Run the practice. Keep care in licensed hands.
Your AI assistant assembles intake packets, keeps reminders and refill queues moving, and prepares the records your team signs.
For Florida outpatient practices and med spas of three to twenty people. Diagnosis, prescribing, dosing, procedures and consent stay with your licensed clinicians.
Film transcript
Before each visit, there is work around the care.
In Studio, your AI assistant organizes the file, flags missing forms, and prepares a visit brief as PDF and editable Word. You review the draft.
Legate brings review into the workflow. Your clinic sets the permissions before anything goes out.
Out of forty-five recurring processes, Regaldi runs twenty-three with your confirmation, prepares sixteen for a clinician's or owner's decision, and leaves six with the clinician. Every process names its tool.
Studio prepares. Legate organizes. Herald handles calls, follow-up, and campaigns, configured for your clinic.
Patient data only under signed agreements. Regaldi never routes prescriptions and receives nothing from pharmacies. Our fee is fixed. You evaluate, discuss consent, prescribe, and treat. Care stays in licensed hands.
Regaldi.
Regulated. Aligned. Digital. Start with one workflow.
Regaldi runs 23 of 45 recurring processes, prepares 16 for the licensed professional’s decision, and leaves 6 with them.
- Regaldi runs
- 23
- A person at the clinic confirms, approves or sends.
- Regaldi prepares
- 16
- The clinician, the medical director or the owner decides.
- Stay with the clinician or owner
- 6
- Medical advice, evaluation, consent, prescribing, procedures, referral agreements.
- Recurring processes
- 45
- Mapped in six groups, from the first inquiry to the referral report.
With our tools · the 39 processes Regaldi runs or prepares
- Regaldi Studio
- 25 processes · runs 12, prepares 13
- Regaldi Legate
- 12 processes · runs 9, prepares 3
- Regaldi Herald
- 4 processes · runs 4, prepares 0
Studio prepares the work. Legate organizes the follow-through. Herald is configured for your clinic’s calls, follow-up and campaigns; it already runs for a pharmacy and has not yet been deployed in a clinic. Clinical decisions stay with licensed clinicians; business decisions stay with the medical director or owner. The 6 human acts are not automated by any tool.
Patient health information is excluded until the applicable Business Associate Agreements and required safeguards are in place. The map is a responsibility map for the agreed clinic setup, with human review, signed BAAs and clinic configuration, not 45 delivered integrations.
In short
Regaldi LLC is a Florida software company that gives outpatient clinics and med spas an AI assistant for administrative work. Regaldi Studio prepares intake packets, records and documents for staff to sign, and Legate keeps reminders, refill queues and approved follow-up moving. Herald can be configured for a clinic’s calls, follow-up and campaigns; it already runs for a pharmacy and has not yet been deployed in a clinic. Of the 45 recurring processes mapped for a clinic, Regaldi runs 23 with a person at the clinic confirming, prepares 16 for the clinician’s or owner’s decision, and leaves 6 with the clinician or owner, including diagnosis, prescribing and dosing, procedures and the informed consent conversation. Patient-data workflows remain excluded until applicable agreements, access controls, safeguards and operating procedures are reviewed and accepted. Regaldi does not practice medicine. Work starts with one workflow and a written scope.
Related professionsDental practicesPharmaciesAll industries
Put the file in order before the visit.
Studio assembles the intake packet, flags missing documents, and prepares a visit brief as a PDF and an editable Word draft.
- 01
Packet arrives
Intake forms, an outside lab PDF and a signed history arrive before the consultation.
- 02
Inventory
Each document is listed with its date and page count and filed in the clinic folder.
- 03
Flags
The consent form is unsigned. Staff get the item to request from the patient.
- 04
Visit brief
Prior notes, labs received and open items go on one sheet, saved as a PDF and an editable Word draft.
- 05
Clinician review
The clinician evaluates the patient, interprets the results and signs the record.
- Intake questionnaire Received All pages present, dated
- Photo ID and contact details Received Checked by staff
- Procedure consent form Signature missing Request from the patient; never filled in by the assistant
- Outside lab results, PDF Received Interpretation pending clinician review
- Screening answers that bear on safety Listed In the patient’s own words, for the clinician
- Clinician review section Blank Evaluation, decision and signature: the clinician
Open items for the clinician
- Consent signature: requested from the patient before the visit.
- Outside labs: for the clinician to interpret.
- Screening answers: for the clinician to evaluate.
Prepared for clinician review. The clinician evaluates the patient, interprets results, and signs the record.
Carry the administrative work through.
Legate organizes inquiries, appointment reminders, refill requests and re-evaluation dates. Studio prepares the documents your team needs.
- 01 Inquiry Legate Answered in the clinic’s words, a consultation slot offered. No health details asked for in open channels.
- 02 Booking Legate Confirmation and reminders to the number the patient gave, within the healthcare message limits.
- 03 Documents Studio Intake packet requested, checked for gaps and assembled into a visit brief.
- 04 Clinician review Licensed clinician Evaluation, consent conversation, treatment decision and signature.
- 05 Approved follow-up Legate Aftercare and the next visit, sent after a person at the clinic approves.
Illustrative workflow. Refill requests go into a queue for the prescriber; Regaldi never authorizes a refill. There is no EHR or e-prescribing connector: authorized staff open supported portals in their own Chrome, and the prescriber signs and transmits prescriptions in their own system.
[Clinic name]: a reminder of your appointment on [date] at [time]. Reply C to confirm or call us to change it. Reply STOP to opt out.
Prepared by an AI assistant for [clinic] · approval by [staff member]
Use the clinic’s approved instructions. Clinical questions and reported symptoms go to a clinician. Emergency language follows the clinic’s preset instructions and does not replace clinical assessment.
The tools around your practice.
Studio prepares. Legate organizes. Herald handles the configured patient line.
Regaldi Studio
25 processes on the mapStudio prepares the work.
- Clinic folder
Intake packets, outside records, consents and lab PDFs read, checked for gaps and filed in the folder you choose. Edits arrive as changes to review.
- Visit notes
Drafts from the clinician’s dictation or a consented recording, in the clinic’s template, for the clinician to correct and sign.
- PDF
Visit briefs, consent packets, the Weight-Loss Consumer Bill of Rights handout, referral reports and estimates as finished PDFs.
- Word
The same drafts as editable Word files, with headings, tables and sources intact.
- Computer use
With your permission the assistant opens supported applications, clicks and types, and records each action.
- Portals in your browser
Lab portals, pharmacy ordering portals and the DOH license search in staff’s own Chrome, one system at a time, each submission confirmed by a person.
- Advertising check
Drafts marked against the Florida advertising rules and the FDA and FTC limits, for the physician’s approval.
- Sunbiz
Officers, filings and registered agents for referring practices and suppliers.
- Email drafts and Calendar
Filled Gmail drafts and Google Calendar entries. A person at the clinic presses Send and saves each entry.
Regaldi Legate
12 processes on the mapLegate organizes the follow-through.
