<이슈 분석>The Significance and Future Outlook of the U.S. FDA’s New Initiative: ‘TEMPO (Technology-Enabled Meaningful Patient Outcomes) for Digital Health Devices Pilot’

*AI’s help in researching data for this article and writing some sentences has had a great effect.

1. Key summary of the TEMPO initiative

On December 5, 2025, the U.S. Food and Drug Administration (FDA) announced the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot, a new voluntary program developed by the Center for Devices and Radiological Health (CDRH). TEMPO is designed to expand patient access to digital health technologies for chronic diseases while maintaining safeguards through real-world data (RWD) collection and oversight.U.S. Food and Drug Administration+1

TEMPO is tightly linked to the CMS Innovation Center’s ACCESS (Advancing Chronic Care with Effective, Scalable Solutions) model, a new payment initiative that ties recurring payments for managing chronic conditions to measurable outcomes. Within this joint framework:CMS+1

• Scope of devices
  Digital health devices (including AI-enabled tools and software-based solutions) that meet the statutory device definition and are used under clinician supervision in the outpatient setting.
• Clinical focus areas (four domains)
  1. Early cardio-kidney-metabolic: hypertension, dyslipidemia, obesity/overweight with central obesity, prediabetes
  2. Cardio-kidney-metabolic: diabetes, chronic kidney disease, atherosclerotic cardiovascular disease
  3. Musculoskeletal: chronic musculoskeletal pain
  4. Behavioral health: depression and anxiety
• Regulatory innovation
  Participating manufacturers may request that FDA exercise enforcement discretion for certain requirements (e.g., premarket authorization, IDE, parts 50/56) so that devices can be used in care covered by ACCESS before full marketing authorization, provided there is a robust plan to manage risk and collect RWD.Federal Register+1
• Participation and timelines
  • Statements of interest accepted from January 2, 2026.
  • FDA expects to select up to about 10 U.S.-based manufacturers per clinical area (total up to ~40), aiming for diversity of size, maturity, and product types.Federal Register+1
  • Follow-up information requests are expected around March 2, 2026 for shortlisted participants.

In essence, TEMPO creates a controlled “regulatory sandbox” embedded in a value-based payment model, in which companies can deploy not-yet-fully-authorized digital health tools under close oversight, generate RWD, and then use those data to support future marketing applications.Holland & Knight+1

2. Implications of TEMPO

2.a. Implications for FDA regulatory policy

1) RWD/RWE as a central regulatory asset, not an add-on

TEMPO moves RWD/RWE from a secondary role to a primary engine of regulatory evidence. The pilot explicitly expects participants to:Federal Register+1

• Collect RWD on device use and outcomes in everyday clinical practice under ACCESS.
• Share those data with FDA throughout the pilot.
• Ultimately submit a marketing application (e.g., 510(k), De Novo) supported by RWD generated under TEMPO, supplemented by other data as needed.

This operationalizes years of policy rhetoric around RWD/RWE in devices into a concrete program that ties real-world performance to enforcement discretion and future market access.

2) A structured model of “enforcement discretion against obligations”

Historically, “enforcement discretion” has often been ad hoc or narrow. TEMPO formalizes a quid pro quo:

• FDA may temporarily not enforce some requirements (premarket authorization, IDE, certain clinical study rules).
• In exchange, the manufacturer must implement:
  • Strong risk-mitigation and patient-safety plans,
  • RWD collection/monitoring/reporting plans,
  • Timelines and plans for submitting a full marketing application.Federal Register+1

This reframes enforcement discretion as a contract-like regulatory instrument, with explicit conditions, milestones, and termination possibilities.

3) Integration of regulatory oversight with payment reform

By embedding TEMPO into the ACCESS payment model, FDA is implicitly acknowledging that how care is paid for influences how technology is used and evaluated. ACCESS pays providers with outcome-aligned recurring payments, and TEMPO piggybacks on this to:CMS+1

• Ensure devices are deployed in organizations already incentivized to track outcomes.
• Use the ACCESS infrastructure (data, reporting, quality safeguards) to support RWD generation.

