Despite Lack of Consensus on Definition and Regulations, Digital Therapeutics Are Becoming General Medical Practice


The market for digital therapeutics products is expected to grow given increasing global access to smart technologies, their cost-effectiveness, and the need for patient-specific treatments.

Although the clinical application of digital therapeutics (DTx) is growing and demand is increasingly high, the use of DTx as a general medical component remains limited by the lack of a cohesive definition.

Credit: ra2 studio -

Credit: ra2 studio -

The use of health care technologies using personal smart devices and information is growing rapidly and is expected to be part of a paradigm shift in medicine and health care. Thus far, these technologies have come in the form of health apps that are primarily used to support major medical practices or to promote wellness through prevention and prognosis management.

However, without a consensus around the definition of DTx, the growing demand for these products can result in products that have not been proven clinically for the prevention, management, or treatment of disease. With this in mind, a growing body of research is investigating the optimal uses and definition of DTx, according to the authors of an article recently published in NPJ Digital Medicine.

The term DTx was first mentioned in 2015 by Sepah et al., who defined DTx as “evidence-based behavioral treatments delivered online” to increase health care accessibility and effectiveness. Additionally, the Digital Therapeutics Alliance has defined DTx as “evidence-based therapeutic interventions that are driven by high-quality software programs to treat, manage, or prevent a disease or disorder.”

However, there is no clear international agreement on the definition, and it is being interpreted and applied differently in countries and research institutes. DTx is considered a subcategory of digital medicine, under the larger umbrella of digital health.

Digital health, digital medicine, and DTx products all have different requirements for clinical evidence and regulatory oversight because of different claim levels and risk levels. DTx with prescription-only characteristics are classified as prescription DTx (PDTx).

Notably, DTx require minimal development cost compared with pharmaceuticals and the development period is approximately half, according to the study authors. In addition, manufacturing facilities and material costs for additional production after initial development are not required, and the delivery path to patients is much simpler than the complex distribution channels for pharmaceuticals.

The primary difference between DTx and wellness applications is that DTx applications are developed with clinical evidence to target specific medical conditions, and particularly major chronic diseases. Commercial DTx that have been released thus far are primarily developed for indications such as chronic and neuropsychiatric diseases, which can be treated through behavioral change. Despite rapid commercialization, however, these products have not been fully implemented into clinical practice due to insufficient evidence that proves their efficacy.

For clinical trials, DTx can obtain marketing approval through piloting, which is optional, and pivotal clinical trials through the medical device regulatory pathway in most countries. Unlike existing pharmacotherapy that has adverse effects (AEs), DTx are considered to have only minor AEs primarily associated with the use of mobile devices. Medication adherence with DTx is known to be approximately 80%, which is notably higher than the 50% adherence to pharmacotherapies.

The authors settled on 45 trials to analyze after screening 50,872 in clinical literature. Detailed clinical trials related to psychiatric indications were the most common (31.1%), followed by neurological (22.2%), endocrine (20%), respiratory (11.2%), poisoning (8.9%), and cardiovascular disease (6.7%). Neuropsychiatric and chronic diseases accounted for the majority of indications in clinical studies currently underway, although the scope of DTx is expanding with indications for other neurological diseases.

In an international comparison, the United States had the most registered trials with 27 (60%). The research was conducted by various institutions, including 24 companies (53.3%), 4 pharmaceutical companies (8.9%), 7 universities (15.6%), 4 hospitals (8.9%), 3 research institutes (6.7%), 2 medical consortiums (4.4%), and 1 other (2.9%).

Many countries are promoting the commercialization of DTx through multi-sector cooperation between regulatory authorities, pharmaceutical companies, and medical experts. In the initial stage, DTx are approved and commercialized primarily for chronic diseases such as diabetes, cardiovascular disease, respiratory disease, and chronic pain or neuropsychiatric diseases.

However, DTx for more diverse indications, such as irritable bowel syndrome, migraine, joint replacement surgery, and ear disease, have been launched more recently. Most DTx have been released through FDA clearance led by the United States.

Finally, the investigators examined current regulation of digital therapeutics. Six guidelines and 1 policy document were investigated for DTx-related regulations within the International Medical Device Regulators Forum member jurisdictions. The FDA has permitted the distribution and use of devices during public health emergencies without filing a premarket notice because the FDA does not consider DTx to pose an undue risk.

Although there are currently no specific guidelines outside of South Korea, the continued approval of DTx through regulatory authorities in the United States, Europe, and Japan suggest that approval is possible within current regulatory systems. However, investigators and experts are pushing for the establishment of a regulatory system suitable for DTx to address issues with vague or insufficient guidance currently available.

Given the growing global access to smart technology, their cost-effectiveness, and patient-specific treatment needs, the experts said they expect the market for DTx products to continue growing. However, for DTx to progress from the introduction stage to become a successful and widely-used treatment technology, barriers such as the vague definition and lack of cohesive guidance must be addressed.


Wang C, Lee C, and Shin H. Digital therapeutics from bench to bedside. NPJ Digital Medicine 6:38(2023). doi:10.1038/s41746-023-00777-z

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