Sanctifi Health — Comprehensive Informed Consent

Sanctifi Health — Comprehensive Informed Consent

Effective Date: March 1, 2025

This Comprehensive Informed Consent ("Consent") is a legal agreement between you ("Patient," "you," or "your") and Sanctifi Health PC, Sanctifi Health PA, and any affiliated professional associations or professional corporations, including their respective healthcare providers, employees, contractors, and agents (collectively, "Sanctifi Health," "we," "us," or "our").

PLEASE READ THIS DOCUMENT CAREFULLY BEFORE AGREEING. This Consent contains important information about our telehealth services, the potential use of off-label medications, and compounded medications in your treatment plan. By checking "I Agree," clicking "Accept," or otherwise indicating your acceptance, you acknowledge that you have read, understood, and agree to all terms and conditions outlined herein.

1. Telehealth Services Consent

1.1 Definition of Telehealth

Telehealth involves the use of electronic communications (telephone, video conferencing, or other digital platforms) to enable healthcare providers at different locations to share individual patient medical information for the purpose of improving patient care. Telehealth services may include:

Patient medical record review
Medical consultations
Diagnosis of symptoms
Prescription of medications
Follow-up care
Management of chronic conditions

1.2 Nature of Telehealth Services

You understand and acknowledge that:

Your healthcare provider will be at a different location from you.
Communications will occur via secure electronic means that comply with applicable federal and state privacy regulations.
The same standard of care applies to telehealth services as in-person medical care.
Details of your medical history, examinations, diagnostic testing, and other health information may be discussed through electronic means.
Physical examination may be limited during telehealth consultations.

1.3 Technology Requirements and Limitations

You understand and acknowledge that:

You are responsible for providing the necessary equipment and internet connection for telehealth appointments.
Technical difficulties may occur before or during telehealth sessions that may necessitate rescheduling.
Despite reasonable efforts, there are risks that technology may fail, causing a delay in medical evaluation and treatment.
In rare cases, security protocols could fail, causing a breach of privacy of personal medical information.

1.4 Emergency Situations

You understand and acknowledge that:

Telehealth services are not intended for emergency situations.
In case of emergency, you will call 911 or go to the nearest emergency department.
Sanctifi Health may determine that telehealth is not appropriate for your condition and require in-person evaluation with a local healthcare provider.
If urgent medical attention is needed during a telehealth consultation, you will be directed to seek immediate in-person medical care.
Sanctifi Health cannot guarantee immediate assistance in case of equipment or service failure.
You are responsible for having an emergency action plan and access to local emergency services.

1.5 Benefits of Telehealth

Potential benefits of telehealth include:

Improved access to medical care
More efficient medical evaluation and management
Reduced travel time and related stresses
Reduced exposure to other potentially contagious patients

1.6 Risks of Telehealth

Potential risks of telehealth include:

Information transmitted may be insufficient for appropriate medical decision-making.
Delays in medical evaluation and treatment could occur due to technology failures.
Security protocols could fail, causing a breach of privacy of personal medical information.
Lack of access to complete medical records may result in adverse drug interactions or allergic reactions.
Limited physical examinations may affect the provider's ability to diagnose certain conditions.

1.7 State Licensing and Geographic Limitations

You understand and acknowledge that:

Sanctifi Health healthcare providers maintain medical licenses in specific states as required by law.
Telehealth services are only available to patients located in states where our providers maintain active medical licenses or where interstate practice is legally permitted.
You will be informed of service availability for your location during the consultation scheduling process.
You must be physically located in an approved service area during any telehealth consultation.
Service availability may change based on licensing requirements and evolving state regulations.
You are responsible for ensuring you are in an approved location during consultations and for providing accurate location information.

2. Off-Label Medication Use Consent

2.1 Definition of Off-Label Use

"Off-label" use refers to the use of FDA-approved medications for purposes, populations, or at dosages that have not been specifically approved by the U.S. Food and Drug Administration (FDA). It is legal and often common medical practice for healthcare providers to prescribe medications for off-label uses when they judge it to be medically appropriate.

2.2 Nature of Off-Label Prescribing

You understand and acknowledge that:

The FDA does not regulate the practice of medicine, and licensed healthcare providers may prescribe FDA-approved medications for off-label uses when deemed medically appropriate.
Off-label prescribing is common and often represents standard medical practice in many specialties.
Medications prescribed off-label have undergone FDA review for safety and effectiveness for at least one indication, but not necessarily for the indication, dosage, or population for which it may be prescribed to you.
Your healthcare provider has determined that an off-label medication may be beneficial for your specific condition based on available medical evidence, clinical experience, and professional judgment.

