Medical Compliance

Lina is a wellness companion app designed specifically for women on GLP-1 medications. We support adherence, track what matters clinically, and never make claims we can't back. Lina is built to support GLP-1 patients, not replace guidance.

SECTION 1: What Lina is and Isn't

Lina is classified as an educational wellness companion — not a medical device, diagnostic tool, or treatment program.

We don't:

- Provide medication recommendations or dosing guidance

- Diagnose or treat any medical condition

- Replace the relationship between patient and provider

- Make unsubstantiated health claims

We do:

- Help patients track behaviors that support GLP-1 success (protein intake, hydration, side effects)
- Provide psychographically-informed emotional support that reduces shame and increases adherence
- Deliver educational content reviewed for regulatory compliance (UK GDPR, MHRA, FDA wellness app guidelines)
- Create accountability through daily check-ins and streak systems Every feature is designed to complement — never contradict — your clinical guidance.

SECTION 2: Why adherence matters

The Gap Between Prescription and Persistence

GLP-1 medications are remarkably effective when patients stay on them. But adherence is complex:
- 66% of women in our research reported shame about using weight loss medication
- Many hide their GLP-1 use from friends and family, increasing isolation
- Side effects in the first 4-6 weeks cause significant dropout
- Fear of weight regain creates anxiety that undermines confidence

Lina addresses the emotional and behavioral dimensions of the GLP-1 journey that clinical visits can't always reach. We meet patients where they are — every day, between appointments.

SECTION 3: Evidence based calculations

Personalized Goals Grounded in Research

Lina's nutritional calculations use established clinical formulas with appropriate safety guardrails. Here's how we approach each:

3.1 Protein Goals

Protein Tracking Based on Current Body Weight

Muscle preservation during GLP-1-induced weight loss is critical. Lina calculates protein goals using:

-Formula: 1.2g protein per kg of current body weight

- This multiplier sits in the middle of the 1.0-1.6g/kg range recommended for muscle preservation during weight loss

- Goals automatically adjust as users log new weights

Safety guardrails:

- Minimum: 50g/day (absolute floor for any adult)

- Maximum: 120g/day (practical ceiling accounting for GLP-1 appetite suppression)

References:

- Phillips SM, et al. "Protein requirements for muscle preservation." Am J Clin Nutr. 2016

- Westerterp-Plantenga MS, et al. "Dietary protein and weight management." Annu Rev Nutr. 2009;29:21-41

3.2 Calorie Goals

Calorie Calculations Using Mifflin-St Jeor

For users who opt into calorie tracking, Lina calculates goals using the Mifflin-St Jeor equation — the gold standard for estimating BMR. Formula: BMR = (10 × weight in kg) + (6.25 × height in cm) - (5 × age) - 161 (for women) TDEE = BMR × activity multiplier Goal = TDEE - 500 kcal (moderate deficit for ~0.5kg/week loss)

Activity multipliers (Harris-Benedict revised):

- Sedentary (1.2)

- Lightly active (1.375)

- Moderately active (1.55)

- Very active (1.725) Safety guardrails:

- Minimum: 1,200 kcal/day (standard minimum for women without medical supervision)

- Maximum: 2,500 kcal/day (ceiling to flag calculation anomalies)

Note: We explicitly acknowledge that GLP-1 medications already reduce appetite, so a moderate deficit is appropriate. Users are never pushed toward extreme restriction.

3.3 BMI with Ethnicity-Adjusted Thresholds

BMI Calculations That Account for Population Differences


Standard BMI cutoffs were developed primarily using White European populations and don't reflect equivalent cardiometabolic risk across ethnicities.

Lina uses research-based ethnicity-specific thresholds. Thresholds (based on equivalent T2DM risk to BMI 30 in White populations).

Reference: Lancet Diabetes & Endocrinology, 2021

Users self-select ethnicity during onboarding. This is optional, and we explain why it matters: "BMI thresholds vary by ethnicity for accurate health assessment."

All BMI displays include a disclaimer: "Lina is not medical advice. Always consult your healthcare provider for personalized guidance."

