Certified Digital Therapeutics Specialist (CDTS)

CDTS (DTX-001) Exam Objectives

This exam certifies that the candidate has the strategic and clinical knowledge to evaluate, implement, and manage digital therapeutic products within a healthcare ecosystem.

Domain 1: Foundations and Landscape of Digital Therapeutics (25%)

• DTx Classification: Differentiate between digital therapeutics, wellness apps, and digital medicine. Classify DTx products based on their mechanism of action (e.g., CBT, sensor-feedback).
• Market Landscape: Identify major therapeutic areas for DTx (e.g., mental health, metabolic disease) and key players in the industry.
• Value Proposition: Articulate the value proposition of DTx for patients, providers, and payers, including potential for improved access, outcomes, and cost savings.

Domain 2: Clinical Evaluation and Application of DTx (35%)

• Evidence Appraisal: Critically evaluate the quality of clinical evidence for a DTx product, including study design (e.g., RCTs), endpoints, and real-world evidence (RWE).
• Formulary and P&T Process: Develop a framework for a digital health formulary review, including the creation of a monograph and presentation to a P&T committee.
• Clinical Integration: Determine the appropriate place in therapy for a specific DTx product, considering its use as monotherapy, adjunctive therapy, or replacement for pharmacotherapy.
• Patient Selection: Identify appropriate patient populations for specific DTx interventions based on indications, contraindications, and technological literacy.

Domain 3: Implementation, Reimbursement, and Regulatory Compliance (30%)

• Regulatory Pathways: Differentiate between FDA regulatory pathways for software as a medical device (SaMD), including 510(k), De Novo, and PMA.
• Reimbursement Models: Compare reimbursement pathways for DTx, including pharmacy benefit (NDC), medical benefit (CPT codes), and value-based contracting.
• Implementation Strategy: Design a plan to integrate a new DTx product into clinical workflows, including provider education, patient onboarding, and technical support.
• Data Privacy and Security: Ensure the implementation and use of DTx products comply with HIPAA and other data privacy regulations.

Domain 4: Patient Engagement and Data Management (10%)

• Patient Onboarding & Adherence: Develop strategies to effectively onboard patients onto a DTx platform and promote long-term engagement and adherence.
• Data Interpretation: Analyze patient-generated data from a DTx product to assess progress and identify the need for clinical intervention.

Eligibility Requirements

To be eligible to sit for a CPS certification exam, candidates must meet the criteria outlined in one of the two pathways below.

Pathway 1: For U.S. Licensed Pharmacists

This pathway is for pharmacists licensed to practice within the United States, regardless of country of graduation.

• Hold an active and unrestricted pharmacist license in any state or territory of the United States.
• Meet educational requirements by being a graduate of an ACPE-accredited school of pharmacy or holding a Foreign Pharmacy Graduate Examination Committee® (FPGEC) Certificate.
• Fulfill the specialty experience requirement as outlined below.

Pathway 2: For International Pharmacists (Non-U.S. Licensed)

This pathway is for pharmacists who practice outside of the United States.

• Hold an active and unrestricted license to practice pharmacy in their country of practice. A certified English translation of the license must be provided if the original is not in English.
• Hold a professional degree in pharmacy equivalent to a U.S. pharmacy degree, such as a Bachelor’s degree (BPharm), Master’s degree in Pharmacy Practice (MPharm), or Doctor of Pharmacy degree (PharmD).
• Fulfill the specialty experience requirement as outlined below.

Specialty Experience Requirement (for all pathways)

To ensure candidates have foundational knowledge in the specialty, one of the following criteria must be met:

• Standard Pathway:
  Completion of at least one year of professional experience in a practice setting directly related to the certification area.
• Certificate Pathway:
  The one-year specialty experience requirement is waived for candidates who hold an active certificate of completion from a nationally recognized provider in a related subject matter. This includes, but is not limited to, the completion of a relevant PGY residency, fellowship, certificate/training program, or a relevant graduate degree (e.g., a Master's degree in the specialty field). Recognized providers of certificate programs include, but are not limited to:
  • American Society of Health-System Pharmacists (ASHP)
  • American Pharmacists Association (APhA)
  • American College of Clinical Pharmacy (ACCP)
  • American Society of Consultant Pharmacists (ASCP)

Career Path for CDTS Professionals

The CDTS certification is for professionals at the intersection of healthcare and technology, including those in pharmacy informatics, managed care, and health system leadership. This credential signifies the strategic expertise needed to lead digital transformation initiatives.

Target Candidates

• Pharmacists in managed care or P&T roles evaluating new technologies.
• Clinical or pharmacy informaticists.
• Pharmacy leaders responsible for innovation and strategy.
• Pharmacists working for digital therapeutics companies or health-tech startups.

Primary Job Roles:

• Digital Health Strategist
• Clinical Informatics Pharmacist (Digital Health)
• Digital Formulary Manager
• Telehealth Program Manager
• Product Manager (Digital Therapeutics)

Career Advancement:

A CDTS is positioned for senior leadership roles focused on healthcare innovation. They can advance to become a Director of Digital Health or a Chief Innovation Officer within a health system or health plan. Their expertise is also highly sought after by DTx companies, digital health startups, and consulting firms.

Study Resources

Prepare for your CDTS exam with resources designed for this innovative and multidisciplinary field.