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Digital Health Statistics 2026: $11.1 Billion Raised, 1,600+ AI Devices Cleared, and the 2027 Deadlines That Decide What Survives

Digital health statistics 2026 chart showing the Digital Health Vital Signs Index at 56.5, with build-side signals at 63.7 and patient-use signals at 38.6, U.S. digital health funding reached .1 billion through Q3 2026 while Medicare telehealth use fell to 12.66% of eligible beneficiaries

Digital Health Statistics 2026

By Axis Intelligence Research

Co-author: Jennifer Miller | Last updated: October 29, 2026 | License: CC BY 4.0

U.S. digital health startups raised $11.1 billion through September 2026, 12.1% ahead of the same point in 2025, while the share of Medicare fee-for-service beneficiaries using telehealth slipped to 12.66% in Q1 2026. Axis Intelligence Research’s new Digital Health Vital Signs Index reads 56.5: the builders are accelerating, patient use is not.


Quick Answer

Digital health in 2026 is a two-speed sector. Venture funding ($11.1 billion through Q3, per Rock Health), FDA AI-enabled device authorizations (over 1,600 cumulative, per FDA) and physician AI use (81%, per the AMA) are all rising. Medicare telehealth use (12.66% of eligible beneficiaries in Q1 2026, per CMS) and digital health M&A are falling. Axis Intelligence Research’s Digital Health Vital Signs Index (DHVSI) puts the build side at 63.7 and the patient-use and exit side at 38.6.

Key Findings

  1. U.S. digital health startups raised $11.1 billion across 358 deals in the first nine months of 2026, up 12.1% from $9.9 billion in the same period of 2025, according to Rock Health’s Q3 2026 market update.
  2. The FDA states it has authorized over 1,600 AI-enabled medical devices as of September 2026; Axis Intelligence Research’s count of its list finds 335 authorizations in 2025 alone, up 42.6% from 235 in 2024.
  3. 81% of U.S. physicians used AI in their practices in the AMA’s 2026 Physician Survey on Augmented Intelligence, up from 66% in the 2024 survey and 38% in 2023.
  4. Only 12.66% of telehealth-eligible Medicare fee-for-service beneficiaries used telehealth in Q1 2026, down from 13.57% in Q1 2025, according to Axis Intelligence Research’s pull of CMS Medicare Telehealth Trends data.
  5. Axis Intelligence Research’s Digital Health Vital Signs Index (DHVSI) reads 56.5 out of 100 on its October 29, 2026 baseline, with a 25.1-point gap between build-side signals (63.7) and patient-use and exit signals (38.6).

The Digital Health Vital Signs Index (DHVSI): Is Digital Health Growing or Stalling in 2026?

The Digital Health Vital Signs Index (DHVSI) is an Axis Intelligence Research composite that converts seven primary-source series into one reading. Each series is scored on its most recent like-for-like change: 50 means flat, above 50 means improving, below 50 means contracting. The baseline reading, as of October 29, 2026, is 56.5.

Vital signLatest comparisonChangeScoreSource
U.S. digital health venture fundingJan–Sep 2026 ($11.1B) vs Jan–Sep 2025 ($9.9B)+12.12%74.24Rock Health
Physician AI use (annualized)81% (2026 survey) vs 66% (2024 survey)+10.78%/yr71.56AMA
FDA AI-enabled device authorizationsJan–Jun 2026 (181) vs Jan–Jun 2025 (176)+2.84%55.68FDA list
Global wearable shipmentsQ1 2026 vs Q1 2025+4.30%58.60IDC
Hospital interoperability, all four domains (annualized)76% (2025) vs 70% (2023)+4.20%/yr58.40ASTP/ONC
Digital health M&A dealsJan–Sep 2026 (164) vs Jan–Sep 2025 (172)−4.65%40.70Rock Health
Medicare FFS telehealth useQ1 2026 (12.66%) vs Q1 2025 (13.57%)−6.71%36.59CMS
DHVSI (equal-weighted)56.5Axis Intelligence Research

Split the seven signs into two groups and the story sharpens. The five build-side signs (capital, clinician AI, FDA clearances, devices, data exchange) average 63.7. The two signs that measure whether patients and acquirers are showing up (Medicare telehealth use and M&A exits) average 38.6.

