Health Tech Compliance

Healthcare regulations for organizations serving vulnerable populations—visualized for quick reference

⚠️ Important Disclaimer
This guide is for informational purposes only and does not constitute legal advice. Always consult with qualified healthcare regulatory attorneys for your specific situation.
🏛️
FDA Medical Device
Determines if your app is a regulated medical device
✓ DO
• Frame as educational resources and health literacy tools
• Provide culturally responsive health information
• Connect users to community health resources and providers
• Include disclaimer: "Not intended to diagnose, treat, cure, or prevent disease"
• Direct users to free/low-cost clinics and healthcare access programs
✗ DON'T
• Diagnose reproductive or gynecological conditions
• Make claims about fertility, pregnancy outcomes, or contraception effectiveness
• Provide specific medical treatment recommendations
• Replace clinical care or professional medical consultation
• Use language that could create fear or shame around women's health
💡 Example Language
✗ Wrong
"Your symptoms indicate PCOS. Follow our treatment plan to regulate your cycle and improve fertility."
✓ Right
"Some people with irregular cycles find it helpful to track patterns. We can help you understand what's normal for you and when you might want to discuss your cycle with a healthcare provider."
🔒
HIPAA
Health data privacy and security requirements
✓ DO
• Encrypt all health data with extra security for vulnerable populations
• Provide anonymous/pseudonymous usage options for safety
• Create multilingual privacy policies and consent forms
• Allow users to delete data completely with no questions asked
• Never share data with immigration authorities or law enforcement
✗ DON'T
• Require real names, addresses, or documentation
• Share data with third parties without explicit, informed consent
• Store location data that could compromise user safety
• Use complex legal language that non-native speakers can't understand
• Retain data longer than necessary (consider 30-90 day auto-delete)
💡 Design Implications
→ Offer app usage without account creation (guest mode)
→ Clear "This data never leaves your phone" messaging
→ One-tap emergency data deletion ("Panic button")
🔬
CLIA
Clinical testing standards (if offering testing services)
✓ DO
• Partner only with CLIA-certified laboratories
• Display lab's CLIA certification number clearly
• Keep lab results separate from your app's insights
• Clearly label what comes from certified lab vs. your analysis
• Allow users to download official lab reports
✗ DON'T
• Provide clinical interpretations without proper credentials
• Suggest you're performing lab analysis yourself
• Mix clinical lab data with non-validated insights without distinction
• Alter or modify official lab reports
💡 Implementation Tips
→ Create separate sections: "Lab Results" vs "Your Health Insights"
→ Use visual design to distinguish clinical data from wellness tracking
→ Footer: "Testing performed by [Lab], CLIA #[Number]"
🛡️
FTC Health Breach
Breach notification for health apps
✓ DO
• Maintain reasonable security practices
• Have a documented breach response plan
• Notify affected users within 60 days of breach
• Notify FTC if breach affects 500+ individuals
• Conduct regular security assessments
✗ DON'T
• Delay breach notifications beyond timeframes
• Minimize or hide data breaches from users
• Fail to investigate security incidents
• Ignore security vulnerabilities once discovered
🗺️
State Privacy Laws
CCPA, CPRA, Virginia CDPA, etc.
✓ DO
• Provide clear privacy notices at collection
• Honor user rights to access, delete, and correct data
• Get explicit consent for sensitive health information
• Respond to privacy requests within 45 days
• Implement "privacy by default" settings
✗ DON'T
• Sell health data without explicit consent
• Make privacy settings hard to find
• Discriminate against users exercising privacy rights
• Use dark patterns to trick users into sharing data
💊
Dietary Supplements
Nutrition recommendations & supplement claims
✓ DO
• Frame recommendations as educational information
• Include FDA disclaimer about supplements
• Suggest users consult healthcare providers
• Cite peer-reviewed research for nutritional suggestions
• Disclose affiliate relationships transparently
✗ DON'T
• Make disease treatment claims about supplements
• Recommend specific supplement dosages like prescriptions
• Suggest supplements can replace medical treatment
• Hide affiliate relationships or financial incentives
• Recommend stopping prescribed medications
💡 Required Disclaimer
"These statements have not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease."
⚕️
Medical Practice
Avoiding unlicensed medical practice
✓ DO
• Provide general educational information
• Empower users to track their own patterns
• Suggest bringing findings to healthcare provider
• Create tools that support informed decision-making
• Acknowledge limitations of your app
✗ DON'T
• Provide personalized medical advice
• Create doctor-patient relationships through app
• Prescribe treatments or protocols
• Diagnose conditions
• Suggest medication changes
💡 Where's the Line?
✓ Acceptable
"Heavy periods can be common, but if you're soaking through pads/tampons every hour, this might be something to discuss with a doctor. We can help you find free clinics near you."
✗ Not Acceptable
"Your heavy bleeding indicates anemia. Take iron supplements and schedule surgery consultation."
🧠
Mental Health
Special considerations for mental health features
✓ DO
• Include multilingual crisis resources (988, domestic violence hotlines)
• Acknowledge trauma-informed care principles
• Connect to culturally specific mental health resources
• Normalize mental health support across cultures
• Provide safety planning resources for domestic violence
✗ DON'T
• Claim to treat depression, anxiety, or mental health conditions
• Diagnose mental health conditions
• Suggest users stop psychiatric medications