2.3 Potential Benefits of Off-Label Medication Use

Access to treatment options when FDA-approved options have failed or are unavailable
Treatment of conditions that have limited FDA-approved medication options
Use of medications that may be supported by medical research but have not undergone the FDA approval process for your specific condition
Personalized treatment approaches tailored to your specific needs

2.4 Potential Risks of Off-Label Medication Use

Less certainty regarding effectiveness for your specific condition compared to FDA-approved uses
Less comprehensive information about optimal dosing, potential side effects, or long-term effects for your specific condition
Possible reduced or absent insurance coverage for off-label medications
Potential for unknown or unexpected side effects
Limited clinical trial data specifically addressing your condition

3. Compounded Medication Consent

3.1 Definition of Compounded Medications

Compounded medications are custom-prepared by licensed pharmacists or physicians to meet the specific needs of an individual patient when commercially available drugs do not meet those needs. These medications are created by combining, mixing, or altering pharmaceutical ingredients.

3.2 Nature of Compounded Medications

You understand and acknowledge that:

Compounded medications are not FDA-approved, meaning they have not undergone the same rigorous testing for safety, effectiveness, and quality as FDA-approved medications.
Compounded medications are prepared in specialized pharmacies that may be subject to different regulatory standards than manufacturers of FDA-approved medications.
The exact formulation of compounded medications may vary between pharmacies and even between batches from the same pharmacy.
Sanctifi Health selects compounding pharmacies based on their credentials, quality standards, and regulatory compliance, but cannot guarantee the quality of compounded products.
Sanctifi Health works only with licensed compounding pharmacies that meet or exceed state and federal regulatory requirements.
Our selected pharmacies maintain appropriate accreditation and quality assurance programs.
Compounding pharmacies operate under different regulatory frameworks than manufacturers of FDA-approved medications.

3.3 Potential Benefits of Compounded Medications

Customized formulations tailored to your specific medical needs
Availability of combinations of medications not commercially available
Alternative forms of medication administration (e.g., topical vs. oral) that may be more suitable for your condition
Formulations free from specific allergens or ingredients you may be sensitive to
Availability of discontinued medications or medications in shortage

3.4 Potential Risks of Compounded Medications

Lack of FDA review for safety, effectiveness, and quality
Possible variations in potency, purity, and consistency between batches
Limited data on stability, shelf-life, and optimal storage conditions
Potential for contamination or product quality issues
Possible adverse reactions not documented in scientific literature
Limited or absent insurance coverage

4. Cash-Pay Model and Financial Responsibility

4.1 Nature of Cash-Pay Services

You understand and acknowledge that:

Sanctifi Health operates on a cash-pay model, meaning we do not accept or bill insurance for services or medications.
All payments for consultations, treatments, medications, and follow-up care are your direct financial responsibility.
Payment is expected at the time services are rendered or medications are prescribed.
We will provide detailed receipts that you may submit to your insurance for possible reimbursement, but we cannot guarantee any insurance coverage or reimbursement.

Additional financial terms are governed by Sanctifi Health's Financial Agreement and Payment Policy.

4.2 Financial Responsibility for Off-Label and Compounded Medications

You understand and acknowledge that:

Insurance companies often do not cover off-label medication uses or compounded medications.
The full cost of these medications will be your responsibility.
Prior to prescribing, we will inform you of the approximate cost of all medications.
You have the right to decline any recommended treatment based on cost considerations.

4.3 Prescription and Medication Delivery

You understand and acknowledge that:

Prescribed medications will be delivered through approved compounding pharmacies or standard pharmacies.
Delivery methods and timelines may vary based on medication type and your location.
You are responsible for ensuring safe receipt and proper storage of delivered medications.
Sanctifi Health is not responsible for delivery delays, damage, or loss during shipping.
You should contact the prescribing pharmacy directly for delivery-related issues.
Temperature-sensitive medications require special handling, and you must be available to receive them promptly.

5. Patient Acknowledgments and Agreement

5.1 Voluntary Consent

Your participation in telehealth services is voluntary.
Your consent to consider off-label medications is voluntary.
Your consent to consider compounded medications is voluntary.
You have the right to withhold or withdraw your consent to any aspect of this agreement at any time.
Withdrawing consent will not affect your right to future care or treatment, nor risk the loss of any program benefits to which you would otherwise be entitled.

5.2 Right to Alternative Treatment

You have been informed of alternative treatment options, including in-person consultations and FDA-approved medications for your condition(s).
You have had the opportunity to discuss these alternatives with your healthcare provider.

5.3 Medical Records and Confidentiality

All existing laws regarding access to your medical information and copies of your medical records apply to telehealth consultations.
All electronic communications will be documented in your medical records.
All telehealth interactions are subject to the same privacy protections as in-person visits under applicable federal and state laws.
You have the right to access, review, and obtain copies of your medical records in accordance with state and federal law.
Requests for medical records should be submitted in writing to Sanctifi Health.
You may be charged reasonable fees for copying and processing medical record requests as permitted by law.

Our handling of your protected health information is further described in our Notice of Privacy Practices and HIPAA Acknowledgment.

5.4 Release of Liability for Technical Failures

You release Sanctifi Health from liability in the event that technical failures prevent adequate telehealth service delivery.
You understand that Sanctifi Health cannot guarantee immediate assistance in case of equipment or service failure.

5.5 Opportunity for Questions

You have had the opportunity to ask questions regarding telehealth services, off-label medication use, and compounded medications.
All your questions have been answered to your satisfaction.