Jennifer Miller: The 25.1-point gap is the number to watch. Clinicians, hospitals and investors are adopting faster than the reimbursement system is converting that capacity into patient visits. A rising index driven only by venture dollars would be fragile; this one also carries FDA clearances and interoperability, which are slower and harder to reverse. What would push the reading down: a lapse in Medicare or DEA telehealth rules, which would hit the two signs already below 50.

How the DHVSI is calculated

Score per sign = 50 + 2 × (percentage change, capped at ±25%). The DHVSI is the plain average of the seven scores. Survey series fielded every other year (AMA, ASTP/ONC) are annualized as (new ÷ old)^(1/2) − 1 so that a two-year jump is not counted as one year. Every input and score is a row in the CSV. The next reading will follow Rock Health’s year-end data in January 2027.

How Much Did Digital Health Startups Raise in 2026?

U.S. digital health startups raised $11.1 billion across 358 deals from January through September 2026, according to Rock Health’s Q3 2026 market update, published October 9, 2026. Q3 alone brought $3.7 billion across 114 deals. Rock Health projects the full year could surpass $14.8 billion if the 2026 quarterly pace holds, which would beat 2025’s $14.2 billion by 4.2%.

PeriodFundingDealsAverage dealSource
2024$10.5B509$20.6MRock Health
2025$14.2B482$29.5MRock Health
Jan–Sep 2025$9.9B351—Rock Health
Jan–Sep 2026$11.1B358$31.0MRock Health
Q1 / Q2 / Q3 2026$4.2B / $3.2B / $3.7B— / — / 114Q3: $32.5M (Axis calc.)Rock Health

Who is getting the money: mega-rounds and fewer, bigger checks

Rounds of $100 million or more took 45% of all capital in H1 2026, up from 42% in 2025 and 22% in 2024, per Rock Health’s H1 2026 overview. Nineteen companies raised those 20 mega-rounds. Median deal size reached $14 million in H1 2026, up from $12 million in 2025. The 2026 year-to-date average deal of $31.0 million is 50.5% above 2024’s $20.6 million (Axis Intelligence Research calculation).

Mental health has been the top-funded clinical indication for seven consecutive years, with weight management second. Among companies that raised in H1 2026, 64% of mental health and weight management startups sell directly to consumers, against 29% of all digital health companies.

AI-enabled vs. non-AI digital health funding

In 2025, AI-enabled companies took 54% of digital health funding, up from 37% in 2024, per Rock Health’s 2025 year-end report. Applying those shares to the totals, Axis Intelligence Research estimates AI-enabled companies raised about $7.67 billion in 2025 (+97.4% from $3.89 billion), while everyone else raised about $6.53 billion (−1.3% from $6.62 billion). The whole 2025 increase went to AI.

That series ends there. Rock Health stopped labeling startups “AI-enabled” in Q1 2026, on the grounds that AI is now too common to distinguish companies. Any 2026 “AI share of digital health funding” figure you see is not Rock Health’s.

Jennifer Miller: Concentration cuts both ways. When 20 rounds absorb 45% of half a year’s capital, the sector’s headline total says more about a handful of balance sheets than about the median startup. Investors are paying for evidence of outcomes and deployment, not for an AI label, which is exactly why the label stopped being tracked.

Exits: IPO window shut, M&A slowing

Five digital health companies went public in 2025: Hinge Health, Omada Health, Heartflow, Carlsmed and Profusa. None has listed in 2026 through Q3, per Rock Health. M&A is running slightly behind: 164 deals through Q3 2026 vs a revised 172 through Q3 2025.

The listed companies are giving later IPO candidates a benchmark. Hinge Health reported Q1 2026 revenue of $182.3 million, up 47% year over year, with a 23% free cash flow margin, and guided full-year 2026 revenue to $798–804 million, per its Q1 2026 results release (company-reported). Deeper coverage: AI investment statistics.

