A New Chapter in Care Delivery: What FDA’s sDHT List Tells Us About the Future of Healthcare

Jennifer Goldsack, Dina Bam, and Smit Patel

On July 10, the FDA published a new list of medical devices that incorporate sensor-based digital health technologies (sDHTs). These tools - wearables, biosensors, ambient monitors, and the apps and platforms that accompany them - go far beyond the gadgets so many of us are now familiar with. They form the foundation of a connected, data-driven care model poised to reshape how healthcare is delivered, accessed, and reimbursed.

This new list offers a high-value inventory, reflecting a maturing landscape of FDA-authorized sDHTs ready for clinical use and reimbursement-eligible deployment across the care continuum. 

The implications for care delivery are profound. Over the last two weeks, I’ve been working with my colleagues Dina Bam and Smit Patel to explore what this list reveals about how our health system is evolving, from hospital-at-home to virtual-first care, from chronic disease management to behavioral health.

Last week, my colleague Sarah and I shared our take on what FDA’s publication of this list means for life sciences and the use of sDHTs in clinical trials.

Here, we focus on what the publication of this list tells us about the maturity of these tools in clinical care delivery today, and what it allows us to forecast for the future. To do that, we also reflect on the wave of policy and regulatory activity from the last two weeks that helps bring this moment into sharp focus. 

Let’s dive in…

📈 sDHTs are tracking with today’s clinical burden in America

The newly released list includes 215 FDA-authorized sDHTs between 2015 and 2025. When we analyzed this dataset, we saw patterns that directly mirror today’s most pressing clinical needs:

• Cardiovascular tools dominate, with over half of all authorizations falling under the cardiovascular review panel. This aligns with heart disease remaining the leading cause of death in the U.S. and the rapid expansion of virtual cardiology and remote hypertension management.

• Glucose monitoring is a mature category, with 17% of sDHTs reviewed under clinical chemistry (mostly continuous glucose monitors). Diabetes care is arguably the furthest along in digital transformation, from clinical adoption to reimbursement.

• Neurology is the emerging frontier, with an increasing number of clearances targeting conditions like epilepsy, Parkinson’s, and stroke recovery. As mental and behavioral health needs grow, so does the demand for objective, continuous measurement.

Sleep remains a high-need, under-represented area, with just 5% of FDA-authorized sDHTs despite strong scientific validation and enormous clinical relevance. We see this as a priority area for regulatory clarity and innovation, alongside opportunities for respiratory products.

📈 FDA authorizations and reimbursement policy are advancing hand in hand

FDA market authorizations of sDHTs have steadily increased alongside the introduction of CPT codes supporting remote patient monitoring (RPM) and remote therapeutic monitoring (RTM). Since CMS first reimbursed RPM in 2018, FDA authorizations for digital health tools have more than doubled, rising from 17 in 2018 to 37 in 2024, tracking closely with key CPT code milestones. It’s important to note that these reimbursement codes only apply to medical devices, not wellness tools or consumer products.

This correlation suggests that reimbursement policy has played a catalytic role in driving both demand and regulatory investment in digital tools, especially those enabling real-time physiological monitoring in virtual care environments. The expanding pipeline of authorized sDHTs reflects not only technological maturity but a growing alignment between regulatory readiness and payment infrastructure.

Given this backdrop, it’s worth asking: what effect will CMS’s recent proposed Medicare Physician Fee Schedule for calendar year 2026 have on the future of sDHT development?

The proposed rule, released earlier this month, includes several important updates that could expand the use of sDHTs across care settings:

• New RPM billing codes for 2–15 day monitoring durations and 10–20 minutes of clinical management time, an ideal fit for transitional monitoring, short-term programs, and hospital-at-home use cases.

• Preserved reimbursement for core RPM codes (99457/99458), providing critical stability for providers scaling virtual services.

• Expanded telehealth flexibilities, including permanent virtual supervision options, supporting distributed care teams and asynchronous care delivery. Notably, the proposed rule also includes reimbursement for diabetes prevention programs delivered fully virtually, signaling CMS’s growing confidence in the safety, effectiveness, and equity of digital-first prevention efforts.

With these expanded reimbursement pathways, digitally enabled care delivery is moving beyond sustainability and becoming a strategic imperative. Remote monitoring will increasingly underpin new care models and revenue streams; an essential shift as the financial pressures of OBBB, including increased uncompensated care, up to $1 trillion in projected Medicaid spending over the next decade, and unprecedented workforce challenges, begin to impact hospitals and clinics across the country.

📌 Note: At DiMe, we’re closely monitoring policies under the new administration alongside industry trends, with active initiatives addressing pressing needs in mental health, opioid use disorder, and oncology.

⚖️ Regulatory clarity in the era of the quantified self

As technology makes it possible to measure virtually any facet of human biology, we must prepare for mounting regulatory challenges, particularly regarding how software platforms that visualize or analyze sDHT data are classified.

Increasingly, intended use statements alone will be insufficient to determine whether a platform qualifies as a medical device. A case in point: FDA’s recent warning letter to Whoop regarding its blood pressure insights feature. While Whoop characterized the feature as part of a wellness product, FDA asserted it represented a clinical use case requiring regulatory clearance.

As more sDHTs are developed for use in reimbursement-enabled care models, the incentive to pursue medical device classification will grow. At the same time, some developers will attempt to avoid regulatory oversight by positioning similar tools as general wellness products. FDA’s list now gives us a tool to monitor these shifts and hopefully a shared foundation for collaboration between developers and regulators.

📌 Note: DATAcc by DiMe has already launched open-access resources to support digital health developers in aligning their regulatory strategy with their commercial strategy. We also operate the DiMe Seal, a symbol of trust for high-quality digital health products, designed to reduce misinterpretation of regulatory status as a proxy for product quality.

⌚️ sDHTs are crucial to modern, value-based care

When we connect the dots between what FDA has authorized, what CMS will reimburse, and what patients want and need, we see new characteristics of high-quality care emerging:

• Data-driven, leveraging high-resolution streams of data, not episodic snapshots. This is especially critical in the AI era, where better predictions and interventions rely on huge amounts of high-quality data.

• Highly personalized, enabling the right treatment for the right patient at the right time.

• Virtual-first, when appropriate, meeting patients where they are, safely, effectively, and on their terms.

• Proactive, not reactive, enabling earlier interventions and promoting prevention over downstream treatment.

Take, for example, UPMC’s postpartum hypertension monitoring program, which remotely tracks blood pressure in new mothers during the critical six weeks after delivery. Using connected devices, patients transmit their readings from home, enabling clinicians to respond quickly with necessary treatment adjustments. In a study of more than 400 participants, nearly 50% required remote medication changes to prevent complications and reduce emergency room visits. This is a clear example of how sDHTs are already delivering real-time value to health systems, clinicians, and patients, particularly among high-risk populations.

👥 Join us: Powering the trusted ecosystem for healthcare 2030

These regulatory shifts and reimbursement milestones aren’t just tactical updates; they’re signposts pointing toward a radically new care model. The groundwork for Healthcare 2030 is being laid today, through the digital tools we build, the care models we pilot, and the data infrastructures we scale.

If you’re charting this future - from remote monitoring programs to enterprise architecture to product & regulatory strategy - your decisions now will define how you exist and thrive in the next 5-years.

Let’s collaborate, so we can chart this future together.

📩 Join us at partnerships@dimesociety.org

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