About the Authors
Ashish Jain, MS, BScPharm, is currently working as senior director, clinical safety and pharmacovigilance at Curis.
Zahabia Adenwala, PharmD, MS, is currently working as director of safety sciences at Biotech.
Spotlight
Clinical Role
Clinical
Supplement Spotlight
CE
Subscribe
Commentary
Article
The Evolving Role of Pharmacovigilance in Digital Therapeutics
Digital therapeutics (DTx), a novel evidence-based software approach, is revolutionizing health care by delivering personalized treatments. Pharmacovigilance ensures DTx safety but faces challenges such as data privacy and standardization.
Digital therapeutics (DTx) are one of the new and remarkable advancements in the health care field over the past several years. Consisting of evidence-based software, DTx administers therapeutic solutions directly to patients and is different from traditional therapeutics that mainly rely on chemical-based agents. Instead, DTx uses digital means—such as mobile apps, online programs, and virtual reality–based systems—to manage and prevent ailments. This novel strategy makes it possible to implement treatment regimens that are tailored to the patient’s needs, increasing patient engagement and adherence to the provided interventions.1-3
The expansion of DTx has been fueled by technological advancements. Image Credit: © adam121 - stock.adobe.com
The expansion of DTx has been fueled by technological advancements, smartphone proliferation, and a growing preference for solutions that require little to no human interaction. The COVID-19 pandemic played a role in accelerating this trend, as health care practices attempted to limit the number of in-person visits while ensuring continuity of care.4,5 The adoption of digital health solutions became critical during this time, resulting in an increased acceptance and uptake of DTx solutions.6,7
DTx Pharmacovigilance
The science of the safe and effective use of medical products is of utmost importance. Patient safety for DTx involves a process of ongoing assessment of DTx adverse events (AEs) that is very different from conventional drug safety evaluation. There are some barriers that are unique to DTx that affect the practice of pharmacovigilance.
Privacy and data security are key concerns, since patient data collection and processing is regulated and patients’ confidentiality has to be maintained.8,9 Furthermore, the absence of standard criteria for documentation of AEs related to DTx adds to the complexity of the evaluation process, leading to further challenges in the development of standardized procedures across various modes of delivery and techniques.10 However, there remains a continued need for the collection of data, despite the challenges that real-time delivery presents.6
The regulatory framework of DTx is developing as the FDA and European Medicines Agency restructure their systems to include these novel technologies. Regulatory agencies have begun to appreciate the role of DTx in the health care setting, which has, in effect, contributed to the development of regulatory frameworks aimed at easing the approval and usage of DTx in practice.11,12 However, the rate at which technology progresses often surpasses the rate at which regulations are established, leading to a gap in the application and understanding of the ways in which DTx should be evaluated and/or supervised.7,13
To ensure effective pharmacovigilance of DTx, some baseline standards should be met. These include establishing mechanisms for reporting AEs, utilizing real-world evidence to guide the assessment of risk-benefit, and encouraging active engagement of relevant stakeholders, including clinical practitioners, DTx manufacturers, and their regulators.6,8
Patient safety should remain the focus of DTx projects. By bringing in different ideas and knowledge, the pharmacovigilance framework of DTx can be enhanced. For example, the combination of artificial intelligence (AI) and blockchain technology has the potential to revolutionize the pharmacovigilance of DTx as it augments safety and security of data. Consider that, in a DTx app for the management of type 2 diabetes, AI-driven algorithms are capable of predicting AEs, such as an episode of low blood sugar (hypoglycemia), through real-time and surveillance information (eg, blood sugar level and intensity of physical activity), allowing the system to notify the patient and doctor in time to reduce further risks. On the other hand, the deployment of blockchain ensures that the AE reports are addressed on an unalterable and consistent basis. For mental health DTx that use blockchain, AEs such as exacerbation of depressive symptoms are noted in real time using smart impressions, making a record of the AEs that cannot be altered and is available only to those with access.
