Digital Health at an Inflection Point: Innovation, Access, and Emerging Risk

Digital health is rapidly reshaping how healthcare is delivered, expanding access while introducing new clinical, regulatory, and liability risks. Technologies such as digital therapeutics (DTx) and telehealth platforms are at the forefront of this transformation, enabling more personalized, scalable, and data-driven care models.

At the same time, these innovations place increasing responsibility on companies operating in the space. As more of the patient experience moves to digital platforms, maintaining trust becomes central to how these technologies are adopted and scaled.

Digital Therapeutics

Digital therapeutics represent a growing segment within digital health, offering evidence-based interventions delivered through software to prevent, manage, or treat medical conditions. Unlike general wellness applications, many DTx products are subject to U.S. Food & Drug Administration (FDA) review, often through the 510(k) clearance pathway, depending on their intended use and risk profile.

These technologies are often used alongside traditional treatments—although some can function as standalone interventions, depending on the clinical context—and are particularly effective in addressing conditions that benefit from behavioral or lifestyle interventions, including diabetes, insomnia, substance use disorders, and mental health conditions.

DTx platforms can take many forms, from mobile applications to interactive programs. Their key advantage lies in their ability to deliver personalized, real-time interventions that adapt to patient input and behavior—capabilities that traditional therapies alone may not achieve.

Case Study: Rejoyn and the Evolution of DTx

One prominent example of this emerging category is Rejoyn, a digital therapeutic developed for individuals with Major Depressive Disorder (MDD). Cleared by the FDA in 2024, Rejoyn is designed as a six-week adjunctive program to be used alongside antidepressant medication.

The platform utilizes memory-based cognitive exercises intended to strengthen connectivity between the amygdala, associated with emotional processing, and the prefrontal cortex, which plays a central role in decision-making and behavioral regulation. This neural pathway is often implicated in individuals with depression.

Early clinical findings suggest that such interventions may improve measures of depression severity, including standardized scoring systems such as the Montgomery-Asberg Depression Rating Scale (MADRS). While additional long-term data will be important, Rejoyn illustrates the potential for DTx solutions to complement pharmacological treatment and enhance patient outcomes through targeted, data-driven engagement.

Telehealth Expansion and Access Considerations

Alongside digital therapeutics, telehealth has become a central component of modern healthcare delivery. Telehealth refers to the provision of healthcare services remotely using telecommunications technologies, including virtual consultations, remote monitoring, and digital prescribing workflows.

By reducing geographic and logistical barriers, telehealth has expanded access to care—particularly for patients in underserved areas or those with limited ability to attend in-person visits. These platforms also offer potential cost efficiencies and improved continuity of care.

However, as telehealth models scale, they also introduce new operational and regulatory complexities, especially where clinical care intersects with prescribing practices, pharmacy services, and fulfillment.

Case Study: Hims & Hers and Compounding Scrutiny

Recent developments involving Hims & Hers Health, Inc. and Novo Nordisk highlight the growing regulatory and reputational considerations associated with digital health business models.

In April 2025, the companies announced a partnership aimed at expanding access to obesity treatments, including Novo Nordisk’s GLP-1 therapy, Wegovy. By June 2025, however, Novo Nordisk terminated the agreement, citing concerns related to the telehealth provider’s approach to compounded medications and potential regulatory compliance issues.

Compounded drugs are custom-prepared formulations intended to meet individual patient needs when commercially available, FDA-approved products are not appropriate. However, regulatory scrutiny increases when compounding activity begins to resemble large-scale manufacturing or is paired with broad commercial marketing efforts.

The dispute between Hims & Hers Health, Inc. and Novo Nordisk has been widely reported as centering on issues of sourcing, scale, and promotion of compounded therapies, in addition to prescribing practices and patient access considerations. While the specifics of the disagreement remain subject to interpretation, the situation underscores the potential for regulatory tension and complexity at the intersection of telehealth, pharmacy services, and commercialization.

Navigating the Regulatory and Ethical Landscape

These developments illustrate the broader challenges facing digital health companies as they innovate within a complex and evolving regulatory environment. Oversight may involve multiple authorities, including the FDA, Federal Trade Commission (FTC), state medical boards, and pharmacy regulators, each with distinct requirements and enforcement priorities.

As the space evolves, companies must navigate several key considerations:

• Regulatory compliance across device, software, and pharmaceutical frameworks;
• Appropriate use of compounding practices, particularly in high-demand therapeutic areas;
• Transparency in marketing and patient communications;
• Data privacy, security, and integrity; and
• Clinical validation and evidence generation.

Failure to adequately address these areas can result in reputational harm, regulatory enforcement, and erosion of patient trust—risks that may be amplified in digitally enabled care models.

Outlook: Balancing Innovation with Accountability

Digital health continues to offer significant promise in redefining healthcare, from expanding access to care, to enabling more personalized and responsive treatment pathways. However, the long-term success of the sector will depend on its ability to balance innovation with rigorous clinical validation, regulatory compliance, and ethical responsibility.

The recent scrutiny of high-profile telehealth and digital health partnerships serves as a reminder that trust is foundational to adoption. Companies that prioritize patient safety, transparency, and adherence to regulatory standards will be better positioned to sustain growth and credibility in an increasingly competitive landscape.

For stakeholders across the ecosystem (including providers, payers, technology developers, and insurers), the focus must remain on ensuring that innovation is matched by accountability. Those organizations that can find and maintain the balance will not only unlock the full potential of digital health but also help define the standards by which the industry is evaluated.

Authored by Jeffrey Pirog, Berkley Life Sciences, Life Sciences Intern