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<!doctype html>
<html lang="en">
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<meta name="viewport" content="width=device-width, initial-scale=1">
<title>Digital health on one page</title>
<meta name="description" content="One figure of the US digital health landscape: who makes the rules, how data moves and how money moves among patients, pharma and medtech, digital health companies, providers, insurers, and schools and public agencies. From the Stanford Biodesign for Digital Health course.">
<meta property="og:title" content="Digital health on one page">
<meta property="og:description" content="Who makes the rules, how data moves and how money moves in US digital health, on one page. Stanford Biodesign for Digital Health.">
<meta property="og:type" content="website">
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<svg width="8" height="119" viewBox="0 0 8 119" preserveAspectRatio="none" style="position: absolute; left: 1195px; top: 1165px; width: 8px; height: 119px; overflow: visible; fill: none; stroke: #008F22; stroke-width: 2; stroke-linecap: round; stroke-linejoin: round"><defs><marker id="dc-arrow-head-filled-14" orient="auto" markerWidth="5" markerHeight="5" refX="2" refY="2" overflow="visible"><path d="M0 0 L4 2 L0 4 Z" fill="#008F22" stroke="none" style="stroke: none; fill: #008F22; fill: context-stroke"></path></marker></defs><path d="M 4 119 L 4 4" marker-end="url(#dc-arrow-head-filled-14)"></path></svg>
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<svg width="740" height="8" viewBox="0 0 740 8" preserveAspectRatio="none" style="position: absolute; left: 1149px; top: 1344px; width: 740px; height: 8px; overflow: visible; fill: none; stroke: #008F22; stroke-width: 2; stroke-linecap: round; stroke-linejoin: round"><path d="M 0 4 L 740 4"></path></svg>
<svg width="16" height="16" viewBox="0 0 16 16" preserveAspectRatio="none" style="position: absolute; left: 1889px; top: 1340px; width: 16px; height: 16px; overflow: visible; fill: none; stroke: #008F22; stroke-width: 2; stroke-linecap: round; stroke-linejoin: round"><path d="M 0 8 A 8 8 0 0 1 16 8"></path></svg>
<svg width="321" height="8" viewBox="0 0 321 8" preserveAspectRatio="none" style="position: absolute; left: 1905px; top: 1344px; width: 321px; height: 8px; overflow: visible; fill: none; stroke: #008F22; stroke-width: 2; stroke-linecap: round; stroke-linejoin: round"><path d="M 0 4 L 321 4"></path></svg>
<svg width="8" height="183" viewBox="0 0 8 183" preserveAspectRatio="none" style="position: absolute; left: 1145px; top: 1165px; width: 8px; height: 183px; overflow: visible; fill: none; stroke: #008F22; stroke-width: 2; stroke-linecap: round; stroke-linejoin: round"><defs><marker id="dc-arrow-head-filled-15" orient="auto" markerWidth="5" markerHeight="5" refX="2" refY="2" overflow="visible"><path d="M0 0 L4 2 L0 4 Z" fill="#008F22" stroke="none" style="stroke: none; fill: #008F22; fill: context-stroke"></path></marker></defs><path d="M 4 183 L 4 4" marker-end="url(#dc-arrow-head-filled-15)"></path></svg>
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<svg width="8" height="247" viewBox="0 0 8 247" preserveAspectRatio="none" style="position: absolute; left: 1893px; top: 1165px; width: 8px; height: 247px; overflow: visible; fill: none; stroke: #008F22; stroke-width: 2; stroke-linecap: round; stroke-linejoin: round"><defs><marker id="dc-arrow-head-filled-27" orient="auto" markerWidth="5" markerHeight="5" refX="2" refY="2" overflow="visible"><path d="M0 0 L4 2 L0 4 Z" fill="#008F22" stroke="none" style="stroke: none; fill: #008F22; fill: context-stroke"></path></marker></defs><path d="M 4 247 L 4 4" marker-end="url(#dc-arrow-head-filled-27)"></path></svg>
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<svg width="40" height="8" viewBox="0 0 40 8" preserveAspectRatio="none" style="position: absolute; left: 1950px; top: 133px; width: 40px; height: 8px; overflow: visible; fill: none; stroke: #10266C; stroke-width: 2; stroke-dasharray: 6 6; stroke-linecap: round; stroke-linejoin: round"><defs><marker id="dc-arrow-head-filled-19" orient="auto" markerWidth="5" markerHeight="5" refX="2" refY="2" overflow="visible"><path d="M0 0 L4 2 L0 4 Z" fill="#10266C" stroke="none" style="stroke: none; fill: #10266C; fill: context-stroke"></path></marker></defs><path d="M 0 4 L 36 4" marker-end="url(#dc-arrow-head-filled-19)"></path></svg>
<svg width="40" height="8" viewBox="0 0 40 8" preserveAspectRatio="none" style="position: absolute; left: 2120px; top: 133px; width: 40px; height: 8px; overflow: visible; fill: none; stroke: #10266C; stroke-width: 2; stroke-dasharray: 1 6; stroke-linecap: round; stroke-linejoin: round"><defs><marker id="dc-arrow-head-filled-28" orient="auto" markerWidth="5" markerHeight="5" refX="2" refY="2" overflow="visible"><path d="M0 0 L4 2 L0 4 Z" fill="#10266C" stroke="none" style="stroke: none; fill: #10266C; fill: context-stroke"></path></marker></defs><path d="M 0 4 L 36 4" marker-end="url(#dc-arrow-head-filled-28)"></path></svg>
<div style="position: absolute; left: 1966px; top: 62px; width: 212px; height: 24px; box-sizing: border-box; padding: 3px 10px; text-align: center; font-size: 13px; line-height: 16px; color: #555B66; background: #F4F4F4; border: 1px solid #D9D9D6; border-radius: 999px">Zoom in to read the detail</div>
<div style="position: absolute; left: 2186px; top: 62px; width: 190px; height: 24px; box-sizing: border-box; padding: 3px 10px; text-align: center; font-size: 13px; line-height: 16px; color: #555B66; background: #F4F4F4; border: 1px solid #D9D9D6; border-radius: 999px">Last updated: Nov 5, 2026</div>
<div style="position: absolute; left: 1740px; top: 96px; width: 22px; height: 22px; box-sizing: border-box; background: #FBE1DB; border: 1px solid #F6B19F; border-radius: 5px"></div>
<div style="position: absolute; left: 200px; top: 168px; width: 2176px; height: 56px; box-sizing: border-box; padding: 8px 12px; display: flex; align-items: flex-start; justify-content: flex-start; text-align: left; background: #FBE1DB; border: 1px solid #F6B19F; border-radius: 8px; font-size: 15px; line-height: 18px"><span><b style="color: #B83A1B">Overarching Legislation:</b> <span class="ac" tabindex="0" data-k="FD&C Act">FD&C Act</span> (1938) what counts as a drug or device · <span class="ac" tabindex="0" data-k="HIPAA">HIPAA</span> (1996) privacy baseline · <span class="ac" tabindex="0" data-k="HITECH">HITECH</span> (2009) $30B+ to adopt <span class="ac" tabindex="0" data-k="EHRs">EHRs</span> · <span class="ac" tabindex="0" data-k="ACA">ACA</span> (2010) Medicaid expansion, marketplaces, <span class="ac" tabindex="0" data-k="CMMI">CMMI</span>, <span class="ac" tabindex="0" data-k="ACOs">ACOs</span>, <span class="ac" tabindex="0" data-k="Sunshine Act">Sunshine Act</span> · <span class="ac" tabindex="0" data-k="MACRA">MACRA</span> (2015) quality-based Medicare pay · 21st Century Cures (2016) information blocking, <span class="ac" tabindex="0" data-k="APIs">APIs</span>, <span class="ac" tabindex="0" data-k="CDS">CDS</span> carve-out, <span class="ac" tabindex="0" data-k="RWE">RWE</span> framework. Most of the agencies below sit inside <span class="ac" tabindex="0" data-k="HHS">HHS</span>; the rest are the <span class="ac" tabindex="0" data-k="FTC">FTC</span>, <span class="ac" tabindex="0" data-k="DEA">DEA</span>, Education, the courts and the states.</span></div>
<div style="position: absolute; left: 200px; top: 236px; width: 300px; height: 88px; box-sizing: border-box; padding: 8px 10px; display: flex; align-items: flex-start; justify-content: flex-start; text-align: left; background: #FBE1DB; border: 1px solid #F6B19F; border-radius: 8px; font-size: 15px; line-height: 18px"><span><b style="color: #B83A1B"><span class="ac" tabindex="0" data-k="FTC">FTC</span></b> · data handling rules for consumer apps that fall outside of <span class="ac" tabindex="0" data-k="HIPAA">HIPAA</span>: deceptive claims (<span class="ac" tabindex="0" data-k="UDAP">UDAP</span>), breach notice (<span class="ac" tabindex="0" data-k="HBNR">HBNR</span>), <span class="ac" tabindex="0" data-k="COPPA">COPPA</span> for under-13s</span></div>
