Palo Alto Health Labs: GuidesGuides on health AI evaluation, FDA and regulatory questions, wearables and medical data labeling.https://paloaltohealthlabs.com/resources/feed.xml2026-10-27T00:00:00-07:00Palo Alto Health Labshttps://paloaltohealthlabs.com/What Is a Fractional CTO? Role, Cost, When to Hirehttps://paloaltohealthlabs.com/resources/what-is-a-fractional-cto.html2026-10-27T00:00:00-07:002026-10-27T00:00:00-07:00What a fractional CTO does, what one costs, how it compares with a full-time CTO, when to hire one, and what changes in digital health.Wearables for Epilepsy: FDA Rules and Deviceshttps://paloaltohealthlabs.com/resources/wearables-for-epilepsy.html2026-10-27T00:00:00-07:002026-10-27T00:00:00-07:00How FDA regulates non-EEG seizure-monitoring wearables under 21 CFR 882.1580, which devices hold POS clearances, and what validation must report.Wearable Validation: V3+ Guide & SAP Templatehttps://paloaltohealthlabs.com/resources/wearable-validation/2026-10-27T00:00:00-07:002026-10-27T00:00:00-07:00How wearable and neurotech teams validate a device with V3+: reference standards, diverse populations, agreement metrics, and a free SAP template.How Accurate Is Wearable Sleep Tracking vs. PSG?https://paloaltohealthlabs.com/resources/wearable-sleep-tracking-accuracy.html2026-10-27T00:00:00-07:002026-10-27T00:00:00-07:00What polysomnography, actigraphy and consumer wrist or ring wearables measure, how validation studies report sleep accuracy, and what affects it.Wearable Data Standards: IEEE 1752.1 & FHIRhttps://paloaltohealthlabs.com/resources/wearable-data-standards.html2026-10-27T00:00:00-07:002026-10-27T00:00:00-07:00How Open mHealth/IEEE 1752.1 schemas, FHIR R4 Observation with LOINC/UCUM, HealthKit and Health Connect represent wearable data, with a heart-rate mapping.How to Verify FDA Clearance Claimshttps://paloaltohealthlabs.com/resources/verify-fda-clearance-claims.html2026-10-27T00:00:00-07:002026-10-27T00:00:00-07:00How to tell FDA registered, cleared, De Novo authorized and PMA approved apart, look a device up in FDA's databases, and read what a PCCP does and doesn't coverSynthetic Health Data and Federated Learning for Medical AIhttps://paloaltohealthlabs.com/resources/synthetic-health-data-federated-learning.html2026-10-27T00:00:00-07:002026-10-27T00:00:00-07:00When synthetic health data helps or misleads medical AI, its re-identification risk, HIPAA de-identification status, what FDA expects, and federated learning.Wearable Sensor Accuracy Standardshttps://paloaltohealthlabs.com/resources/sensor-accuracy-validation.html2026-10-27T00:00:00-07:002026-10-27T00:00:00-07:00Sensor accuracy standards for wearables: FDA's DHT guidance, CTA heart-rate standards, ISO 81060-2 for blood pressure and FDA's pulse-ox skin-tone draft.Selling to Health Systems: Vendor Security Reviewhttps://paloaltohealthlabs.com/resources/selling-to-health-systems-vendor-security-review.html2026-10-27T00:00:00-07:002026-10-27T00:00:00-07:00What health systems ask digital health vendors for in security review: BAAs, HICP, HITRUST, SOC reports, SIG and CAIQ questionnaires, and AI transparency.Section 1557 & Health AI Bias: 45 CFR 92.210https://paloaltohealthlabs.com/resources/section-1557-health-ai-bias-audit.html2026-10-27T00:00:00-07:002026-10-27T00:00:00-07:00What 45 CFR 92.210 under Section 1557 requires of hospitals using clinical decision support, what it means for AI vendors, and a subgroup audit worksheet.SBIR & STTR for Digital Health Startups (2026)https://paloaltohealthlabs.com/resources/sbir-sttr-funding.html2026-10-27T00:00:00-07:002026-10-27T00:00:00-07:00SBIR/STTR after the April 2026 reauthorization: phases, award sizes at NIH and other agencies, eligibility, and a checklist for digital health startups.Study App Platforms: ResearchKit, CardinalKit & Morehttps://paloaltohealthlabs.com/resources/research-study-app-platforms.html2026-10-27T00:00:00-07:002026-10-27T00:00:00-07:00Compare ResearchKit, CareKit, CardinalKit, Android Health Connect and custom builds for research study apps: