Situations: If the situation is an emergency, call 911. In some situations, telehealth is not an appropriate method of care. If you require immediate or urgent care, you must seek care at an emergency room facility or other provider equipped to deliver urgent or emergent care. If you are not experiencing an emergency or do not require immediate or urgent care, you can communicate with Providers through the secure message service in the Platforms. If a technical failure prevents you from communicating with your Providers through the Platforms, you should call the following number:
Phone: (650) 563-8696 (M-F 9AM – 5PM PT).
Data Privacy and Protection: The electronic systems used in the Service will incorporate network and software security protocols to protect the privacy and security of your information, and will include measures to safeguard data against intentional or unintentional corruption. Personal information that identifies you or contains protected health information will not be disclosed to any third party without your consent, except as authorized by law for the purposes of consultation, treatment, payment/billing, and certain administrative purposes, or as otherwise set forth in your Provider’s Notice of Privacy Practices.
Your Acknowledgements By clicking “I Agree”, checking a related box to signify your acceptance, using any other acceptance protocol presented through the Service or otherwise affirmatively accepting this consent, you are agreeing and providing your consent with respect to the following: Healthcare services provided to you by Providers via the Service will be provided by telehealth. Certain technology, including the Service, may be used while still in a beta testing and development phase, and before such technology is a final and finished product. Technology used to deliver care, including the Service, may contain bugs or other errors, including ones which may limit functionality, produce erroneous results, render part or all of such technology unavailable or inoperable, produce incorrect records, transmissions, data or content, or cause records, transmissions, data or content to be corrupted or lost, any or all of which could limit or otherwise impact the quality, accuracy and/or effectiveness of the medical care or other services that you receive from your Provider(s). The delivery of healthcare services via telehealth is an evolving field and the use of telehealth or other technology in your medical care and treatment from Provider(s) may include uses of technology different from those described in this Consent or not specifically described in this Consent. No potential benefits from the use of telehealth or other technology or specific results can be guaranteed. Your condition may not be cured or improved, and in some cases, may get worse. There are limitations in the provision of medical care and treatment via telehealth and technology, including the Service, and you may not be able to receive diagnosis and/or treatment through telehealth for every condition for which you seek diagnosis and/or treatment. There are potential risks to the use of telehealth and other technology, including but not limited to the risks described in this Consent. You have the opportunity to discuss the use of telehealth, including the Service, with your Provider(s), including the benefits and risks of such use and the alternatives to the use of telehealth. You have the right to withdraw your consent to the use of telehealth in the course of your care, without prejudice to any future care or treatment and without risking the loss or withdrawal of any health benefits to which your entitled, but you understand that the Providers who utilize the Service do not offer in-person treatment. Any withdrawal of your consent will be effective upon receipt of written notice to your Providers, except that such withdrawal will not have any effect on any action taken by Healthspan or your Provider(s) in reliance on this Consent before it received your written notice of withdrawal. Any withdrawal of your consent will not affect any other provision of this Consent, and you will continue to be bound by this Consent. You understand that the use of telehealth involves electronic communication of your personal medical information to Provider(s). You understand that it is your duty to provideHealthspan. and your Provider(s) truthful, accurate and complete information, including all relevant information regarding care that you may have received or may be receiving from healthcare providers. You understand that each of your Provider(s) may determine in his or sole discretion that your condition is not suitable for diagnosis and/or treatment using telehealth technology, including the Service, and that you may need to seek medical care and treatment from your Provider(s), or a specialist or other healthcare provider, outside of such telehealth technology. Healthspan has a commercial relationship with several partner pharmacies. Healthspan has a financial relationship with the entity that employs or contracts with your Provider. You are free to obtain your medical examination from another healthcare provider that is not associated with Healthspan. Healthspan will use its pharmacy partner to fulfill your order directly to your door. You are free to obtain your prescription from any pharmacy of your choice by contacting our support team. You must pay the full amount of the costs associated with use of the Service, including any prescription you may receive, and you will not attempt to submit a claim to Medicare, any other federal payor, or any state or private insurer.
Additional State-Specific Disclosures
The following disclosures apply to users accessing the Healthspan Platform for the purposes of participating in a telehealth visit as required by the states listed below:
Iowa: I have been informed that if I want to register a formal complaint about a provider, I should visit the medical board’s website, here: https://medicalboard.iowa.gov/consumers/filing-complaint.
Kentucky: I have been informed that if I want to register a formal complaint about a provider, I should visit the medical board’s website, here: https://kbml.ky.gov/grievances/Pages/default.aspx.
Maine: I have been informed that if I want to register a formal complaint about a provider, I should visit the medical board’s website, here: https://www.maine.gov/md/complaint/file-complaint.
New York: I have been informed that to get information regarding your rights and how to report professional misconduct, I should visit, here: https://www.health.ny.gov/professionals/doctors/conduct.
Oregon: I have been informed that if I want to register a formal complaint about a provider, I should visit the medical board’s website, here: https://www.oregon.gov/omb/investigations/pages/how-to-file-a-complaint.aspx.
Rhode Island: I have been informed that if I want to register a formal complaint about a provider, I should visit the medical board’s website, here: [https://health.ri.gov/complaints/.](https://health.ri.gov/complaints/)
Texas: I have been informed of the following notice:NOTICE CONCERNING COMPLAINTS- Complaints about physicians, as well as other licensees and registrants of the Texas Medical Board, including physician assistants, acupuncturists, and surgical assistants may be reported for investigation at the following address: Texas Medical Board, Attention: Investigations, 333 Guadalupe, Tower 3, Suite 610, P.O. Box 2018, MC-263, Austin, Texas 78768-2018, Assistance in filing a complaint is available by calling the following telephone number: 1-800-201-9353, For more information, please visit our website at www.tmb.state.tx.us.AVISO SOBRE LAS QUEJAS- Las quejas sobre médicos, asi como sobre otros profesionales acreditados e inscritos del Consejo Médico de Tejas, incluyendo asistentes de médicos, practicantes de acupuntura y asistentes de cirugia, se pueden presentar en la siguiente dirección para ser investigadas: Texas Medical Board, Attention: Investigations, 333 Guadalupe, Tower 3, Suite 610, P.O. Box 2018, MC-263, Austin, Texas 78768-2018, Si necesita ayuda para presentar una queja, llame al: 1-800-201-9353, Para obtener más información, visite nuestro sitio web en www.tmb.state.tx.us
Vermont: I have been informed that if I want to register a formal complaint about a provider, I should visit the medical board’s website, here: http://www.healthvermont.gov/health-professionals-systems/board-medical-practice/file-complaint; or Board of Osteopathic Examiners can be found at: https://sos.vermont.gov/opr/complaints-conduct-discipline/
Wyoming: I have been informed that if I want to register a formal complaint about a provider, I should visit the medical board’s website, here: [http://wyomedboard.wyo.gov/consumers/file-a-complaint.](http://wyomedboard.wyo.gov/consumers/file-a-complaint)