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INNOSC Theranostics and
Pharmacological Sciences Digital therapeutics for obesity management

Figure 1. The workflow of prescription digital therapeutic solutions. Image is created by author.

developers must provide robust evidence from randomized
controlled trials (RCTs) or other well-designed studies
showing that the DTx achieve the intended health outcomes.
In addition, the software must adhere to strict data privacy
and security standards, ensuring the protection of patient
information in compliance with regulations like the Health
Insurance Portability and Accountability Act (HIPAA). 13
Beyond the FDA, other regulatory bodies worldwide,
such as the European Medicines Agency and various
national health authorities, have established guidelines
and frameworks for the approval and oversight of PDTs.
These regulations ensure that PDTs can be safely and
effectively integrated into healthcare systems globally,
providing patients with reliable and clinically validated
DTx options. 14
In summary, PDTs represent a transformative approach
in managing obesity, blending advanced technology with
clinical rigor. The stringent regulatory pathways they Figure 2. Uses of digital therapeutics. Image created by author.
navigate underscore their potential as powerful tools in
modern healthcare, offering personalized and effective Addressing both physical and mental health is crucial
interventions to combat obesity and improve overall health for lifestyle modifications. High motivation is essential
for adherence to these changes. Patients can develop
outcomes. Figure 2 illustrates the uses of DTx.
stimulus control by managing eating-related cues, using
3. DTx for obesity: An integrated and cognitive techniques to address maladaptive thinking,
multidisciplinary approach and enhancing coping skills for emotional regulation and
stress management. These psychological mechanisms,
3
Diseases like obesity and eating behavioral disorders are vital for mental health, are closely linked to physical
complex in nature and require a mix of lifestyle changes health and influence clinical outcomes. Consequently,
and medical treatment for effective management. 15 mental health should be a key component of DTx for

Volume 7 Issue 4 (2024) 3 doi: 10.36922/itps.4042