- Health Insurance Portability and Accountability ActHIPAA
- US federal law setting national standards for protected health information (PHI). HIPAA Privacy + Security Rules govern any digital product touching patient data; civil penalties run $100–$50,000 per violation, capped at $1.5M/year per category.
- FDA 510(k) Clearance510(k)
- Premarket notification pathway proving a medical device or SaMD is substantially equivalent to a legally marketed predicate. Median FDA review 3–6 months; required for most Class II software-as-a-medical-device tools.
- De Novo ClassificationDe Novo
- FDA pathway for novel low/moderate-risk devices with no predicate. Review 6–12 months; used by first-in-class AI diagnostics (e.g. IDx-DR, Paige Prostate). Establishes a new predicate for future 510(k)s.
- Premarket ApprovalPMA
- FDA pathway for Class III high-risk devices requiring clinical trial evidence of safety and efficacy. Timeline 1–3 years, cost typically $10M+. Used by implantables and life-sustaining digital therapeutics.
- Software as a Medical DeviceSaMD
- IMDRF/FDA classification for software intended to diagnose, treat, cure, mitigate or prevent disease without being part of a hardware device. Regulated under Predetermined Change Control Plans (PCCP) since 2024.
- Electronic Health RecordEHR/EMR
- Longitudinal digital patient chart. US market is dominated by Epic (40%+ acute care) and Oracle Cerner. EHR integration via SMART-on-FHIR is the dominant distribution moat in healthcare infrastructure.
- Fast Healthcare Interoperability ResourcesFHIR
- HL7 open standard (R4) for exchanging healthcare data via REST APIs. Mandated by ONC 21st Century Cures Act since 2022; the primary interoperability layer for new digital health products.
- Health Level Seven InternationalHL7
- Family of healthcare data standards (v2 messaging, CDA documents, FHIR APIs). HL7 v2 still dominates legacy hospital interfaces; FHIR is the modern API-first replacement.
- Trusted Exchange Framework and Common AgreementTEFCA
- ONC framework (live since Dec 2023) enabling nationwide health-data exchange via Qualified Health Information Networks (QHINs). Removes the need for one-off EHR integrations.
- Qualified Health Information NetworkQHIN
- Designated network under TEFCA capable of brokering nationwide health-data exchange. Initial QHINs include Health Gorilla, eHealth Exchange, Epic Nexus, Konza and CommonWell — primary distribution rail for new entrants.
- Revenue Cycle ManagementRCM
- End-to-end financial process from patient registration to final payment: eligibility, coding, claims, denials, AR. US RCM software market ~$50B; AI-native entrants (Waystar, AKASA, Cedar) compress denial rates 30–50%.
- Prior AuthorizationPA
- Payer requirement for advance approval before a service or medication. Avg US PA cost ~$11 per request; AI-driven automation (Cohere Health, Anterior, Tennr) approves 70–90% without human review.
- Digital TherapeuticDTx
- Evidence-based software-only intervention that prevents, manages or treats a disease, often FDA-cleared (e.g. CT-132, EndeavorRx, reSET). Reimbursement remains the category killer — see Pear Therapeutics collapse 2023.
- Remote Patient MonitoringRPM
- Continuous capture of patient physiological data outside the clinic via connected devices. Medicare reimburses RPM under CPT 99453/99457/99458 — a ~$100/patient/month recurring revenue line for providers.
- Continuous Glucose MonitorCGM
- Wearable interstitial-glucose sensor (Dexcom, Abbott Libre) streaming readings every 1–5 minutes. CGM-as-platform plays (Levels, January AI, Function) extend the device into preventive metabolic SaaS.
- Value-Based CareVBC
- Payment model rewarding providers for outcomes and total cost of care rather than fee-for-service volume. VBC capitated contracts are the buyer profile for population-health and care-navigation tools.
- Payvider
- Vertically integrated entity acting as both payer (insurer) and provider (clinic). Examples: Oscar Health, Clover Health, Devoted Health, Kaiser Permanente. Aligned incentives compress care delivery cost.
- Telehealth Parity Law
- State or federal regulation requiring payers to reimburse telehealth visits at parity with in-person care. Post-PHE expirations and shifting state rules are the #1 variable in telehealth unit economics.