• Use clinical assessment tools without licensing
• Replace mental health care with wellness tracking
💡 Safety Features to Include
→ Multilingual crisis resources accessible without login
→ National Domestic Violence Hotline (1-800-799-7233) prominently displayed
→ Local immigrant-serving organizations and legal aid contacts
🔬
IRB & Research Ethics
Institutional Review Board requirements for research activities
✓ DO
• Obtain IRB approval before collecting data for research purposes
• Clearly distinguish between service delivery and research activities
• Provide separate informed consent for research participation
• Document IRB approval numbers and renewal dates
• Report adverse events and protocol deviations to IRB
✗ DON'T
• Use service data for research without proper consent and IRB approval
• Coerce vulnerable populations into research participation
• Assume app usage automatically equals research consent
• Fail to provide opt-out options for research activities
• Share identifiable research data without proper de-identification
💡 Key IRB Considerations
→ Vulnerable population protections (pregnant women, children, prisoners, etc.)
→ Layered consent: Service use + Optional research participation
→ Data retention policies that comply with both IRB and HIPAA
🏛️
Tax-Exempt Status
501(c)(3) and charitable organization regulations
✓ DO
• Maintain 501(c)(3) status by serving charitable mission
• Document that services primarily benefit underserved populations
• Avoid political campaign activities or excessive lobbying
• Ensure no private inurement (profits to individuals)
• File Form 990 annually with detailed program descriptions
✗ DON'T
• Operate primarily for commercial purposes
• Provide excessive compensation to executives
• Engage in unrelated business income without paying UBIT
• Discriminate in service delivery (must be open to all who qualify)
• Sell user data for profit (violates charitable purpose)
💡 Tax-Exempt Specific Risks
→ Free vs. paid features (must maintain primary charitable mission)
→ Corporate partnerships (avoid quid pro quo arrangements)
→ Data monetization is generally prohibited for 501(c)(3) organizations
📊 Feature Risk Assessment
Low Risk Generally Safe Features
Health tracking & journaling
Symptom logging
Educational content library
Clinic/resource finder
Multilingual health glossary
Community forum (moderated)
Appointment reminders
Medium Risk Requires Careful Language
Health condition education & symptom guides
Wellness recommendations & lifestyle tips
Medication adherence reminders
Health metric tracking with insights
Provider matching or referral features
Peer support or community forums
High Risk Extra Caution Required
Research data collection without IRB approval
Experimental interventions or clinical trials
Data sharing with academic institutions for research
Predictive algorithms for health outcomes
Fertility/pregnancy outcome predictions
Medical procedure recommendations
Monetizing user data (prohibited for tax-exempt orgs)
🌍 Special Considerations for Vulnerable Populations
Language & Accessibility
Multi-language support (not just translation)
Low-literacy design (icons, images, audio)
Offline functionality for limited connectivity
No smartphone-only requirements
SMS/text-based alternatives
Safety & Privacy
No mandatory real name/ID requirements
Panic button for quick app exit/data deletion
Never store location data
Zero data sharing with government agencies
Disguised app icon/name option
No push notifications that reveal app purpose
Cultural Competency
Trauma-informed design principles
Respect for cultural health beliefs
Diverse representation in imagery
Avoid Western-centric assumptions
Partner with community organizations
Include traditional/complementary practices respectfully
Healthcare Access
Free/low-cost clinic finder
Sliding-scale provider directory
Community health worker connections
Insurance navigation support
Legal aid resources (healthcare rights)
No insurance required messaging
Grant Compliance & Reporting
Track metrics required by funders
Maintain audit trail for grant expenses
Document program outcomes and impact
Separate restricted vs. unrestricted funds
Annual reporting to foundation/government funders
Acknowledge funding sources appropriately
Community Accountability
Community advisory board input
User feedback mechanisms
Transparent data usage policies
Regular community impact reports
Participatory design with target population
Cultural humility and responsiveness
✅ Pre-Launch Compliance Checklist
□
Legal review by healthcare regulatory attorney
□
IRB approval obtained for any research activities
□
501(c)(3) status maintained and documented
□
Privacy policy in multiple languages
□
Safety features tested with target community
□
All content reviewed for cultural sensitivity
□
Data security measures exceed HIPAA standards
□
Anonymous usage option available
□
Crisis resources in all supported languages
□
Partnership agreements with community organizations
□
Research consent separate from service consent (if applicable)
□
IRB protocol includes vulnerable population protections
□
Grant reporting metrics integrated into app analytics
□
Community advisory board established
□
Low-literacy design tested with community members
□
Offline functionality verified
□
No medical claims in app content
□
Free clinic finder database updated
□
Trauma-informed design review completed
□
Form 990 preparation includes digital health program details
□
No data monetization or selling to third parties
□
Board of directors trained on digital health compliance
□
Adverse event reporting process to IRB documented
□
No data sharing with immigration/law enforcement confirmed

🤝 Centering community needs • 🌍 Cultural competency is essential • 🔒 Safety first, always

This guide was created for informational purposes and does not constitute legal advice. Consult qualified legal counsel familiar with health tech regulations and vulnerable population protections.