How Many AI Medical Devices Has the FDA Authorized?

The FDA says it has authorized over 1,600 AI-enabled medical devices for U.S. marketing as of September 2026, on its AI-enabled medical devices page. The downloadable list holds 1,614 records with decisions through June 29, 2026, by Axis Intelligence Research’s count.

Year (decision date)AI-enabled authorizationsChange
2024235—
2025335+42.6%
Jan–Jun 2025176—
Jan–Jun 2026181+2.8%

Source: Axis Intelligence Research count of the FDA AI-Enabled Medical Device List CSV (decisions through June 29, 2026), by Date of Final Decision. 1,230 of the 1,614 listed devices (76.2%) have Radiology as lead panel.

Jennifer Miller: An authorization is not adoption. The list records regulatory clearances, not installed units or clinical use, and most entries are imaging tools cleared as equivalent to an existing device. The more useful 2027 question is how many of these show measurable outcome changes in peer-reviewed follow-up. Specialty and pathway breakdown: FDA AI medical device statistics.

How Many Doctors and Hospitals Use AI in 2026?

81% of U.S. physicians used AI in their practice in the AMA’s 2026 Physician Survey on Augmented Intelligence, released March 12, 2026, up from 38% in 2023. The average physician now has 2.3 AI use cases, up from 1.1 in 2023; research summaries and clinical documentation lead. The 2024 AMA survey measured 66%.

70% of physicians see AI as a tool for automating the tasks behind burnout, and 85% want to be consulted or directly involved in AI adoption decisions.

On the hospital side, 71% of U.S. non-federal acute care hospitals used predictive AI integrated into their EHR in 2024, up from 66% in 2023, per ASTP/ONC Data Brief No. 80.

Measure202320242026Source
Physicians using AI38%66%81%AMA
Hospitals using predictive AI in the EHR66%71%—ASTP/ONC

Jennifer Miller: “Uses AI” in the AMA survey counts any professional use, including a literature summary. It does not mean AI touched a diagnosis. Read 81% as breadth of exposure. For clinical-grade deployment and evidence, see AI healthcare statistics and generative AI in healthcare statistics.

How Many Medicare Patients Use Telehealth Now?

12.66% of telehealth-eligible Medicare fee-for-service beneficiaries (2,737,802 of 21,629,728) used telehealth in Q1 2026, according to Axis Intelligence Research’s pull of the CMS Medicare Telehealth Trends dataset (data through March 31, 2026). That is 0.91 points below Q1 2025 (13.57%). For context, 47.91% of eligible beneficiaries used telehealth at some point in 2020 and 23.25% did in 2025. The quarterly low was Q4 2025 at 10.76%, the quarter in which the flexibilities briefly lapsed after September 30, 2025; use was back at 12.66% in Q1 2026, after the flexibilities were restored.

Medicare FFS group, Q1 2026Share using telehealthSource
All telehealth-eligible beneficiaries12.66%CMS
Urban13.46%CMS
Rural9.92%CMS
Dual-eligible (Medicare and Medicaid)22.76%CMS

Axis Intelligence Research calculates that dual-eligible beneficiaries used telehealth at 1.80 times the overall rate, and urban beneficiaries at 1.36 times the rural rate.

By state, Q1 2026 use ranged from 21.94% in California to 5.03% in Mississippi, a 4.36-fold spread. 39 of 51 jurisdictions (50 states plus DC) were below their Q1 2025 level, 11 were higher and one was unchanged (Axis Intelligence Research calculation from the CMS file; all 51 are in the dataset).

Commercial telehealth: up quarter over quarter, and mostly mental health

Among commercially insured patients, telehealth rose from 5.01% to 5.51% of medical claim lines between Q4 2025 and Q1 2026, and 18.39% of patients had a telehealth claim, per FAIR Health’s Quarterly Telehealth Regional Tracker. 52.1% of patients with a telehealth claim had a mental health diagnosis, the top category in every age group and region.

The rural gap is wider in commercial data than in Medicare. FAIR Health shows 18.6% of urban vs 10.3% of rural commercially insured patients with a telehealth claim (1.81 times), against 1.36 times in Medicare (Axis Intelligence Research calculation). The two datasets measure different populations and are shown side by side, not merged.