<div style="position: absolute; left: 559px; top: 236px; width: 740px; height: 184px; box-sizing: border-box; padding: 8px 10px; display: flex; align-items: flex-start; justify-content: flex-start; text-align: left; background: #FBE1DB; border: 1px solid #F6B19F; border-radius: 8px; font-size: 15px; line-height: 18px"><span><b style="color: #B83A1B"><span class="ac" tabindex="0" data-k="FDA">FDA</span></b> · safety, efficacy, marketing rules. <b style="color: #B83A1B"><span class="ac" tabindex="0" data-k="CDRH">CDRH</span></b> (devices, including <span class="ac" tabindex="0" data-k="SaMD">SaMD</span>): is it a device? Intended use and claims decide, not the hardware. General wellness → not regulated (see the 2026 update below). <span class="ac" tabindex="0" data-k="CDS">CDS</span> → exempt only if the clinician can check the basis. <span class="ac" tabindex="0" data-k="SaMD">SaMD</span> → Class I / II / III, cleared via <span class="ac" tabindex="0" data-k="510(k)">510(k)</span>, De Novo or <span class="ac" tabindex="0" data-k="PMA">PMA</span>; Breakthrough Devices speeds review; AI devices need <span class="ac" tabindex="0" data-k="GMLP">GMLP</span> and a <span class="ac" tabindex="0" data-k="PCCP">PCCP</span>; connected devices, cybersecurity (<span class="ac" tabindex="0" data-k="524B">524B</span>). <b style="color: #B83A1B"><span class="ac" tabindex="0" data-k="CDER">CDER</span> / <span class="ac" tabindex="0" data-k="CBER">CBER</span></b> (drugs, biologics): <span class="ac" tabindex="0" data-k="IND">IND</span> → trials → <span class="ac" tabindex="0" data-k="NDA">NDA</span> / <span class="ac" tabindex="0" data-k="BLA">BLA</span>; a drug packaged with an app is a combination product; <span class="ac" tabindex="0" data-k="DTC">DTC</span> drug ads are policed by <span class="ac" tabindex="0" data-k="OPDP">OPDP</span>. Investigational use of anything needs an <span class="ac" tabindex="0" data-k="IND">IND</span> or <span class="ac" tabindex="0" data-k="IDE">IDE</span> plus an <span class="ac" tabindex="0" data-k="IRB">IRB</span>. <span class="ac" tabindex="0" data-k="RWD">RWD</span>/<span class="ac" tabindex="0" data-k="RWE">RWE</span> from devices and apps increasingly count as evidence. <b style="color: #B83A1B"><span class="ac" tabindex="0" data-k="TEMPO">TEMPO</span></b>: use inside <span class="ac" tabindex="0" data-k="CMS">CMS</span>'s <span class="ac" tabindex="0" data-k="ACCESS">ACCESS</span> Model before clearance.</span></div>
<div style="position: absolute; left: 1358px; top: 236px; width: 659px; height: 88px; box-sizing: border-box; padding: 8px 10px; display: flex; align-items: flex-start; justify-content: flex-start; text-align: left; background: #FBE1DB; border: 1px solid #F6B19F; border-radius: 8px; font-size: 15px; line-height: 18px"><span><b style="color: #B83A1B"><span class="ac" tabindex="0" data-k="OCR">OCR</span></b> · <span class="ac" tabindex="0" data-k="HIPAA">HIPAA</span> for covered entities (providers, plans, clearinghouses) and their business associates (<span class="ac" tabindex="0" data-k="BAAs">BAAs</span>): all <span class="ac" tabindex="0" data-k="BA's">BA's</span> (like digital health companies) need to handle data according to <span class="ac" tabindex="0" data-k="HIPAA">HIPAA</span> requirements and are liable for information breaches · <span class="ac" tabindex="0" data-k="ACA">ACA</span> Section 1557: no discriminatory algorithms or decision tools</span></div>
<div style="position: absolute; left: 2076px; top: 236px; width: 300px; height: 88px; box-sizing: border-box; padding: 8px 10px; display: flex; align-items: flex-start; justify-content: flex-start; text-align: left; background: #FBE1DB; border: 1px solid #F6B19F; border-radius: 8px; font-size: 15px; line-height: 18px"><span><b style="color: #B83A1B">Department of Education</b> · <span class="ac" tabindex="0" data-k="FERPA">FERPA</span> governs student records, including a lot of school health data, instead of <span class="ac" tabindex="0" data-k="HIPAA">HIPAA</span></span></div>
<div style="position: absolute; left: 200px; top: 332px; width: 300px; height: 88px; box-sizing: border-box; padding: 8px 10px; display: flex; align-items: flex-start; justify-content: flex-start; text-align: left; background: #FBE1DB; border: 1px solid #F6B19F; border-radius: 8px; font-size: 15px; line-height: 18px"><span><b style="color: #B83A1B">States & <span class="ac" tabindex="0" data-k="AGs">AGs</span></b> · privacy laws (<span class="ac" tabindex="0" data-k="CCPA">CCPA</span>/<span class="ac" tabindex="0" data-k="CPRA">CPRA</span>, <span class="ac" tabindex="0" data-k="CMIA">CMIA</span>, <span class="ac" tabindex="0" data-k="MHMDA">MHMDA</span>); AI laws (CA, CO, IL, NY); Attorneys General investigate and sue</span></div>
<div style="position: absolute; left: 1358px; top: 332px; width: 300px; height: 88px; box-sizing: border-box; padding: 8px 10px; display: flex; align-items: flex-start; justify-content: flex-start; text-align: left; background: #FBE1DB; border: 1px solid #F6B19F; border-radius: 8px; font-size: 15px; line-height: 18px"><span><b style="color: #B83A1B"><span class="ac" tabindex="0" data-k="ONC">ONC</span> / <span class="ac" tabindex="0" data-k="ASTP">ASTP</span></b> · certifies <span class="ac" tabindex="0" data-k="EHRs">EHRs</span> (<span class="ac" tabindex="0" data-k="CEHRT">CEHRT</span>: <span class="ac" tabindex="0" data-k="USCDI">USCDI</span>, <span class="ac" tabindex="0" data-k="FHIR">FHIR</span> <span class="ac" tabindex="0" data-k="APIs">APIs</span>), enforces information blocking rules to allow data exchange, runs <span class="ac" tabindex="0" data-k="TEFCA">TEFCA</span></span></div>
<div style="position: absolute; left: 1717px; top: 332px; width: 300px; height: 88px; box-sizing: border-box; padding: 8px 10px; display: flex; align-items: flex-start; justify-content: flex-start; text-align: left; background: #FBE1DB; border: 1px solid #F6B19F; border-radius: 8px; font-size: 15px; line-height: 18px"><span><b style="color: #B83A1B"><span class="ac" tabindex="0" data-k="CMS">CMS</span></b> · Medicare: <span class="ac" tabindex="0" data-k="PFS">PFS</span> codes & rates, coverage (<span class="ac" tabindex="0" data-k="NCD">NCD</span>/<span class="ac" tabindex="0" data-k="LCD">LCD</span>), <span class="ac" tabindex="0" data-k="MA">MA</span> Star Ratings · Medicaid: 1115 waivers, <span class="ac" tabindex="0" data-k="ILOS">ILOS</span>, <span class="ac" tabindex="0" data-k="MCO">MCO</span> rules · <span class="ac" tabindex="0" data-k="CCIIO">CCIIO</span>: <span class="ac" tabindex="0" data-k="ACA">ACA</span> plans</span></div>
<div style="position: absolute; left: 2076px; top: 332px; width: 300px; height: 88px; box-sizing: border-box; padding: 8px 10px; display: flex; align-items: flex-start; justify-content: flex-start; text-align: left; background: #FBE1DB; border: 1px solid #F6B19F; border-radius: 8px; font-size: 15px; line-height: 18px"><span><b style="color: #B83A1B">Public health & local government</b> · <span class="ac" tabindex="0" data-k="CDC">CDC</span> and state agencies run registries (<span class="ac" tabindex="0" data-k="IIS">IIS</span>, <span class="ac" tabindex="0" data-k="PDMP">PDMP</span>) and surveillance; local budgets fund school health</span></div>
<div style="position: absolute; left: 200px; top: 428px; width: 300px; height: 88px; box-sizing: border-box; padding: 8px 10px; display: flex; align-items: flex-start; justify-content: flex-start; text-align: left; background: #FBE1DB; border: 1px solid #F6B19F; border-radius: 8px; font-size: 15px; line-height: 18px"><span><b style="color: #B83A1B">Courts</b> · product liability and malpractice apply with no new law needed (see the Character.AI and OpenAI suits)</span></div>
<div style="position: absolute; left: 559px; top: 428px; width: 300px; height: 88px; box-sizing: border-box; padding: 8px 10px; display: flex; align-items: flex-start; justify-content: flex-start; text-align: left; background: #FBE1DB; border: 1px solid #F6B19F; border-radius: 8px; font-size: 15px; line-height: 18px"><span><b style="color: #B83A1B"><span class="ac" tabindex="0" data-k="OIG">OIG</span> / <span class="ac" tabindex="0" data-k="DOJ">DOJ</span></b> · <span class="ac" tabindex="0" data-k="AKS">AKS</span> ('free' software needs a safe harbor), <span class="ac" tabindex="0" data-k="Stark">Stark</span>, <span class="ac" tabindex="0" data-k="FCA">FCA</span> · <span class="ac" tabindex="0" data-k="Sunshine Act">Sunshine Act</span>: payments to doctors go public</span></div>
<div style="position: absolute; left: 999px; top: 428px; width: 300px; height: 88px; box-sizing: border-box; padding: 8px 10px; display: flex; align-items: flex-start; justify-content: flex-start; text-align: left; background: #FBE1DB; border: 1px solid #F6B19F; border-radius: 8px; font-size: 15px; line-height: 18px"><span><b style="color: #B83A1B">Buyer gates</b> · not law, but required to sell: <span class="ac" tabindex="0" data-k="SOC 2">SOC 2</span> / <span class="ac" tabindex="0" data-k="HITRUST">HITRUST</span>, a signed <span class="ac" tabindex="0" data-k="BAA">BAA</span>, <span class="ac" tabindex="0" data-k="EHR">EHR</span> integration, an <span class="ac" tabindex="0" data-k="IRB">IRB</span> for any pilot with patients</span></div>
