What do we know about Digital Therapeutics?
What Are Digital Therapeutics (DTx)?
It’s more than telehealth, the trend that had emerged before the pandemic and took hold as the convention of care for many of us during the lockdowns and quarantines of the past year and a half. Digital therapeutics is a phrase used to reference a field of software-based tools and technology that support health. They are designed — primarily by healthcare professionals and providers — to be functional health resources that integrate seamlessly with extant or developing health and wellness plans. Digital therapeutics have been especially prevalent and beneficial among the many Americans managing chronic illnesses.
While some wellness apps and related consumer products have been considered to be “digital therapeutics,” there are some key differences. Most wellness apps have broad reach with limited definition, while most tools considered part of digital therapeutics are narrowly focused on particular aspects of health management or particular conditions. Digital therapeutics differ from wellness apps in that they can work closely with or replace other treatments, like medications and therapies. And it is only in very rare cases that an insurance company will support a carrier using a wellness app or consumer health product, while many digital therapeutics are covered by insurance plans. But the key distinction that separates digital therapeutics from consumer products is that digital therapeutics have been rigorously evaluated before they are made available, and are as scrupulously regulated as any other therapy or medication: consumer health products don’t require a prescription, while most digital therapeutics do.
Not Just for the Chronically Ill
While digital therapeutics have had the greatest impact on people managing chronic illnesses, and are frequently used in conjunction with behavioral health services, they have proven a very broad and versatile resource. Digital therapeutics are used to support and even administer treatment; to integrate with ongoing therapies and interventions; decrease a patient’s reliance on other potentially more invasive courses, such as pharmaceuticals and extensive therapies; provide an expanding range of healthcare and wellness options.
Some of the conditions that are being treated and managed with digital therapeutics include: asthma and related disorders; attention deficit disorder and attention deficit hyperactivity disorder; behavioral health issues; chronic pain; concussions; diabetes; hypertension; neurological disorder; obesity; sleep disorders; substance abuse, and many others.
Digital Health Vs. Digital Therapeutics
“Digital health” includes digital therapeutics. Digital therapeutics are one aspect of digital health. A number of other emerging conventions are also considered elements beneath the digital health umbrella. A few of them: the wearable devices that help patients manage conditions such as diabetes and heart disease; consumer wearables such as activity trackers and dietary apps; interfaces that promote personalized wellness plans; telehealth: remote appointments and monitoring; and even the technology being used to manage patient records, including prescription management.
Digital Therapeutics: Safety, Evaluation, Efficacy
As stated above, digital therapeutics are as strictly evaluated and regulated by health agencies as are any other medical intervention, including pharmaceuticals. Digital therapeutics conform with rigid state and federal standards, comply with regulatory agencies, and must meet precise criteria during their manufacture, distribution, and administration. An overview of the regulatory process for digital therapeutics includes, in addition to the above: Strict compliance with advertising and labeling regulations; certification by relevant regulatory agencies; and established, clinical proof that the efficacy of the therapeutic has been supported by trials and other evaluations.
As with any intervention resource, the efficacy of digital therapeutics is of the greatest importance. A treatment that is safe and regulable would have limited utility if it were not effective. Extensive testing and clinical trials must yield evidence-based affirmative proof of efficacy before a digital therapeutic is approved for use. In most cases, this means completing a randomized control trial.
A randomized control trial administers the therapeutic to participants in a clinical trial. The participants are divided: one group receives the therapeutic that is being evaluated, while another receives a placebo — this group is the “control group.” The results are then compared. For a trial of this kind to be effective, it must be randomized, the number of participants must be statistically relevant, and the trial must be conducted under the supervision — and with the authorization of — the respective agencies.
How Are Digital Therapeutics Beneficial?
In the simplest terms, digital therapeutics provide options and flexibility. But they do a great deal more than that. They can be a critical tool in the sustained treatment and management of a range of disorders, chronic and otherwise. Digital therapeutics also provide agency: they allow patients to be more proactive in the management of their health and wellness than they can be when relying on in-person or clinical interventions alone. Digital therapeutics also increase awareness, aid in educating patients about their health and conditions, a vital step in the process of making informed decisions about courses of treatment.
Digital therapeutics are also a crucial resource for wellness, enabling patients who are not struggling with chronic conditions with health maintenance resources, customized care, and, most essentially, the potential for early diagnosis of conditions that are or could become life-threatening.
The Future of Digital Therapeutics
The list of tools, resources, and interventions that are considered digital therapeutics is growing rapidly. Already, an exhaustive list would be obsolete by the time it’s completed. The COVID-19 pandemic has moved digital therapeutics from the margins to the center and they are here to stay. They have become an imperative bridge between clinical care and self-care and are bringing both well and at-risk patients into the vanguard of the most important technology and empowering them with it.