Jennifer Miller: Earlier versions of this page cited a 68.9% mental health share from a single 2024 month. FAIR Health’s quarterly measure is 52.1%, and it counts patients rather than claim lines. Same direction, different denominator: quote the current figure with its definition. Utilization detail: telehealth statistics; international comparison: telehealth adoption by country.

What Changes for Digital Health in 2027? The Deadline Calendar

Six dated policy events set the 2027 operating environment. Axis Intelligence Research counts the days from October 29, 2026.

DateEventDays awaySource
Dec 31, 2026DEA telemedicine flexibilities for prescribing controlled substances without an in-person visit expire (fourth temporary extension)63DEA
Mar 26, 2027European Health Data Space (EHDS) Regulation’s general date of application148EUR-Lex, Reg. (EU) 2025/327
Dec 2, 2027EU AI Act obligations for stand-alone (Annex III) high-risk AI begin399EUR-Lex, Reg. (EU) 2026/1744
Dec 31, 2027Medicare telehealth flexibilities (home as originating site, expanded practitioners, audio-only) expire428CMS Telehealth FAQ
2027WHO Global Strategy on Digital Health ends; a 2028–2033 strategy follows—WHO
Aug 2, 2028EU AI Act high-risk obligations for AI embedded in Annex I products, including medical devices643EUR-Lex, Reg. (EU) 2026/1744

The Medicare cliff. Congress extended Medicare telehealth flexibilities through December 31, 2027 in the Consolidated Appropriations Act, 2026 (Public Law 119-75), enacted February 3, 2026. After that date, CMS’s FAQ says new mental health telehealth patients need an in-person visit within six months before the first telehealth service; patients who began home telehealth on or before December 31, 2027 are treated as established and need an in-person visit every 12 months. The 2.74 million fee-for-service beneficiaries who used telehealth in Q1 2026 are the population whose rules change.

The EU timeline moved. Regulation (EU) 2026/1744, published in the Official Journal on July 24, 2026, pushed AI Act high-risk obligations for product-embedded AI, which covers AI-enabled medical devices, from August 2, 2027 to August 2, 2028.

What is new in U.S. reimbursement. CMS’s ACCESS (Advancing Chronic Care with Effective, Scalable Solutions) Model, a voluntary 10-year model that began in July 2026, pays Outcome-Aligned Payments for technology-supported care in four tracks: early cardio-kidney-metabolic, cardio-kidney-metabolic, musculoskeletal and behavioral health, per the CMS Innovation Center. CMS lists more than 160 participants as of October 20, 2026.

On the health IT side, HHS finalized the HTI-5 rule on October 26, 2026, which it projects will save more than $1.5 billion in regulatory costs for the ONC Health IT Certification Program, per the HHS announcement.

Jennifer Miller: For buyers planning 2027 budgets, the DEA date matters first: 63 days is less than one contracting cycle. For investors, ACCESS is the first Medicare channel that pays for outcomes rather than device minutes, which is the model most virtual chronic-care companies have pitched for a decade.

How Connected Are U.S. Hospitals? Interoperability Statistics

76% of U.S. non-federal acute care hospitals engaged in all four interoperability domains (send, receive, find and integrate) in 2025, up from 70% in 2023 and 23% in 2014, per ASTP/ONC Quick Stat #66, based on the AHA IT Supplement fielded April–October 2025.

Domain, 2025Share of hospitals
Send summary of care records96%
Find (query outside records)94%
Receive93%
Integrate without manual entry79%
All four domains76%

Integration is the bottleneck. It moved from 78% in 2023 to 79% in 2025 while sending, receiving and finding all rose significantly. Records arrive; fewer than four in five hospitals can file them into the chart without retyping.

On the patient side, 77% of U.S. adults were offered online access to their medical records in 2024, and 65% were offered access and used it, per ASTP/ONC Data Brief No. 77. The 12-point gap between offer and use is an Axis Intelligence Research calculation. Portal fragmentation and the Care Loop Conversion Index (CLCI): consumer health tech adoption statistics.

