The first part of this two-article series on digital therapeutics (DTx), “The Rise of Digital Therapeutics,” provided visibility into this growing landscape or care and outlined key considerations for developer. This second installment sheds light on challenges faced by the companies in the DTx market and outlines hurdles that must be overcome to achieve success.

As a new technological course of treatment, DTx face challenges on several fronts. To ensure the advancement of these digital treatments, the industry will need to navigate the following:

Regulatory

Regulation is an area that has the potential to slow the development, creation and release of digital therapies. Legislation and the approval process for new entrants are advancing slower than the evolution occurring with DTx technologies. The rapid pace of innovation will be negatively impacted if regulations can’t modernize at the same rate. If the U.S. Food and Drug Administration (FDA) and other regulatory bodies cannot implement scalable policies and processes to swiftly approve the ever-changing and ever-improving DTx offerings, regulations could inhibit innovation and growth.

Adoption

Adoption of DTx can be a multi-front battle. From the patient perspective, interest in the technology may wane if outcomes are not immediate. This is problematic for treatments where the impact requires long-term use.

In general, technology use tends to have a higher adoption rate among higher socioeconomic groups. The hope that DTx can serve as a bridge to deliver care to underserved areas and demographics can be left unrealized if the same targeted users don’t utilize the technology, thus broadening the same divide that DTx could help narrow.

Data privacy concerns extend to all patient classes and can be an inhibitor to using DTx. With a large proportion of the U.S. population consisting of seniors, the potential exists for a vast portion of the patient population to opt-out of DTx, as this demographic is typically hesitant (even resistant) to adopt and utilize new technology.

Clinicians, physicians and healthcare providers may have an initial bandwidth burden to implement new processes and deliver extensive training necessary for staff to administer DTx and make the most of the vast amount of data that the technology provides.

Ongoing Support

One barrier that companies within the DTx industry will need to overcome is ensuring that their therapeutic apps and technologies are supported over the long-term. Unlike durable medical equipment that does not require ongoing upkeep, DTx apps must be supported throughout patient use. Bug fixes, operating system upgrades and ongoing enhancements are needed to keep apps updated. This is critical as these treatments impact patient health, and downtime has the potential for adverse consequences.

Moreover, not all patients find new technologies intuitive and will require technical assistance and live support. Providers will face similar challenges in usage and require some type of technical or customer service. DTx manufacturers will need to make a significant commitment and investment to app upkeep and maintenance.

Efficacy

Being able to prove a demonstratable impact is a hurdle that DTx will need to overcome to separate the technology from novelty apps and fitness trackers. If DTx manufacturers are unable to provide measurable clinical outcomes, healthcare providers and prescribers are unlikely to endorse a DTx solution. Clinical trials that prove the effectiveness of treatment through clinical evidence, real-world outcomes and peer-reviewed publications are an integral part of articulating the benefits of DTx.

Monetization

Ultimately, DTx need to provide proof of value to remain viable. If a therapy can demonstrate that it lowers healthcare costs, reduces complications, diminishes acute-care utilization or supplants more expensive in-person provider visits with an app or a remote/virtual visit, payers are more likely to value this type of care. If any of these can be accomplished, DTx have a greater likelihood of being reimbursed.

Payer reimbursement is going to be key. While some DTx companies are utilizing a subscription-based direct-to-consumer model, it may be an uphill climb as consumers expect their insurance will cover the cost of their healthcare, regardless of the mode of delivery. For insured patients, the therapy being provided could be covered by the payer as a pharmacy benefit, medical benefit or even a wellness benefit.

In certain instances, digital medicine companies sell or license their products directly to healthcare providers. Providers then make products available to their patients as part of their treatment plan, typically in the form of remote patient monitoring, virtual reality and other means of relaying data for use in clinical decision-making.

Privacy

Security and confidentiality are significant considerations facing DTx. With the extensive amount of personal data captured and processed through a complex digital ecosystem, the possibility of a patient’s profile being repurposed is a real concern. As data is collected and processed across numerous operating systems and digital platforms, application providers might unknowingly create vulnerabilities that could lead to unlawful access across devices and providers due to security flaws. Given the sensitivity and amount of personal data flowing through a DTx application, any data breach could pose a significant threat to the patient.

Promising opportunities exist for innovators in the DTx space who can successfully navigate the regulatory waters, bolster adoption, demonstrate clinically impactful results, successfully monetize their technologies and ensure patient data safety. There has never been an opportunity to collect and analyze vast amounts of data on the same scale as with DTx. With these technologies, we have the potential to provide more efficient, accurate and personalized courses of treatment that continue to evolve and improve.