- Inquiries and booking
Web forms and email answered in the clinic’s words, with a consultation slot offered. No health details asked for in open channels.
- Reminders
Appointment confirmations and reminders within the TCPA healthcare limits, with an opt-out in every message.
- Refill and re-evaluation queue
Refill requests queued for the prescriber and re-evaluations booked before they fall due. Never an authorization.
- Lead Finder
Primary care, OB/GYN, dermatology, dietitians and physical therapists by area, for business relationships. Never patient lists.
- CRM
Every relationship, reply and agreed next contact in one history.
- Approvals
Each outgoing message waits in the Trust Center for the person the clinic names.
- Review requests
A short request to patients who agreed to hear from the clinic. Nothing is given for a positive review.
Regaldi Herald
4 processes on the mapHerald handles the configured patient line.
Already running for a pharmacy. Not yet deployed in a clinic. Configured per clinic within an engagement.
- Call center
Calls answered and categorized, missed calls turned into callbacks, an after-hours voice assistant where configured. Transcription only with every party’s consent.
- Follow-up
Aftercare sheets and check-ins on the clinic’s schedule. Any reported symptom goes to a clinician.
- Campaigns to current patients
Messages about the clinic’s own services to patients who agreed, with suppression, a frequency cap, opt-out and approval.
- Payments
Memberships and packages charged on the agreed schedule with receipts, after a clinic-specific setup and authorization.
Not connected No EHR, practice-management, e-prescribing, E-FORCSE or medical-license feed. Portals open in staff’s own Chrome, one system at a time, each submission confirmed.
Not on this page Quarry holds no medical licensing data and carries no clinic process. Herald pharmacy screens and results are not shown here.
45 recurring processes. Responsibility made visible.
A small clinic runs on 45 recurring processes. Regaldi runs 23 of them with a person at the clinic confirming, prepares 16 for a professional decision, and leaves 6 with the clinician or owner. Every process the system runs or prepares names the Regaldi tool that does it.
- S · System runs it. Administrative work with clinic confirmation.
- P · System prepares it. The AI assistant prepares; the clinician, medical director or owner decides.
- H · Clinician or owner only. The qualified person performs the act or makes the decision.
Hover, focus or tap a process to see what the system does.
Inquiries and booking
5 · 1 · 1- S · The system runs the administrative work; a person at the clinic confirms, approves or sends. A voice assistant answers hours, location, published prices and booking, says it is automated, gives no medical advice and transfers every clinical question to staff. Calls are recorded or transcribed only with every party’s consent. Tool: Regaldi Herald.Clinic configuration required.Patient-data gate: signed BAAs and safeguards first.§934.03; §458.331(1)(l)
- S · The system runs the administrative work; a person at the clinic confirms, approves or sends. Web forms, email and social messages are logged, answered in the clinic’s words and offered a consultation slot. No health details are asked for in open channels. Tool: Regaldi Legate.45 CFR 164.530(c); §456.057(7)(a)
- S · The system runs the administrative work; a person at the clinic confirms, approves or sends. Forms, ID, consent packets and outside records are requested, collected and checked for completeness. Missing items go to staff. Tool: Regaldi Legate and Regaldi Studio.Patient-data gate: signed BAAs and safeguards first.Rule 64B8-9.012(4); rule 64B8-9.003(3)
- S · The system runs the administrative work; a person at the clinic confirms, approves or sends. Estimates are prepared from the clinic’s published schedule, itemized for programs, and issued on time for self-pay patients after a staff check. Tool: Regaldi Studio.45 CFR 149.610; §400.9935(1)(i); §501.0575
- S · The system runs the administrative work; a person at the clinic confirms, approves or sends. Appointment confirmations and reminders go to the number the patient gave, name the clinic and carry an opt-out: at most one a day and three a week, with no promotion and no billing. Tool: Regaldi Legate.Patient-data gate: signed BAAs and safeguards first.47 CFR 64.1200(a)(9)(iv), (a)(10)
- P · The AI assistant prepares it; the clinician, the medical director or the owner decides. Intake answers that bear on safety (pregnancy, thyroid cancer history, kidney or heart disease, current medications, allergies) are listed for the clinician in the patient’s own words. The clinician evaluates. Tool: Regaldi Studio.Patient-data gate: signed BAAs and safeguards first.Rule 64B8-9.012(4); §458.331(1)(w)
- H · The qualified person performs the act or makes the decision. The system records around it. Whether a person is a candidate, which dose, whether it is safe with a medication: only a licensed clinician answers. The system books the consultation and records that the question was passed on.Ch. 458, 459, F.S.; §456.072(1)(o)
Consultation, consent and treatment
2 · 2 · 4- S · The system runs the administrative work; a person at the clinic confirms, approves or sends. Before each visit, prior notes, labs received, the last re-evaluation date, consents on file and outstanding forms are put on one sheet for the clinician. Tool: Regaldi Studio.Patient-data gate: signed BAAs and safeguards first.
- H · The qualified person performs the act or makes the decision. The system records around it. The system lays out the file. The history, examination, diagnosis and the decision whether to treat are the clinician’s, in person or by telehealth at the same standard of care.Rule 64B8-9.012(1), (4); §456.47(2)(a)
- H · The qualified person performs the act or makes the decision. The system records around it. Procedure-specific consent forms and the Weight-Loss Consumer Bill of Rights are prepared. The risks-and-benefits conversation and the signature happen with the clinician.Rule 64B8-9.012(5), (7); §501.0575
- H · The qualified person performs the act or makes the decision. The system records around it. Drug, dose, titration, IV formula, units and device settings are the prescriber’s. So is any finding that a compounded drug makes a significant difference for this patient.§458.331(1)(q); 21 U.S.C. 353a(b)(2)
- H · The qualified person performs the act or makes the decision. The system records around it. Injections, IV starts, fillers and laser treatments are done by licensed staff within scope and under the required supervision. The system records who did what.§458.3485(2)(a)4; rule 64B9-12.005; §458.348(2)
- P · The AI assistant prepares it; the clinician, the medical director or the owner decides. A draft note is prepared from the clinician’s dictation or a consented recording, in the clinic’s template. The clinician corrects and signs it. Tool: Regaldi Studio.Patient-data gate: signed BAAs and safeguards first.§458.331(1)(m); rule 64B8-9.003; §934.03
- S · The system runs the administrative work; a person at the clinic confirms, approves or sends. Product, concentration, lot, expiration or beyond-use date, the compounding pharmacy or manufacturer, site, amount and date are captured for staff to confirm. Tool: Regaldi Studio.Patient-data gate: signed BAAs and safeguards first.Rule 64B8-9.003(4)
- P · The AI assistant prepares it; the clinician, the medical director or the owner decides. Results arriving by portal or fax are matched to the patient and queued for the clinician, with out-of-range values marked. The clinician interprets and tells the patient. Lab portals open in staff’s own Chrome. Tool: Regaldi Studio.Patient-data gate: signed BAAs and safeguards first.