How Many People Use Wearables and Health AI Chatbots?

32% of U.S. adults used AI chatbots for health information in Rock Health’s December 2025 survey of 8,000 adults, double the 16% a year earlier, per Rock Health’s 2025 Consumer Adoption Survey. The same survey found 46% of respondents own a wearable and 57% have tracked their health digitally.

Global wearable shipments reached 145.7 million units in Q1 2026, up 4.3% year over year, IDC estimates; Apple held 18.1% of units. IDC forecasts 693.2 million annual units by 2030 (2.6% compound annual growth), with smart rings at 4.9 million and smart glasses at 13.6 million units in 2026.

Jennifer Miller: Owning a device is not the same as a clinician seeing its data. Medicare paid over $500 million for remote patient monitoring in 2024, per the HHS Office of Inspector General, which flagged billing risks in the same report. Device-to-clinician flow: connected health statistics; devices: wearable technology statistics and smart ring statistics.

How Big Is the Digital Health Market?

Axis Intelligence Research does not publish a single global “digital health market size,” because published estimates disagree by tens of billions of dollars depending on whether they include EHR software, consumer wearables, telehealth services or pharmacy. None of those totals is produced by a body that measures the market with a disclosed, auditable method.

What can be measured: $14.2 billion of U.S. venture funding in 2025 (Rock Health); over $500 million in Medicare RPM payments in 2024 (HHS OIG); company-reported revenue such as Hinge Health’s $798–804 million 2026 guidance; and 145.7 million wearables shipped in one quarter (IDC). Those are the inputs a buyer or investor can check. Total health spending context: healthcare costs statistics.

Methodology

Collection. Axis Intelligence Research fetched every figure on this page from its producing organization between October 28 and 29, 2026: Rock Health (venture, M&A and consumer survey), FDA, AMA, ASTP/ONC, CMS, FAIR Health, IDC, HHS OIG, HHS, DEA, the CMS Innovation Center, EUR-Lex and WHO. Company figures are labeled company-reported; IDC figures are estimates.

Medicare telehealth. National rows (all demographics, all geographies) come from the CMS Medicare Telehealth Trends public use file (TMEDTREND_PUBLIC_260914) for each quarter of 2025, Q1 2026, and full-year 2020 and 2025. Q1 is compared with Q1 to remove seasonality.

FDA counts. The FDA states a rounded total (“over 1,600”). Axis Intelligence Research counted the FDA’s downloadable list (1,614 records, decisions through June 29, 2026) by Date of Final Decision: 226 (2023), 235 (2024), 335 (2025), 176 (H1 2025), 181 (H1 2026). The FDA adds devices retroactively, so earlier snapshots show lower counts for the same years.

Axis calculations. AI-enabled funding = Rock Health total × AI share (both rounded at source, so results are estimates). Ratios and percentage changes are shown with their formulas in the CSV method_note column.

DHVSI. Seven components, equal weights, score = 50 + 2 × capped change; biennial surveys annualized. The index mixes U.S. series with one global series (wearables) and measures direction of change, not absolute size.

Not included. Market-size estimates from report publishers, AI-share-of-funding figures for 2026, and any statistic we could not trace to its producer.

About This Dataset

digital-health-statistics.csv contains 270 rows: every number on this page, plus Medicare telehealth use by state for Q1 2025 and Q1 2026, with its unit, as-of date, period, source organization, document, URL, retrieval date and a flag for Axis calculations. License: CC BY 4.0. The page is updated when a source publishes new data, not on a fixed calendar.

How to Cite This Page

APA: Axis Intelligence Research, & Miller, J. (2026, October 29). Digital health statistics 2026: $11.1 billion raised, 1,600+ AI devices cleared, and the 2027 deadlines that decide what survives. Axis Intelligence. https://axis-intelligence.com/digital-health-statistics/

MLA: Axis Intelligence Research, and Jennifer Miller. “Digital Health Statistics 2026: $11.1 Billion Raised, 1,600+ AI Devices Cleared, and the 2027 Deadlines That Decide What Survives.” Axis Intelligence, 29 Oct. 2026, axis-intelligence.com/digital-health-statistics/.