platform, license, modules, backend and best fit.Red-Teaming Health LLMs: Test Categories, Red-Team Sets, Severityhttps://paloaltohealthlabs.com/resources/red-teaming-health-llms-clinical-ai.html2026-10-27T00:00:00-07:002026-10-27T00:00:00-07:00How to red-team a health LLM: test unsafe advice, PHI leakage, prompt injection and bias, build a clinician-written set, score severity, map to NIST/OWASP.Real-World Evidence for Medical Deviceshttps://paloaltohealthlabs.com/resources/real-world-evidence-digital-health-medical-devices.html2026-10-27T00:00:00-07:002026-10-27T00:00:00-07:00What FDA's December 2025 device RWE guidance says about relevant, reliable real-world data, the 2026 transition, and study design for digital health startups.Patient-Directed EHR Data Access for Health Appshttps://paloaltohealthlabs.com/resources/patient-ehr-data-access.html2026-10-27T00:00:00-07:002026-10-27T00:00:00-07:00How health apps get data at the patient's direction: HIPAA right of access, certified EHR APIs, CMS Patient Access APIs, information blocking and TEFCA IAS.Wearables & Digital Measures in Parkinson's Diseasehttps://paloaltohealthlabs.com/resources/parkinsons-disease-wearables-digital-measures.html2026-10-27T00:00:00-07:002026-10-27T00:00:00-07:00How wearables measure tremor, bradykinesia, dyskinesia and gait in Parkinson's disease, which tools hold FDA 510(k) clearance, and what the evidence shows.Medicare Digital Mental Health Treatment (DMHT) Codeshttps://paloaltohealthlabs.com/resources/medicare-digital-mental-health-treatment-codes.html2026-10-27T00:00:00-07:002026-10-27T00:00:00-07:00How Medicare's DMHT codes G0552, G0553 and G0554 work, which FDA regulations qualify a device, the 2026 ADHD expansion and what it means for startups.Medical Imaging for AI: DICOM De-ID & Labelinghttps://paloaltohealthlabs.com/resources/medical-imaging-dicom-deidentification-annotation.html2026-10-27T00:00:00-07:002026-10-27T00:00:00-07:00How to prep medical images for labeling: DICOM PS3.15 Annex E de-identification, SEG vs. RTSTRUCT vs. NIfTI, 3D Slicer vs. MONAI Label vs. CVAT, and handoff.Medical Data Annotation Guideline Templatehttps://paloaltohealthlabs.com/resources/medical-data-annotation-guideline-template.html2026-10-27T00:00:00-07:002026-10-27T00:00:00-07:00A free annotation guideline template for medical AI datasets, mapped to GMLP principles on reference standards, data independence and population coverage.Medical AI Test Set Sample Size & Splitshttps://paloaltohealthlabs.com/resources/medical-ai-test-set-sample-size.html2026-10-27T00:00:00-07:002026-10-27T00:00:00-07:00How many cases a medical AI test set needs for a target sensitivity or AUC, with formula and tables, plus patient-level splits, leakage and subgroup coverage.Medical AI Benchmarks vs. Custom Evalshttps://paloaltohealthlabs.com/resources/medical-ai-benchmarks-vs-custom-evals.html2026-10-27T00:00:00-07:002026-10-27T00:00:00-07:00MedQA, MedMCQA, PubMedQA, MultiMedQA, HealthBench and MedHELM compared, the contamination problem with static test sets, and why a private custom eval matters.Local Validation of Vendor AI Modelshttps://paloaltohealthlabs.com/resources/local-validation-vendor-ai.html2026-10-27T00:00:00-07:002026-10-27T00:00:00-07:00Why hospitals should validate vendor and EHR-supplied predictive models on their own data, what surveys show, and a 7-step local validation checklist.LLM APIs, PHI and HIPAA BAAshttps://paloaltohealthlabs.com/resources/llm-apis-phi-hipaa-baa.html2026-10-27T00:00:00-07:002026-10-27T00:00:00-07:00Which LLM API and cloud vendors offer a HIPAA business associate agreement, what their pages say about covered features, and what a BAA does not do.Is My App a Medical Device?https://paloaltohealthlabs.com/resources/is-my-app-a-medical-device.html2026-10-27T00:00:00-07:002026-10-26T00:00:00-07:00A five-question FDA guide to whether your health app or wearable is a medical device: general wellness, device software functions, CDS, enforcement discretion.IRB Review & eConsent for Digital Health