Prescriptions, pharmacies and supplies
4 · 4 · 0- P · The AI assistant prepares it; the clinician, the medical director or the owner decides. From the signed plan, the order form, patient details and shipping are prepared. The prescriber signs and transmits to the pharmacy the patient chose. Regaldi never chooses or routes to a pharmacy. Tool: Regaldi Studio.Patient-data gate: signed BAAs and safeguards first.§458.331(1)(o); §465.0276(2)(c); §456.42; §817.505
- S · The system runs the administrative work; a person at the clinic confirms, approves or sends. Each order the prescriber sent is followed to shipment and delivery. Delays, substitutions and short beyond-use dates go to staff. Pharmacy portals open in staff’s own Chrome. Tool: Regaldi Studio and Regaldi Legate.Patient-data gate: signed BAAs and safeguards first.
- S · The system runs the administrative work; a person at the clinic confirms, approves or sends. Refill requests are queued for the prescriber with the last visit date, and re-evaluations are booked before they fall due. The system never authorizes a refill. Tool: Regaldi Legate.Patient-data gate: signed BAAs and safeguards first.Rule 64B8-9.012(6)
- P · The AI assistant prepares it; the clinician, the medical director or the owner decides. Messages are routed to the clinician with the history. Words the clinic lists as urgent trigger its emergency instructions at once. The system gives no clinical answer. Tool: Regaldi Legate.Patient-data gate: signed BAAs and safeguards first.§456.0575
- P · The AI assistant prepares it; the clinician, the medical director or the owner decides. Before a controlled-substance prescription, a reminder and the prior-prescription file go to the prescriber or a human designee, who consults E-FORCSE. Receipts and counts are logged. Tool: Regaldi Studio.Patient-data gate: signed BAAs and safeguards first.§893.055(8)
- S · The system runs the administrative work; a person at the clinic confirms, approves or sends. Where the clinic dispenses, the patient gets the written prescription and the any-pharmacy notice, labels follow pharmacy law, and each dispensing is logged. Tool: Regaldi Studio.Patient-data gate: signed BAAs and safeguards first.§465.0276(2)(a)–(c)
- S · The system runs the administrative work; a person at the clinic confirms, approves or sends. Neurotoxins, fillers, IV fluids, vitamins and vials are tracked by lot and expiration or beyond-use date, with refrigerator logs and items to remove flagged. Tool: Regaldi Studio.Rule 64B8-9.003(4)
- P · The AI assistant prepares it; the clinician, the medical director or the owner decides. A suggested order is built from usage and par levels. The owner or medical director approves; patient-specific 503A orders stay separate from 503B office stock. Tool: Regaldi Studio.21 U.S.C. 353a(a)
Follow-up, programs and payments
4 · 2 · 0- S · The system runs the administrative work; a person at the clinic confirms, approves or sends. The clinic’s aftercare sheet and a check-in message go out on its schedule. Any reported symptom goes to the clinician. No promotion in these messages. Tool: Regaldi Herald.Clinic configuration required.Patient-data gate: signed BAAs and safeguards first.47 CFR 64.1200(a)(9)(iv)
- S · The system runs the administrative work; a person at the clinic confirms, approves or sends. Weight, BMI, measurements and photos taken at visits are filed by date and charted for the clinician’s re-evaluation. Tool: Regaldi Studio.Patient-data gate: signed BAAs and safeguards first.Rule 64B8-9.012(6); rule 64B8-9.003
- S · The system runs the administrative work; a person at the clinic confirms, approves or sends. Charges run on the agreed schedule with receipts, and failed payments go to staff. A package sold by phone gets a signed written contract before any charge. Tool: Regaldi Herald.Clinic configuration required.Patient-data gate: signed BAAs and safeguards first.§501.059(6)–(7); §456.062
- P · The AI assistant prepares it; the clinician, the medical director or the owner decides. The history, contract terms and charges are assembled. The owner decides. Tool: Regaldi Legate.§456.062
- P · The AI assistant prepares it; the clinician, the medical director or the owner decides. Complaints are logged with a timeline. Public replies are drafted without confirming that the reviewer is a patient or mentioning care. The owner approves. Tool: Regaldi Legate.§456.057(7)(a); HHS OCR 2022
- S · The system runs the administrative work; a person at the clinic confirms, approves or sends. Requests are logged, identity is checked by staff, and copies are prepared within the deadline for the records owner to release. Tool: Regaldi Studio.Patient-data gate: signed BAAs and safeguards first.45 CFR 164.524(b)(2); §456.057
Compliance, records and staff
3 · 5 · 0- S · The system runs the administrative work; a person at the clinic confirms, approves or sends. Practitioner licenses, DEA registrations, dispensing-practitioner registration, the AHCA clinic license or exemption and device registrations are tracked with renewal dates. Staff verify on the DOH license search. Tool: Regaldi Legate.§400.991; §465.0276(2)(a); §400.9935(1)
- P · The AI assistant prepares it; the clinician, the medical director or the owner decides. Who supervises whom, at which office, under which protocol: notices due within 30 days, the one-extra-office limit for aesthetic offices, the posted physician schedule. The medical director decides. Tool: Regaldi Studio.§458.348(1), (3)(c)–(d); §464.0123
- S · The system runs the administrative work; a person at the clinic confirms, approves or sends. Each person’s license, IV course, laser training and continuing education are on file, and tasks outside scope are flagged before scheduling. Tool: Regaldi Studio.§458.3485; rule 64B9-12.005; §458.348(2)
- P · The AI assistant prepares it; the clinician, the medical director or the owner decides. The posted director sign, referral contracts for review, the periodic billing review and the posted schedule of charges are prepared for the director to sign off. Tool: Regaldi Studio.§400.9935(1)(a), (c), (g), (i)
- P · The AI assistant prepares it; the clinician, the medical director or the owner decides. A timeline and the DOH report are drafted for mailing within 15 days. The clinician tells the patient in person. Tool: Regaldi Studio.Patient-data gate: signed BAAs and safeguards first.§458.351(3); §456.0575(1)
- P · The AI assistant prepares it; the clinician, the medical director or the owner decides. The vendor and BAA register, access logs, notice of privacy practices and risk-analysis inputs are kept current for the privacy officer. Tool: Regaldi Studio.45 CFR 164.504(e), 164.530
- P · The AI assistant prepares it; the clinician, the medical director or the owner decides. If a breach is suspected, the timeline and notice drafts are prepared: HIPAA at most 60 days, Florida 30 days, the FTC rule for non-HIPAA health apps. Counsel and the clinic decide. Tool: Regaldi Studio.45 CFR 164.404(b); §501.171; 16 CFR Part 318
- S · The system runs the administrative work; a person at the clinic confirms, approves or sends. Charts, consents and correspondence are filed with a retention date at least five years from last contact; video and audio ads are kept six months. Tool: Regaldi Studio.Rule 64B8-10.002(2); rule 64B8-11.001(4)
New patients and referral relationships
5 · 2 · 1- S · The system runs the administrative work; a person at the clinic confirms, approves or sends. Primary care, OB/GYN, dermatology, dietitians and physical therapists: introductions, follow-ups and a history per relationship, sent after approval. Nothing of value per referral. Tool: Regaldi Legate.§817.505; §456.054; §458.331(1)(i)
- S · The system runs the administrative work; a person at the clinic confirms, approves or sends. For referred patients: the license-type notice, the patient’s signed choice of practitioner, and the consultation report sent within 10 business days after the physician reviews it. Tool: Regaldi Studio.Patient-data gate: signed BAAs and safeguards first.§458.348(4)
