Prescription Digital Therapeutics: Evidence-Based Therapeutics in Mental Health Care

Prescription digital therapeutics (PDTs) are evidence-based, software-driven treatments designed to address various disorders, including mental health conditions such as depression, anxiety, and substance use disorders.^1,2 PDTs are rigorously evaluated for safety and effectiveness in randomized controlled trials and are developed under stringent quality standards, including Good Manufacturing Practices.¹ Unlike general wellness apps, PDTs require regulatory clearance and are subject to post-marketing surveillance requirements similar to regulated pharmaceutical products.^1,2 Given the increasing prevalence of mental health disorders and ongoing treatment gaps, technologies such as PDTs are emerging as a possible solution.¹  

PDTs Require Regulatory Authorization and Clinical Oversight

The US Food and Drug Administration (FDA) regulates digitally administered therapies as software as a medical device (SaMD), which is defined as software intended for the diagnosis, treatment, or prevention of disease without being part of a hardware medical device.² PDTs are commonly regulated as Class II medical devices, which suggests that they pose a low-to-moderate risk of harm to patients and require clinical data to demonstrate safety and effectiveness.^2,3 PDTs are authorized through either the de novo pathway, requiring clinical evidence of the safety and effectiveness of the device, or the 510(k) pathway, which requires clinical data demonstrating comparable safety and effectiveness to an already approved device.^1,2 In 2017, the FDA introduced the Software Precertification Pilot Program to address software-specific challenges, focusing on developer quality rather than individual products to hopefully enable faster updates and streamlined oversight.²  

Currently, there are more than 20 PDTs, with 9 cleared to treat the behavioral dimensions of mental health disorders, including insomnia.^1,4 The use of a PDT requires a prescription from a licensed healthcare professional.² PDTs may be prescribed as a standalone therapy or as an add-on to current therapy, and they may be covered by health insurance.^2,5  

Current Status of Digital Therapeutics in Psychiatric Care

Over 400 clinical trials have investigated the effectiveness of digital therapeutics in reducing symptoms of a myriad of conditions, including neurological, metabolic, psychiatric, and musculoskeletal diseases.⁶ Digital therapeutics are attractive because they may allow healthcare providers to offer treatment options for patients at a larger scale than traditional treatment modalities.⁶ Though PDTs offer increased convenience, some patients with complex conditions may require continued direct intervention to promote PDT compliance.1 Additionally, further education on PDTs is needed for providers to support the theoretical and practical implementation of PDTs into clinical practice.¹  

Conclusion

PDTs are validated, evidence-based software developed to address behavioral dimensions of various disorders and mental health conditions.^1,2 PDTs are classified as SaMD products and typically regulated by the FDA as Class II medical devices, which requires demonstrated evidence of safety and effectiveness for authorization.^2,3 While PDTs continue to offer promising solutions in psychiatric care, further work is needed to increase understanding and awareness for clinicians and patients.^1,6 

References:

1. Brezing CA, Brixner DI. The rise of prescription digital therapeutics in behavioral health. Adv Ther. 2022;39:5301-5306. doi:10.1007/s12325-022-02320-0
2. Watson A, Chapman R, Shafai G, et al. FDA regulations and prescription digital therapeutics: Evolving with the technologies they regulate. Front Digit Health. 2023. doi:10.3389/fdgth.2023.1086219
3. U.S. Food and Drug Administration. Class II Special Controls Document. Updated June 14, 2022. Accessed March 6, 2025. https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/class-ii-special-controls-documents
4. Phan P, Mitragotri S, Zhao Z. Digital therapeutics in the clinic. Bioeng Transl Med. 2023;8:e10536. doi: 10.1002/btm2.10536
5. Xiong x, Braun S, Stitzer M, et al. Evaluation of real-world outcomes associated with use of a prescription digital therapeutic to treat substance use disorders. Am J Addict. 2022. doi: 10.1111/ajad.13346
6. Miao BY, Sushil M, Xu A, Wang M, Arneson D, Berkley E. Characterization of digital therapeutic clinical trials: A systematic review with natural language processing. Lancet Digital Health. 2024;6(3):e222-e229. 

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