This is a significant cross-agency convergence of regulation and reimbursement, and a notable departure from siloed, pathway-specific oversight.

4) A successor to, not a repeat of, Pre-Cert

The Digital Health Software Pre-Certification Pilot explored firm-level assurances but struggled with scalability and statutory constraints. TEMPO shifts emphasis from company-level pre-certification to context-specific enforcement discretion within a defined payment and care model:U.S. Food and Drug Administration+1

• It leverages an existing statutory device framework.
• It uses the TAP program’s life-cycle advisory and “sprint” discussions to maintain early, iterative engagement.
• It positions “home as a health care hub” and chronic disease management as primary test beds, rather than generic SaMD.

If successful, TEMPO could become the template for future “reg outcomes sandboxes” in other therapeutic domains.

2.b. Implications for the industry and related companies

1) Earlier, controlled market entry for digital tools

For eligible devices, TEMPO offers a way to:U.S. Food and Drug Administration+1

• Deploy products in real clinical workflows under ACCESS before full authorization,
• Demonstrate pragmatic effectiveness and safety under supervision,
• Build a data package in parallel with revenue-generating care.

This is attractive for companies with:

• Mature prototypes and preliminary evidence,
• But not enough data yet for a traditional 510(k) or De Novo.

2) Data and quality infrastructure become competitive differentiators

Entry into TEMPO is not simply about having a novel app or algorithm. FDA’s Federal Register notice signals specific expectations: device description, safety/benefit rationale, quality management system (QMS), detailed RWD plans, performance goals, and timelines.Federal Register+1

Companies strong in:

• QMS and regulatory operations,
• Data engineering and analytics for RWD,
• Governance of patient consent, privacy, and security,

will be better positioned to win slots in the pilot and to convert participation into eventual authorization.

3) Strategic positioning within four high-value clinical domains

The four TEMPO domains map to huge U.S. markets:

• Cardiometabolic and kidney disease (GLP-1 era, CKD/heart failure, etc.)
• Chronic musculoskeletal pain (post-opioid crisis, non-pharmacologic care)
• Behavioral health (depression, anxiety, virtual therapy, CBT apps)

Digital health developers in these spaces can treat TEMPO as:

• A signal to focus on outcomes that CMS is willing to pay for,
• A path to embed solutions in ACCESS participants rather than selling directly app-by-app.

4) Consolidation and partnership dynamics

TEMPO will likely accelerate:

• Partnerships between device/software startups and ACCESS-participating provider organizations.
• M&A by larger medtech and health-IT players who want to bring TEMPO-ready portfolios in-house.members.medicaldevices.org+1

For many companies, the realistic strategy may be co-developing or white-labeling their technology to ACCESS participants who have the care delivery and data infrastructure required.

2.c. Implications for public health

1) Potential for improved chronic disease control at scale

If TEMPO works as intended, the public-health upside is substantial:

• More patients with diabetes, CKD, ASCVD, depression, anxiety, and chronic pain could access technology-enabled, integrated care that tracks and adjusts treatment between visits.CMS+1
• Devices used in TEMPO will be explicitly outcome-oriented, aligning with ACCESS’s payment logic and focusing on measurable improvements rather than just engagement metrics.

2) A more responsive, evidence-generating care system

RWD generated under TEMPO can:

• Reveal which patients, under which conditions, benefit most from specific digital tools.
• Support adaptive learning health systems, where treatment and product design co-evolve.

This shifts digital health from a “download an app and hope” model toward continuous, data-driven public health surveillance and optimization.

3) Equity, access, and risk of digital divides

There are clear risks:

• ACCESS participants may be large, better-resourced systems; smaller or rural providers may be under-represented.
• Devices may require smartphones, connectivity, or digital literacy, potentially leaving behind marginalized groups.