SECTION 4: Health score and AI Food Insights

Helping Patients Understand Their Food Choices

Lina's AI-powered meal analysis provides a "Health Score" (0-100) for logged meals. This score helps users understand the nutritional quality of their food without moral judgment.

How it works:

- Users photograph or describe their meal
- AI estimates nutritional content using USDA standard reference values
- A health score is calculated based on:
- Protein and fiber content (positive factors)
- Sugar and sodium (limiting factors)
- Whole vs. processed food indicators

Score ranges: - 70-100: Nutritious (high protein, fiber, whole foods)
- 40-69: Moderate (some processed elements)
- 0-39: Consider alternatives (high sugar, fried, ultra-processed)

Important framing: The score is explicitly labeled as "an estimate to help guide healthier choices" — not a medical assessment. Users can tap for more information explaining how the score was calculated. This empowers patients to make more informed choices without triggering diet culture shame or obsessive tracking behaviors.

SECTION 5: Insight Content - Compliance reviewed insights

900+ Insights Reviewed for Medical and Regulatory Compliance

Lina delivers daily "Lina Says" insights tailored to each user's journey stage, medication type, and behavior patterns. Every insight has been reviewed against UK and US regulatory requirements. Our content standards:
- No prescriptive medical advice (dosing, timing, specific treatments)
- Hedged language for clinical claims ("many people find...", "research suggests...")
- Brand names removed (e.g., "gentle stool softener" instead of product names)
- Side effect normalization without minimizing ("this is common" vs. "this is harmless")
- All statistics include source framing ("clinical trials have shown...")
- Permission-based messaging that reduces shame without being preachy

Education (helping patients understand their medication):

"Your body already makes GLP-1 — the medication amplifies your natural signal."
"Many people find their stomach empties more slowly
— which is why smaller meals often feel right."
"Many people describe feeling free from constant thoughts about food."


Side Effect Normalization (reducing dropout from early discomfort):

"Many people report nausea in the first few weeks — and find it improves."
"Some people notice fatigue in the early weeks as their body adjusts."
"Many people find side effects improve once they reach a stable dose."

Timing/Practical Guidance (supporting adherence):

"As your healthcare provider may have recommended, rotating injection sites can help with comfort." "Many users find consistent injection timing helps maintain steady effects."
"Eating lighter the night before your dose can help with tolerability."

Permission/Mindset (addressing the shame that undermines adherence):

"Obesity has biological drivers. Using effective treatment isn't weakness — it's wisdom."
"Using medication isn't cheating — it's healthcare."
"It's okay to have complicated feelings about this journey."

Plateau Support (preventing discouragement at critical moments):

"Plateaus happen to almost everyone. Your body isn't failing — it's recalibrating."
"The scale doesn't capture everything that's changing."
"Your metabolism adapts to weight loss — this is normal."

SECTION 6: What Lina Tracks

Clinically Relevant Data Points

Lina captures data that supports the behavioral dimensions of GLP-1 success:

Daily check-ins:
- Mood and energy levels (5-point scale)
- Side effects (user-selected from common GLP-1 effects)
- Non-scale victories (fitting into clothes, energy improvements, etc.)
- Sleep quality Nutrition tracking:
- Protein intake (g) with personalized goals
- Water intake (oz/ml) with personalized goals
- Meal logging with AI-powered nutritional estimates Medication adherence:
- Injection tracking (date, time, dose if user enters)
- Injection site rotation reminders
- Next dose reminders Progress visualization:

- Weight trends (with smart smoothing to reduce daily noise anxiety)

- Progress photos with side-by-side comparison

- Streak tracking for daily engagement All data is user-reported and user-controlled. We never access prescription records, pharmacy data, or medical records.

