Digital Therapeutics (DTx): Can an App Be a Prescription? The New Category of FDA-Approved "Digital Drugs" You Need to Know

Digital Therapeutics (DTx): Can an App Be a Prescription? The New Category of FDA-Approved “Digital Drugs” You Need to Know

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Can a prescription be software? Digital therapeutics (DTx) say yes. These are evidence-based treatments delivered through software—often on your phone or tablet—that aim to prevent, manage, or treat a diagnosed condition. A growing number have been reviewed by the U.S. Food and Drug Administration (FDA), giving clinicians a new tool to prescribe. For patients, that can mean structured therapy at home, with progress measured in real time. For health systems, it introduces a new category of “digital drugs” that must meet medical standards, not just app-store ratings.

What are Digital Therapeutics?

Digital therapeutics are medical treatments delivered as software. They are part of a broader category called Software as a Medical Device (SaMD). Unlike general health or wellness apps, DTx make clinical claims—such as improving attention in pediatric ADHD or reducing insomnia symptoms—and support those claims with trials, much like a drug or device would.

Why this matters: software can deliver a consistent, coach-like intervention every day, at scale. Many conditions respond to structured training, behavioral therapy, or cognitive techniques. When those are encoded into software, patients can practice between visits, data can guide adjustments, and clinicians can see objective progress. This closes the gap between clinic advice and day-to-day follow-through.

How DTx Differ from Health Apps and Telehealth

  • Clinical claims: DTx target specific diseases or symptoms and promise measurable change. Wellness apps focus on general wellbeing without disease claims.
  • Evidence standard: DTx use controlled trials and validated endpoints. Wellness tools rarely do.
  • Regulation: Many DTx are cleared or authorized by FDA as medical devices. Most apps are not regulated beyond basic consumer protections.
  • Quality systems: DTx makers follow medical-grade development and risk management. This reduces errors when software updates or devices change.
  • Integration: DTx often connect with EHRs and care teams. Telehealth platforms deliver clinician time, not a software treatment.

How the FDA Regulates “Digital Drugs”

The FDA treats DTx as medical devices. Most go through one of two pathways:

  • De Novo authorization: for novel devices with no similar predicate. The FDA sets special controls for safety and effectiveness.
  • 510(k) clearance: for devices shown substantially equivalent to an existing one.

Important nuance: you will see “FDA cleared” or “FDA authorized” more often than “FDA approved.” Approval is typically reserved for Class III devices and drugs. The difference matters because it tells you how the evidence was evaluated and under what controls the device can evolve.

DTx may be prescription-only or available over the counter, depending on risk and intended use. FDA also expects plans for cybersecurity, human factors (is the app usable by the intended population?), and post-market monitoring. That ongoing oversight is essential because software changes frequently; the risk is that a good version today could become unsafe or ineffective after an update if controls are weak.

Examples You Might See in Practice

Availability can change as companies pivot, but these illustrate the range of FDA-reviewed DTx and related software-based treatments:

  • EndeavorRx: a prescription-only video game treatment authorized to improve attention function in children with ADHD. It uses adaptive gameplay to train specific cognitive skills. It matters because attention can be trained, and software can dose that training with precision.
  • reSET and reSET-O: prescription programs delivering cognitive behavioral therapy (CBT) for substance use disorder and opioid use disorder (with buprenorphine). Trials showed improved engagement and, in some settings, better abstinence or retention. The rationale: structured CBT reduces relapse risk, and software increases access and consistency.
  • Somryst: a prescription CBT for chronic insomnia. It guides patients through sleep restriction, stimulus control, and cognitive techniques. These are standard-of-care strategies in sleep medicine; delivering them through software helps when trained therapists are scarce.
  • Mahana IBS (Parallel): a digital CBT program cleared to reduce IBS symptom severity. IBS symptoms are strongly influenced by gut-brain interactions; targeted skills training can reduce symptom amplification.
  • Luminopia: a prescription VR-based treatment for amblyopia in children. It modifies visual input to encourage use of the weaker eye. This is a software-mediated approach to a long-known mechanism, similar in principle to patching but potentially more engaging.
  • NightWare: a prescription system using a smartwatch and app to interrupt nightmares associated with PTSD by detecting physiological distress and delivering vibration. It demonstrates how sensing plus timely intervention can form a therapeutic loop.

There are also cleared programs for diabetes self-management and musculoskeletal pain. Some are not formally prescription-only but are still used under clinician guidance. The core idea is the same: software encodes a validated therapeutic method and personalizes it over time.