CMS’s requirement for enhanced consent and attention to quality and safety under ACCESS is a safeguard, but it will be critical to monitor: who is actually enrolled, whose outcomes improve, and whether gaps widen or narrow across socioeconomic and racial lines.CMS

4) New transparency around outcomes

ACCESS will publish risk-adjusted outcomes for participating organizations, and TEMPO devices are embedded in that ecosystem.Federal Register+1

In the long run, this could:

• Make digital health performance more visible to the public,
• Put pressure on vendors whose tools do not show meaningful benefit,
• Encourage a culture where public-health metrics drive product iteration.

3. Anticipated future developments

Looking forward, several trajectories are likely.

1) Expansion beyond the initial four clinical domains

If TEMPO proves workable, FDA and CMS could:

• Extend similar pilots to oncology survivorship, COPD/asthma, heart failure, or neurodegenerative diseases, where home-based monitoring is critical.
• Use the TEMPO model as a “template” for new ACCESS-like models in other high-burden conditions.

2) Formal guidance and possible codification

Depending on outcomes, TEMPO could lead to:

• CDRH guidance documents outlining when and how enforcement discretion tied to RWD can be used for digital health devices.
• Eventually, legislative proposals to refine statutory authorities for digital health and RWD-based evaluations, especially if the program surfaces gaps in current law.

3) Stronger international ripple effects

Other jurisdictions (EU, UK, Canada, Singapore, Korea) are already exploring RWD in device regulation. TEMPO could:U.S. Food and Drug Administration

• Serve as a reference model for pilots that link reimbursement reforms with digital device regulatory sandboxes.
• Drive efforts via IMDRF or other fora to harmonize RWD/RWE frameworks for SaMD and digital tools.

4) Integration with AI-specific policy

Given that many TEMPO-eligible devices will be AI-enabled, expect:

• Closer alignment with broader FDA AI/ML frameworks and post-market learning approaches.
• Possible AI-specific variants of TEMPO that experiment with continuous learning systems, subject to updated change-management policies.

5) Evolution of “Home as a Health Care Hub”

TEMPO is explicitly framed as part of the Home as a Health Care Hub initiative. Over time, we can anticipate:U.S. Food and Drug Administration

• More formal recognition of home-based device ecosystems (remote monitoring, wearables, sensors) with integrated regulatory expectations.
• A re-balancing of oversight between facility-based devices and home-based DHTs.

4. Expected response strategies from the U.S. medical industry

The TEMPO-ACCESS bundle is likely to provoke differentiated responses across stakeholders.

4.1 Provider organizations (health systems, IDNs, large group practices)

• Build “TEMPO-ready” digital care pathways
  • Identify chronic disease care lines (e.g., diabetes, CKD, depression) where digital tools can be integrated into ACCESS participation.
  • Standardize workflows for device onboarding, remote monitoring, and escalation.
• Invest in data infrastructure and governance
  • Strengthen capabilities to integrate device data into EHRs, normalize and analyze outcomes, and report to both CMS and FDA-linked partners.
  • Enhance consent processes, with special attention to enhanced consent requirements for TEMPO device users under ACCESS.CMS
• Form strategic alliances with device manufacturers
  • Co-design pilot projects with manufacturers applying to TEMPO, ensuring alignment on outcomes and risk-mitigation.
  • Negotiate data-sharing and IP terms up front.

4.2 Payers and health plans

• Align benefit designs with ACCESS/TEMPO devices
  • For Medicare Advantage and commercial plans, incorporate successful TEMPO devices into digital formularies or preferred technology lists.
  • Tie reimbursement to documented outcome improvements.
• Monitor cost-effectiveness and scaling potential
  • Evaluate whether TEMPO-involved tools can be scaled beyond ACCESS participants, and under what conditions they generate ROI.

