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 qualified medical professionals and state-licensed 503A compounding pharmacies.
1Nature of Telehealth Services
Telehealth involves the delivery of healthcare services using interactive electronic audio, video, or store-and-forward asynchronous data communications. Electronic systems used will incorporate network and software security protocols to protect the confidentiality of patient identity and imaging data and will include measures to safeguard data integrity against intentional or unintentional corruption.
By agreeing to this consent, you authorize qualified 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, therapeutic peptides, and hormone replacement therapy (TRT/HRT).
2Expected Benefits & Potential Clinical Risks
Expected Benefits
- Improved access to qualified medical specialists 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 Doctor Visit
In accordance with applicable state medical board rules (including Minnesota Statute § 147.092 and Ryan Haight Act provisions), 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 visit and evaluation by a qualified medical professional first.
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 real-time synchronous video consultation or robust asynchronous clinical evaluation by a qualified medical professional where permitted by state medical board statutes.
- Independent medical determination by the doctor 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 licensed doctor.
4Compounded Medication Disclosures (503A) & Partner Lab Standards
Compounded medications provided through partner pharmacies are prepared pursuant to individual patient-specific prescriptions issued by licensed providers 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.
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.