Chicago: Axis Intelligence Research and Jennifer Miller. “Digital Health Statistics 2026: $11.1 Billion Raised, 1,600+ AI Devices Cleared, and the 2027 Deadlines That Decide What Survives.” Axis Intelligence, October 29, 2026. https://axis-intelligence.com/digital-health-statistics/.

Frequently Asked Questions

Is Medicare telehealth coverage ending in 2027?

The pandemic-era Medicare telehealth flexibilities run through December 31, 2027, under the Consolidated Appropriations Act, 2026 (Public Law 119-75, February 3, 2026), per CMS’s Telehealth FAQ. After that date, home-based telehealth for most non-behavioral services reverts to pre-pandemic rules unless Congress acts again. Behavioral health telehealth at home is permanent, but new patients will need an in-person visit within six months before starting.

Can doctors still prescribe controlled substances by telehealth in 2027?

Only if the DEA acts again. The fourth temporary extension lets DEA-registered clinicians prescribe Schedule II–V medications via telemedicine without a prior in-person exam through December 31, 2026, per the DEA. Two narrower final rules (buprenorphine treatment and VA continuity of care) took effect December 31, 2025 and remain after that date.

How many AI-enabled medical devices has the FDA cleared?

Over 1,600 as of September 2026, according to the FDA. Axis Intelligence Research’s count of its list finds 1,614 records through June 29, 2026, including 335 authorizations decided in 2025 and 181 in the first half of 2026. About three in four (76.2%) are radiology devices.

Is digital health venture funding up or down in 2026?

Up. U.S. startups raised $11.1 billion through September 2026, 12.1% ahead of 2025’s pace, per Rock Health, which projects more than $14.8 billion for the year. The money is concentrated: $100 million-plus rounds took 45% of H1 2026 capital, and no digital health company has gone public in 2026 through Q3.

What is the CMS ACCESS Model?

ACCESS is a voluntary 10-year CMS Innovation Center model, started in July 2026, that pays Outcome-Aligned Payments to organizations delivering technology-supported care for cardio-kidney-metabolic conditions, chronic musculoskeletal pain, depression and anxiety in Original Medicare. CMS lists more than 160 participants as of October 20, 2026.

Do U.S. digital health companies need to care about the EU’s 2027 rules?

Yes, if they sell into Europe. The European Health Data Space Regulation begins to apply on March 26, 2027, per EUR-Lex. AI-enabled medical devices face EU AI Act high-risk obligations from August 2, 2028, a year later than first planned, after Regulation (EU) 2026/1744.

Are most doctors really using AI, or just experimenting?

81% of physicians report some professional AI use, with an average of 2.3 use cases, per the AMA’s 2026 survey; documentation and research summaries lead. Hospital deployment is narrower: 71% of hospitals used predictive AI in their EHR in 2024, per ASTP/ONC, mostly for inpatient risk and outpatient follow-up.

Why do telehealth statistics disagree so much?

They measure different people. CMS reports 12.66% of eligible Medicare fee-for-service beneficiaries used telehealth in Q1 2026; FAIR Health reports 18.39% of commercially insured patients had a telehealth claim in the same quarter. Quarterly shares are also far lower than annual shares: 23.25% of eligible Medicare beneficiaries used telehealth at some point in 2025.


Correction, October 29, 2026: An earlier version of this page (June 15, 2026) stated that 96% of U.S. hospitals had adopted certified EHRs “by 2025”; that figure is from 2021 ONC/AHA data. It reported 66% physician AI use as a 2025 figure; 66% is from the AMA’s 2024 survey, and the 2026 survey reports 81%. It cited a 68.9% mental health share of telehealth claim lines from April 2024; FAIR Health’s current measure is 52.1% of telehealth patients (Q1 2026). Figures attributed to the AMA for healthcare-organization AI adoption (85%), organization AI ROI (82%) and ambient documentation adoption (100%), along with market-size and market-share estimates from report publishers, could not be traced to a producing source and have been removed.

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