<div style="position: absolute; left: 1358px; top: 428px; width: 300px; height: 88px; box-sizing: border-box; padding: 8px 10px; display: flex; align-items: flex-start; justify-content: flex-start; text-align: left; background: #FBE1DB; border: 1px solid #F6B19F; border-radius: 8px; font-size: 15px; line-height: 18px"><span><b style="color: #B83A1B">States</b> · licensure & scope of practice (only humans), <span class="ac" tabindex="0" data-k="CPOM">CPOM</span> → <span class="ac" tabindex="0" data-k="MSO">MSO</span> + <span class="ac" tabindex="0" data-k="PC">PC</span>, <span class="ac" tabindex="0" data-k="IMLC">IMLC</span> · <b style="color: #B83A1B"><span class="ac" tabindex="0" data-k="DEA">DEA</span></b> controlled substances <span class="ac" tabindex="0" data-k="Rx">Rx</span> · <b style="color: #B83A1B"><span class="ac" tabindex="0" data-k="SAMHSA">SAMHSA</span></b> <span class="ac" tabindex="0" data-k="42 CFR Part 2">42 CFR Part 2</span></span></div>
<div style="position: absolute; left: 1717px; top: 428px; width: 300px; height: 88px; box-sizing: border-box; padding: 8px 10px; display: flex; align-items: flex-start; justify-content: flex-start; text-align: left; background: #FBE1DB; border: 1px solid #F6B19F; border-radius: 8px; font-size: 15px; line-height: 18px"><span><b style="color: #B83A1B"><span class="ac" tabindex="0" data-k="CMMI">CMMI</span></b> · tests new payment models: <span class="ac" tabindex="0" data-k="ACCESS">ACCESS</span> (tech-enabled chronic care; <span class="ac" tabindex="0" data-k="FDA">FDA</span>'s <span class="ac" tabindex="0" data-k="TEMPO">TEMPO</span> rides along), <span class="ac" tabindex="0" data-k="ASPIRE">ASPIRE</span> & <span class="ac" tabindex="0" data-k="InCK">InCK</span> (Medicaid kids), <span class="ac" tabindex="0" data-k="ACOs">ACOs</span></span></div>
<div style="position: absolute; left: 2076px; top: 428px; width: 300px; height: 88px; box-sizing: border-box; padding: 8px 10px; display: flex; align-items: flex-start; justify-content: flex-start; text-align: left; background: #FBE1DB; border: 1px solid #F6B19F; border-radius: 8px; font-size: 15px; line-height: 18px"><span><b style="color: #B83A1B"><span class="ac" tabindex="0" data-k="EU">EU</span></b> · <span class="ac" tabindex="0" data-k="GDPR">GDPR</span>, the <span class="ac" tabindex="0" data-k="MDR">MDR</span> and the <span class="ac" tabindex="0" data-k="AI Act">AI Act</span> apply the moment you have a European user</span></div>
<div style="position: absolute; left: 200px; top: 524px; width: 2176px; height: 72px; box-sizing: border-box; padding: 8px 12px; display: flex; align-items: flex-start; justify-content: flex-start; text-align: left; background: #FBE1DB; border: 1px solid #F6B19F; border-radius: 8px; font-size: 15px; line-height: 18px"><span><b style="color: rgb(184, 58, 27)">New in 2026 · <span class="ac" tabindex="0" data-k="FDA">FDA</span>'s January 6, 2026 guidance.</b> <b>General wellness:</b> a non-invasive wearable can now estimate blood pressure, blood glucose, <span class="ac" tabindex="0" data-k="SpO2">SpO2</span> or <span class="ac" tabindex="0" data-k="HRV">HRV</span> and stay outside <span class="ac" tabindex="0" data-k="FDA">FDA</span> oversight, as long as the claims stay wellness-only (sleep, activity, stress): no disease names, no clinical thresholds, no 'medical grade' claims, no ongoing disease monitoring; a 'consider seeing a clinician' nudge is fine. <b><span class="ac" tabindex="0" data-k="CDS">CDS</span>:</b> software may now propose a single treatment plan rather than a list of options, as long as the clinician reviews, revises and finalizes it and can see the basis; analyzing images or signals is still a device.</span></div>
<div style="position: absolute; left: 200px; top: 934px; width: 300px; height: 230px; box-sizing: border-box; padding: 14px 16px; display: block; text-align: left; background: #ffffff; border: 2px solid #111111; border-radius: 12px; font-size: 15px; line-height: 19px"><svg width="28" height="28" viewBox="0 0 24 24" fill="none" stroke="#111111" stroke-width="1.75" stroke-linecap="round" stroke-linejoin="round" aria-hidden="true" style="float: right; margin: 0 0 8px 8px"><circle cx="9" cy="7" r="3.5"></circle><path d="M2.5 21v-1.5a6.5 6.5 0 0 1 13 0V21"></path><circle cx="17.5" cy="9" r="2.5"></circle><path d="M17 15a4.5 4.5 0 0 1 4.5 4.5V21"></path></svg><span><b style="font-size: 20px; line-height: 26px">Patient & Family</b><br>Generates the data: wearables, apps, portal visits. Pays premiums, taxes, copays and sometimes a <span class="ac" tabindex="0" data-k="D2C">D2C</span> subscription. About half of US kids are on Medicaid or <span class="ac" tabindex="0" data-k="CHIP">CHIP</span>.</span></div>
<div style="position: absolute; left: 559px; top: 934px; width: 300px; height: 230px; box-sizing: border-box; padding: 14px 16px; display: block; text-align: left; background: #ffffff; border: 2px solid #111111; border-radius: 12px; font-size: 15px; line-height: 19px"><svg width="28" height="28" viewBox="0 0 24 24" fill="none" stroke="#111111" stroke-width="1.75" stroke-linecap="round" stroke-linejoin="round" aria-hidden="true" style="float: right; margin: 0 0 8px 8px"><rect x="3" y="8.5" width="18" height="7" rx="3.5" transform="rotate(-45 12 12)"></rect><path d="M12 8.5v7" transform="rotate(-45 12 12)"></path></svg><span style="width: 303px; height: 185px"><b style="font-size: 20px; line-height: 26px">Pharma & MedTech</b><br>Drug, biologic and device makers. To the <span class="ac" tabindex="0" data-k="DH">DH</span> company, they are a customer, a data provider, or a distribution channel (the app ships with the device/pharma product). Sometimes the Pharma or MedTech company is the <span class="ac" tabindex="0" data-k="DH">DH</span> company.</span></div>
<div style="position: absolute; left: 999px; top: 934px; width: 300px; height: 230px; box-sizing: border-box; padding: 14px 16px; display: block; text-align: left; background: #111111; color: #F4F4F4; border: 2px solid #111111; border-radius: 12px; font-size: 15px; line-height: 19px"><svg width="28" height="28" viewBox="0 0 24 24" fill="none" stroke="#00AB28" stroke-width="1.75" stroke-linecap="round" stroke-linejoin="round" aria-hidden="true" style="float: right; margin: 0 0 8px 8px"><rect x="7" y="2" width="10" height="20" rx="2"></rect><path d="M9 12h1.5l1-2.5 1.5 5 1-2.5H15"></path></svg><span><b style="font-size: 20px; line-height: 26px; color: #00AB28">Digital Health Company</b><br>App, device, <span class="ac" tabindex="0" data-k="SaMD">SaMD</span>, <span class="ac" tabindex="0" data-k="DTx">DTx</span>, <span class="ac" tabindex="0" data-k="SaaS">SaaS</span>. Or, a pharma or device company's digital arm. Sells <span class="ac" tabindex="0" data-k="D2C">D2C</span>, by subscription (<span class="ac" tabindex="0" data-k="SaaS">SaaS</span>, <span class="ac" tabindex="0" data-k="PMPM">PMPM</span>), or bills insurance itself, which requires licensed clinicians (<span class="ac" tabindex="0" data-k="MSO">MSO</span> + <span class="ac" tabindex="0" data-k="PC">PC</span>). <span class="ac" tabindex="0" data-k="HIPAA">HIPAA</span> applies to <span class="ac" tabindex="0" data-k="DH">DH</span> company through a <span class="ac" tabindex="0" data-k="BAA">BAA</span>.</span></div>
<div style="position: absolute; left: 1358px; top: 934px; width: 300px; height: 230px; box-sizing: border-box; padding: 14px 16px; display: block; text-align: left; background: #ffffff; border: 2px solid #111111; border-radius: 12px; font-size: 15px; line-height: 19px"><svg width="28" height="28" viewBox="0 0 24 24" fill="none" stroke="#111111" stroke-width="1.75" stroke-linecap="round" stroke-linejoin="round" aria-hidden="true" style="float: right; margin: 0 0 8px 8px"><path d="M6 3v5a5 5 0 0 0 10 0V3"></path><path d="M11 13v3a4.5 4.5 0 0 0 9 0v-2"></path><circle cx="20" cy="11.5" r="2.5"></circle></svg><span><b style="font-size: 20px; line-height: 26px">Providers: Clinicians & Health Systems</b><br>Generally, only licensed humans can deliver care. The <span class="ac" tabindex="0" data-k="EHR">EHR</span> records it in <span class="ac" tabindex="0" data-k="SNOMED CT">SNOMED CT</span>, <span class="ac" tabindex="0" data-k="LOINC">LOINC</span>, <span class="ac" tabindex="0" data-k="RxNorm">RxNorm</span>; bills it in <span class="ac" tabindex="0" data-k="ICD-10-CM">ICD-10-CM</span> + <span class="ac" tabindex="0" data-k="CPT">CPT</span>/<span class="ac" tabindex="0" data-k="HCPCS">HCPCS</span>. Share records via <span class="ac" tabindex="0" data-k="HIE">HIE</span>, <span class="ac" tabindex="0" data-k="TEFCA">TEFCA</span>/<span class="ac" tabindex="0" data-k="QHINs">QHINs</span>; report to <span class="ac" tabindex="0" data-k="IIS">IIS</span>, <span class="ac" tabindex="0" data-k="PDMP">PDMP</span>.</span></div>