The Future of DTx
The future of DTx and pharmacovigilance is promising, with potential developments including the integration of AI and blockchain technology. These innovations could enhance data security, streamline reporting processes, and improve the overall effectiveness of pharmacovigilance systems.4,7 Furthermore, the shift towards personalized medicine approaches may lead to more tailored DTx interventions, necessitating adaptive pharmacovigilance strategies that can respond to the unique characteristics of individual patients.3,5
In conclusion, the rise of DTx is reshaping the health care landscape, necessitating re-evaluation of pharmacovigilance practices to ensure patient safety and treatment effectiveness. As technology continues to advance, the integration of innovative solutions and collaborative frameworks will be essential in navigating the challenges and opportunities presented by this dynamic field.
REFERENCES
Phan P, Mitragotri S, Zhao Z. Digital therapeutics in the clinic. Bioeng Transl Med. 2023;8(4):e10536. doi:10.1002/btm2.10536
Sverdlov O, van Dam J, Hannesdottir K, Thornton‐Wells T. Digital therapeutics: an integral component of digital innovation in drug development. Clin Pharmacol Ther. 2018;104(1):72-80. doi:10.1002/cpt.1036
Dang A, Arora D, Rane P. Role of digital therapeutics and the changing future of healthcare. J Family Med Prim Care. 2020;9(5):2207-2213. doi:10.4103/jfmpc.jfmpc_105_20
Yoo JH, Jeong H, Chung TM. Cutting-edge technologies for digital therapeutics: a review and architecture proposals for future directions. Applied Sciences. 2023;13(12):6929. doi:10.3390/app13126929
Kadakia K, Patel B, Shah A. Advancing digital health: FDA innovation during COVID-19. NPJ Digit Med. 2020;3(1):161. doi:10.1038/s41746-020-00371-7
van Kessel R, Roman-Urrestarazu A, Amderson M, et al. Mapping factors that affect the uptake of digital therapeutics within health systems: scoping review. J Med Internet Res. 2023;25:e48000. doi:10.2196/48000
Torous J, Stern AD, Bourgeois FT. Regulatory considerations to keep pace with innovation in digital health products. NPJ Digit Med. 2022;5(1):121. doi:10.1038/s41746-022-00668-9
Van Velthoven MH, Cordon C. Sustainable adoption of digital health innovations: perspectives from a stakeholder workshop. J Med Internet Res. 2019;21(3):e11922. doi:10.2196/11922
Iyamu I, Gómez-Ramírez O, Xu AX, et al. Challenges in the development of digital public health interventions and mapped solutions: findings from a scoping review. Digit Health. 2022;8:20552076221102255. doi:10.1177/20552076221102255
Lutz J, Offidani E, Taraboanta L, Lakhan SE, Campellone TR. Appropriate controls for digital therapeutic clinical trials: a narrative review of control conditions in clinical trials of digital therapeutics (DTx) deploying psychosocial, cognitive, or behavioral content. Front Digit Health. 2022;4:823977. doi:10.3389/fdgth.2022.823977
Watson A, Chapman R, Shafai G, Maricich Y. FDA regulations and prescription digital therapeutics: evolving with the technologies they regulate. Front Digit Health. 2023;5:1086219. doi:10.3389/fdgth.2023.1086219
Sharma B, Gurung A, Pradhan P, Dargee D, Kotla NK. Navigating the regulatory landscape: key trends shaping today’s regulatory affairs environment. Int J Drug Reg Affairs. 2023;11(4):87-92. doi:10.22270/ijdra.v11i4.639
Gutierrez L, Cauchon NS, Christian TR, Giffin MJ, Abernathy MJ. The confluence of innovation in therapeutics and regulation: recent CMC considerations. J Pharm Sci. 2020;109(12)3524-3534. doi:10.1016/j.xphs.2020.09.025
Related Videos
Related Content
Published: March 12th 2025 | Updated: March 13th 2025
MDMA Rejected: The Story of a Study Participant Entrenched in Ethical Violations and a Data Breach
