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Digital therapeutics (Roadblocks (Regulatory (Complexity (Evolving…
Digital therapeutics
Roadblocks
Data privacy
Data collection
Study to generate data
Mining to find data repositories
Data quality
Regulatory
Complexity
Evolving regulation
FDA pre cert pilot
Unfamiliarity
Fear of 510K
Study requirements
Riskier IP protection
Different industry, ci\ulture HR, etc
Benefits
Saves lives
More efficient than traditional medicine
Low cost
Less time
Less complexity / low user knowledge
Behavioural Strategy
Reliability of measurment
Real-world validity
Longitudinal efficacy
Qualitative and quantitative assessment
Gold standard comparison
Applications
Precision Medicine
Psy chatbot
Digitall Biomarkers
Patient stratification
Diagnostic support
Diagnostics
Determinant of health
Treatment algorythms
Predictors
Digital phenotyping
Outcome Measurement
Personalized treatment
Tailored situations/contexts
Individual differences
Nature vs. nurture
Prognosis
forecasting disease
predicting exacerbations
Prevention
Health maintenance
What is it
(definition)
Digital intervention with Claim and Measurable Impact
Other?
Digital Biomarkers
Precision medicine
Uniqueness
Updatable
Medical device
Decision Science
Input and output is data
Forecasting
Uses and generates data
Software
Where did it come from
Data
-Omics
Wearables
Machine learning
Limitations of chemistry
Limitations
Correlational vs. causational
Never 100% accurate
Individual differences of genetics x environment
Minimum viable lab