<div style="position: absolute; left: 1717px; top: 934px; width: 300px; height: 230px; box-sizing: border-box; padding: 14px 16px; display: block; text-align: left; background: #ffffff; border: 2px solid #111111; border-radius: 12px; font-size: 15px; line-height: 19px"><svg width="28" height="28" viewBox="0 0 24 24" fill="none" stroke="#111111" stroke-width="1.75" stroke-linecap="round" stroke-linejoin="round" aria-hidden="true" style="float: right; margin: 0 0 8px 8px"><path d="M12 2.5l8 3v5.5c0 5-3.5 9-8 10.5C7.5 20 4 16 4 11V5.5z"></path><path d="M12 8.5v7M8.5 12h7"></path></svg><span><b style="font-size: 20px; line-height: 26px">Health Insurance</b><br>Medicare (Parts A, B, C = <span class="ac" tabindex="0" data-k="MA">MA</span>, D). Medicaid & <span class="ac" tabindex="0" data-k="CHIP">CHIP</span>, mostly via <span class="ac" tabindex="0" data-k="MCOs">MCOs</span> (<span class="ac" tabindex="0" data-k="EPSDT">EPSDT</span> guarantees kids' benefits). Commercial & employer plans (<span class="ac" tabindex="0" data-k="ESI">ESI</span>, self-insured via a <span class="ac" tabindex="0" data-k="TPA">TPA</span>), <span class="ac" tabindex="0" data-k="PBMs">PBMs</span>. Funded by premiums and taxes; <span class="ac" tabindex="0" data-k="CMS">CMS</span> sets the fee schedule.</span></div>
<div style="position: absolute; left: 2076px; top: 934px; width: 300px; height: 230px; box-sizing: border-box; padding: 14px 16px; display: block; text-align: left; background: #ffffff; border: 2px solid #111111; border-radius: 12px; font-size: 15px; line-height: 19px"><svg width="28" height="28" viewBox="0 0 24 24" fill="none" stroke="#111111" stroke-width="1.75" stroke-linecap="round" stroke-linejoin="round" aria-hidden="true" style="float: right; margin: 0 0 8px 8px"><path d="M3 21h18"></path><path d="M12 3L3 8.5h18z"></path><path d="M5 8.5V21M10 8.5V21M14 8.5V21M19 8.5V21"></path></svg><span><b style="font-size: 20px; line-height: 26px">Schools, <span class="ac" tabindex="0" data-k="CBOs">CBOs</span> & Public Agencies</b><br>The other sector, especially for kids: school-based health (bills Medicaid), <span class="ac" tabindex="0" data-k="CBOs">CBOs</span>, local programs, public health. School records: covered under <span class="ac" tabindex="0" data-k="FERPA">FERPA</span>, not <span class="ac" tabindex="0" data-k="HIPAA">HIPAA</span>. Pays for prevention whose savings aren't seen in the health sector.</span></div>
<div style="position: absolute; left: 200px; top: 1488px; width: 2176px; height: 56px; box-sizing: border-box; padding: 8px 12px; display: flex; align-items: flex-start; justify-content: flex-start; text-align: center; background: #F4F4F4; border: 1px solid #D9D9D6; border-radius: 8px; font-size: 15px; line-height: 18px"><span><b>Value-based care depends on quality metrics:</b> <span class="ac" tabindex="0" data-k="HEDIS">HEDIS</span> (<span class="ac" tabindex="0" data-k="NCQA">NCQA</span>) · Star Ratings (<span class="ac" tabindex="0" data-k="MA">MA</span>) · Child & Adult Core Sets (Medicaid/<span class="ac" tabindex="0" data-k="CHIP">CHIP</span>) · <span class="ac" tabindex="0" data-k="MIPS">MIPS</span>/<span class="ac" tabindex="0" data-k="QPP">QPP</span> & Promoting Interoperability · <span class="ac" tabindex="0" data-k="eCQMs">eCQMs</span> · <span class="ac" tabindex="0" data-k="CAHPS">CAHPS</span> · <span class="ac" tabindex="0" data-k="HCC">HCC</span> risk adjustment · <span class="ac" tabindex="0" data-k="SDOH">SDOH</span>/<span class="ac" tabindex="0" data-k="HRSN">HRSN</span> screening</span></div>
<div style="position: absolute; left: 64px; top: 64px; font-size: 40px; line-height: 48px; font-weight: 700">Digital health on one page</div>
<div style="position: absolute; left: 64px; top: 118px; width: 1500px; font-size: 17px; line-height: 22px; color: #555B66">An overview of the legislation, finances, and data flow in digital health.</div>
<div style="position: absolute; left: 1770px; top: 96px; width: 160px; font-size: 16px; line-height: 22px">Rules & regulators</div>
<div style="position: absolute; left: 2000px; top: 96px; width: 50px; font-size: 16px; line-height: 22px">Data</div>
<div style="position: absolute; left: 2120px; top: 96px; width: 70px; font-size: 16px; line-height: 22px">Money</div>
<div style="position: absolute; left: 2000px; top: 126px; width: 100px; font-size: 16px; line-height: 22px">Distribution</div>
<div style="position: absolute; left: 2170px; top: 126px; width: 180px; font-size: 16px; line-height: 22px">Ad hoc data sharing</div>
<div style="position: absolute; left: 72px; top: 170px; width: 116px; font-size: 14px; line-height: 18px; font-weight: 700; letter-spacing: 2px; color: #B83A1B">RULES</div>
<div style="position: absolute; left: 72px; top: 638px; width: 116px; font-size: 14px; line-height: 18px; font-weight: 700; letter-spacing: 2px; color: #10266C">DATA</div>
<div style="position: absolute; left: 72px; top: 946px; width: 116px; font-size: 12px; line-height: 18px; font-weight: 700; letter-spacing: 1.5px; color: #111111">STAKEHOLDERS</div>
<div style="position: absolute; left: 72px; top: 1176px; width: 116px; font-size: 14px; line-height: 18px; font-weight: 700; letter-spacing: 2px; color: #007A1C">MONEY</div>
<div style="position: absolute; left: 72px; top: 1494px; width: 116px; font-size: 14px; line-height: 18px; font-weight: 700; letter-spacing: 2px; color: #555B66">QUALITY</div>
<div style="position: absolute; left: 388px; top: 830px; width: 300px; text-align: center; font-size: 15px; line-height: 18px; color: #10266C">Distribution: the app ships with the<br>drug or device as a digital companion</div>
<div style="position: absolute; left: 771px; top: 830px; width: 300px; text-align: center; font-size: 15px; line-height: 18px; color: #10266C">Device data streams (<span class="ac" tabindex="0" data-k="CGMs">CGMs</span>, inhalers,<br>implants) and clinical trial data</div>
<div style="position: absolute; left: 1187px; top: 830px; width: 283px; text-align: center; font-size: 15px; line-height: 18px; color: #10266C"><span class="ac" tabindex="0" data-k="FHIR">FHIR</span> · <span class="ac" tabindex="0" data-k="SMART on FHIR">SMART on FHIR</span> · <span class="ac" tabindex="0" data-k="CDS Hooks">CDS Hooks</span><br><span class="ac" tabindex="0" data-k="HL7 v2">HL7 v2</span> · <span class="ac" tabindex="0" data-k="C-CDA">C-CDA</span> · <span class="ac" tabindex="0" data-k="USCDI">USCDI</span></div>
<div style="position: absolute; left: 1525px; top: 830px; width: 340px; text-align: center; font-size: 15px; line-height: 18px; color: #10266C">Claims: <span class="ac" tabindex="0" data-k="X12 837">X12 837</span> in, <span class="ac" tabindex="0" data-k="835">835</span> remittance back<br>Prior auth · quality reporting (<span class="ac" tabindex="0" data-k="eCQMs">eCQMs</span>)</div>
<div style="position: absolute; left: 509px; top: 766px; width: 480px; text-align: center; font-size: 15px; line-height: 18px; color: #10266C">Patient-generated data: wearables, apps, <span class="ac" tabindex="0" data-k="RPM">RPM</span>/<span class="ac" tabindex="0" data-k="RTM">RTM</span> streams<br><span class="ac" tabindex="0" data-k="HIPAA">HIPAA</span> and Consumer Protection laws apply to data handling</div>
<div style="position: absolute; left: 1490px; top: 766px; width: 440px; text-align: center; font-size: 15px; line-height: 18px; color: #10266C">Ad hoc data sharing: screenings, referrals, attendance,<br>program outcomes (data use agreements, <span class="ac" tabindex="0" data-k="FERPA">FERPA</span> consent)</div>
<div style="position: absolute; left: 499px; top: 702px; width: 800px; text-align: center; font-size: 15px; line-height: 18px; color: #10266C">Visits and the patient portal: notes and results released after they're signed/finalized<br>Patient-access <span class="ac" tabindex="0" data-k="FHIR">FHIR</span> <span class="ac" tabindex="0" data-k="API">API</span>: the <span class="ac" tabindex="0" data-k="EHR">EHR</span> must hand the record to any app the patient picks (e.g., Apple Health)</div>
<div style="position: absolute; left: 871px; top: 638px; width: 460px; text-align: center; font-size: 15px; line-height: 18px; color: #10266C">Patient Access <span class="ac" tabindex="0" data-k="API">API</span> (<span class="ac" tabindex="0" data-k="FHIR">FHIR</span>): the plan must hand claims<br>and clinical data to whatever app the member picks</div>
<div style="position: absolute; left: 691px; top: 1232px; width: 400px; text-align: center; font-size: 15px; line-height: 18px; color: #007A1C">Buys companion apps, patient support<br>programs, <span class="ac" tabindex="0" data-k="RWE">RWE</span> and clinical trial recruitment</div>
<div style="position: absolute; left: 1207px; top: 1232px; width: 300px; text-align: center; font-size: 15px; line-height: 18px; color: #007A1C">Capitated revenue: subscription (<span class="ac" tabindex="0" data-k="SaaS">SaaS</span>,<br><span class="ac" tabindex="0" data-k="PMPM">PMPM</span>) paid by the health system</div>
