Patient Telehealth Informed Consent
Please read this document carefully before initiating electronic clinical consultations or submitting medical intake questionnaires through Alpha 1 Labs.
Clinical Care Model, Partner Disclosures & Physician-Patient Relationship
Alpha 1 Labs ("Company", "we", "us") is an administrative management and healthcare coordination platform, not a medical practice or pharmacy. We partner with OutfitMD (www.outfitmd.com) and their licensed U.S.-based pharmacy partners to coordinate access to prescribers and state-licensed 503A compounding pharmacies.
1Nature of Telehealth Services
Telehealth through this platform involves the delivery of healthcare services using real-time, synchronous interactive audio and video communications (with telephone available where video is not feasible). Electronic systems used incorporate network and software security protocols to protect the confidentiality of patient identity and data and include measures to safeguard data integrity against intentional or unintentional corruption. Initial prescriptions are not issued based solely on asynchronous (store-and-forward) or questionnaire-only evaluation.
By agreeing to this consent, you authorize prescribers to review your health history, lab biomarker reports, current medications, and symptoms remotely to evaluate your medical candidacy for therapeutic protocols including GLP-1 weight management and hormone replacement therapy (TRT/HRT).
2Expected Benefits & Potential Clinical Risks
Expected Benefits
- Improved access to prescribers without travel burden.
- Efficient digital review of comprehensive blood biomarker diagnostics.
- Direct cold-chain home delivery of prescribed compounded preparations.
- Ongoing asynchronous or video follow-up monitoring.
Potential Risks & Limitations
- Inability to perform a physical hands-on palpation or physical exam.
- Delays in medical evaluation due to equipment or internet transmission failure.
- In rare instances, security protocol failure causing breach of health information.
- Potential need for in-person follow-up if clinical findings warrant physical evaluation.
3Validity of Prescriptions & Mandatory Prescriber Evaluation
In accordance with applicable state medical board rules (including Minnesota Statute § 147.033) and the federal Ryan Haight Online Pharmacy Consumer Protection Act, prescribers will only issue a prescription after establishing a valid prescriber-patient relationship. No 503A compounded medications may or will be dispensed without an individualized clinical evaluation by a prescriber first.
Consultation format: the clinical evaluation that establishes this relationship is conducted as a synchronous (real-time) video consultation directly with a prescriber through OutfitMD, with a telephone visit available where video is not feasible. The prescriber reviews your medical history and relevant laboratory biomarker results with you during this live visit before determining whether treatment is clinically appropriate. Purely asynchronous (store-and-forward) or questionnaire-only evaluation is not used to issue an initial prescription.
Ryan Haight Act compliance: the Ryan Haight Act prohibits dispensing a controlled substance by means of the internet without a valid prescription issued following at least one in-person medical evaluation, unless an applicable DEA telehealth exception applies. Where any controlled substance is considered, OutfitMD's prescribers follow the applicable federal and state requirements, and Alpha 1 Labs and OutfitMD do not prescribe controlled substances based solely on an online questionnaire or payment. For non-controlled compounded preparations, every prescription still requires a live clinical evaluation by a prescriber.
Establishing this valid clinical relationship requires:
- Verification of patient identity and geographic state location.
- Review of thorough patient-reported health history and relevant biomarker diagnostic blood panels analyzed by CLIA-certified partner laboratories.
- A synchronous (real-time) video consultation — or telephone consultation where video is not feasible — conducted directly with a prescriber through OutfitMD, in compliance with each state's telehealth rules.
- Independent medical determination by the prescriber that the requested treatment is clinically appropriate, safe, and indicated for the patient.
Prescriptions are never automatically issued based solely on questionnaire submission or payment. Every prescription requires a clinical evaluation by a prescriber.
Care is provided only when the treating provider is appropriately licensed or otherwise legally authorized to provide care in the patient's jurisdiction.
4Compounded Medication Disclosures (503A) & Partner Lab Standards
Compounded medications provided through partner pharmacies are prepared pursuant to individual patient-specific prescriptions issued by prescribers following a medical consult. Compounded preparations are not FDA-approved brand-name drugs. Compounded formulations are prepared by licensed pharmacy partners under applicable federal and state compounding requirements, including applicable USP standards where required.
All partner diagnostic laboratories coordinating biomarker analyses through our partner OutfitMD (www.outfitmd.com) are CLIA-certified under federal regulatory requirements. Laboratory testing is performed by applicable CLIA-certified laboratory partners.
Medications are subject to analytical testing designed to verify identity and purity, sterility verification, and endotoxin screening where applicable. Certificates of Analysis (COA) are maintained and accessible upon request.
5Emergency Situations & Medical Disclaimer
If you are experiencing a medical emergency, acute chest pain, severe shortness of breath, sudden allergic reaction, or thoughts of self-harm, call 911 immediately or go to the nearest hospital emergency room. Do not rely on electronic communications or portal messages for urgent medical needs.
6Patient Rights, Freedom of Choice & Revocation
You maintain full patient autonomy at all times. You have the right to:
- Withhold or withdraw consent to telehealth consultations at any time without affecting your right to future care.
- Request your prescriptions be sent to any retail pharmacy of your choice capable of filling the order.
- Inspect and receive copies of your telehealth medical records.
- Ask your clinician questions regarding alternative treatment options, side effects, or drug interactions.
Patient Electronic Acknowledgment
By checking the consent box during online intake, clicking "Submit Medical Review", or continuing with a clinical consultation through Alpha 1 Labs, you certify that:
- You are at least 18 years of age and reside in a state served by our licensed provider network.
- You have read and understood this Informed Consent document in its entirety.
- You agree to provide true, accurate, and complete health history information.
- You give informed consent to receive telehealth clinical services and state-licensed prescribing evaluations.