Beyond Proof of Concept
Software-enabled care is no longer experimental. Remote patient monitoring, digital therapeutics, and hybrid care models are increasingly part of care delivery.
It is no longer simply whether digital tools can influence outcomes. It is whether they can operate effectively within everyday care.
The first wave of digital therapeutics demonstrated that software could generate measurable results under controlled conditions. Remote monitoring showed that care could extend beyond traditional settings. Yet adoption has been uneven. Regulatory clearance has not guaranteed routine use, and reimbursement has not meant sustained implementation.
Healthcare systems are under increasing pressure from chronic disease growth, aging populations, and workforce shortages. Non-communicable diseases now account for approximately 74% of global deaths. Diabetes alone exceeds $1 trillion annually in global health expenditure, and mental health conditions remain a leading cause of long-term disability worldwide. These pressures are structural. If software-enabled care is to play a meaningful role in addressing them, it must function within existing systems rather than operate alongside them.
The next phase is not about proving that digital works. It is about proving that it fits.
From Add-On to Embedded
Many early digital therapeutics entered clinical environments as standalone interventions. They required new prescribing behaviors, separate dashboards, and data streams outside established EHR workflows. In systems already stretched thin, even clinically valuable tools added complexity.
Patients faced similar barriers. Sustained engagement depended on technical literacy and confidence in how personal data was handled. Concerns around privacy, interoperability, and device reliability slowed adoption. Uptake was uneven — not because digital tools lacked promise, but because they did not align with how care is organized and delivered.
What is evolving is how software-enabled care is positioned within treatment pathways.
Remote patient monitoring (RPM) is increasingly embedded within discharge and chronic care programs rather than positioned as an add-on. A recent meta-analysis found that RPM significantly reduced heart failure-related hospitalizations compared to standard care and improved health-related quality of life. As multimorbidity rises, such models offer a practical way to detect deterioration earlier and reduce unplanned admissions.
In diabetes, programs combining continuous monitoring with behavioral support align with the condition’s long-term management demands. By enabling real-time visibility and reducing treatment burden, they improve glycemic control while expanding access to specialized care in rural and underserved communities.
Mental health reflects both progress and constraint. FDA-cleared digital therapeutics such as EndeavorRx (ADHD) and reSET (addiction) established regulatory precedent, yet real-world uptake has remained limited, in part due to reimbursement uncertainty and unclear implementation pathways. When integrated alongside conventional treatment, digitally enabled mental health models offer a promising complement in a field defined by long wait times and growing need.
These examples point to a recalibration. Digital therapeutics and remote monitoring gain traction when positioned as structured extensions of care rather than discrete products.
Formalizing Digital Care
As digital tools become more embedded in care delivery, institutional frameworks are adjusting to reflect that shift.
The U.S. Food and Drug Administration’s (FDA) recent updates to digital health guidance, including refinements around clinical decision support and certain lower-risk software functions, signal continued normalization of software-enabled care. The FDA’s Prescription Drug Use-Related Software (PDURS) framework and Europe’s Health Data Space (EHDS) Regulation further clarify how software and newly generated health data can operate within regulatory boundaries.
At the same time, reimbursement pathways are maturing. Germany’s Digitale-Versorgung-Gesetz (Digital Care Act), or DiGA, remains a leading example of how digital health applications can be systematically evaluated, prescribed, and reimbursed within a statutory healthcare system under defined evidentiary standards.
In the United States, expanded billing codes for remote patient monitoring and related digital services reflect that care increasingly spans connected devices, patient homes, and virtual touchpoints. More than 400 U.S. hospitals are now approved to provide hospital-at-home services, underscoring the normalization of distributed care models.
Digital care is increasingly being incorporated into established regulatory and reimbursement processes rather than treated as a separate category.
Digital and the Treatment Model
As digital tools move from experimental deployments to institutional incorporation, their influence extends beyond delivery and into therapeutic strategy.
Pharma has long experimented with digital — through adherence programs, patient support services, connected drug–device ecosystems, digital biomarkers, and decentralized clinical trials. Historically, these initiatives supported treatment use or data collection rather than shaping how therapy functions in routine care.
That distinction is narrowing. As remote monitoring and software-enabled interventions become part of structured care models, digital components increasingly influence real-world therapeutic performance and clinical outcomes. In conditions where adherence, behavioral reinforcement, symptom tracking, or early detection meaningfully affect outcomes, software can shape effectiveness alongside pharmacology.
This shift is visible across therapeutic areas. Otsuka’s collaboration with Click Therapeutics on Rejoyn for major depressive disorder reflects efforts to pair software with traditional treatment. In oncology, digital companions that support symptom management facilitate oversight between visits. Connected devices, from smart insulin pens to sensor-enabled inhalers, embed monitoring directly into daily at-home therapeutic use.
As patient-facing services expand and digital tools increasingly inform evidence generation, the strategic question shifts from whether to participate in digital health to how therapies are positioned within care models that are themselves becoming more digital.
Integration and Longevity
Software-enabled care is at an inflection point. Clinical validation has advanced in certain therapeutic areas, regulatory frameworks are evolving, and reimbursement pathways are adapting. What remains uneven is how consistently these tools function within everyday care delivery.
Health systems worldwide face mounting pressures and require models that extend care without increasing fragmentation. Digital interventions demonstrate value when they align with care delivery realities — integrated into structured pathways, complementing existing therapies, and functioning within established regulatory and reimbursement frameworks.
The future of digital health will not be determined by novelty alone. It will depend on whether software can operate reliably, generate measurable value, and remain aligned with the systems responsible for delivering care over time.
To continue the conversation on how digital care is moving from validation to operational and economic sustainability, apply to join our virtual roundtable, Digital Health Business Models: From Evidence to Economic Alignment, on March 11.