<div style="position: absolute; left: 1515px; top: 1232px; width: 344px; text-align: center; font-size: 15px; line-height: 18px; color: #007A1C">Fee-for-service: per <span class="ac" tabindex="0" data-k="CPT">CPT</span>/<span class="ac" tabindex="0" data-k="HCPCS">HCPCS</span> code, <span class="ac" tabindex="0" data-k="DRGs">DRGs</span><br><span class="ac" tabindex="0" data-k="VBC">VBC</span>: capitation (<span class="ac" tabindex="0" data-k="PMPM">PMPM</span>), <span class="ac" tabindex="0" data-k="ACO">ACO</span> shared savings</div>
<div style="position: absolute; left: 1909px; top: 1232px; width: 230px; text-align: center; font-size: 15px; line-height: 18px; color: #007A1C">Medicaid pays school-based<br>health centers (<span class="ac" tabindex="0" data-k="SBHCs">SBHCs</span>)<br>and <span class="ac" tabindex="0" data-k="EPSDT">EPSDT</span> services</div>
<div style="position: absolute; left: 562px; top: 1296px; width: 400px; text-align: center; font-size: 15px; line-height: 18px; color: #007A1C">Direct to consumer (<span class="ac" tabindex="0" data-k="D2C">D2C</span>): subscriptions,<br>app stores, <span class="ac" tabindex="0" data-k="HSA">HSA</span>/<span class="ac" tabindex="0" data-k="FSA">FSA</span> dollars</div>
<div style="position: absolute; left: 1157px; top: 1296px; width: 732px; text-align: center; font-size: 15px; line-height: 18px; color: #007A1C">Capitated revenue from plans & employers (<span class="ac" tabindex="0" data-k="PMPM">PMPM</span> / <span class="ac" tabindex="0" data-k="PEPM">PEPM</span>), or billable to insurance:<br>the company bills the payer itself for eligible supplies or health services</div>
<div style="position: absolute; left: 1290px; top: 1360px; width: 560px; text-align: center; font-size: 15px; line-height: 18px; color: #007A1C">Other payers: grants & contracts from schools, <span class="ac" tabindex="0" data-k="CBOs">CBOs</span>, public agencies<br>The wrong-pocket problem: who pays isn't who saves</div>
<div style="position: absolute; left: 843px; top: 1424px; width: 560px; text-align: center; font-size: 15px; line-height: 18px; color: #007A1C">Premiums (plus the taxes that fund Medicare and Medicaid);<br>cost sharing (copays, deductibles) when care is used</div>
<img src="assets/biodesign-logo.png" alt="Stanford Mussallem Center for Biodesign" style="position: absolute; left: 72px; top: 1560px; width: 262px; height: 90px">
<div style="position: absolute; left: 400px; top: 1569px; width: 1976px; font-size: 13px; line-height: 18px; color: #555B66">Questions, comments, or feedback? Email aydinz@stanford.edu. Many thanks to Meghana Nerurkar for inspiring the creation of this diagram.<br>Learn more about our Biodesign for Digital Health course <a href="https://med.stanford.edu/biodesign/programs/stanford-courses/biodesign-for-digital-health.html">here</a>.</div>
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var DEF={"FD&C Act": {"f": "Federal Food, Drug, and Cosmetic Act", "d": "The law that gives FDA its authority, and whose definition of a \"device\" (as amended by the Cures Act) decides whether your software is regulated at all."}, "HIPAA": {"f": "Health Insurance Portability and Accountability Act", "d": "The federal law that sets the baseline privacy and security rules for health data held by providers, health plans, clearinghouses, and their vendors; people are often surprised to learn it doesn't cover most consumer apps."}, "HITECH": {"f": "Health Information Technology for Economic and Clinical Health Act", "d": "The landmark federal legislation that enabled much of the digital health industry, providing over $30B in incentives for health systems to adopt electronic health records (it also added breach notification and much bigger HIPAA penalties)."}, "EHRs": {"f": "Electronic Health Records", "d": "The system where clinical care is documented, ordered, and billed; technically an EMR is one practice's record and an EHR is the longitudinal, shareable version, but in practice people use the terms interchangeably."}, "ACA": {"f": "Affordable Care Act", "d": "The health reform law that expanded Medicaid, created the insurance marketplaces, and set up CMMI, ACOs, and much of the value-based payment machinery we talk about in this course."}, "CMMI": {"f": "Center for Medicare and Medicaid Innovation", "d": "The arm of CMS created by the ACA to test new payment and delivery models (ACOs, InCK, ACCESS, ASPIRE) before they're expanded or shut down."}, "ACOs": {"f": "Accountable Care Organizations", "d": "A group of providers that agrees to be accountable for the total cost and quality of care for a defined population and keeps a share of any savings (the Medicare Shared Savings Program, MSSP, is the permanent and largest version)."}, "Sunshine Act": {"f": "Physician Payments Sunshine Act (Open Payments)", "d": "The part of the ACA (run as Open Payments) that requires drug and device makers to publicly report what they pay physicians and teaching hospitals."}, "MACRA": {"f": "Medicare Access and CHIP Reauthorization Act", "d": "The law that replaced the old Medicare physician payment formula with the Quality Payment Program, which pays clinicians partly on quality and cost performance."}, "APIs": {"f": "Application Programming Interfaces", "d": "The defined way one piece of software talks to another; in health IT \"the API\" almost always means a FHIR endpoint."}, "CDS": {"f": "Clinical Decision Support", "d": "Software that gives clinicians information or recommendations to support a decision; the Cures Act exempts it from FDA oversight only if, among other criteria, the clinician can independently review the basis for the recommendation rather than just trust the output (and since FDA's January 2026 guidance it may propose a single treatment plan, not just a list of options, as long as the clinician reviews and finalizes it)."}, "RWE": {"f": "Real-World Evidence", "d": "Data collected outside traditional trials (EHRs, claims, wearables, registries) and the evidence built from it, which FDA increasingly accepts in regulatory decisions."}, "HHS": {"f": "US Department of Health and Human Services", "d": "The cabinet-level department that houses nearly every federal health agency on this list (CMS, FDA, CDC, NIH, OCR, ONC, SAMHSA), so most federal health policy is ultimately HHS policy."}, "FTC": {"f": "Federal Trade Commission", "d": "The consumer protection and competition agency that goes after deceptive marketing claims and unfair data practices, which makes it the de facto privacy regulator for all the health apps HIPAA doesn't cover."}, "DEA": {"f": "Drug Enforcement Administration", "d": "The Justice Department agency that controls prescribing of controlled substances, including the still-temporary rules that let clinicians prescribe them over telehealth without an in-person visit."}, "UDAP": {"f": "Unfair or Deceptive Acts or Practices (Section 5 of the FTC Act)", "d": "The FTC's catch-all authority over unfair or deceptive business practices, which is what it uses against health apps that overstate what they do or mishandle data."}, "HBNR": {"f": "Health Breach Notification Rule", "d": "The FTC rule requiring health apps and other companies outside HIPAA to notify users and the FTC when health data is breached or shared without permission."}, "COPPA": {"f": "Children's Online Privacy Protection Act", "d": "The FTC-enforced law that restricts collecting personal data online from children under 13 without verifiable parental consent, which every pediatric app has to design around."}, "FDA": {"f": "Food and Drug Administration", "d": "The agency that regulates drugs, devices, and the software that counts as a device, and decides whether a product can be sold at all; CDRH (the Center for Devices and Radiological Health) is the part that handles devices and digital health."}, "CDRH": {"f": "Center for Devices and Radiological Health", "d": "The FDA center that regulates medical devices, which includes software as a medical device and therefore most of digital health."}, "SaMD": {"f": "Software as a Medical Device", "d": "Software that is itself the medical device (an app that diagnoses or guides treatment) rather than software embedded in a hardware device, which is SiMD, software in a medical device."}, "510(k)": {"f": "Premarket Notification (section 510(k) of the FD&C Act): show substantial equivalence to a device already on the market", "d": "The most common FDA pathway, where you show your device is \"substantially equivalent\" to one already on the market; most AI-enabled devices have gone this route."}, "PMA": {"f": "Premarket Approval", "d": "The most rigorous FDA pathway, reserved for Class III devices and usually requiring clinical trials."}, "GMLP": {"f": "Good Machine Learning Practice", "d": "The ten principles FDA (with Health Canada and the UK's MHRA) published for developing AI and machine learning devices responsibly."