My degree in the Development of Digital Therapeutics for Psychotherapy focuses on understanding the creation, evaluation, and use of a variety of technologies to treat mental illness. The term digital therapeutics was first coined in 2012 by Click Therapeutics, but the field was formally defined by Dr. Cameron Sepah in 2015 as developing “evidence-based behavioral treatments delivered online that can increase accessibility and effectiveness of health care.”2 The field is now identified by the Digital Therapeutics Alliance (DTA) as a subset of digital health, which offers “evidence-based therapeutic interventions driven by high quality software programs to prevent, manage, or treat a medical disorder or disease.”9 Whereas, digital health products focus on wellness, telehealth, and general support systems for healthcare. Digital therapeutics are strictly evidence-based interventions that actively treat, manage, and improve health concerns. All digital therapeutics are required to be verified by 3rd party clinical evidence to support product claims.10
The Digital Therapeutics Alliance distinguishes digital therapeutics from the broader category of digital health through their requirements for clinical evidence and approval from appropriate regulatory bodies.10 From a regulatory perspective, digital therapeutics belong to the category of Software as a Medical Device (SaMD). This term, established by the International Medical Device Regulators Forum and used by the Food and Drug Administration, views digital therapeutics as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.”8 While not every software as a medical device is considered a digital therapeutic, all DTx products belong to this regulatory category.
Currently, digital therapeutics are being tested in the FDA’s Software Precertification Pilot Program. This program has allowed nine pilot companies, including DTx company Pear Therapeutics, to receive a more streamlined review process for their software as a medical device products.11 The process uses iterative cycles of product development, based on real world performance. It draws heavily upon entrepreneurial techniques, as shown by the FDA’s hiring of three entrepreneurs in residence to oversee the development of the process.11 Additionally, leading companies, such as Pear Therapeutics and Big Health, have created an entrepreneurial culture by organizing and operating as agile startups.12,13 Executives of DTx companies, such as Big Health’s Peter Hames, often have a background in software development and hire a team of medical or psychological experts to support the development of a new digital therapeutic.12,13
Given the complexity of evidence, regulation, software development, and entrepreneurial techniques within the field of digital therapeutics, my degree seeks to create an integrated explanation of these main areas of concern. I draw upon the discipline of psychology to gather knowledge in clinical psychology, psychotherapy, and research methodologies that inform and verify the efficacy of digital therapeutics. Information systems and philosophy explain the complicated ethical and regulatory concerns of digital therapeutics. Specifically, I use knowledge from health care informatics to understand the various payors, providers, and security concerns that govern digital therapeutics. Building on my associates degree in computer science, coursework in information systems exposes me to a wide variety of development methodologies and programming languages for creating digital therapeutics. Human computer interaction is necessary for evaluating product user interfaces and creating enjoyable user experiences. Coursework in entrepreneurship provides a framework for understanding the rapidly evolving field of digital therapeutics and identifying areas for innovation. Management fundamentals also prepare me to achieve my long-term goals of being a digital therapeutic entrepreneur or team lead. An interdisciplinary degree enables me to draw upon explanatory knowledge from the social sciences in order to develop better products in the digital therapeutics field.