- H · The qualified person performs the act or makes the decision. The system records around it. Only the medical director or owner signs. The system flags per-patient, per-lead or percentage-of-revenue payment terms before signature.§400.9935(1)(c); §817.505(3)(i)
- P · The AI assistant prepares it; the clinician, the medical director or the owner decides. Drafts are checked for the license type of every named practitioner, no superiority or unrecognized-specialty claims, the weight-loss limits, no “FDA-approved”, “generic” or “same as” for compounded drugs, and the 72-hour statement on discounts. The physician approves. Tool: Regaldi Studio.§456.072(1)(t); rule 64B8-11.001; rule 64B8-9.012(8); 21 U.S.C. 352(bb); §456.062
- P · The AI assistant prepares it; the clinician, the medical director or the owner decides. Only real patients with signed authorization, typical results stated or disclosed, any discount or gift disclosed. The owner approves. Tool: Regaldi Studio.Patient-data gate: signed BAAs and safeguards first.45 CFR 164.508(a)(3); §456.057(7)(a); 16 CFR 255.2, 255.5
- S · The system runs the administrative work; a person at the clinic confirms, approves or sends. Messages about the clinic’s own services to patients who agreed, with suppression, a frequency cap and opt-out. Texts and AI calls only with written consent; no third-party-paid messages. Tool: Regaldi Herald.Clinic configuration required.Patient-data gate: signed BAAs and safeguards first.45 CFR 164.501; 47 CFR 64.1200(a)(2); CAN-SPAM; §501.059
- S · The system runs the administrative work; a person at the clinic confirms, approves or sends. People who inquired and did not book get a follow-up by email. Texts or AI calls only with written consent, and “stop” ends contact. Tool: Regaldi Legate.§501.059(5), (8)(a), (10)(c); 47 CFR 64.1200(a)(10)
- S · The system runs the administrative work; a person at the clinic confirms, approves or sends. A short request to patients who agreed to hear from the clinic. Nothing is given for a positive review, and negative reviews are not hidden. Tool: Regaldi Legate.16 CFR 465.4, 465.7; 16 CFR 255.2(d)
Read the whole map as a list
| No. | Process | Who carries it | Tool | What the system does | Rule |
|---|---|---|---|---|---|
| Inquiries and booking | |||||
| 01 | Calls to the front desk | S · System runs it | Herald | A voice assistant answers hours, location, published prices and booking, says it is automated, gives no medical advice and transfers every clinical question to staff. Calls are recorded or transcribed only with every party’s consent. Patient-data gate applies. Clinic configuration required. | §934.03; §458.331(1)(l) |
| 02 | Online inquiries and booking | S · System runs it | Legate | Web forms, email and social messages are logged, answered in the clinic’s words and offered a consultation slot. No health details are asked for in open channels. | 45 CFR 164.530(c); §456.057(7)(a) |
| 03 | Intake forms and history before the visit | S · System runs it | Legate · Studio | Forms, ID, consent packets and outside records are requested, collected and checked for completeness. Missing items go to staff. Patient-data gate applies. | Rule 64B8-9.012(4); rule 64B8-9.003(3) |
| 04 | Price lists, estimates and Good Faith Estimates | S · System runs it | Studio | Estimates are prepared from the clinic’s published schedule, itemized for programs, and issued on time for self-pay patients after a staff check. | 45 CFR 149.610; §400.9935(1)(i); §501.0575 |
| 05 | Confirmations and reminders | S · System runs it | Legate | Appointment confirmations and reminders go to the number the patient gave, name the clinic and carry an opt-out: at most one a day and three a week, with no promotion and no billing. Patient-data gate applies. | 47 CFR 64.1200(a)(9)(iv), (a)(10) |
| 06 | Screening answers flagged for the clinician | P · System prepares it | Studio | Intake answers that bear on safety (pregnancy, thyroid cancer history, kidney or heart disease, current medications, allergies) are listed for the clinician in the patient’s own words. The clinician evaluates. Patient-data gate applies. | Rule 64B8-9.012(4); §458.331(1)(w) |
| 07 | Medical questions from people who inquire | H · Clinician or owner only | Licensed clinician | Whether a person is a candidate, which dose, whether it is safe with a medication: only a licensed clinician answers. The system books the consultation and records that the question was passed on. | Ch. 458, 459, F.S.; §456.072(1)(o) |
| Consultation, consent and treatment | |||||
| 08 | Visit preparation | S · System runs it | Studio | Before each visit, prior notes, labs received, the last re-evaluation date, consents on file and outstanding forms are put on one sheet for the clinician. Patient-data gate applies. | |
| 09 | Evaluation, diagnosis and candidacy | H · Clinician or owner only | Licensed clinician | The system lays out the file. The history, examination, diagnosis and the decision whether to treat are the clinician’s, in person or by telehealth at the same standard of care. | Rule 64B8-9.012(1), (4); §456.47(2)(a) |
| 10 | Informed consent conversation | H · Clinician or owner only | Licensed clinician | Procedure-specific consent forms and the Weight-Loss Consumer Bill of Rights are prepared. The risks-and-benefits conversation and the signature happen with the clinician. | Rule 64B8-9.012(5), (7); §501.0575 |
| 11 | Treatment plan, prescribing and dosing | H · Clinician or owner only | Licensed clinician | Drug, dose, titration, IV formula, units and device settings are the prescriber’s. So is any finding that a compounded drug makes a significant difference for this patient. | §458.331(1)(q); 21 U.S.C. 353a(b)(2) |
| 12 | Procedures and administration | H · Clinician or owner only | Licensed clinician | Injections, IV starts, fillers and laser treatments are done by licensed staff within scope and under the required supervision. The system records who did what. | §458.3485(2)(a)4; rule 64B9-12.005; §458.348(2) |
| 13 | Visit notes from the clinician’s dictation | P · System prepares it | Studio | A draft note is prepared from the clinician’s dictation or a consented recording, in the clinic’s template. The clinician corrects and signs it. Patient-data gate applies. | §458.331(1)(m); rule 64B8-9.003; §934.03 |
| 14 | Administration records for injectables and compounded products | S · System runs it | Studio | Product, concentration, lot, expiration or beyond-use date, the compounding pharmacy or manufacturer, site, amount and date are captured for staff to confirm. Patient-data gate applies. | Rule 64B8-9.003(4) |
| 15 | Lab results routing | P · System prepares it | Studio | Results arriving by portal or fax are matched to the patient and queued for the clinician, with out-of-range values marked. The clinician interprets and tells the patient. Lab portals open in staff’s own Chrome. Patient-data gate applies. | |
| Prescriptions, pharmacies and supplies | |||||
| 16 | Prescription paperwork for the pharmacy | P · System prepares it | Studio | From the signed plan, the order form, patient details and shipping are prepared. The prescriber signs and transmits to the pharmacy the patient chose. Regaldi never chooses or routes to a pharmacy. Patient-data gate applies. | §458.331(1)(o); §465.0276(2)(c); §456.42; §817.505 |
| 17 | Order and shipment status with the pharmacy | S · System runs it | Studio · Legate | Each order the prescriber sent is followed to shipment and delivery. Delays, substitutions and short beyond-use dates go to staff. Pharmacy portals open in staff’s own Chrome. Patient-data gate applies. | |
| 18 | Refill requests and 3-month re-evaluations | S · System runs it | Legate | Refill requests are queued for the prescriber with the last visit date, and re-evaluations are booked before they fall due. The system never authorizes a refill. Patient-data gate applies. | Rule 64B8-9.012(6) |