4.3 Digital health and device companies

• Temporarily re-prioritize pipelines toward TEMPO-aligned indications
  • Companies with broad portfolios may prioritize products in cardiometabolic, musculoskeletal, and behavioral health to access the pilot and its RWD advantages.
• Strengthen regulatory and RWD competencies
  • Build internal teams (or contract partners) specializing in:
    • FDA device submissions,
    • GCP/QMS for software and connected devices,
    • RWD/RWE study design and analysis.
• Design outcome-focused products rather than feature-heavy apps
  • Because ACCESS payments are explicitly outcome-aligned, products that show clear, measurable improvements in blood pressure, HbA1c, pain scores, PHQ-9/GAD-7 scores, etc. will be favored.CMS+1

5. How Korean companies should prepare and respond

For Korean digital health and medtech companies, TEMPO is both a signal and an opportunity. It sets the direction of U.S. policy for the next wave of chronic disease technology.

5.1 Clarify a U.S. market strategy anchored in TEMPO domains

• Prioritize products in TEMPO’s four clinical areas:
  • Diabetes, hypertension, dyslipidemia, obesity, CKD, ASCVD
  • Chronic musculoskeletal pain
  • Depression and anxiety
• Evaluate whether existing Korean solutions (e.g., remote glucose monitoring, hypertension coaching apps, musculoskeletal rehab platforms, CBT-based mental health apps) can be adapted to U.S. clinical guidelines and measurement frameworks.

5.2 Establish a “U.S.-ready” presence and regulatory posture

• U.S. base
  • TEMPO limits participation to U.S.-based manufacturers, primarily for oversight and inspection reasons.Federal Register
  • Korean firms serious about TEMPO should consider:
    • U.S. subsidiaries,
    • Joint ventures with U.S. device makers,
    • Licensing core technology to U.S. partners who will act as the manufacturer of record.
• Regulatory alignment
  • Map existing Korean MFDS approvals (if any) to the FDA device categories and risk classes.
  • Build the QMS, cybersecurity, and SaMD documentation needed to satisfy FDA expectations even in an enforcement-discretion context.

5.3 Invest early in RWD and outcome-measurement capabilities

To be attractive for TEMPO:

• Design products with built-in outcome measures:
  • e.g., automatic capture of blood pressure logs, step counts, PROs like PHQ-9, pain VAS scores, etc.
• Build or partner for:
  • Data pipelines from device → app → cloud → EHR,
  • Analytics that can generate regulator-grade RWD reports (e.g., pre-specified endpoints, handling of missing data, subgroup analyses).

Korean companies with strong engineering but weaker clinical trial/RWE experience should seriously consider alliances with CROs or U.S. academic partners that can help design RWD collection under TEMPO.

5.4 Partner with ACCESS participants rather than going alone

Because devices in TEMPO must be used within ACCESS model participants, a direct-to-consumer or small-clinic strategy will not suffice.CMS+1

Recommended approach:

• Identify large U.S. integrated delivery networks (IDNs), academic health systems, or multi-state group practices that plan to join ACCESS.
• Offer co-development projects where the Korean technology is localized and integrated into their chronic care pathways.
• Share RWD and IP so both parties benefit (the provider on payment/quality metrics, the company on regulatory progression).

5.5 Use TEMPO as a strategic “North Star” for Korean policy and MFDS engagement

At the policy level, Korean firms and industry associations could:

• Brief MFDS and Korean payers on TEMPO and ACCESS as reference models for:
  • RWD-based evaluation of digital chronic disease tools,
  • Limited, structured enforcement discretion to enable real-world pilots,
  • Linking reimbursement to outcomes rather than simple coding.
• Advocate for Korean analogues: localized digital-health sandboxes in diabetes, hypertension, mental health, and MSK care, where RWD is collected in the NHIS/HIRA ecosystem.

Such alignment could make Korean products more TEMPO-compatible from the outset and ease bilateral recognition or data-sharing discussions in the future.

Closing thought

TEMPO is not just another digital health pilot; it is effectively a prototype of a new regulatory–reimbursement architecture for chronic disease technologies in the United States. For regulators, it tests whether enforcement discretion plus RWD can safely accelerate innovation. For companies, it foregrounds outcomes, data systems, and partnerships over “apps on an app store.” For Korean firms looking at the U.S. market, it offers a clear signal: build for real-world outcomes, design for integrated care, and be ready to live in a world where regulatory approval and payment both depend on what your product actually changes in patients’ lives.