Telehealth Consent

If you are having a medical emergency, call 911 or go to the nearest emergency room. If you are thinking about harming yourself, call or text 988.

1. Who will treat you

Your care is provided by [pending: the physician’s name], a [pending: license type] licensed in [pending: state] (license number [pending]) and registered with the Florida Department of Health as an out-of-state telehealth provider under s. 456.47(4), Florida Statutes (registration number [pending: once issued]), through [pending: the Practice’s legal name] (the “Practice”). Your physician’s registration and background are listed by the Department of Health here: [pending: the Department of Health’s registrant page]. As a registered out-of-state provider, your physician has no office in Florida and does not provide in-person care to patients in Florida (s. 456.47(4)(f)).

Florida’s Patient’s Bill of Rights and Responsibilities (s. 381.026, Florida Statutes) is summarized here: [pending: link to the summary].

Oona (Lumenos AI Inc.) runs the website, the Clinical Skin Analysis, your account, billing and shipping for the Practice. Oona does not practice medicine. Your physician alone decides whether to treat you and what to prescribe.

2. What telehealth means here

Telehealth is health care delivered by electronic communication between a provider in one place and a patient in another. At Oona it works like this:

You take the Clinical Skin Analysis (its questions and a photo) and, after you order, return a DNA sample.
Your physician reviews your answers, your photo, your Clinical Skin Analysis report and, when they arrive, your DNA results, and decides on your request within 2 business days. There is no video or phone visit unless your physician asks for one.
If your physician approves treatment, your physician writes your prescriptions, sets your starting doses from your intake and starts you right away. Your DNA results make your supplement formula and, at your physician’s discretion, can adjust your metformin schedule.
Your physician may ask you questions through your account, relayed by the care team.
You can ask your physician a question at any time through the chat in your account. The care team passes it to your physician, who answers you there, usually within one business day.

Your physician may decide that telehealth is not suitable for you, that more information is needed, or that you should see a physician in person. If your physician does not approve treatment, you are not charged.

3. Benefits

You can be assessed and treated without an office visit, at a time that suits you, and your physician can follow your progress from your account.

4. Limits and risks

Your physician cannot examine you in person. What you tell your physician and what your physician sees in your photo may not be enough to decide, and your physician may need to decline or to refer you to in-person care.
A delay or failure in technology, or an unanswered message, may delay your care.
Information sent over the internet can, despite our safeguards, be lost or seen by someone it was not meant for.
Because care is provided remotely, some treatments and some tests cannot be offered.
Your medications, if prescribed, are compounded by a licensed U.S. pharmacy. Compounded medications are not FDA-approved and are not evaluated by the FDA for safety or efficacy.
No treatment can promise a result. Your skin may improve, stay the same or get worse.

5. What we ask of you

Answer every question truthfully and completely, including your health history, your medications and your allergies. Withholding or misstating information to obtain treatment can harm you.
Tell your physician, through the chat in your account, when anything changes: a new condition, a new medication, a pregnancy, a side effect or a reaction.
Follow the instructions that come with your medications.
Keep your own doctor. Oona does not replace your primary care physician or your dermatologist, and your physician treats only what your program covers.

6. Your medications

If your physician prescribes them, your program’s medications are a topical rapamycin cream, low-dose metformin (Metformin XR) and NAD+ injections. Your physician decides which of them are appropriate for you, and may prescribe fewer than all three. Each comes with instructions and a dosing schedule from your physician. Topical rapamycin can make skin more sensitive to sunlight, so daily sunscreen is part of the plan. The pharmacy’s label shows the medication’s generic name, which you can give any other clinician who asks what you take. [pending: prescribing information in your account]

Medication prescribed for you is for you alone. Do not share it.

7. Your DNA & Methylation Test

Your program includes the Complete Skin Intelligence Test, an at-home DNA & Methylation Test. Your physician orders the test from the laboratory as part of your plan. You collect a cheek swab with the kit shipped to you and return it in the prepaid mailer. Gencove’s CLIA-certified, CAP-accredited U.S. laboratories [pending: the laboratory’s confirmation] sequence your sample and read the markers your program uses. The results make your supplement formula and, at your physician’s discretion, adjust your metformin schedule, and are explained in your plan.

How your sample is collected and used. The kit collects a cheek swab. The laboratory sequences your genome at low coverage and reads a panel of genetic markers related to skin aging from it and returns the results to your physician and to Oona. The results are used for your program only. Your sample is [pending: the laboratory’s sample retention and destruction policy].

Express consent. Florida law (ss. 760.40 and 817.5655, Florida Statutes) allows your DNA to be collected and analyzed only with your express consent, given after a clear disclosure of how your sample is collected, used, kept and shared. You give that consent when you activate your kit in your account, after it is delivered and before you mail your sample, by ticking its own box under its own disclosure. Agreeing to this document is not that consent, and the laboratory does not analyze a sample without it.

Notice under s. 760.40(3). The laboratory performs the analysis, and your physician and Oona receive the results. On your request, your results will be made available to your physician. Your results are not used in any decision to grant or deny insurance, employment, a mortgage, a loan, credit or an educational opportunity.

Your results are yours. Under Florida law the results of your DNA analysis are your exclusive property, are confidential, and may not be disclosed without your express consent, except as the law requires. They are shared with your physician, the Practice and Oona to run your program, and with no one else.

What the test is not. It is a sequencing panel of markers related to skin aging. It is not a diagnostic test, not a test for disease risk, and not a paternity or ancestry test.

8. Your records

Your physician documents your care in your medical record to the same standard as in-person care (s. 456.47(3), Florida Statutes). Your record is confidential under s. 456.057, Florida Statutes. The Practice keeps it for at least five years after your last contact, as Florida’s Board of Medicine requires. You may ask the Practice for a copy of your record, or ask it to send your record to another provider, as the Practice’s Notice of Privacy Practices explains. Your information is otherwise collected, used, kept and protected as Oona’s Privacy Policy and the Practice’s Notice describe.

9. Fees and insurance

Your plan price includes your physician’s review and care [pending: how the Practice is paid]. You pay Oona for your program; the Practice bills no one. Neither Oona nor the Practice bills insurance or takes part in Medicare, Medicaid or any insurance plan, and payments to Oona may not count toward any deductible. Oona’s Payment & Billing Consent and Refunds and Cancellation Policy apply.

You may withdraw this consent at any time by cancelling your plan in your account or by emailing concierge@withoona.com. Withdrawing it ends your telehealth care through Oona; it does not affect care already given or charges already made under the Refunds and Cancellation Policy.

If you have a concern about your physician, you may contact the Florida Department of Health, Consumer Services, 4052 Bald Cypress Way, Bin C-75, Tallahassee, FL 32399, or file a complaint at flhealthsource.gov. [pending: confirmation of the current address and link]

11. Your acknowledgments

By ticking the box that names this document, you confirm that:

You have read this consent and understand the benefits, limits and risks of telehealth.
You are 18 or older and located in Florida.
You consent to receive care by telehealth from your physician through the Practice, in the way described above.
You will give complete and truthful information and keep your physician informed.
You understand your physician may decline to treat you, or may end treatment, and may refer you to in-person care.
You understand that telehealth cannot be used for emergencies, and that you will call 911 in an emergency.
You understand that your DNA sample is collected and analyzed only with the express consent you give when you activate your kit, as section 7 describes.
You understand how your information will be used and shared, as the Privacy Policy and the Practice’s Notice of Privacy Practices describe.
You understand that no result is promised.

[pending: the Practice’s legal name] · [pending: the Practice’s address] · [pending: the Practice’s contact]