| 19 | Side-effect and dosing messages from patients | P · System prepares it | Legate | Messages are routed to the clinician with the history. Words the clinic lists as urgent trigger its emergency instructions at once. The system gives no clinical answer. Patient-data gate applies. | §456.0575 |
| 20 | Controlled substances: PDMP check and records | P · System prepares it | Studio | Before a controlled-substance prescription, a reminder and the prior-prescription file go to the prescriber or a human designee, who consults E-FORCSE. Receipts and counts are logged. Patient-data gate applies. | §893.055(8) |
| 21 | In-office dispensing records | S · System runs it | Studio | Where the clinic dispenses, the patient gets the written prescription and the any-pharmacy notice, labels follow pharmacy law, and each dispensing is logged. Patient-data gate applies. | §465.0276(2)(a)–(c) |
| 22 | Inventory, lots, expirations and cold chain | S · System runs it | Studio | Neurotoxins, fillers, IV fluids, vitamins and vials are tracked by lot and expiration or beyond-use date, with refrigerator logs and items to remove flagged. | Rule 64B8-9.003(4) |
| 23 | Purchasing from suppliers and outsourcing facilities | P · System prepares it | Studio | A suggested order is built from usage and par levels. The owner or medical director approves; patient-specific 503A orders stay separate from 503B office stock. | 21 U.S.C. 353a(a) |
| Follow-up, programs and payments | |||||
| 24 | Aftercare instructions and check-ins | S · System runs it | Herald | The clinic’s aftercare sheet and a check-in message go out on its schedule. Any reported symptom goes to the clinician. No promotion in these messages. Patient-data gate applies. Clinic configuration required. | 47 CFR 64.1200(a)(9)(iv) |
| 25 | Program progress records | S · System runs it | Studio | Weight, BMI, measurements and photos taken at visits are filed by date and charted for the clinician’s re-evaluation. Patient-data gate applies. | Rule 64B8-9.012(6); rule 64B8-9.003 |
| 26 | Memberships, packages and payments | S · System runs it | Herald | Charges run on the agreed schedule with receipts, and failed payments go to staff. A package sold by phone gets a signed written contract before any charge. Patient-data gate applies. Clinic configuration required. | §501.059(6)–(7); §456.062 |
| 27 | Refunds, cancellations and disputes | P · System prepares it | Legate | The history, contract terms and charges are assembled. The owner decides. | §456.062 |
| 28 | Complaints and online review replies | P · System prepares it | Legate | Complaints are logged with a timeline. Public replies are drafted without confirming that the reviewer is a patient or mentioning care. The owner approves. | §456.057(7)(a); HHS OCR 2022 |
| 29 | Medical records requests | S · System runs it | Studio | Requests are logged, identity is checked by staff, and copies are prepared within the deadline for the records owner to release. Patient-data gate applies. | 45 CFR 164.524(b)(2); §456.057 |
| Compliance, records and staff | |||||
| 30 | Licenses and registrations | S · System runs it | Legate | Practitioner licenses, DEA registrations, dispensing-practitioner registration, the AHCA clinic license or exemption and device registrations are tracked with renewal dates. Staff verify on the DOH license search. | §400.991; §465.0276(2)(a); §400.9935(1) |
| 31 | Supervision and protocols | P · System prepares it | Studio | Who supervises whom, at which office, under which protocol: notices due within 30 days, the one-extra-office limit for aesthetic offices, the posted physician schedule. The medical director decides. | §458.348(1), (3)(c)–(d); §464.0123 |
| 32 | Staff scope and training records | S · System runs it | Studio | Each person’s license, IV course, laser training and continuing education are on file, and tasks outside scope are flagged before scheduling. | §458.3485; rule 64B9-12.005; §458.348(2) |
| 33 | Medical director file | P · System prepares it | Studio | The posted director sign, referral contracts for review, the periodic billing review and the posted schedule of charges are prepared for the director to sign off. | §400.9935(1)(a), (c), (g), (i) |
| 34 | Adverse incidents | P · System prepares it | Studio | A timeline and the DOH report are drafted for mailing within 15 days. The clinician tells the patient in person. Patient-data gate applies. | §458.351(3); §456.0575(1) |
| 35 | HIPAA privacy and security file | P · System prepares it | Studio | The vendor and BAA register, access logs, notice of privacy practices and risk-analysis inputs are kept current for the privacy officer. | 45 CFR 164.504(e), 164.530 |
| 36 | Breach response | P · System prepares it | Studio | If a breach is suspected, the timeline and notice drafts are prepared: HIPAA at most 60 days, Florida 30 days, the FTC rule for non-HIPAA health apps. Counsel and the clinic decide. | 45 CFR 164.404(b); §501.171; 16 CFR Part 318 |
| 37 | Records retention | S · System runs it | Studio | Charts, consents and correspondence are filed with a retention date at least five years from last contact; video and audio ads are kept six months. | Rule 64B8-10.002(2); rule 64B8-11.001(4) |
| New patients and referral relationships | |||||
| 38 | Referral relationships with practitioners | S · System runs it | Legate | Primary care, OB/GYN, dermatology, dietitians and physical therapists: introductions, follow-ups and a history per relationship, sent after approval. Nothing of value per referral. | §817.505; §456.054; §458.331(1)(i) |
| 39 | Reports back to referring practitioners | S · System runs it | Studio | For referred patients: the license-type notice, the patient’s signed choice of practitioner, and the consultation report sent within 10 business days after the physician reviews it. Patient-data gate applies. | §458.348(4) |
| 40 | Referral and marketing agreements | H · Clinician or owner only | Medical director or owner | Only the medical director or owner signs. The system flags per-patient, per-lead or percentage-of-revenue payment terms before signature. | §400.9935(1)(c); §817.505(3)(i) |
| 41 | Advertising and website review | P · System prepares it | Studio | Drafts are checked for the license type of every named practitioner, no superiority or unrecognized-specialty claims, the weight-loss limits, no “FDA-approved”, “generic” or “same as” for compounded drugs, and the 72-hour statement on discounts. The physician approves. | §456.072(1)(t); rule 64B8-11.001; rule 64B8-9.012(8); 21 U.S.C. 352(bb); §456.062 |
| 42 | Before-and-after photos and testimonials | P · System prepares it | Studio | Only real patients with signed authorization, typical results stated or disclosed, any discount or gift disclosed. The owner approves. Patient-data gate applies. | 45 CFR 164.508(a)(3); §456.057(7)(a); 16 CFR 255.2, 255.5 |
| 43 | Newsletters and offers to current patients | S · System runs it | Herald | Messages about the clinic’s own services to patients who agreed, with suppression, a frequency cap and opt-out. Texts and AI calls only with written consent; no third-party-paid messages. Patient-data gate applies. Clinic configuration required. | 45 CFR 164.501; 47 CFR 64.1200(a)(2); CAN-SPAM; §501.059 |
| 44 | Follow-up with people who asked | S · System runs it | Legate | People who inquired and did not book get a follow-up by email. Texts or AI calls only with written consent, and “stop” ends contact. | §501.059(5), (8)(a), (10)(c); 47 CFR 64.1200(a)(10) |
| 45 | Review requests | S · System runs it | Legate | A short request to patients who agreed to hear from the clinic. Nothing is given for a positive review, and negative reviews are not hidden. | 16 CFR 465.4, 465.7; 16 CFR 255.2(d) |
No medical advice from the AI assistant. No cold patient calls or texts. No paid patient referrals. No prescription routing.
