Digital Treatment Options: Are They for You?

This article is for parents and care partners of people living with attention-deficit/hyperactivity disorder (ADHD), or anyone who wants to learn more about non-medicine digital treatments. The goal of this patient education activity is to provide an overview of these treatment options.

You will learn about:

• What a prescription non-medicine digital treatment, or prescription digital therapeutic (PDT), is

• How PDTs work

• What health needs or medical conditions your doctor may recommend a PDT for

• How PDTs are different from other treatments and health tools

• Talking to your doctor about PDTs

Prescription medical devices listed in this activity have either a US Food and Drug Administration (FDA) approval or clearance. The content in this activity is accurate based on the information that was available at the time of its publication. This resource is provided for educational and informational purposes only. We do not provide medical advice, diagnosis, or treatment.

A prescription non-medicine digital treatment, or prescription digital therapeutic (PDT), is a treatment option that your doctor may recommend to help manage your health or to help prevent, manage, or treat a certain medical condition you have.

PDTs are considered to be medical devices by the FDA. They are developed to have a favorable impact on a specific health need or medical condition for a certain group of people (for example, adults or children of a certain age) and use technology as their main treatment method instead of medicine. Certain PDTs may also be used in combination with medicine or another type of treatment, such as cognitive behavioral therapy (CBT).

PDTs can work in several different ways. They often use their technology to allow you and your doctor to target and change specific behaviors you have that can affect your individual health needs or your medical condition. Many PDTs will put you and your doctor directly in touch with a mobile health platform.

Depending on which PDT is used, it may:

• Track your medical condition

• Work to improve your function, symptoms, or quality of life

• Help you and your doctor manage your treatment plan

• Help you take other treatments, such as medicines, as directed

PDTs may be used to help manage a number of different health needs and medical conditions. Like prescription medicines and other medical devices, they should only be used as recommended by your doctor for a specific condition and for certain people at certain ages.

Health needs and medical conditions PDTs may be recommended for can include:

• Diabetes

• Chronic (long-term) insomnia

• Psychiatric conditions, such as schizophrenia, bipolar I disorder, or major depressive disorder (MDD)

• Substance use disorders

• Lung conditions, such as asthma or chronic obstructive pulmonary disease (COPD)

• Women's health, such as for fertility awareness and contraception (birth control)

• ADHD (for children at certain ages)

Many PDTs use computer software and applications (apps) as their main technology. Some may also use hardware such as a monitor, sensor, wearable, or hand-held device.

Different ways PDTs use technology can include:

• An app on your smartphone to help track your health, medical condition, or other treatments such as medicine

• A tiny sensor you swallow, along with medicine, that sends a signal to a patch you wear that connects with your smartphone

More ways PDTs use technology include:

• Devices or apps that provide CBT, a common type of therapy

• A sensor that attaches to an inhaler containing medicine that tracks its use and sends information to an app on your smartphone

• A device that sends electrical signals to your nerves through a patch that you apply to your body

• An app that you play like a video game on a device

PDTs are held to similar standards for safety and efficacy (how well they work) as other medical devices and prescription medicines by the FDA. And like medicines and devices, they are carefully reviewed by the FDA before they can be allowed for use.

PDTs and other medical devices are reviewed by the FDA for the specific health need or medical condition and group of people they were developed for. The FDA can then allow them for use by giving an approval or a clearance. An approval means the FDA has found that the device provides enough benefits to outweigh any known and potential risks. A clearance means it has been shown to be reasonably safe and effective for its intended use.

While many digital health products are unregulated, PDTs are regulated by the FDA as medical devices. And unlike many wellness apps, medication reminders, health tools, or digital treatments you can get without a prescription, PDTs have been reviewed by the FDA for safety and for their ability to cause a specific change in your health, function, or quality of life. PDTs also need to be prescribed by your doctor.

All treatments, including PDTs, can work differently for different people. So talk to your doctor about if a PDT may be recommended, alone or in combination with other types of treatment, as part of your or your child's treatment plan.

Questions you can ask your doctor about PDTs can include:

• Is there a PDT allowed for use for my or my child's health needs or medical condition?

• Where can I fill a prescription for a PDT?

• How do I use the PDT and how we will know if it's working?

• Will I need to use other types of treatment along with the PDT, such as medicine or counseling?

• Where can I find additional resources and information?

Congratulations!

You have successfully completed the program Digital Treatment Options: Are They for You?

View Additional Materials on this topic that you may find useful:

What is Digital Health?

Dealing With ADHD: What You Need to Know

Understanding ADHD -- CHADD