}, "PCCP": {"f": "Predetermined Change Control Plan", "d": "A plan submitted with an AI-enabled device describing how the model will be updated or retrained over time, so the manufacturer doesn't have to go back to FDA for every change."}, "524B": {"f": "Section 524B of the FD&C Act: cybersecurity requirements for cyber devices", "d": "The 2022 addition to the FD&C Act that makes cybersecurity (a software bill of materials, a plan for patching vulnerabilities) a premarket requirement for any connected 'cyber device'."}, "CDER": {"f": "Center for Drug Evaluation and Research", "d": "The FDA center that regulates drugs and decides whether a new medicine can be marketed."}, "CBER": {"f": "Center for Biologics Evaluation and Research", "d": "The FDA center that regulates biologics: vaccines, blood products, and cell and gene therapies."}, "IND": {"f": "Investigational New Drug application", "d": "The FDA filing that lets a company start human trials of an investigational drug; nothing goes into a trial participant without one."}, "NDA": {"f": "New Drug Application", "d": "The application a drug maker files with FDA to get a new drug approved, built on the trial data generated under its IND."}, "BLA": {"f": "Biologics License Application", "d": "FDA's approval application for a biologic (vaccines, antibodies, cell and gene therapies), the counterpart of the NDA for a drug."}, "DTC": {"f": "Direct-to-Consumer", "d": "Marketing a prescription product straight to patients (the ads that end with 'ask your doctor'), which only the US and New Zealand allow."}, "OPDP": {"f": "Office of Prescription Drug Promotion", "d": "The FDA office that polices prescription drug advertising and promotion, including direct-to-consumer ads."}, "IDE": {"f": "Investigational Device Exemption", "d": "FDA's permission to study an unapproved, significant-risk device in people, the device-world counterpart of the IND."}, "IRB": {"f": "Institutional Review Board", "d": "The committee that reviews and approves research on human subjects, which you'll deal with for any study, pilot, or dataset involving real patients."}, "RWD": {"f": "Real-World Data", "d": "Data collected outside traditional trials (EHRs, claims, wearables, registries) and the evidence built from it, which FDA increasingly accepts in regulatory decisions."}, "TEMPO": {"f": "Technology-Enabled Meaningful Patient Outcomes pilot", "d": "FDA's pilot, paired with CMS's ACCESS Model, that lets manufacturers use digital health devices with ACCESS patients before they have marketing authorization, in exchange for sharing real-world data with FDA."}, "CMS": {"f": "Centers for Medicare & Medicaid Services", "d": "The agency that runs Medicare, Medicaid, CHIP, and the ACA marketplaces; it's the largest payer in the country, and commercial insurers tend to copy its coverage and payment decisions."}, "ACCESS": {"f": "Advancing Chronic Care with Effective, Scalable Solutions Model", "d": "The CMMI model, with its first cohort starting in 2026, that pays organizations delivering technology-enabled care to Medicare patients with chronic conditions on outcomes rather than per service; it's the first Medicare payment model built around digital health companies, and the kind of thing pediatrics doesn't have yet."}, "OCR": {"f": "Office for Civil Rights", "d": "The HHS office that enforces HIPAA (it investigates breaches and levies the fines) as well as the ACA's nondiscrimination rules, including how they apply to clinical algorithms."}, "BAAs": {"f": "Business Associate Agreements", "d": "A vendor that handles PHI on behalf of a covered entity, and the contract that makes it legally responsible for protecting that data; if you sell to health systems you'll sign a lot of these."}, "BA's": {"f": "Business Associates", "d": "A vendor that handles PHI on behalf of a covered entity, and the contract that makes it legally responsible for protecting that data; if you sell to health systems you'll sign a lot of these."}, "FERPA": {"f": "Family Educational Rights and Privacy Act", "d": "The federal law protecting student education records, which governs (instead of HIPAA) most health information held by schools and school-based programs."}, "AGs": {"f": "Attorneys General", "d": "Each state's top lawyer, who can investigate and sue companies under state consumer protection, privacy, and AI laws, and who lately has been more aggressive on health tech than the federal agencies."}, "CCPA": {"f": "California Consumer Privacy Act", "d": "California's general consumer privacy law, which covers the health data that falls outside HIPAA and has been the template for most other state privacy laws (Washington's My Health My Data Act is the first one aimed squarely at consumer health data)."}, "CPRA": {"f": "California Privacy Rights Act", "d": "California's general consumer privacy law, which covers the health data that falls outside HIPAA and has been the template for most other state privacy laws (Washington's My Health My Data Act is the first one aimed squarely at consumer health data)."}, "CMIA": {"f": "Confidentiality of Medical Information Act (California)", "d": "California's medical privacy law, which is stricter than HIPAA in places and explicitly reaches some apps and vendors HIPAA doesn't."}, "MHMDA": {"f": "My Health My Data Act (Washington)", "d": "Washington State's 2023 consumer health data privacy law, the first state law aimed squarely at the health data HIPAA doesn't cover, and one that lets consumers sue."}, "ONC": {"f": "Office of the National Coordinator for Health Information Technology", "d": "The federal agency that maintains rules and regulations behind interoperability in the US, certifies EHRs, and runs TEFCA; most people still just say ONC."}, "ASTP": {"f": "Assistant Secretary for Technology Policy (ONC's parent office since 2024)", "d": "The HHS office that ONC was folded into in 2024; the two names now appear together as ASTP/ONC, and most people still just say ONC."}, "CEHRT": {"f": "Certified EHR Technology", "d": "An EHR that has passed ONC's certification program, which is the prerequisite for most federal quality and incentive programs and the lever ONC uses to push new standards into the market."}, "USCDI": {"f": "United States Core Data for Interoperability: the minimum data set certified EHRs must be able to exchange", "d": "The federally defined minimum set of data elements (problems, meds, labs, notes, and so on) that certified EHRs must be able to exchange, updated roughly annually; the US Core FHIR profiles spell out exactly how each element is represented."}, "FHIR": {"f": "Fast Healthcare Interoperability Resources", "d": "The data standard that is used to transfer health data between applications and EHRs, built on ordinary web technology (REST APIs and JSON) rather than older messaging formats."}, "TEFCA": {"f": "Trusted Exchange Framework and Common Agreement", "d": "The ONC-led framework for nationwide exchange, where a small number of designated networks (QHINs) agree to one set of rules so data can move anywhere in the country instead of through a patchwork of regional HIEs."}, "PFS": {"f": "Physician Fee Schedule", "d": "CMS's annual rule setting Medicare payment for each code, which is also where new digital health codes (RPM, RTM, digital mental health treatment) get created each year."}, "NCD": {"f": "National Coverage Determination", "d": "Medicare's formal decisions on whether a service is covered nationwide (an NCD) or only in a region (an LCD, issued by the regional Medicare Administrative Contractor, or MAC, that processes claims there)."}, "LCD": {"f": "Local Coverage Determination", "d": "Medicare's formal decisions on whether a service is covered nationwide (an NCD) or only in a region (an LCD, issued by the regional Medicare Administrative Contractor, or MAC, that processes claims there)."}, "MA": {"f": "Medicare Advantage", "d": "Private plans paid a risk-adjusted capitated rate by CMS to cover Medicare beneficiaries, now more than half of them, which makes MA plans a major buyer of anything that improves Star ratings or lowers cost."}, "ILOS": {"f": "In Lieu of Services", "d": "The Medicaid managed care option to pay for a substitute service (medically tailored meals, a digital program) instead of a covered one when it's cost-effective, a relatively new way to get non-traditional services paid for."}, "MCO": {"f": "Managed Care Organization", "d": "An arrangement where an insurance company gets paid on a per-capita basis to take care of a subgroup of the population; most Medicaid enrollees are now in MCOs rather than state-run fee-for-service Medicaid."}, "CCIIO": {"f": "Center for Consumer Information and Insurance Oversight", "d": "The CMS office that oversees the ACA marketplaces and the private insurance rules the ACA created."