From Insight to Intervention: Why Over-the-Counter Digital Therapeutics (ODTx) are the Next Step for LLMs and Wearables

Consumers have never had more access to health information. Wearables, such as fitness trackers, smartwatches, and smart rings can track sleep, heart rate, and activity with increasing sophistication. Today’s generalist large language models (LLMs), like OpenAI’s ChatGPT and Anthropic’s Claude, can instantly answer health questions, summarize symptoms, and suggest next steps. And increasingly, these solutions offer healthcare versions with more specific value props, like validated atrial fibrillation detection for wearables, or improved data security and health record integration for LLMs. But for the tech giants and health innovators behind these tools, the real question is: now that we’ve mastered the ‘insight,’ when do we start delivering the actual intervention?

As impressive as these modern consumer offerings are, they have an express limitation: they are primarily designed to interpret data from the past and offer guidance in the “now.” In other words, while they excel at showing where a person has been, and suggesting in the moment what to do next, they have yet to figure out how to reach into the future – to promise reliable long-term behavior change or goal attainment. This is because these products have yet to offer treatment solutions designed to get users from their current health state to a desired future health state. 

This creates a massive, untapped opening for tools that move people from awareness to action in a clinically meaningful way, without the cost and access barriers of engaging the healthcare system or requiring a prescription. Over-the-counter digital therapeutics (ODTx) are emerging as a credible solution to that problem, offering a middle ground between consumer wellness tools and prescription-only digital treatments.

Data is everywhere, direction is not

Consumer wearables and LLMs are highly effective at observation and interpretation. Sensors collect physiological data over time, and algorithms increasingly identify patterns that may correlate with stress, sleep disruption, or disease risk. LLM chatbots, meanwhile, have become a popular first stop for consumers seeking explanations or advice, sometimes even substituting for conversations with clinicians.

However, both approaches share a structural limitation – they stop short of delivering a reliable and validated treatment experience. Wearables can highlight trends, but leave users to decide what to do next. LLMs can suggest strategies, but they rely heavily on user initiative and diligence for follow-through. Without structure, accountability, and validation, even well-intentioned guidance often fails to translate into sustained behavior change or improved clinical outcomes.

As a result, consumers frequently assemble their own patchwork of solutions, mixing apps, advice, and tracking tools, or turn to wellness products that promise results without evidence. At best, this means consumers can now identify health needs sooner and make changes more quickly, helping them become more active participants in their own care. At worst, this patchwork can skew users’ perception of their health situations and delay access to appropriate, validated medical treatments.  

Accessible interventions – the missing link

While the digital health landscape is largely defined by unregulated wellness apps that lack clinical rigor, increasingly, prescription digital therapeutics (PDTs) are authorized by the U.S. Food and Drug Administration (FDA) to treat specific diseases and are supported by robust clinical trials. ODTx occupies a relatively new space between these categories. They are regulated as software-as-a-medical-device (SaMD) and require FDA authorization supported by clinical evidence. Unlike prescription products, however, they can be accessed directly by consumers without clinician oversight; addressing patient’s need for accessible care, while still providing medical guardrails. 

The distinction matters because regulation shapes both trust and accessibility. FDA authorization enables ODTx to make therapeutic claims that are backed by evidence – something wellness apps and general consumer tools cannot do. At the same time, their over-the-counter status removes barriers that often limit the adoption of prescription-only solutions.

This combination creates several potential advantages. First, ODTx are designed not just to inform or advise, but to deliver a structured intervention over time. Rather than offering isolated insights or one-off recommendations, they provide a defined treatment experience intended to drive measurable change.

Second, they can integrate with broader digital ecosystems. Data from wearables or inputs from consumer LLMs can help inform the therapeutic experience, while the digital therapeutic itself provides the action layer – turning insight into guided, evidence-based intervention.

Third, accessibility plays a central role. Consumers increasingly expect healthcare tools to be available on demand, much like other digital services. ODTx align with that expectation by allowing individuals to independently choose between different validated treatments and get instant access to them without waiting for appointments or coverage decisions. 

Fourth, ODTx can ‘level up’ the existing strengths of these consumer technologies. For wearables, this can mean leveraging highly sensitive sensor data to deliver closed-loop, adaptive treatments. For LLMs, this can mean providing specialized clinical interventions using their existing natural language interface. For example, our company, Click Therapeutics, has done work on each of these opportunities: by investigating ways to modify GLP-1 dosing based on biometric data, and by adapting LLM chat agents to deliver social skills training.

And ultimately, ODTx offer trust. Trust remains foundational to medicine, and as such is a critical issue in digital health, particularly as these new technologies increasingly move into the center of clinical care. While consumer LLMs can be useful for education and support, they are generally not regulated as medical devices nor designed to deliver treatment. They don’t require clinical validation of their performance, nor are they subject to the quality or cybersecurity requirements of medical devices. Their outputs can vary, and they typically lack the personalized follow through needed to support adherence over time.

ODTx, by contrast, are evaluated for safety and efficacy for specific uses. This does not make them a replacement for clinicians or the healthcare system, but it does provide consumers with a higher degree of confidence that the intervention they are using has been reviewed and validated. FDA authorization enables clearer communication about what a product is intended to do and what outcomes it can support, reducing ambiguity in a crowded market.

ODTx as a path forward

As more people use wearables and LLMs to inform their wellness, demand is growing for digital health solutions that deliver tangible outcomes without unnecessary friction. Meeting that demand will require LLM and wearable companies to move beyond insights and invest in outcomes. ODTx are poised to bridge that gap, and provide a pathway to consumer-accessible treatments that maintain clinical rigor while fitting naturally into everyday digital life.

Investment in ODTx addresses a growing recognition that insight, advice, and treatment serve different roles. When combined thoughtfully, these elements can reinforce one another. Data can identify needs, AI can contextualize them, and ODTx can provide a validated path forward. 

For consumers, this integration offers something the current market too often lacks: clarity. Instead of navigating a landscape of tools that they have to patchwork together, individuals can move through a more coherent health journey that is actionable, personalized, and grounded in clinical evidence. For companies, the opportunity is equally clear. Those that invest in ODTx can move from monitoring health to meaningfully improving it, creating double value for users and the healthcare system alike. 

ODTx enable a shift from monitoring health to mastering it, delivering clinical outcomes at a scale that our overstretched healthcare system can no longer provide alone. They represent the missing link, converting the passive data of wearables and the raw insights of LLMs into a promising new category of consumer healthcare. The companies that recognize this opportunity, and begin now to build a comprehensive ‘doctor’s bag’ of ODTx, will soon stand out as delivering the next generation of healthcare – one that is accessible, on-demand and puts patients at the center.

Photo: LDProd, Getty Images

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