By Nelly Abulata, MD, PhD, MBA

What once felt futuristic is now part of routine care. We’ll look at what digital therapeutics are, the evidence behind them, and how clinicians around the world can safely and effectively integrate them into practice.

Imagine this, your next prescription isn’t a pill, it’s an app.

Let’s dive in.

Let’s first start with clear definitions. Digital therapeutics, or digital prescriptions, are evidence-based, software-driven clinical interventions designed to prevent, manage, or treat medical conditions. They are fundamentally different from wellness apps.

Where wellness apps track steps or encourage mindfulness, digital prescriptions are clinically validated, regulated, and designed to deliver measurable clinical outcomes. Many undergo evaluation through pathways such as FDA clearance or De Novo authorization, as well as regulatory frameworks across the EU, the UK, Canada, and Asia Pacific.

Some representative examples include:

- reSET and reSET-O: These are FDA-cleared digital therapeutics for substance use disorders. They deliver daily cognitive behavioral therapy modules, reward adherence, and allow clinicians to track progress.

- EndeavorRx: A prescription video game-based therapy for children with ADHD (attention-deficit/hyperactivity disorder) between the ages of 8 and 12 that uses adaptive tasks to train attention. It’s prescribed 25 minutes a day, 5 days a week, and provides clinicians with progress reports.

- BlueStar: An FDA-cleared platform for diabetes self-management that integrates glucose data, medications, meals, and activity to provide personalized, real-time coaching.

Think of digital therapeutics as digitally delivered clinical interventions that complement medical management and support diagnostic or therapeutic goals.

Now here’s the question clinicians ask most often: Do these apps actually work?

In many cases, yes.

So what does the evidence show? The research base is growing and current studies suggest that:

- reSET-O has been associated with improved treatment retention for patients on buprenorphine.

- EndeavorRX has demonstrated significant improvements in objective attention measures in children with ADHD.

- BlueStar has shown reductions in glycated hemoglobin when integrated into routine diabetes management.

These aren’t wellness apps. They are prescribable, validated interventions; many supported by randomized control trials.

New digital prescriptions are also emerging for insomnia, chronic pain, PTSD (post-traumatic stress disorder), irritable bowel syndrome, and anxiety disorders. Some are authorized while others are investigational.

The key takeaway is digital prescriptions are clinical tools, not digital extras.

So when and why should clinicians consider prescribing digital therapeutics? Here are three common scenarios:

1. When behavior change is central to care. Chronic conditions such as diabetes, hypertension, anxiety, or substance use disorders benefit from continuous support between visits. Digital prescriptions can deliver structured, scalable reinforcements outside the clinic.

2. When access to care is constrained. Digital prescriptions can help bridge gaps created by geography, clinician shortages, long waitlists, or limited subspecialty availability.

3. When patient engagement determines success. Interactive, personalized, and sometimes gamified interventions can outperform static educational materials and improve adherence.

It’s important to remember: Digital prescriptions extend care, but they do not replace clinicians.

Okay, ready to prescribe?

Here’s a simple checklist.

1. First of all, verify regulatory authorization. Look for FDA clearance or authorization, or approval from your relevant regional regulators, such as the MHRA in the UK, Health Canada, the EMA, Australia TGA, Singapore HSA, or the Saudi FDA.

2. Second, check interoperability and workflow fit. Some digital therapeutics can be prescribed directly through major electronic health record systems or through digital prescribing platforms.

3. Third, set expectations and document the plan with your patient. Explain the purpose of the digital therapeutics, the expected outcomes, the duration of use, engagement requirements, and the follow-up schedules. Document indication, rationale, and the patient’s consent, similar to any therapeutic intervention.

As with prescribing medication, the key is matching the right tool to the right patient. Digital prescriptions complement therapy. They support behavioral change and provide measurable clinical outcomes, unlike wellness apps, which are motivational or educational only.

Before we close, let’s address four common concerns.

1. First, data, privacy, and security. Digital prescriptions should meet strong privacy standards, like HIPAA and the GDPR or regional equivalents. Look for encryption, transparent data policies, and secure storage.

2. Second, digital divide and accessibility. Not all patients have equal access to devices, bandwidth, or have the same digital literacy. Also, consider factors such as age, infrastructure, and the availability of support programs.

3. Coverage and reimbursements vary across countries and insurers. Some digital prescriptions are integrated into national health systems while others are covered privately or through employer plans.

4. Last, but not least, clinical liability and governance. Clinicians remain responsible for care decisions. Choose products with strong evidence, clear indications, and documented governance. Ensure documentation and follow-up plans are in place.

Digital therapeutics are no longer experimental. They are part of the regularly expanding toolbox available to clinicians worldwide. They don’t replace us. They extend our reach, especially between visits.

We prescribe medication. We support behavior change. We empower self-management. Now we have a new way to do that: the digital prescription.