This is a responsibility map for an agreed setup, not 45 delivered integrations. 22 of the 39 run or prepared processes touch patient health information and wait for signed BAAs and safeguards; until then a clinic starts with the other 17, such as price lists, staff and license files, advertising drafts and referral-practice research. Herald workflows need clinic configuration, and approval controls are set before any outgoing action. Left off on purpose: cold calls or texts to people who never contacted the clinic, AI or prerecorded marketing calls or texts without prior express written consent (47 CFR 64.1200(a)(2); §501.059(8)(a)), paying anyone per patient, per lead or as a share of revenue (§817.505), and choosing a pharmacy for a patient (§465.185).
The decision belongs to the person licensed to make it.
Medical advice, evaluation, informed consent, prescribing, dosing and procedures stay with qualified licensed clinicians. Referral and marketing agreements stay with the medical director or owner.
Regaldi LLC is a Florida software company. It does not practice medicine, employ your clinicians, own your medical records, or choose your pharmacies.
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07 Medical questions from people who inquire
Ch. 458 and 459, Fla. Stat.- What the law places with the clinician
- Answering whether a person is a candidate, which drug or dose suits them, or whether a treatment is safe with their medication is the practice of medicine or advanced nursing practice. It belongs to a licensed clinician acting within scope.
- The file work around it
- Whether a person is a candidate, which dose, whether it is safe with a medication: only a licensed clinician answers. The system books the consultation and records that the question was passed on.
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09 Evaluation, diagnosis and candidacy
Rule 64B8-9.012(1), (4); §456.47(2)(a)- What the law places with the clinician
- Before any anti-obesity drug, the rule requires an initial evaluation with history, physical and tests, against BMI or body-fat criteria. Telehealth is held to the same standard of care as an in-person visit.
- The file work around it
- The system lays out the file. The history, examination, diagnosis and the decision whether to treat are the clinician’s, in person or by telehealth at the same standard of care.
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10 Informed consent conversation
Rule 64B8-9.012(5), (7); §501.0575- What the law places with the clinician
- Written informed consent comes before prescribing, and each weight-loss patient receives the Weight-Loss Consumer Bill of Rights. The risks-and-benefits conversation is the clinician’s.
- The file work around it
- Procedure-specific consent forms and the Weight-Loss Consumer Bill of Rights are prepared. The risks-and-benefits conversation and the signature happen with the clinician.
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11 Treatment plan, prescribing and dosing
§458.331(1)(q); 21 U.S.C. 353a(b)(2)- What the law places with the clinician
- Prescribing happens only in the course of professional practice. For a compounded drug that is essentially a copy of a commercial product, the significant difference for an identified patient is determined by the prescribing practitioner.
- The file work around it
- Drug, dose, titration, IV formula, units and device settings are the prescriber’s. So is any finding that a compounded drug makes a significant difference for this patient.
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12 Procedures and administration
§458.3485(2)(a)4; rule 64B9-12.005; §458.348(2)- What the law places with the clinician
- Medical assistants give nonintravenous injections under direct supervision and do not start IVs. LPNs need a 30-hour IV course. Laser hair removal by non-physicians needs direct supervision. Delegating to someone not qualified is a ground for discipline (§458.331(1)(w)).
- The file work around it
- Injections, IV starts, fillers and laser treatments are done by licensed staff within scope and under the required supervision. The system records who did what.
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40 Referral and marketing agreements
§817.505; §400.9935(1)(c)- What the law places with the medical director or owner
- Paying or receiving anything to induce the referral of a patient is a felony for any person in Florida, including split-fee arrangements in any form. A licensed clinic’s medical director reviews referral contracts. The signature belongs to the medical director or owner.
- The file work around it
- Only the medical director or owner signs. The system flags per-patient, per-lead or percentage-of-revenue payment terms before signature.
A software assistant is not a medical assistant or a clinical licensee, and it does not perform or delegate procedures. Licensed nurses administer ordered treatment within their own scope and supervision. Summaries of the Florida Statutes and Board of Medicine rules as fetched on October 13, 2026; read the full texts at leg.state.fl.us and flrules.org. General information, not legal or medical advice.
Measure the work before expanding it.
Use your volumes to estimate administrative workload, then measure one workflow with your team.
≈ hours a week
Modeled administrative workload: hours a week, of the team’s paid hours. The part selected for evaluation is of those hours.
(40 inquiries × 12 min + 150 visits × 8 min + 200 program patients × 30 min × 12 ÷ 52) ÷ 60 = 51.1 hours a week; × 51.1% = 26.1 selected for evaluation
An estimate from the assumptions shown, not a measurement of a clinic or a promised saving. Review and approval take time. Adjust overlapping work and the selected share before using the estimate.
Prepare the introduction. Keep the clinical relationship human.
Organize referring-practice relationships and approved follow-up with people who contacted your clinic.
Find
LegateTrack A · referral relationshipsPrimary care, OB/GYN, dermatology, dietitians and physical therapists near the clinic who see the same patients.
Track B · patients who asked or agreedThe clinic’s own inquiries and current patients who agreed to hear from it. No people lists are built or bought.
Nothing of value per referral (§817.505; §456.054). Lead sources paid per patient or per lead go to counsel first.
Research
Studio · LegateTrack A · referral relationshipsEach practice from public sources: Sunbiz, the DOH license search opened by staff, services offered.
Track B · patients who asked or agreedBefore anything goes out: is the person a current patient who agreed, for which purpose and on which channel.