SECTION 7: Privacy and Data Handling

Patient Data Stays With Patients

Lina is committed to the highest standards of data privacy:
- UK GDPR compliant (data controller: Lina Health Ltd)
- Data encrypted at rest and in transit -

- No data sold to third parties — ever

- Users can export or delete all data at any time

- Apple Health integration is optional and user-controlled

What we collect:

- Self-reported wellness data (mood, side effects, nutrition, weight)

- Account information (email, basic profile)

What we don't collect:

- Prescription records

- Pharmacy data

- Medical records

- Insurance information

- Precise location

SECTION 8: Our Commitment to Accuracy

We Don't Make Claims We Can't Back

Every feature in Lina has been reviewed for regulatory compliance across UK and US markets. Our internal compliance process includes:

- Line-by-line review of all 900+ insights for medical accuracy and appropriate hedging

- Removal of brand name recommendations

- Source verification for all cited statistics

- Clear distinction between educational content and medical advice

- Prominent disclaimers throughout the app

Recent compliance audit results:

- 11 high/medium priority items identified and resolved (December 2024)

- All absolute medical claims softened with appropriate qualifiers

- All brand names removed from recommendations

- All prescriptive language reframed as user experience ("Many users find...")

We maintain a detailed compliance checklist covering:

- Legal disclaimers (Terms of Use, Privacy Policy)

- All insight content by category

- Onboarding screens

- Health Score feature

- UK-specific requirements (UK GDPR, MHRA classification)

- US-specific requirements (FDA wellness app guidance, FTC advertising rules)

SECTION 9: How we can work together

Partnership Opportunities


We believe the best outcomes happen when digital tools and clinical care work together. Here are ways we can collaborate:

Patient recommendation:

Lina can be recommended as a between-visit support tool for patients on GLP-1 medications. The app is free to start, with premium features available via subscription. With enough patients we can heavily discount the product or allow you to pay as a provider and give to your patients for free.

Content collaboration:

If you're interested in contributing educational content, we'd love to hear from you. All content is reviewed for compliance before publication.

Research partnerships:

We're interested in research collaborations that could help us better understand and support GLP-1 patient outcomes.

Feedback and input:

We welcome clinical feedback on our approach. If you see something that concerns you, we want to know.

To discuss any of these opportunities: hellolinahealth@gmail.com

SECTION 10: Frequently asked questions

FAQ Items

Q: Is Lina a medical device?

A: No. Lina is classified as an educational wellness companion, not a medical device. We don't provide diagnosis, treatment recommendations, or medical advice. We support the behavioral and emotional dimensions of the GLP-1 journey.

Q: Does Lina provide dosing guidance?

A: Absolutely not. We track when users take their medication (if they choose to log it), but we never recommend doses, timing changes, or medication adjustments. Those decisions belong to the prescribing provider.

Q: How does Lina handle side effect reporting?

A: Users can log side effects they're experiencing from a list of common GLP-1 effects. This data is for their own awareness and pattern recognition — we don't diagnose, and we encourage users to discuss concerning symptoms with their healthcare provider.

Q: Are the nutritional calculations reliable?

A: Our protein and calorie calculations use established formulas (Mifflin-St Jeor, 1.2g/kg protein) with conservative safety guardrails. AI meal analysis uses USDA reference values and is clearly labeled as an estimate. We emphasize general guidance, not precision nutrition.

Q: What about patients with eating disorder history?

A: We've designed Lina to avoid triggering patterns associated with disordered eating. There's no calorie counting requirement (protein-first approach), no "good/bad" food labeling, no punishment for missed days, and permission-based messaging throughout. However, patients with active eating disorders or significant ED history should consult their treatment team before using any tracking app.

Q: How do you ensure content accuracy?

A: All educational content is reviewed against current clinical understanding. We use hedged language for claims that aren't universally applicable ("many people find...", "research suggests...") and cite sources for statistics. Our compliance process is documented and regularly updated.

Q: Can patients share data with their provider?

A: Users can export their data at any time. We're exploring more streamlined provider-sharing features for future releases.

We built Lina because we saw a gap between what patients experience on GLP-1 medications and the support available to them. We're committed to being a responsible part of the care ecosystem. If you have questions, feedback, or concerns about Lina, we want to hear from you.