Studieshttps://paloaltohealthlabs.com/resources/irb-econsent.html2026-10-27T00:00:00-07:002026-10-27T00:00:00-07:00When digital-health studies need IRB review, how eConsent works under FDA and OHRP rules, and what startups should plan before enrolling participants.Inter-Rater Agreement for Medical Labels: Kappa to Dicehttps://paloaltohealthlabs.com/resources/inter-rater-agreement-medical-data-labeling.html2026-10-27T00:00:00-07:002026-10-27T00:00:00-07:00Which agreement metric fits which medical label: Cohen's and Fleiss' kappa, Krippendorff's alpha, ICC, Dice/IoU and event F1, plus an adjudication workflow.Human Factors & Usability for SaMD and Wearableshttps://paloaltohealthlabs.com/resources/human-factors-usability-samd-wearables.html2026-10-27T00:00:00-07:002026-10-27T00:00:00-07:00How FDA human factors guidance and IEC 62366-1 apply to SaMD, wearables and health apps: critical tasks, formative vs. summative tests, HF reports.How to Evaluate an AI Medical Scribe: PDQI-9 & Pilothttps://paloaltohealthlabs.com/resources/how-to-evaluate-ai-medical-scribe.html2026-10-27T00:00:00-07:002026-10-27T00:00:00-07:00How to test an AI medical scribe: measure hallucination and omission rates, score notes with PDQI-9, run a fair multi-vendor pilot and question vendors.How to Evaluate a Health LLMhttps://paloaltohealthlabs.com/resources/how-to-evaluate-a-health-llm.html2026-10-27T00:00:00-07:002026-10-27T00:00:00-07:00How to evaluate a health LLM: define the harm, go past exam benchmarks, grade with clinician rubrics, measure worst-case reliability, check the grader.Wearable HRV: RMSSD vs. SDNN, PPG vs. ECGhttps://paloaltohealthlabs.com/resources/heart-rate-variability-wearables.html2026-10-27T00:00:00-07:002026-10-27T00:00:00-07:00What RMSSD, SDNN, pNN50 and LF/HF measure, how PPG-derived HRV compares with ECG, what affects accuracy, and when an HRV claim becomes a device claim.Health Data for AI: MIMIC-IV, All of Us, UK Biobankhttps://paloaltohealthlabs.com/resources/health-data-sources-for-medical-ai.html2026-10-27T00:00:00-07:002026-10-27T00:00:00-07:00Where to get data to train and validate medical AI: MIMIC-IV, eICU, All of Us, UK Biobank, NIH repositories, commercial RWD and health-system partnerships.Health Apps HIPAA Doesn't Cover: FTC & State Lawshttps://paloaltohealthlabs.com/resources/health-apps-hipaa-doesnt-cover.html2026-10-27T00:00:00-07:002026-10-27T00:00:00-07:00When HIPAA doesn't apply to a health app, the FTC Health Breach Notification Rule, FTC Act Section 5 and state health data laws can. What they require.Health AI Validation Claims: 8 Red Flagshttps://paloaltohealthlabs.com/resources/health-ai-validation-claims-red-flags.html2026-10-27T00:00:00-07:002026-10-27T00:00:00-07:00Eight red flags in health AI validation claims, from retrospective-only evidence and no external validation to leakage and hidden stratification.FDA PCCPs for AI-Enabled Devices: What Goes in Onehttps://paloaltohealthlabs.com/resources/fda-pccp-ai-enabled-devices.html2026-10-27T00:00:00-07:002026-10-27T00:00:00-07:00What an FDA Predetermined Change Control Plan is, its three parts, which AI model changes fit and which need a new 510(k), De Novo or PMA, with examples.FDA Device Cybersecurity & Section 524B Guidehttps://paloaltohealthlabs.com/resources/fda-cybersecurity-524b.html2026-10-27T00:00:00-07:002026-10-27T00:00:00-07:00What FDA's premarket cybersecurity guidance and section 524B require of connected wearables and SaMD: the cyber device definition, SBOM, threat modeling.FDA-Authorized AI Neurology Devices: 73 on FDA's List | PAHLhttps://paloaltohealthlabs.com/resources/fda-authorized-ai-neurology-devices.html2026-10-27T00:00:00-07:002026-10-27T00:00:00-07:00All 73 AI-enabled devices with Neurology as lead panel on FDA's AI-Enabled Medical Device List, with counts by year, pathway and product code. Source: FDA.EU MDR & EU AI Act for Medical AI: Startup Guidehttps://paloaltohealthlabs.com/resources/eu-mdr-ai-act.html2026-10-27T00:00:00-07:002026-10-27T00:00:00-07:00How the EU MDR and EU AI Act apply to medical