Who leads this work?
Led by Mike Hittle, PhD (Stanford, epidemiology and clinical research), a postdoc in the Ramayya Lab at Stanford Neurosurgery building a wearable-based neurological exam for the ICU, and creator of the PHENOMS neurology eCOA platform. Built on published work on wearables (Apple Watch sleep, F1000Research 2019), MS mobility (Timed 25-Foot Walk, Multiple Sclerosis Journal 2021), MS prevalence (JAMA Neurology 2023), and the CardinalKit mobile research platform (JAMIA Open 2023).
Who is wearables and neurology digital biomarker work for?
- Teams turning wearable signals into a clinical claim or endpoint.
- Neurology programs (MS, headache and migraine, movement, sleep) that want digital outcome measures.
- Investors and partners who need an independent read on a wearable's evidence.
How do you validate a wearable or digital biomarker?
We follow the DiMe V3 framework: verification (does the sensor measure accurately), analytical validation (does the algorithm match a reference standard), and clinical validation (does the measure track the clinical state that matters). We design each study, specify the reference standards and agreement statistics, and analyze the data.
What does wearables and neurology digital biomarker work include?
- Evidence-gap review — your current claims against V3 and FDA expectations.
- Validation and feasibility protocols — sample size, reference standard, and analysis plan.
- Real-world data analyses — cohort design, bias and confounding, missing wear-time.
- Neurology outcome-measure strategy — which digital measures map to EDSS, T25FW, or headache diaries.
- Ready-to-ship results — tables, figures, and a manuscript or regulatory summary.
How does a wearables and neurology digital biomarker work engagement run?
- Scoping callYour device, signal, claim, and timeline.
- Initial AuditA fixed-scope, two-week review of the evidence and the gaps.
- Protocol or analysis projectValidation study design, or analysis of the data you already have.
- Ongoing advisoryOptional, as the study runs and the results go out.
Research access to consumer and research-grade wearables
The first technical question in most wearable studies is what data you can actually get out of the device, at what resolution, and under what agreement. Summary metrics (daily steps, nightly sleep stages) are easy to get; raw sensor streams usually are not. This table summarizes what each vendor's own developer documentation describes. Access terms change, so confirm against the linked docs before you lock a protocol.
| Platform | How research teams get data | Granularity | FDA-authorized features (examples) | Official docs |
|---|---|---|---|---|
| Apple Watch (HealthKit, ResearchKit) | Your own iOS app reads HealthKit data on the participant's phone with their permission; there is no Apple-hosted research data API. ResearchKit is Apple's open-source framework for consent and study tasks. | Samples as written to HealthKit by Apple and third-party apps; varies by data type | ECG app (De Novo DEN180044, 2018); Sleep Apnea Notification Feature (510(k) K240929, 2024) | HealthKit, ResearchKit |
| Fitbit (Google) Web API | Cloud Web API with user OAuth consent | Daily summaries by default; intraday data for other users' accounts is granted case by case on request | Check FDA's 510(k) and De Novo databases for the specific feature | Web API, Intraday access |
| Oura API (v2) | Cloud API with user OAuth consent | Daily summaries (sleep, readiness, activity) plus time-series endpoints such as heart rate | Positioned as wellness; confirm any feature against FDA databases | API v2 docs |
| Garmin Connect Developer Program | Push-based APIs (Health, Activity and others) under a developer program; business access on commercial terms | Health summaries in JSON; activity files in .FIT | Confirm any feature against FDA databases | Program overview |
| Empatica | Research and clinical-trial platform sold by Empatica | Raw sensor data and derived digital biomarkers | Embrace seizure-monitoring system (510(k) K181861, 2018) | empatica.com |
| ActiGraph | Research-grade devices with the CentrePoint platform, sold for trials | Raw accelerometry retained alongside derived activity and sleep measures | Check FDA databases by product | theactigraph.com |
FDA authorizations above were confirmed in FDA's De Novo and 510(k) databases. An authorization covers one feature with its labeled intended use, not the whole device or its other metrics.
Digital measures in neurology
Neurology is where wearables have the clearest path to clinical use, because many symptoms (tremor, gait, seizures, sleep) are physical and episodic, and clinic visits miss them. Some examples of what is already authorized or in use:
- Parkinson's disease, tremor and dyskinesia: the Rune Labs Kinematic System, software running on the Apple Watch, received FDA 510(k) clearance in June 2022 to quantify tremor and dyskinesia in adults 45 and older with mild to moderate Parkinson's disease (K213519).
- Epilepsy, seizure detection: Empatica's Embrace wristband was cleared in December 2018 (K181861) as a prescription adjunct to seizure monitoring that detects patterns associated with generalized tonic-clonic seizures and alerts a designated caregiver.
- Sleep: Apple's Sleep Apnea Notification Feature was cleared in September 2024 (K240929). Consumer sleep staging without such a clearance remains a wellness feature.
- Multiple sclerosis, mobility: walking measures such as the Timed 25-Foot Walk are standard in MS trials, and continuous gait and step measures from wearables are a major research target. Mike's published work on the T25FW (Multiple Sclerosis Journal, 2021) is the starting point for how we map digital measures to it.
To see which digital endpoints sponsors have already used in trials, start with DiMe's Library of Digital Endpoints. If you plan to use a wearable in a clinical investigation, FDA's guidance on digital health technologies for remote data acquisition (final, December 2023) sets out what FDA expects on verification, validation and usability. We design the validation study itself under clinical study design.
Frequently asked questions about wearables and neurology digital biomarker work
How do you validate a wearable or digital biomarker?
We follow the DiMe V3 framework: verification, analytical validation against a reference standard, and clinical validation, with study design and analysis delivered by PAHL.
Do you run the study?
We design and analyze it. Recruitment and site operations stay with you or your CRO; we can coordinate with them.
Can you label the signals too?
Yes. See expert clinical labeling for EEG, neurology, and wearable signals.
Do you work outside neurology?
Yes, including cardiometabolic, sleep, and activity. Neurology is our depth.
Can you build the data-collection app?
Yes. See healthcare mobile app development (CardinalKit experience).
Can we get raw sensor data from an Apple Watch or Fitbit?
Not easily. Apple Watch data reaches researchers through HealthKit in your own iOS app, at the resolution HealthKit stores. Fitbit's Web API gives daily summaries by default, and intraday data for other users is granted case by case. If raw signals matter for your endpoint, research-grade devices such as Empatica or ActiGraph are usually the better fit.
Does an FDA-cleared wearable make our study endpoint valid?
No. A clearance covers one feature for its labeled intended use. Your endpoint still needs verification, analytical validation and clinical validation in your population and context of use, which is what our validation studies cover.
Which neurology conditions have FDA-cleared wearable tools?
Examples in FDA's databases include seizure alerting for generalized tonic-clonic seizures (Empatica Embrace, K181861), Parkinson's tremor and dyskinesia measurement (Rune Labs, K213519) and sleep apnea notification (Apple, K240929). Always check the FDA 510(k) and De Novo databases for the exact intended use.
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