}, "CDC": {"f": "Centers for Disease Control and Prevention", "d": "The federal public health agency, which touches digital health mostly through surveillance, immunization registries, and public health reporting standards."}, "IIS": {"f": "Immunization Information System", "d": "The state and local immunization registries that EHRs report vaccines to, which in pediatrics are often the most complete record a child has."}, "PDMP": {"f": "Prescription Drug Monitoring Program", "d": "The state databases of controlled substance prescriptions that clinicians have to check before prescribing opioids and similar drugs."}, "OIG": {"f": "Office of Inspector General (HHS)", "d": "HHS's internal watchdog, which audits federal health programs, investigates fraud, waste, and abuse, and can exclude providers from Medicare and Medicaid."}, "DOJ": {"f": "Department of Justice", "d": "The Department of Justice, which prosecutes healthcare fraud cases alongside HHS's Office of Inspector General."}, "AKS": {"f": "Anti-Kickback Statute", "d": "The criminal law against paying or receiving anything of value for referrals of federally funded healthcare business, which is why \"free\" software or devices for providers have to fit a safe harbor; its civil cousin, the Stark Law, bars physicians from referring to entities they have a financial stake in."}, "Stark": {"f": "Stark Law: the physician self-referral law", "d": "The physician self-referral law, the civil cousin of the Anti-Kickback Statute: physicians can't refer Medicare patients to entities they have a financial stake in unless an exception applies."}, "FCA": {"f": "False Claims Act", "d": "The law that makes billing Medicare or Medicaid for things you didn't do (or shouldn't have billed) a federal offense, with whistleblower provisions that make it the government's main fraud enforcement tool."}, "SOC 2": {"f": "System and Organization Controls 2 (security audit report)", "d": "The third-party audit report (from the AICPA) that health systems and payers almost always ask vendors for as proof that security controls actually work as described."}, "HITRUST": {"f": "Health Information Trust Alliance (CSF certification)", "d": "A healthcare-specific security certification that bundles HIPAA, NIST, ISO, and other requirements into one assessment; expensive to get, but it opens enterprise doors."}, "BAA": {"f": "Business Associate Agreement", "d": "A vendor that handles PHI on behalf of a covered entity, and the contract that makes it legally responsible for protecting that data; if you sell to health systems you'll sign a lot of these."}, "EHR": {"f": "Electronic Health Record", "d": "The system where clinical care is documented, ordered, and billed; technically an EMR is one practice's record and an EHR is the longitudinal, shareable version, but in practice people use the terms interchangeably."}, "CPOM": {"f": "Corporate Practice of Medicine doctrine", "d": "The state-law rule, strongest in California, New York, and Texas, that only licensed physicians can own medical practices or employ physicians, which is why telehealth companies are structured as an MSO contracting with a physician-owned professional corporation."}, "MSO": {"f": "Management Services Organization", "d": "The company that supplies the non-clinical side of a practice (technology, staff, billing, marketing) under a management agreement, the standard way to build a venture-backed clinical business under CPOM."}, "PC": {"f": "Professional Corporation (physician-owned)", "d": "The physician-owned professional corporation that actually employs the clinicians and bills for care, paired with an MSO to satisfy corporate practice of medicine rules."}, "IMLC": {"f": "Interstate Medical Licensure Compact", "d": "The agreement among most states that speeds up getting licensed in several of them, which matters because a telehealth clinician has to be licensed where the patient is, not where the clinician sits (PSYPACT is the equivalent for psychologists)."}, "Rx": {"f": "prescriptions", "d": "Prescriptions; 'controlled substances Rx' means prescribing the drugs the DEA schedules, like opioids and stimulants, which have their own telehealth rules."}, "SAMHSA": {"f": "Substance Abuse and Mental Health Services Administration", "d": "The HHS agency for mental health and substance use, which also owns the 42 CFR Part 2 confidentiality rules for substance use treatment records."}, "42 CFR Part 2": {"f": "Title 42, Code of Federal Regulations, Part 2: confidentiality of substance use disorder treatment records", "d": "The federal rule that gives substance use disorder treatment records more protection than HIPAA does, generally requiring patient consent before they can be shared (recently brought a bit closer to HIPAA)."}, "ASPIRE": {"f": "Accelerating State Pediatric Innovation Readiness and Effectiveness Model", "d": "The CMMI model announced in March 2026 as the successor to InCK: a 10-year, up-to-five-state, $125M program that pays Medicaid providers to take accountability for the quality and cost of care for kids under 21 with (or at risk of) complex medical and behavioral needs."}, "InCK": {"f": "Integrated Care for Kids Model", "d": "The CMMI model (2020 through 2026) that funded state and local partnerships to integrate physical, behavioral, and social services for Medicaid-covered children, with alternative payment models to support it."}, "EU": {"f": "European Union", "d": "The European Union, whose rules (GDPR, the MDR, the AI Act) apply as soon as a product has European users."}, "GDPR": {"f": "General Data Protection Regulation", "d": "The EU's privacy law, which treats health data as a special category and gives individuals rights (access, erasure, portability) that go well beyond HIPAA; it applies the moment you have a European user."}, "MDR": {"f": "Medical Device Regulation (EU)", "d": "The EU's Medical Device Regulation, its counterpart to FDA device rules and generally stricter about clinical evidence."}, "AI Act": {"f": "EU Artificial Intelligence Act", "d": "The EU's 2024 law that regulates AI by risk tier, under which most medical AI counts as high-risk and carries extra obligations."}, "SpO2": {"f": "Blood oxygen saturation", "d": "Blood oxygen saturation, the pulse-oximetry reading that smartwatches estimate optically; a wellness feature under FDA's 2026 policy unless it is tied to a disease claim."}, "HRV": {"f": "Heart rate variability", "d": "Heart rate variability, the beat-to-beat variation that wearables use as a proxy for stress, recovery, and sleep quality."}, "D2C": {"f": "Direct to Consumer", "d": "The company sells access to its product straight to the patient or caregiver, with no insurer, employer, or provider in between (an app subscription, for example)."}, "CHIP": {"f": "Children's Health Insurance Program", "d": "The federal-state program for kids whose families earn too much for Medicaid but can't afford private coverage, usually run alongside Medicaid."}, "DH": {"f": "Digital Health", "d": "Digital health: the company, product, or industry this figure is about."}, "DTx": {"f": "Digital Therapeutics", "d": "Software that delivers a clinical intervention on its own (CBT for insomnia, for example) with evidence behind it; \"prescription\" DTx are FDA-cleared and ordered by a clinician, and until the 2025 DMHT codes had almost no reimbursement pathway."}, "SaaS": {"f": "Software as a Service", "d": "Subscription software hosted by the vendor, which is how most digital health is sold to providers and plans and structurally looks a lot like capitation (a recurring per-unit fee)."}, "PMPM": {"f": "Per Member Per Month", "d": "The standard unit of capitated payment and of digital health pricing to plans and health systems (a $2 PMPM contract for 100,000 members is $2.4M a year); PEPM, per employee per month, is the same idea when selling to employers."}, "SNOMED CT": {"f": "Systematized Nomenclature of Medicine, Clinical Terms", "d": "The comprehensive clinical terminology for problems, findings, and procedures the way clinicians document them (as opposed to ICD, which is organized for billing)."}, "LOINC": {"f": "Logical Observation Identifiers Names and Codes", "d": "The standardized terminology that's used to describe observations like lab tests and vitals."}, "RxNorm": {"f": "RxNorm: standardized clinical drug names from the National Library of Medicine", "d": "The National Library of Medicine's standardized names and codes for clinical drugs, which is what lets a system recognize that two differently branded products are the same medication."}, "ICD-10-CM": {"f": "International Classification of Diseases, 10th Revision, Clinical Modification", "d": "The diagnosis code set on every US claim, which is what justifies that a service was medically necessary; ICD-11 exists, but the US hasn't moved yet."