💚 pack: digital-health-pack

Ship wearable AI + physician HITL without FDA SaMD, GDPR Art. 9, and HealthKit policy landmines.

Wearable telemetry (Apple Watch, Garmin, Samsung), mental-health AI, nutrition AI, or physician HITL? GreatCTO auto-attaches digital-health-pack with FDA General Wellness vs SaMD classification, GDPR Art. 9 special-category consent, HealthKit / Health Connect / Garmin SDK API compliance, AFSP safe-messaging mental-health crisis protocol, drug–supplement interaction safety layer, and a 4-tier physician HITL risk-routing gate from day one.

$ npx great-cto init All packs ↗
Auto-attach signals

Detected by CLI when:

healthkit · health-connect · garmin-connect-iq · samsung-health · fitbit · oura · whoop · wearable · apple watch · mental health ai · nutrition ai · supplement recommendation · physician hitl · personalised training · wellbeing · stress detection · burnout detection

The pack rides on top of your base archetype (web-service, ai-system, fintech, …) — it doesn't replace it. Auto-injects reviewer agents into the pipeline + opens human gates listed below.

Reviewer agents activated

3 specialists added to the pipeline.

01 · digital-health-reviewer

FDA General Wellness vs SaMD classification · GDPR Art. 9 special-category data + DPIA · HealthKit / Health Connect / Garmin SDK API rules · physician HITL 4-tier risk routing · drug–supplement interaction safety (OpenFDA / DrugBank) · AFSP safe-messaging crisis protocol · EU AI Act Annex III healthcare · FTC Health Breach Notification Rule (2024)

02 · ai-clinical-reviewer

Hallucination guardrails + citation grounding for any SaMD-path feature · subgroup fairness audit

03 · healthcare-reviewer

HIPAA applicability matrix (consumer wellness vs employer / provider deployment) · BAA requirements · PHI minimisation

Human gates introduced

5 new gate types on top of gate:plan + gate:ship.

GateOwnerTrigger
gate:wellness-vs-samdregulatory leadafter digital-health-reviewer classifies intended use — before any patient-facing feature
gate:hitl-designclinical lead + productphysician HITL tier matrix signed off before any HIGH/CRITICAL risk feature
gate:wearable-api-accessplatform lead + legalHealthKit / Health Connect / Garmin entitlement justification filed before data read
gate:supplement-safetyclinical pharmacistdrug–supplement interaction layer validated before recommendation goes live
gate:mental-health-protocolclinical lead + safety officerAFSP safe-messaging + crisis-escalation path signed off before mental-health features ship
Required artefacts before senior-dev claims tasks

10 concrete deliverables.

EVAL suite required

8 golden-set scenarios shipped as templates.

Each EVAL has ≥5 test cases, pass threshold, regression interpretation, cross-refs to TM + gates. Run via your existing test framework.

Regulatory surface covered

12 standards / regulations addressed.

FDA General Wellness Policy (2019) FDA GMLP (2021) GDPR Art. 9 special-category health data GDPR Art. 35 DPIA HIPAA Privacy + Security Rules FTC Health Breach Notification Rule (2024) EU AI Act Annex III medical / wellness Apple HealthKit App Store guidelines 5.1.3 Google Health Connect policies AFSP Safe Messaging Guidelines (2023) California CMIA Washington My Health MY Data Act (2023)
Real-world examples

28 companies in this space.

Hinge Health
Digital physical therapy + musculoskeletal care
publicUS
Life360
Family safety app + wearable for kids
publicUS
Tempus AI
AI + data for precision medicine
publicUS
Withings
Connected health devices + analytics
publicFR
AG1 (Athletic Greens)
Personalised daily nutritional supplements
growthUS
Calm
Mindfulness + mental health app
growthUS
Cerebral
Online mental health care + prescriptions
growthUS
Headspace
Meditation + sleep app
growthUS
Lyra Health
Mental health benefits platform
growthUS
Noom
AI-powered weight + wellness coaching
growthUS
Oura
Smart ring for sleep + health tracking
growthFI
Persona Nutrition
Personalised vitamin + supplement recommendations
growthUS
Sword Health
AI-powered physical therapy with human oversight
growthUS
WHOOP
Wearable fitness + recovery tracker
growthUS
Spring Health
AI-powered mental health benefit for employers
series-eUS
Virta Health
Reverse type-2 diabetes with remote care
series-eUS
Biofourmis
Wearable biosensors + remote patient monitoring
series-dSG
Lark Health
AI health coaching for chronic disease
series-dUS
Kaia Health
AI-powered digital therapeutics for chronic pain
series-cDE
Corti
AI clinical decision support at the point of care
series-bDK
Future
AI-matched personal training with human coach
series-bUS
Thyme Care
Cancer care navigation + physician HITL
series-bUS
Ultrahuman
Metabolic health ring + continuous monitoring
series-bIN
Woebot Health
AI-powered mental health support chatbot
series-bUS
Bodyport
Cardiac monitoring scale with AI
series-aUS
Levels
Continuous glucose monitoring + metabolic health
series-aUS
Nutrisense
CGM + nutrition AI coaching
series-aUS
Polar
Sports watches + training analytics
privateFI

Listed companies operate in this space. Inclusion is based on publicly available product descriptions and does not imply endorsement of or by GreatCTO.

FAQ

Common questions about digital-health-pack.

When does digital-health-pack auto-attach?
When the CLI detects these signals in your repo: healthkit · health-connect · garmin-connect-iq · samsung-health · fitbit · oura · whoop · wearable · apple watch · mental health ai · nutrition ai · supplement recommendation · physician hitl · personalised training · wellbeing · stress detection · burnout detection. Override anytime by editing packs: in PROJECT.md.
What human gates does digital-health-pack introduce?
gate:wellness-vs-samd (regulatory lead), gate:hitl-design (clinical lead + product), gate:wearable-api-access (platform lead + legal), gate:supplement-safety (clinical pharmacist), gate:mental-health-protocol (clinical lead + safety officer). These layer on top of the standard plan/ship gates.
What if my project doesn't match these signals exactly?
You can manually add the pack name to PROJECT.md or run /migrate to re-run detection with updated rules.
30 seconds

Drop GreatCTO into any repo — digital-health-pack attaches automatically.

$ npx great-cto init
no signup·runs locally·pay your own API