Our Wellness Position Email Us

BodySleepMind is a wellness ecosystem designed to help users understand and improve the body, sleep, and mind — with intelligence, compassion, and choice.

In one line: We combine questionnaires, user-reported lab information, accredited wellness technologies, AI food intelligence, day-planning tools, and Body–Sleep–Mind platforms into a single Wellness Report that can be shared with medical professionals.

What We Do

The platform facilitates a clear, holistic picture of wellness and provides practical, personalised ways to act on it.

We provide a Wellness Questionnaire that highlights body, sleep, and mind risk patterns.
We allow for the verification of questionnaire-based risks using user-selected tests or monitors.
We provide “Verified” badges for items confirmed by external data.
We use answers and badges to personalise food, activity, sleep, and mind/anxiety wellness support.
We point users toward accredited third-party wellness blood packages and testing services.
We allow for the manual entry of lab results and associated risk statements provided by those labs.
We support biome, skin-microbiome, and DNA-based wellness insights from accredited partners.
We use all user-reported information to build a living Wellness Report.
We encourage sharing the Wellness Report with a doctor for professional guidance.

The Body, Sleep & Mind Platforms

The ecosystem includes several specialized intelligence layers:

Wholefood Intelligence — nutrients, intolerances, dietary conformities, recipes, and meal planners.
AI Food Analysis — supermarket, restaurant, and takeaway foods analysed for wellness alignment.
Activity Intelligence — EAT/NEAT activities, MET ratings, and personalised movement planning.
Sleep Intelligence — CBT-I tools, sleep-anxiety support, OSA and circadian pattern insights, and therapy libraries.
Mind & Stress Intelligence — neuro-analysis, anxiety/stress profiling, and personalised mind-wellness planning.
Day Plans & Scheduler — tools to build and track daily wellness routines.
Wellness Channel — educational media, soundscapes, and wellness breakthroughs.
Host for Approved Wellness Technologies — providing access to emerging accredited wellness tools.

Wellness Insights (Scope)

Based on questionnaires and user-reported information, the platform provide wellness insights for:

Insomnia risk, OSA risk, Circadian rhythm issues, Lactose sensitivity, IBS patterns, SIBO-like symptoms, Gluten sensitivity patterns, Anxiety patterns, Stress patterns, BMI & body-fat wellness

These are wellness insights, not medical diagnoses.

Regulatory Boundaries

To stay aligned with regulatory expectations, we do not:

Interpret blood glucose.
Interpret cholesterol.
Interpret CRP, hormones, or antibodies.
Diagnose IBS, SIBO, OSA, celiac disease, or anxiety disorders.
Predict disease using biomarkers.
Provide medical treatment plans.

We react to user-reported statements (including lab-stated risks) within a wellness context only.

Partner Technologies

We integrate accredited partner technologies that sit fully within the wellness domain, such as gut biome tests, skin-microbiome analysis, and DNA-based wellness insights. These provide lifestyle insights, not diagnoses.

Why ChatGPT/Claude/etc can say “your health risks are…” :

1. *They claim “general info only”* => OpenAI’s terms: “Not medical advice. For informational purposes”. FDA currently treats big LLMs as “general info tools”, not medical devices, because they don’t market themselves for diagnosis.

BSM Position: We do not market ourselves or for that matter consider ourselves as a firm that does any diagnosis. We accept diagnosis is for the medical experts.

2. *FDA enforcement focus => FDA 2022 CDS guidance + 2024 AI draft guidance both say they’re prioritizing “high risk” devices. A general chatbot answering “what could cause chest pain” is low on their list vs an app that says “You have OSA, buy this CPAP”.

BSM Position: We don’t recommend anything deemed to be a medical solution – for anything

3. *No Doctor gate, but also no promise* => ChatGPT won’t say “I diagnose you”. It says “possible causes include… consult a doctor”. That wording keeps it in “educational” lane.

BSM Position: We don’t just say consult a doctor. We go much further. We provide the mechanism to help users consult a doctor at a click of a button together with all of the user data from our site so doctors have the complete picture. That’s good for the doctor and good for the patient.

FDA looks at 3 things: *Intended use + Marketing + Workflow*

FDA says: If you build a structured questionnaire for disease X and output risk for disease X, that’s SaMD. If user types random symptoms into ChatGPT, FDA calls that “patient-initiated inquiry”.