Evidence: What “Clinically Validated” Software Means

To claim therapeutic benefit, DTx typically need trials with clear endpoints. Good evidence includes:

  • Randomized controlled trials (RCTs): to separate true effects from placebo and engagement effects. Digital placebos (e.g., sham apps) matter because interaction alone can help some patients.
  • Validated measures: for example, standard attention tests in ADHD, insomnia severity indexes, or symptom scales in IBS. These make results comparable and meaningful.
  • Real-world durability: the benefit should last beyond the training period. Short-lived gains have limited clinical value.
  • Adherence data: software captures exactly how much “dose” a patient received. That lets clinicians see whether a lack of effect is due to poor fit or low use.
  • Safety profile: while DTx are low-risk compared with drugs, they can still cause issues—sleep restriction can worsen fatigue initially, VR may cause dizziness, and some content could trigger distress if not designed well.

Can You Really Get a Prescription for an App?

Yes. Prescription digital therapeutics (PDTx) are ordered by a clinician. The process usually looks like this:

  • Eligibility: clinician confirms the diagnosis and checks the DTx indication and contraindications.
  • e-Prescribe or enroll: the prescription is sent via the EHR or a secure portal. Patients often receive an access code and onboarding steps.
  • Coverage and payment: some DTx run through the pharmacy benefit (occasionally using codes similar to NDC identifiers). Others bill under the medical benefit or are paid by employers. Coverage is improving but uneven; prior authorization is common.
  • Use and monitoring: patients complete short daily or weekly sessions. Clinicians view dashboards or receive reports to adjust care.
  • Refills or time-limited courses: many DTx are prescribed for a defined period, sometimes with renewals based on response.

Who Should Consider a DTx?

  • Patients without local access to trained therapists for CBT-I, CBT for IBS, or substance use therapies.
  • Children and adolescents who engage better with interactive or game-based formats.
  • People needing structured practice between visits—attention training, exposure tasks, sleep retraining.
  • Patients on medications who want non-pharmacologic add-ons to boost effect or reduce dose.
  • Chronic conditions where self-management is pivotal, such as diabetes or MSK pain, and consistent coaching improves outcomes.

They are not for emergencies, active crises, or conditions requiring close in-person supervision. For severe depression with suicidality, for example, software is an adjunct at best, not the backbone.

Benefits and Limitations

  • Access and consistency: software delivers guideline-based methods the same way every time, reducing variation in care.
  • Personalization: adaptive algorithms increase difficulty or change content based on performance, aiming for the right dose of challenge.
  • Measurement: objective usage and symptom data help distinguish nonresponse from nonadherence and guide decisions.
  • Scalability: once built, the marginal cost per patient is low, enabling broader reach.
  • Engagement drop-off: many users fall off after a few weeks without support. Successful programs pair software with brief human check-ins.
  • Digital divide: device access, language, and usability barriers can widen inequities if not addressed.
  • Scope limits: DTx target defined indications; they are not general solutions for complex multimorbidity.
  • Privacy and security: medical-grade apps follow stricter controls, but patients should still ask how data are used and shared.

What to Ask Your Clinician or Vendor

  • Indication and population: Is it cleared for my diagnosis, age, and severity?
  • Evidence strength: How many RCTs? What effect size should I expect, and how soon?
  • Safety: Any known risks, adverse events, or groups who should not use it?
  • Therapy “dose”: How often and how long will I use it? What happens if I miss sessions?
  • Support: Is there coaching or clinician monitoring? Who troubleshoots access issues?
  • Data: What is collected, who sees it, and how is it protected? Can I get copies?
  • Workflow: Does my care team receive reports in the EHR? How will it change my visits?
  • Cost and coverage: Is it covered by my plan? Is prior authorization required?

For Health Systems and Payers: How to Evaluate and Implement

  • Clinical fit: Map the DTx to guidelines and gaps in your network (e.g., CBT-I scarcity). Define clear inclusion/exclusion criteria.
  • Regulatory status: Verify FDA pathway, labeling, and post-market obligations. Check change management for software updates.
  • Evidence and outcomes: Examine RCTs and real-world data. Require outcome metrics you can reproduce in your population.
  • Equity and access: Offer devices or data stipends if needed. Ensure language and accessibility support.
  • Data security: Assess HIPAA compliance, encryption, audit trails, and third-party data sharing.
  • Reimbursement: Determine whether it runs under pharmacy or medical benefit, and build prior authorization criteria.
  • Workflow integration: Embed ordering, dashboards, and alerts into EHR. Assign accountability for monitoring and follow-up.
  • Pilot design: Start with a focused use case, define success (e.g., ISI reduction, reduced ED visits), and set a stop/scale decision gate.

The Road Ahead

DTx are moving toward more adaptive, data-driven care. Expect tighter integration with wearables and EHR data, allowing “closed-loop” interventions that respond to real-time physiology and context. Regulators are refining frameworks for iterative updates so software can improve without sacrificing safety. Payers are experimenting with outcomes-based contracts, which align cost with measured benefit.

The key takeaway: an app can be a prescription when it behaves like medicine—clear indication, tested benefit, defined risks, and reliable delivery. Digital therapeutics are not a cure-all, but in the right scenario they provide structured, measurable care between visits. That is why clinicians, payers, and patients should learn how to judge their quality and where they fit in the treatment plan.

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