Value of DTx  /  Patients & Caregivers

Digital therapeutic products must be proven as effective via rigorous testing such as Randomized Control Trials (RCT). Published results must include clinical trials results demonstrating that each technology is safe, effective, credible, and delivers clinically meaningful results.

DTx companies collect, analyze, and apply ongoing real-world evidence generation and analysis of product performance data to demonstrate ongoing clinical impact, product usability, and value.

Additionally, DTx products align with industry best practices which include well-established Good Clinical Practice protocols.

DTx manufacturers are expected to design products using a human-centered approach and account for the user’s core needs, their environment, and the types of devices that will be used. While some digital therapeutics are purely software-based, others are paired with hardware components, such as wearable and wireless devices, sensors, diagnostic products, and virtual reality systems.

No matter how many components are integrated into a DTx product, all product developers must engage end users – including patients, caregivers, and clinicians – every step of the way. This patient-centered focus enables digital therapeutics to more seamlessly blend into clinical guidelines, care delivery systems, and patient lifestyles from the privacy of their own environments.

Digital therapeutic products improve patient outcomes for a wide range of diseases and disorders with clinically proven technologies that are accessible through devices such as smartphones and personal tablets.

DTx products may expand access to proven therapies, offer treatment options for un- or undertreated conditions, and empower patients with self-management tools. They are used independently or in concert with medications, devices, or other therapies to optimize patient care and health outcomes.

Yes. DTx products are subject to national and regional privacy rules which define strict standards for the protection of personal health information (e.g., HIPAA, GDPR).

Compared to products that track fitness, encourage medication adherence, or monitor patient activity, DTx products deliver medical interventions directly to patients. As such, digital therapeutics undergo rigorous testing and are held to the same standards of evidence and regulatory requirements as traditional medical treatments.

Wellness and fitness apps that consumers download to their smartphones are not typically regulated, nor do they need to prove product claims by scientific testing or clinical evidence.

Patient access to DTx products is generally granted through a prescription by a qualified healthcare provider, a referral or authorization from a clinician, or through the delivery of a product activation code via a payor or employer.