BSM Position: We ask a wide range of questions about a patient’s symptoms. We compare the answers to a wide range of wellness issues and give users an insight into the possible risks so users can prioritise medical advice and further tests. And so we can personalise our food, activity, sleep and mind plans. We are not disease focused.

KEY POSITION

Unlike any AI or large organisation that sell devices or medical services led by a disease focused Q and A [eg a CPAP seller asking patients OSA specific questions. Or Boots offering patients disease risk analysis based on AI imaging with no doctor intervention]. we are far closer to regulatory philosophy because we construct the entire package to send to doctors and we point users at accredited third party verification tests so the doctor is even better informed. This can only help time and cost constrained doctors. And we go one step further we give the patient curate wellness tools focused on what they tell us. See how that beats the approved GPT methods whilst staying even closer in line with regulators patient safety objectives

For info: Chat GPT Position:
1. *Free text only, no scoring*: User types “I snore + tired”. AI lists “causes of fatigue: poor sleep, anemia, thyroid…”. No STOP-Bang, no 0-28 score.
2. *No disease-specific flow*: Don’t brand as “OSA screener”. Brand as “general wellness chat”.
3. *Strong disclaimers*: “I’m not a doctor. This is general info…”
Problem: Doctor wants structured eg STOP-Bang PDF, not ChatGPT transcript. And the tech CAN do it safely-safer if the doctor gateway is proactive .

BSM Position: Our goal is to meet the user-doctor need whilst keeping users safe and ensuring we stay with regulatory guidelines through the two step doctor intervention.

The Pharmaceutical / Device Sales Firms:
Example: How CPAP companies stay on the right side of the regulatory line using our 2 step process that FDA accepts:

*Step 1: Patient- “education +disease focused questionnaire. eg
a.Do you snore?
b.Wake up tired?
c.Have you been told you stop breathing?
You may be at risk for sleep apnea. Take this 8-question screener. Talk to your doctor about a sleep study.

STEP1 : Process features the following regulatory comfort factor:
1. “May be at risk” = not diagnosis
2. “Talk to your doctor” = HCP gate
3. “Sleep study” = test, not treatment
An online example http://SleepTest.com,

*STEP 2 : Doctor-facing =
Doctor does the diagnosis and the prescription
Doctor reviews questionnaire -> orders home sleep test -> confirms OSA → CPAP
As opposed to ->
1. You have sleep apnea”* → That’s diagnosis without HCP-> Warning letter.
2. Buy CPAP now, no doctor needed”* → FDA will shut site fast.

BSM Position: Is to exactly follow that process. To ask the questions but NEVER diagnose a disease nor prescribe medical solution. Offer personalised wellness support.
.Snore? Tired? Questionnaire to see if user should talk to doctor
.App: “Score 6/8 on STOP-Bang questionnaire->Upper range of scale. Share with doctor
.Doctor-> Reviews ->orders test -> prescribe
. BSM offer food, activity plan to reduce weight and educate user why weight is a common airway issue
*Bottom line: CPAP sellers are absolutely regulated. They just never let the website/app make the diagnosis. Diagnosis always happens with doctor + test. That’s been approved.,

BSM Position-our steps are compliant by design and intent
1. Questions*: Patient-entered STOP-Bang / ISI / symptom checklist
2. Risk*: “Score 6/8. This is toward upper range of 0-8 scale” + shareable PDF for doctor
3. Action: “Discuss with healthcare provider if a sleep study fits your needs”

No diagnosis. No treatment. Just: “Here are your answers → Here’s where it sits on scale → Here’s what doctors usually do next” AND HERE IS WHAT YOU CAN DO FROM A WELLNESS PERSPECTIVE.

So doctors get the structured data they want. Patients get clarity. Regulators see a bonafida HCP gate. FDA doesn’t regulate “helping patients prepare for doctor visits”. They regulate “software that diagnoses/treats”.

BSM Position: Our flow stops at the doctor’s door. Doctor makes all medical decisions. CPAP sellers, Boots, WebMD symptom checker — all use this exact bridge. Advice is we can:
1. Build the questionnaire,
2. show the score + scale,
3. add “talk to doctor about next steps”.
4. That’s wellness + admin CDS, not medical device.
5. Offer wellness support (food, activities…)

Regulators 100% prefer “help fix it” over “suspend which is their last resort.

BSM Position: Embrace the regulator in early days. Explain our workflow. Modify wording as required. Create a specific regulator interface/email for this purpose.

