Distinguish a prescription digital therapeutic with clinical evidence from an unregulated wellness application.
Healthcare & Pharmaceutical Management
Digital Therapeutics Evaluation and Clinical Adoption
Evaluate digital therapeutics against clinical evidence and reimbursement criteria, then lead their adoption through a formulary-style review, prescriber workflow integration and adherence design.
🗓️Duration5 training days
📚Content4 modules · 8 sessions
🎓On completionAccredited attendance certificate
About the programme
Course Overview
Health systems are approached constantly by vendors offering an app that claims to treat a chronic condition, and distinguishing a genuine prescription digital therapeutic with clinical evidence behind it from a repackaged wellness tool has become a core skill for clinical and pharmacy leaders. This course builds that skill systematically. Participants learn to define digital therapeutics precisely, separating them from adjacent categories of wellness and monitoring apps, and to interrogate a vendor's clinical evidence using the same standards applied to a drug or device: study design, control groups and clinically meaningful endpoints. The regulatory and reimbursement module covers the approval routes prescription digital therapeutics have used to reach market and the health economic evaluation methods needed to judge whether a therapeutic justifies its cost. A dedicated session builds a formulary-style evaluation committee process, adapting familiar pharmacy and therapeutics committee methods to a digital product. The adoption modules address the practical barriers that sink most digital therapeutic programmes: prescriber workflow integration, patient onboarding, and adherence design informed by behavioural science. The course closes with data privacy considerations and a framework for monitoring real-world outcomes once a therapeutic is in routine use.
Expected Learning Outcomes
Critically appraise a vendor's clinical evidence package using appropriate study design and endpoint standards.
Compare regulatory approval routes used by prescription digital therapeutics to reach clinical use.
Conduct a health economic evaluation to judge whether a digital therapeutic justifies its cost to a payer.
Design a formulary-style evaluation committee process for reviewing digital therapeutic adoption requests.
Integrate a digital therapeutic into prescriber workflow and patient onboarding without adding clinical burden.
Design an adherence strategy informed by behavioural science to sustain patient engagement over time.
Who Should Attend
Pharmacy and therapeutics committee members evaluating digital therapeutic adoption requests
Digital health leads assessing vendor claims for prescription digital therapeutics
Chronic disease programme managers integrating digital therapeutics into care pathways
Health economists and payer representatives assessing digital therapeutic reimbursement value
Clinicians prescribing or recommending digital therapeutics to patients
Health system innovation officers building digital therapeutic procurement processes
Course Modules
Select any module to see its sessions and points.
01Digital Therapeutics Landscape and Evidence Standards
2 sessions · 8 points
Session 1Defining Digital Therapeutics and Distinguishing from Wellness Apps
- Apply a definitional framework that separates prescription digital therapeutics from general wellness applications.
- Identify the clinical claim a digital therapeutic makes and the evidence standard that claim requires.
- Compare digital therapeutics against traditional treatment options for the same condition.
- Assess vendor marketing materials critically for language that overstates unproven clinical benefit.
Session 2Clinical Evidence Requirements and Study Design for DTx
- Evaluate a digital therapeutic's clinical study design for control group adequacy and blinding limitations.
- Identify clinically meaningful endpoints appropriate to the target condition and intervention type.
- Assess sample size and study duration against the persistence of effect a therapeutic claims.
- Distinguish engagement metrics from clinical outcome evidence when reviewing a vendor's evidence package.
02Regulatory Pathways and Reimbursement
2 sessions · 8 points
Session 1Regulatory Approval Routes for Prescription Digital Therapeutics
- Compare the regulatory routes available to a prescription digital therapeutic seeking market authorisation.
- Assess how a digital therapeutic's risk classification shapes its evidence and review requirements.
- Identify postmarket obligations a manufacturer must meet after a digital therapeutic reaches market.
- Track labelling claims permitted under a therapeutic's specific regulatory clearance.
Session 2Reimbursement Models and Health Economic Evaluation
- Compare reimbursement models applied to digital therapeutics across different health systems.
- Build a cost-effectiveness analysis comparing a digital therapeutic to standard care alternatives.
- Model budget impact of adopting a digital therapeutic across an eligible patient population.
- Present a reimbursement business case that addresses payer scepticism about durable clinical benefit.
03Clinical Adoption and Workflow Integration
2 sessions · 8 points
Session 1Formulary-Style Evaluation Committee for Digital Therapeutics
- Design a committee review process adapting pharmacy and therapeutics methods to digital products.
- Define evaluation criteria weighing clinical evidence, safety, cost and workflow burden.
- Structure a vendor submission template that standardises evidence presentation for committee review.
- Document committee decisions with clear approval conditions and review renewal dates.
Session 2Prescriber Workflow Integration and Patient Onboarding
- Integrate digital therapeutic prescribing into existing electronic prescribing workflow.
- Design a patient onboarding process that sets expectations for use and expected benefit timeline.
- Train prescribers to identify which patients are suitable candidates for a specific therapeutic.
- Address technology access barriers that could exclude eligible patients from a digital therapeutic.
04Patient Engagement, Data and Sustained Use
2 sessions · 8 points
Session 1Adherence Design and Patient Engagement Strategy
- Apply behavioural science principles to design features that sustain patient engagement over time.
- Identify common drop-off points in digital therapeutic use and design interventions to address them.
- Design a clinician check-in cadence that reinforces continued use without adding excessive workload.
- Evaluate engagement data to distinguish genuine therapeutic use from passive app installation.
Session 2Data Privacy and Real-World Outcome Monitoring
- Assess a digital therapeutic vendor's data privacy and security practices before adoption.
- Establish a real-world outcome monitoring plan to confirm benefit persists outside the trial setting.
- Design a process for reviewing adverse event or safety signal reports linked to therapeutic use.
- Decide renewal or discontinuation criteria based on accumulated real-world performance data.
What the participant receives
4 course modules
A structured syllabus
8 training sessions
across 5 days
32 detailed points
Applied, detailed content
Accredited attendance certificate
On completing the programme
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