5.6 Disclosure of Medical Information

You consent to the disclosure of your medical information, including health history, medications, and treatment plans, to other healthcare providers involved in your care.
You understand that this disclosure is for the purpose of coordinating your care and ensuring safe and effective treatment.

5.7 Full Disclosure of Medical History

You agree to provide complete and accurate information about your medical history, current medications, allergies, and any other factors that may affect your treatment.
You understand that failure to provide complete information may result in adverse outcomes.

5.8 Compliance with Treatment Recommendations

You agree to follow treatment recommendations, including medication dosages and schedules.
You agree to report any side effects or adverse reactions promptly to Sanctifi Health.
You understand that failure to comply with treatment recommendations may result in adverse outcomes.

5.9 Assumption of Risk

You assume the risk of potential adverse outcomes associated with telehealth services, off-label medication use, and compounded medications.
You understand that despite Sanctifi Health's best efforts, no guarantees or assurances can be made about the results of any treatment.

6. Release and Indemnification

To the fullest extent permitted by law, you hereby release, discharge, and agree to hold harmless Sanctifi Health PC, Sanctifi Health PA, any affiliated professional associations or professional corporations, and their respective healthcare providers, employees, contractors, and agents from any and all claims, actions, suits, proceedings, costs, expenses, damages, and liabilities, including attorney's fees, arising out of, connected with, or resulting from:

Your participation in telehealth services
The prescription or use of off-label medications
The prescription or use of compounded medications
Any adverse outcomes resulting from your treatment, provided that such outcomes were not the result of gross negligence or willful misconduct

You further agree to indemnify and hold harmless Sanctifi Health PC, Sanctifi Health PA, any affiliated professional associations or professional corporations, and their respective healthcare providers, employees, contractors, and agents from any claims brought by third parties arising from your treatment by any Sanctifi Health entity.

7. Governing Law and Dispute Resolution

7.1 Governing Law

This Consent shall be governed by and construed in accordance with the laws of the State of Arizona, without giving effect to any choice of law or conflict of law provisions.

7.2 Arbitration

Any dispute, claim, or controversy arising out of or relating to this Consent or the breach, termination, enforcement, interpretation, or validity thereof, shall be determined by arbitration in Phoenix, Arizona before a single arbitrator. The arbitration shall be administered by JAMS pursuant to its Comprehensive Arbitration Rules and Procedures. Judgment on the award may be entered in any court having jurisdiction.

7.3 Class Action Waiver

You agree to waive any right to pursue disputes on a class-wide basis, including participating as a member of a class of claimants with respect to any dispute with Sanctifi Health PC, Sanctifi Health PA, or any affiliated professional associations or professional corporations.

7.4 Limitation of Liability

In no event shall the liability of Sanctifi Health PC, Sanctifi Health PA, or any affiliated professional associations or professional corporations for any claim arising out of or related to this Consent exceed the total amount paid by you to the specific Sanctifi Health entity for the service(s) giving rise to such claim.

8. Miscellaneous Provisions

8.1 Severability

If any provision of this Consent is held to be unenforceable, the remaining provisions shall remain in full force and effect.

8.2 Entire Agreement

This Consent constitutes the entire agreement between you and the Sanctifi Health entities with respect to the subject matter hereof and supersedes all prior or contemporaneous communications, representations, or agreements, whether oral or written.

8.3 Amendments

This Consent may only be amended in writing signed by both you and an authorized representative of the applicable Sanctifi Health entity.

9. Third-Party Platform Access and Data Sharing

9.1 Access Through Wellness Platforms

You understand and acknowledge that:

You may access Sanctifi Health services through third-party wellness platforms such as Geviti Inc.
These platforms operate independently from Sanctifi Health and are subject to separate terms and conditions.
You are responsible for reviewing and agreeing to the terms of any third-party platform you use to access our services.

9.2 Information Sharing for Coordinated Care

You consent to Sanctifi Health sharing relevant medical information with approved wellness platforms for the purpose of:

Coordinating your overall wellness and medical care
Enabling wellness coaches to provide appropriate non-medical guidance
Ensuring continuity of care between medical and wellness services
Improving health outcomes through integrated care approaches

9.3 Data Protection

All information sharing will be conducted in compliance with HIPAA regulations and applicable state privacy laws. You may withdraw this consent for information sharing at any time by providing written notice to any Sanctifi Health entity.

10. Acknowledgment and Electronic Consent

By checking the "I Agree" box, clicking "Accept," or otherwise indicating your acceptance electronically:

You acknowledge that you have read, understood, and agree to all terms and conditions outlined in this Comprehensive Informed Consent.
You consent to the telehealth services, potential off-label medication use, and potential compounded medication use as described herein.
You acknowledge that your electronic consent is legally binding and equivalent to your handwritten signature.
You agree that by engaging with any Sanctifi Health entity, whether directly through our website or application, or through any third-party platform through which Sanctifi Health provides services, you are bound by the terms of this Comprehensive Informed Consent.
You understand that you may request a copy of this Consent for your records at any time by contacting any Sanctifi Health entity.