How FDA/MHRA actually work with startups:

**Regulator** **“Help first” program** **What it does**
**FDA** Q-Sub / Pre-Sub meeting Free 60-min meeting. You show your app flow + wording. FDA tells you: “This is CDS” or “This needs 510(k)”. Costs $0 for small companies.
**MHRA** Innovation Service / AI Airlock UK’s “regulatory sandbox”. You describe your AI + they give informal guidance on UK MDR rules.
**EU** Notified Body consultation Before CE Mark, you can pay NB for gap analysis. They’ll say “add this disclaimer, remove this claim”

The Regulatory Process

1. *Step 1: Warning letter / email* => Your app says ‘you have OSA’. Remove disease claim + add HCP gate. You have 15 days to respond.” 90% of cases stop here after you fix wording.

2. *Step 2: Untitled letter / meeting* => Come talk to us. Show us your changes.” Still no suspension.

3. *Step 3: Suspension / import ban* => Only if: You ignored warnings + patients were harmed + you’re selling prescription device with no doctor. => Lots of startups are doing exactly this and betting FDA won’t act yet. 3 outcomes:

*FDA sends warning letter* → They reword to “general info” + add disclaimers

*They get 510(k)* → Like IDx-DR did for diabetic retinopathy AI

*They stay under radar* → Low user count, no complaints, no FDA action yet

BSM Position: To work with regulators particularly in the early days

FDA Position:

1. *Digital Health Center of Excellence*: FDA created a whole team in 2020 just to help startups, not police them.
2. *Pre-Cert pilot*: They know software updates fast. Prefer to coach than chase.
3. *Patient access*: They do not want patients to lose new tools. So they draw lines instead.

CPAP companies, Boots, even ChatGPT got “feedback” before any enforcement. Companies who ask early almost never have a serious problem.

BSM Position: Want me to pull FDA’s Q-Sub request template so you can see how easy it is to get their opinion in writing?

MHRA Position

is one of the most startup-friendly regulators right now. They way rather chat than suspend. MHRA’s “help first” programs is designed with that philosophy:

1. MHRA Innovation Service* => This is MHRA’s front door for startups. Free 1-hour call + written feedback.

Send them: 3-step flow “Questions → Risk score → Talk to doctor-> WELLNESS focused support apps”

Cost: £0 for initial advice. Link: http://gov.uk/guidance/mhra-innovation-service

Turnaround: ∼20 working days for written advice.

*2. AI/Airlock Regulatory Sandbox* => MHRA + NHS + NICE run this together. You test your AI with real regulators watching.

Goal: Prove your app is safe + compliant before launch. If issues pop up, they tell you how to fix vs just banning it.

Perfect for our “Questions → Risk → See doctor” flow.

Their vibe: Pro-innovation, but patients must be safe. Must show HCP gate + no diagnosis. What to send them to get clarity fast:
1.Flowchart of patient journey
2. Screenshots of patient result screen with exact wording
3. Screenshots of PDF you send to doctor
4. Your intended use statement: “To help patients prepare structured info for healthcare professional review”

BSM Position: Pre Roll Out Action: Book Innovation Service. mhra.innovation@mhra.gov.uk