}, "CPT": {"f": "Current Procedural Terminology", "d": "The AMA-owned code set for procedures and services that drives most outpatient billing, including the telehealth, RPM, and care management codes; Category III codes are temporary ones for new technologies that get tracked but usually not paid, the first step toward reimbursement for a new device or procedure."}, "HCPCS": {"f": "Healthcare Common Procedure Coding System", "d": "CMS's code set that includes CPT (Level I) plus Level II codes for supplies, drugs, equipment, and services CPT doesn't cover, including many of the newer Medicare care management codes (the ones starting with G)."}, "HIE": {"f": "Health Information Exchange", "d": "A regional or statewide organization (or the activity itself) that moves patient records between unaffiliated providers."}, "QHINs": {"f": "Qualified Health Information Networks", "d": "A network approved to participate in TEFCA and exchange with every other QHIN (Epic, eHealth Exchange, Health Gorilla, and CommonWell are examples)."}, "MCOs": {"f": "Managed Care Organizations", "d": "An arrangement where an insurance company gets paid on a per-capita basis to take care of a subgroup of the population; most Medicaid enrollees are now in MCOs rather than state-run fee-for-service Medicaid."}, "EPSDT": {"f": "Early and Periodic Screening, Diagnostic, and Treatment", "d": "Medicaid's benefit guarantee for anyone under 21, which entitles kids to all medically necessary care, including screening and developmental services adult Medicaid doesn't have to cover; it's the legal hook for a lot of pediatric services."}, "ESI": {"f": "Employer-Sponsored Insurance", "d": "Coverage through an employer, which is how most working-age adults are insured and why employer benefits are such a common sales channel for adult-focused digital health."}, "TPA": {"f": "Third-Party Administrator", "d": "A third-party administrator, the company a self-insured employer hires to process claims and run its plan without taking on the insurance risk itself."}, "PBMs": {"f": "Pharmacy Benefit Managers", "d": "The middleman that manages drug benefits for plans and employers, negotiating rebates and deciding which drugs are covered."}, "CBOs": {"f": "Community-Based Organizations", "d": "Nonprofits like food banks, family resource centers, and youth programs, which along with schools and government agencies are the \"other\" payers funding a lot of pediatric mental health and social-needs programs."}, "HEDIS": {"f": "Healthcare Effectiveness Data and Information Set", "d": "NCQA's standardized set of quality measures that health plans report (immunization rates, well-child visits, A1c control), which is what plans are graded on and therefore what they'll pay vendors to move."}, "NCQA": {"f": "National Committee for Quality Assurance", "d": "The nonprofit that accredits health plans and maintains HEDIS and the Patient-Centered Medical Home (PCMH) recognition program."}, "MIPS": {"f": "Merit-based Incentive Payment System", "d": "The MACRA program that adjusts Medicare physician payment up or down based on quality, cost, improvement activities, and interoperability performance."}, "QPP": {"f": "Quality Payment Program", "d": "The MACRA program that adjusts Medicare physician payment up or down based on quality, cost, improvement activities, and interoperability performance."}, "eCQMs": {"f": "electronic Clinical Quality Measures", "d": "Electronic clinical quality measures, the quality metrics calculated directly from EHR data rather than from claims or chart review, which providers report to CMS."}, "CAHPS": {"f": "Consumer Assessment of Healthcare Providers and Systems", "d": "The AHRQ-developed patient experience surveys that feed into Star Ratings and hospital quality scores."}, "HCC": {"f": "Hierarchical Condition Category (risk adjustment)", "d": "The risk adjustment coding system CMS uses to pay more for sicker populations, which is why documenting diagnoses completely is worth real money in Medicare Advantage and ACOs (and why there's so much fraud enforcement around it)."}, "SDOH": {"f": "Social Determinants of Health", "d": "The non-medical factors (housing, food, transportation, income) that shape health, and the individual-level version of them (this patient is food insecure), which Medicaid programs are increasingly screening for and paying to address."}, "HRSN": {"f": "Health-Related Social Needs", "d": "The non-medical factors (housing, food, transportation, income) that shape health, and the individual-level version of them (this patient is food insecure), which Medicaid programs are increasingly screening for and paying to address."}, "CGMs": {"f": "Continuous Glucose Monitors", "d": "Continuous glucose monitors, the wearable sensors (Dexcom, Abbott's Libre) that are the most successful device-data stream in digital health so far."}, "SMART on FHIR": {"f": "Substitutable Medical Applications, Reusable Technologies on FHIR: the standard for launching apps inside an EHR", "d": "The open standard for launching a third-party app inside an EHR and letting it read FHIR data with the user's permission, which is how most EHR-integrated apps are built."}, "CDS Hooks": {"f": "Clinical Decision Support Hooks: the HL7 standard for pushing decision support into the EHR workflow", "d": "The HL7 standard that lets an outside service push decision support \"cards\" into the EHR workflow at defined trigger points, like when an order is signed."}, "HL7 v2": {"f": "Health Level Seven version 2 messaging standard", "d": "The decades-old pipe-delimited messaging standard that still carries most hospital data traffic (lab results, ADT feeds, orders); ugly, but everywhere."}, "C-CDA": {"f": "Consolidated Clinical Document Architecture", "d": "HL7's XML document standard for packaging a clinical summary to send between systems; the Continuity of Care Document (CCD) is the most common type and what gets exchanged in most transitions of care."}, "X12 837": {"f": "ASC X12 837: the electronic claim transaction", "d": "The transaction standards HIPAA requires for claims, eligibility checks, and payments (the 837 claim and the 835 remittance are the ones you'll hear about)."}, "835": {"f": "ASC X12 835: the electronic remittance advice (payment and denial detail)", "d": "The transaction standards HIPAA requires for claims, eligibility checks, and payments (the 837 claim and the 835 remittance are the ones you'll hear about)."}, "RPM": {"f": "Remote Patient (Physiologic) Monitoring", "d": "The CPT codes that pay for supplying a patient a connected device and reviewing the data it sends, which is the main reimbursement pathway for device-based digital health."}, "RTM": {"f": "Remote Therapeutic Monitoring", "d": "The parallel codes for monitoring non-physiologic data like medication adherence, pain, or therapy exercises, which opened reimbursement to app-based products and to physical therapists and others who can't bill RPM."}, "API": {"f": "Application Programming Interface", "d": "The defined way one piece of software talks to another; in health IT \"the API\" almost always means a FHIR endpoint."}, "DRGs": {"f": "Diagnosis-Related Groups", "d": "The inpatient payment unit where Medicare pays a hospital a fixed amount per admission based on the diagnosis, regardless of what the stay actually cost."}, "VBC": {"f": "Value-Based Care", "d": "The umbrella term for payment arrangements that tie what a provider earns to quality and cost outcomes rather than volume."}, "ACO": {"f": "Accountable Care Organization", "d": "A group of providers that agrees to be accountable for the total cost and quality of care for a defined population and keeps a share of any savings (the Medicare Shared Savings Program, MSSP, is the permanent and largest version)."}, "SBHCs": {"f": "School-Based Health Centers", "d": "A clinic located in a school, often run by an FQHC or hospital, that bills Medicaid and is one of the few places where the health and education sectors actually share patients and money."}, "HSA": {"f": "Health Savings Account", "d": "A health savings account: pre-tax dollars tied to a high-deductible plan that patients can spend on eligible health products, including some digital health apps and devices."}, "FSA": {"f": "Flexible Spending Account", "d": "A flexible spending account, the employer-sponsored version of pre-tax health dollars, with a use-it-or-lose-it deadline each year."}, "PEPM": {"f": "Per Employee Per Month", "d": "The standard unit of capitated payment and of digital health pricing to plans and health systems (a $2 PMPM contract for 100,000 members is $2.4M a year); PEPM, per employee per month, is the same idea when selling to employers."}};
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