A business listing or an inbound contact does not prove written consent. HIPAA marketing rules apply to current patients (45 CFR 164.501, 164.508(a)(3)).
Write
Studio · LegateTrack A · referral relationshipsAn introduction and a one-page referral guide, sent from the clinic’s mailbox after approval.
Track B · patients who asked or agreedWebsite, education and permitted service messages: license type on every name, no result promises, no “FDA-approved” or “same as” wording for compounded drugs.
The physician approves and remains responsible for advertising (rule 64B8-11.001(5); rule 64B8-9.012(8)). CAN-SPAM for email.
Call
Legate · Herald, configuredTrack A · referral relationshipsCalls arranged with practices that agreed to be called. The assistant says it is automated and books time with the clinic’s lead.
Track B · patients who asked or agreedCalls only to people who asked for one, to book and collect non-clinical details. Medical questions go to a clinician.
AI marketing calls and marketing texts need prior express written consent (47 CFR 64.1200(a)(2); FCC 24-17; §501.059(8)(a)). No cold calls. Recording only with every party’s consent.
Follow up
Legate · StudioTrack A · referral relationshipsEvery reply and referral in the relationship history; the report back to the referring practitioner after clinical review.
Track B · patients who asked or agreedHealth questions routed to a clinician. Opt-outs honored at once and kept.
Reports within 10 business days where they apply (§458.348(4)). Revocation by any reasonable means stops contact.
Present
StudioTrack A · referral relationshipsA factual service guide for referring practitioners: what the clinic treats, its criteria, how it reports back.
Track B · patients who asked or agreedPatient education with the material risks stated. Before-and-after material only with authorization and typical results disclosed.
No invented testimonials, outcome promises or misleading photos (16 CFR 255.2, 255.5).
Close
Licensed clinicianTrack A · referral relationshipsThe referral is recorded and thanked without anything of value.
Track B · patients who asked or agreedThe clinician evaluates, holds the consent conversation and decides treatment.
A fixed fee for Regaldi: nothing per patient, booking, treatment or prescription, and no share of revenue.
Fitness studios and employers can be professional relationships, but receive nothing for patient referrals. There is no clinic case study behind this section and no patient-acquisition figure to publish; this is the method.
- Healthcare reminders
Only where the healthcare exemption applies to a covered clinic and the message: the number the patient supplied, the clinic named, free to the recipient, an opt-out in each message, at most one a day and three a week, and no advertising, promotion, billing or debt collection. 47 CFR 64.1200(a)(9)(iv)
- Marketing calls and texts
Marketing texts and AI or prerecorded marketing calls need prior express written consent. An existing patient relationship, an inbound call or a text does not take its place. No cold calls or texts to people who never contacted the clinic. §501.059(8)(a)
- Opt-outs
Revocation by any reasonable means is honored at once as policy, inside the federal 10 business days and the Florida 15 days for a STOP reply. Callers give their true name and the clinic’s; “do not call me” ends calls. §501.059(5), (10)(c)
- No pressure, signed packages
No pressure for an immediate answer (§458.331(1)(l)). A package sold by phone is charged only after a signed written contract (§501.059(6)–(7)). §458.331
- No paid patients
No one is paid per patient, per lead or as a share of revenue for a referral: not a gym, a salon, an influencer or Regaldi. This applies to every person in Florida. §817.505
- Recording
A call is recorded or transcribed only with the consent of every party. Transcripts are part of the patient record. §934.03
Your patients choose their pharmacy.
Regaldi never routes a clinic’s prescriptions to any pharmacy and receives nothing from pharmacies in connection with them.
We charge a fixed fee for software and services. No fee per lead, patient, booking, treatment or prescription. No share of clinic revenue. We do not buy referrals, recommend a pharmacy to a patient, or introduce a clinic to a pharmacy for compensation. Clinic and pharmacy data stay separate.
The prescriber signs and transmits to the pharmacy the patient chooses. Studio may prepare the paperwork from the signed plan, and staff may track an order already sent; neither lets Regaldi select a recipient or transmit a prescription. This is written plainly because Herald also serves a pharmacy.
Patient Brokering Act §817.505 · kickbacks §456.054 · split fees §458.331(1)(i) · pharmacy rebates §465.185 · the federal Anti-Kickback Statute where federal health care program business is involved. A fixed fee is not a legal safe harbor by itself; it reflects the services actually provided.
Prepare clear copy. Keep the claims supportable.
Studio prepares advertising drafts and flags issues for the physician’s review. Nothing is published without approval.
- The physician approves
The physician approves and remains responsible for advertising, including advertising placed through an agent. Each named practitioner is identified with their license type. No invented specialties, superiority or expectations of beneficial results. §456.072(1)(t); rule 64B8-11.001
- Weight-loss limits
No specific, rapid, dramatic, effortless or certain weight-loss results; no “safe weight loss” claim and no suggestion that diet or exercise is unnecessary. Rule 64B8-9.012(8)
- Compounded drugs
Compounded drugs are not FDA approved. A draft never describes a compounded preparation as FDA approved, generic, the same as a brand, containing the same active ingredient as a brand, or clinically proven, and never puts a brand name beside it. The prescriber makes the patient-specific clinical determination. 21 U.S.C. 352(bb)
- Free or discounted offers
An offer of free or discounted services carries the capitalized 72-hour statement the statute requires. This page makes no such offer. §456.062
- Testimonials and photos
Real patients only, with written authorization, typical results stated or disclosed, and material connections disclosed. Marketing uses of health information need a HIPAA authorization, separate from telephone consent. 16 CFR 255; 45 CFR 164.508(a)(3)
- Reviews and replies
No fabricated reviews, no reward tied to positive sentiment, no suppression of negative reviews, and no public reply that confirms someone is a patient or mentions their care. 16 CFR 465.4, 465.7
- Checked Named practitioners Each name carries its license type: MD, DO, PA, APRN or RN.
- Checked Service description Factual. No superiority claim and no unrecognized specialty.
- Flagged Weight-loss wording “Rapid results” flagged under rule 64B8-9.012(8).
- Checked Compounded products No brand name beside a compounded product; no “FDA-approved”, “generic” or “same as”.
- Checked Patient material No patient photo or testimonial without written authorization.
- Checked Offer disclosures No discount in this draft, so no 72-hour statement is needed.
Set the terms before patient work begins.
Patient health information is excluded until the applicable Business Associate Agreements and required safeguards are in place. A signed agreement is one condition: patient-data workflows remain excluded until applicable agreements, access controls, safeguards and operating procedures are reviewed and accepted.
- Your computerThe clinic folderstays here
- Regaldi’s serverPasses the task textstores conversation memory and uploaded attachments
- AI providerAnthropic or OpenAIprocesses the text used for a task
Before setup, agree permitted data, account access, retention, deletion, and the people responsible for review. AI output can be wrong. Check sources, records and recipients before relying on the work.
Who approves what
Which actions wait for approval, and who approves them, is agreed in writing with the clinic before any account is connected. The assistant never authorizes a refill, transmits a prescription or gives a clinical answer.