AI software: Rule 11 classification, high-risk AI obligations, MDCG 2025-6 on their interplay, and timelines.EEG & Wearable Data Formats: EDF, BIDS, WFDBhttps://paloaltohealthlabs.com/resources/eeg-wearable-data-formats-for-annotation.html2026-10-27T00:00:00-07:002026-10-27T00:00:00-07:00What EDF, EDF+, BDF, BIDS-EEG, WFDB, NWB, DICOM waveform and CSV/Parquet store, how each handles annotations, header PHI risk, and what to send a labeling team.eCOA & ePRO for Trials: FDA Guidance, BYODhttps://paloaltohealthlabs.com/resources/ecoa-epro-digital-health-trials.html2026-10-27T00:00:00-07:002026-10-27T00:00:00-07:00COA types (PRO, ClinRO, ObsRO, PerfO), paper-to-electronic migration evidence, BYOD vs. provisioned devices, and what FDA reviewers look for in eCOA.ECG Annotation & Arrhythmia Evaluation: AAMI EC57https://paloaltohealthlabs.com/resources/ecg-annotation-arrhythmia-algorithm-evaluation-ec57.html2026-10-27T00:00:00-07:002026-10-27T00:00:00-07:00How ECG beat and rhythm labels, the MIT-BIH, AHA, NST and European ST-T databases, and ANSI/AAMI EC57 reporting fit into arrhythmia algorithm evals.Digital Tools for Migraine: Devices & Predictionhttps://paloaltohealthlabs.com/resources/digital-tools-for-migraine.html2026-10-27T00:00:00-07:002026-10-27T00:00:00-07:00Which wearable migraine stimulators FDA has authorized under product codes PCC and QGT, and what a prospective study found about predicting attacks.Digital Health Due Diligence Checklisthttps://paloaltohealthlabs.com/resources/digital-health-due-diligence-checklist.html2026-10-27T00:00:00-07:002026-10-27T00:00:00-07:00A 10-point claim-to-evidence matrix for digital health investors: FDA status, wellness and CDS claims, AI validation, cybersecurity, HIPAA and AI governance.Digital Cognitive Assessments for Alzheimer'shttps://paloaltohealthlabs.com/resources/digital-cognitive-assessments-alzheimers.html2026-10-27T00:00:00-07:002026-10-27T00:00:00-07:00How FDA regulates computerized cognitive assessment aids under 21 CFR 882.1470, which devices are on record, and how they fit Alzheimer's trials.Clinical NLP on EHR Notes: Annotation, n2c2, MIMIC-IV-Note, De-IDhttps://paloaltohealthlabs.com/resources/clinical-nlp-ehr-note-annotation.html2026-10-27T00:00:00-07:002026-10-27T00:00:00-07:00How to annotate clinical notes for AI (entities, assertions, relations), get n2c2/i2b2 and MIMIC-IV-Note data, de-identify text and score LLM extraction.Medical Data Labeling: In-House vs. Crowd vs. Experthttps://paloaltohealthlabs.com/resources/choosing-medical-data-labeling-approach.html2026-10-27T00:00:00-07:002026-10-27T00:00:00-07:00Compare in-house clinician, crowd and specialist expert labeling for medical AI on expertise, QC, PHI handling, turnaround and cost, plus a vendor checklist.FDA Breakthrough Devices & CMS TCET: Startup Guidehttps://paloaltohealthlabs.com/resources/breakthrough-devices-tcet.html2026-10-27T00:00:00-07:002026-10-27T00:00:00-07:00How FDA Breakthrough Device designation works, how CMS's TCET pathway builds on it for Medicare coverage, and what startups should weigh before applying.21 CFR Part 11 for eCOA, Wearables & E-Signatureshttps://paloaltohealthlabs.com/resources/21-cfr-part-11.html2026-10-27T00:00:00-07:002026-10-27T00:00:00-07:00When 21 CFR Part 11 applies to digital health, eCOA and wearable data, what FDA enforces today, key controls for electronic records and signatures, a checklist.RPM & RTM Billing Codes for Wearables (2026)https://paloaltohealthlabs.com/resources/rpm-rtm-billing-codes-for-wearables.html2026-10-26T00:00:00-07:002026-10-26T00:00:00-07:00The 2026 Medicare RPM and RTM CPT codes for wearables, including the new 2–15 day and 10-minute codes, what a device needs to qualify, and product decisions.Digital Health Readiness Checklisthttps://paloaltohealthlabs.com/resources/digital-health-readiness-checklist.html2026-10-26T00:00:00-07:002026-08-04T00:00:00-07:00A free 60-point checklist for digital health founders: test SaMD classification, architecture, FHIR, HIPAA security and evidence before you build.