- Health Insurance Portability and Accountability ActHIPAA
- US federal law setting national standards for protected health information (PHI). HIPAA Privacy + Security Rules govern any digital product touching patient data; civil penalties run $100–$50,000 per violation, capped at $1.5M/year per category.
- FDA 510(k) Clearance510(k)
- Premarket notification pathway proving a medical device or SaMD is substantially equivalent to a legally marketed predicate. Median FDA review 3–6 months; required for most Class II software-as-a-medical-device tools.
- De Novo ClassificationDe Novo
- FDA pathway for novel low/moderate-risk devices with no predicate. Review 6–12 months; used by first-in-class AI diagnostics (e.g. IDx-DR, Paige Prostate). Establishes a new predicate for future 510(k)s.
- Premarket ApprovalPMA
- FDA pathway for Class III high-risk devices requiring clinical trial evidence of safety and efficacy. Timeline 1–3 years, cost typically $10M+. Used by implantables and life-sustaining digital therapeutics.
- Software as a Medical DeviceSaMD
- IMDRF/FDA classification for software intended to diagnose, treat, cure, mitigate or prevent disease without being part of a hardware device. Regulated under Predetermined Change Control Plans (PCCP) since 2024.
- Electronic Health RecordEHR/EMR
- Longitudinal digital patient chart. US market is dominated by Epic (40%+ acute care) and Oracle Cerner. EHR integration via SMART-on-FHIR is the dominant distribution moat in healthcare infrastructure.
- Fast Healthcare Interoperability ResourcesFHIR
- HL7 open standard (R4) for exchanging healthcare data via REST APIs. Mandated by ONC 21st Century Cures Act since 2022; the primary interoperability layer for new digital health products.
- Health Level Seven InternationalHL7
- Family of healthcare data standards (v2 messaging, CDA documents, FHIR APIs). HL7 v2 still dominates legacy hospital interfaces; FHIR is the modern API-first replacement.
- Trusted Exchange Framework and Common AgreementTEFCA
- ONC framework (live since Dec 2023) enabling nationwide health-data exchange via Qualified Health Information Networks (QHINs). Removes the need for one-off EHR integrations.
- Qualified Health Information NetworkQHIN
- Designated network under TEFCA capable of brokering nationwide health-data exchange. Initial QHINs include Health Gorilla, eHealth Exchange, Epic Nexus, Konza and CommonWell — primary distribution rail for new entrants.
- Revenue Cycle ManagementRCM
- End-to-end financial process from patient registration to final payment: eligibility, coding, claims, denials, AR. US RCM software market ~$50B; AI-native entrants (Waystar, AKASA, Cedar) compress denial rates 30–50%.
- Prior AuthorizationPA
- Payer requirement for advance approval before a service or medication. Avg US PA cost ~$11 per request; AI-driven automation (Cohere Health, Anterior, Tennr) approves 70–90% without human review.
- Digital TherapeuticDTx
- Evidence-based software-only intervention that prevents, manages or treats a disease, often FDA-cleared (e.g. CT-132, EndeavorRx, reSET). Reimbursement remains the category killer — see Pear Therapeutics collapse 2023.
- Remote Patient MonitoringRPM
- Continuous capture of patient physiological data outside the clinic via connected devices. Medicare reimburses RPM under CPT 99453/99457/99458 — a ~$100/patient/month recurring revenue line for providers.
- Continuous Glucose MonitorCGM
- Wearable interstitial-glucose sensor (Dexcom, Abbott Libre) streaming readings every 1–5 minutes. CGM-as-platform plays (Levels, January AI, Function) extend the device into preventive metabolic SaaS.
- Value-Based CareVBC
- Payment model rewarding providers for outcomes and total cost of care rather than fee-for-service volume. VBC capitated contracts are the buyer profile for population-health and care-navigation tools.
- Payvider
- Vertically integrated entity acting as both payer (insurer) and provider (clinic). Examples: Oscar Health, Clover Health, Devoted Health, Kaiser Permanente. Aligned incentives compress care delivery cost.
- Telehealth Parity Law
- State or federal regulation requiring payers to reimburse telehealth visits at parity with in-person care. Post-PHE expirations and shifting state rules are the #1 variable in telehealth unit economics.