- Signed agreements
- Patient health information is used only under signed Business Associate Agreements and the required safeguards, including the relevant service-provider arrangements. Until then, the work excludes patient information.
- Approval setup
- Before patient messages, portal submissions or payment actions are enabled for a clinic, Studio’s “Act without asking” mode is locked off and each approval path is tested with the clinic.
- Who is covered
- The clinic remains the covered entity, or, where HIPAA does not apply, the records owner under §456.057. Florida confidentiality, FIPA (§501.171) and the FTC Health Breach Notification Rule can apply without HIPAA. Cash-pay status alone settles none of this.
- AI says so
- The AI assistant identifies itself on calls and in messages and passes clinical questions to your staff. This is Regaldi policy; Florida has no clinic AI statute.
- Tracking
- No advertising pixels on booking or intake pages without counsel.
- Claims not made
- No HIPAA certification, no “HIPAA-compliant software”, no SOC 2 or ISO, no zero data retention, and no local-only processing claim.
Business associate contracts 45 CFR 164.504(e), marketing authorizations 45 CFR 164.508 and §501.171 in full.
Keep the clinical rules attached to the work.
Every workflow names the licensed decision, the source and the record the clinic keeps. Florida has no statute specific to med spas or IV hydration; the practice acts, the Board rules and the Health Care Clinic Act govern.
License and scope§458.3485; rule 64B9-12.005
Diagnosis and prescribing remain with authorized clinicians. Medical assistants do not start IVs; their nonintravenous injections need physician supervision. RNs administer prescribed or authorized medication; LPN IV work needs direction and the 30-hour course. Non-physician laser hair removal needs direct supervision. No software delegation of these acts. Read the text
Protocols and office supervision§458.348(1), (3)(c)–(d)
APRN autonomous practice is limited to primary care; aesthetic and weight-loss APRNs work under a physician protocol filed within 30 days. A supervising physician at a primarily aesthetic office is board certified or eligible in dermatology or plastic surgery, stays within 25 miles or a contiguous county no more than 75 miles away, supervises one such office besides the primary location, and posts a schedule. The medical director decides staffing and scope. Read the text
Weight-loss careRule 64B8-9.012; §501.0575
Clinicians apply the BMI or body-fat criteria, take a history, examine and test, obtain written informed consent before prescribing, re-evaluate at least every three months, and give the Weight-Loss Consumer Bill of Rights with itemized program prices. Software tracks completeness and dates only. Read the text
Compounding and supply21 U.S.C. 353a
503A compounding is for an identified patient on a valid prescription and stays distinct from 503B office stock. Essentially-copy limits and any significant-difference finding stay with the prescriber. Semaglutide salts are not the same active ingredient, and expired shortage-period policies are not current permission. In-office admixture and compounding need counsel and clinical review. Read the text
Prescribing, dispensing and PDMP§893.055(8); §465.0276
No e-prescribing or E-FORCSE connection. The prescriber or a human designee consults E-FORCSE for controlled-substance prescriptions for patients 16 or older. In-office dispensing for a fee needs registration, lawful labels and records, and a notice that the prescription may be filled at any pharmacy. Read the text
Clinic license and medical director§400.9905; §400.9935
An AHCA clinic license or exemption depends on the entity and its activities; whether a cash-only clinic needs one is a question for counsel, and ownership changes can end an exemption. A licensed clinic’s medical director accepts in writing the duties for license checks, referral-contract review, records, billing review and the posted schedule of charges. Read the text
Clinical recordsRule 64B8-9.003; rule 64B8-10.002
Records justify the course of treatment, and the clinician corrects and signs draft notes. For compounded products given in the office: name, concentration, lot, expiration, the pharmacy or manufacturer, site, amount and date. Records are kept at least five years from last contact; electronic-media ads six months. These are clinic duties, not a promise of Regaldi server retention. Read the text
Access and incidents45 CFR 164.524; §458.351(3)
Staff verify identity and the records owner releases copies; HIPAA access requests are answered within 30 days. Office adverse incidents go to DOH by certified mail within 15 days, and the practitioner tells the patient in person about serious harm. Read the text
Privacy and breaches45 CFR 164.404; §501.171
Breach timelines are drafted for counsel: HIPAA without unreasonable delay and at most 60 days; FIPA notice to individuals within 30 days, the Department of Legal Affairs at 500 or more Floridians, and a vendor’s notice to the clinic within 10 days. The FTC rule applies where a non-HIPAA health record app is involved. Read the text
Estimates and consumer terms45 CFR 149.610
Good Faith Estimates for self-pay patients within one business day when scheduled at least three business days ahead, and three business days when scheduled ten days ahead or on request. Counsel decides whether purely cosmetic services are in scope. Read the text
Referrals and conflicts§458.348(4); §456.052
On an initial referral the patient is told the license types and chooses on a signed form, and a report goes back within 10 business days. Investment-interest disclosures name two alternative sources where required. No split fees, kickbacks, paid patients or pharmacy steering. Read the text
AI and telehealth§456.47
Telehealth is held to the in-person standard of care, out-of-state practitioners register, and Schedule II is not prescribed by telehealth outside the listed cases. The assistant provides neither the evaluation nor the prescription. Read the text
Start with one workflow.
Choose the work, define the permissions, and review the result with your team.
- 01
Scope
One recurring process, a named reviewer, the permitted data, a baseline measured with your team and the fixed-fee scope, agreed in writing.
- 02
Configure
The agreed tools, access, review steps and channel permissions, with the patient-data safeguards where the workflow needs them.
- 03
Evaluate
Actual work reviewed for accuracy, correction effort, completion and approvals before anything is expanded.
A fixed fee for the agreed software and service scope. Nothing per lead, patient, booking, treatment or prescription, and no share of clinic revenue (§817.505; §458.331(1)(i)).
Before patient-data and approval controls are ready, a clinic starts with work that holds no patient information: a general service guide, a staff-license checklist or an advertising draft. Clinical responsibility never moves to software. Studio, Legate and Herald are scoped in writing; Regaldi reports what it observes and its limits and does not promise results.
Prices: regaldi.ai/pricing/
Tell us where the work collects.
Describe one administrative process your clinic wants to improve: the clinic, your role, team size and the workflow. A principal reads every inquiry and writes back by email. This form asks for a business discussion with Regaldi; it is not consent to marketing calls.
Do not send patient information, medical records, account credentials, or documents containing health details.
Do not include patient information, client files or passwords. Sending this does not purchase a service. Your message is relayed to office@regaldi.ai through FormSubmit; our Privacy Policy applies.
Regaldi LLC is a Florida software company and provides software and services, not medical care. It does not practice medicine, employ the clinic’s clinicians, own its records or choose its pharmacies. General information, not legal or medical advice. Each clinic remains responsible for its own compliance, including licensing, supervision, advertising, consent for calls and texts, privacy and records. The rule summaries on this page are simplified; read the full texts linked here. AI output can be inaccurate and must be reviewed by a qualified person before it is relied on.