Competition Analysis

Company	Revenue (approx)	Source	Product / service	Why not regulated
ZOE	£70–90m	UK	Microbiome and food-response wellness programme with personalised nutrition guidance.	Positions outputs as nutrition and lifestyle wellness insights, not diagnosis or treatment.
Thriva	£10–15m	UK	At-home blood tests with lifestyle-oriented commentary on vitamins, hormones and wellness markers.	Reports are framed as wellness information and lifestyle guidance, not clinical interpretation or care.
Headspace	£150–200m	USA	Meditation, CBT-style exercises and sleep/stress content for mental wellbeing.	Delivers self-help content and behavioural tools, not mental-health diagnosis or therapy.
Calm	£150–200m	USA	Mindfulness, sleep stories and relaxation content for emotional wellness.	Provides media and self-guided practices, not clinical assessment or treatment.
Noom	£300–400m	USA	Behaviour-change and nutrition-coaching app focused on habits, weight and lifestyle.	Operates as lifestyle coaching and education, not medical weight-management or prescribing.
MyFitnessPal	£150–200m	USA	Food logging, calorie and macro tracking with basic activity integration.	Offers tracking and general wellness advice, not medical nutrition therapy or diagnosis.
Lifesum	£40–60m	Sweden	Diet and lifestyle app with meal plans, food scoring and habit tracking.	Frames outputs as dietary wellness guidance, not clinical dietetics or disease management.
InsideTracker	£20–30m	USA	User-entered or partner-lab blood data turned into lifestyle and performance suggestions.	Interprets markers only for wellness and performance, explicitly not for medical diagnosis.
Levels	£15–25m	USA	Metabolic-wellness platform using glucose trends to inform lifestyle choices.	Positions insights as metabolic wellness education, not diabetes care or clinical monitoring.
DayTwo	£10–15m	Israel / USA	Microbiome-based food recommendations and glycaemic-response wellness guidance.	Provides food and lifestyle suggestions, not diagnostic use of microbiome data.
Viome	£40–60m	USA	Microbiome and cellular-wellness analysis with supplement and diet suggestions.	Markets results as wellness and longevity insights, not clinical laboratory reporting.
Thorne	£150–200m	USA	Supplements and wellness-focused tests (vitamins, minerals, microbiome).	Positions testing and reports as consumer wellness information, not medical diagnostics.
Hinge Health	£200–250m	USA	Digital musculoskeletal & movement‑wellness coaching platform.	Provides exercise guidance & behavioural support, not clinical physiotherapy or diagnosis.
BetterHelp	£800m–£1bn	USA	Online mental‑wellness counselling marketplace.	Acts as a platform connecting users to independent counsellors; not a regulated medical provider.
Happify	£20–30m	USA	Digital emotional‑wellbeing & resilience training programmes.	Delivers behavioural exercises & self‑help content, not clinical mental‑health treatment.
Rise Science	£10–20m	USA	Sleep‑wellness app focused on circadian rhythm coaching.	Provides behavioural sleep guidance, not sleep‑medicine diagnostics.
Welltory	£20–30m	USA	Stress, HRV & lifestyle‑wellness analytics app.	Interprets trends for wellness only; does not diagnose cardiovascular or stress disorders.
Holly Health	£2–4m	UK	Digital habit‑change and lifestyle‑wellness coaching app.	Provides behavioural nudges and wellbeing guidance, not clinical treatment or diagnosis.
Manual (Hims & Hers UK)	£20–30m (UK segment)	UK	Men’s wellbeing platform offering lifestyle programmes, supplements and self‑guided health tools.	Operates as a wellness & lifestyle service; medical services are outsourced to independent clinicians.
SelfDecode (UK market)	£10–15m	UK/USA	DNA‑based lifestyle‑wellness insights and personalised nutrition recommendations.	Provides genomics‑based wellness suggestions, not medical genetic interpretation.
Lifesum	£40–60m	Sweden	Diet, calorie tracking, food scoring and lifestyle‑wellness app.	Provides general wellness guidance and tracking, not clinical nutrition or diagnosis.
Cronometer	£15–25m	Canada	Advanced calorie, macro and micronutrient tracking for wellness users.	Offers nutrition data and logging only, not medical nutrition therapy.
Lose It!	£40–50m	USA	Calorie and macro tracking app with weight‑loss habit tools.	Operates as lifestyle coaching and tracking, not regulated weight‑management.
Yazio	£30–40m	Germany	Food logging, calorie tracking and personalised meal plans.	Provides wellness meal planning, not clinical dietetics.
Nutracheck	£10–15m	UK	UK‑focused calorie and food‑tracking app with barcode scanning.	Tracks food intake for wellness, not medical nutrition assessment.
Simple	£20–30m	USA	Fasting‑focused calorie tracking and habit‑change app.	Provides lifestyle fasting guidance, not clinical metabolic care.
FatSecret	£10–20m	Australia	Global calorie‑tracking and food diary platform.	Offers general wellness tracking, not regulated nutrition services.
Carb Manager	£20–30m	USA	Low‑carb and keto‑focused food and macro tracking.	Provides dietary‑wellness tools, not medical carbohydrate management.
Fooducate	£5–10m	USA	Food scoring, calorie tracking and nutrition‑wellness education.	Scores foods for wellness purposes, not clinical nutrition evaluation.
Eat This Much	£5–10m	USA	Automated meal‑planning and calorie‑targeting app.	Generates meal plans for wellness, not medical diet prescriptions.

Regulatory Alignment

We respect the purpose of regulators: protecting the public from unsafe or misleading products. Our model aligns with that purpose by:

Operating strictly as a wellness platform.
Using user-reported information only.
Providing wellness-oriented guidance only.
Encouraging doctor involvement at every stage.
Working with accredited partners for wellness testing.

Our intent is to remain aligned with international regulatory frameworks. If any aspect of our service needs closer alignment, we invite contact via the form below.