{ "schema_version": "1.1", "generated_on": "2026-09-03", "publisher": "Prevention for Longevity (P4L)", "purpose": "Canonical current-state records for volatile public claims; dependent surfaces reference or hydrate from these records rather than maintain disconnected current-state copies.", "records": { "tempo": { "record_id": "VOL-TEMPO-001", "entity": "FDA TEMPO for Digital Health Devices Pilot", "current_status": "Current but high-volatility", "verified_on": "2026-09-03", "source_content_current_as_of": "2026-08-21", "authoritative_source": "https://www.fda.gov/medical-devices/digital-health-center-excellence/participants-selected-tempo-digital-health-devices-pilot", "current_claim": "FDA's maintained TEMPO participant table currently lists four participants: SonderMind, Inc. / SonderMind Adjunctive Care Application (SACA); Limbic Inc. / Unpacked; Cadence Solutions, Inc. / HypertensionOS; and Dexcom, Inc. / Dexcom Glucose Health Program.", "establishes": [ "The maintained FDA participant table currently lists SonderMind, Inc. / SonderMind Adjunctive Care Application (SACA).", "The maintained FDA participant table currently lists Limbic Inc. / Unpacked.", "The maintained FDA participant table currently lists Cadence Solutions, Inc. / HypertensionOS.", "The maintained FDA participant table currently lists Dexcom, Inc. / Dexcom Glucose Health Program." ], "does_not_establish": [ "Clinical effectiveness for the participating intended uses.", "General FDA approval or clearance beyond what separate device-specific sources establish.", "CMS ACCESS participation, Medicare coverage, endorsement, or scaled adoption." ], "boundary": "FDA states that effectiveness for the participating intended uses has not yet been evaluated. Participation does not establish general FDA approval or clearance, Medicare coverage, endorsement, final CMS ACCESS participation, or scaled adoption.", "related": { "signal": "/signal/2026-08-21-tempo-four-participants/", "stable_object": "/signals/fda-tempo/", "evidence": "/evidence/tempo-participants-2026/", "proof": "/proof/tempo-participants/", "graph": "/intelligence-graph/", "brief": "/brief/" }, "verified_at": "2026-09-03", "source_updated_at": "2026-08-21", "next_review_due": "2026-09-10", "change_detected_at": null, "freshness": "Current" }, "access": { "record_id": "VOL-ACCESS-001", "entity": "CMS ACCESS Model", "current_status": "Current but high-volatility", "verified_on": "2026-09-03", "source_last_updated": "2026-08-17", "authoritative_source": "https://www.cms.gov/priorities/innovation/access-model-accepted-applicants", "current_claim": "CMS’s accepted-applicant page was updated August 17, 2026 and lists more than 150 accepted organizations. CMS says private payers representing 165 million members across Medicare Advantage, Medicaid, and commercial coverage have committed to align with the ACCESS payment approach, with many beginning in 2026. Inclusion on the accepted-applicant list is not CMS endorsement and does not guarantee final participation; participation remains contingent on Medicare enrollment, an executed agreement, final approval, and other requirements.", "establishes": [ "CMS’s accepted-applicant page was updated August 17, 2026 and lists more than 150 accepted organizations.", "CMS says private payers representing 165 million members across Medicare Advantage, Medicaid, and commercial coverage have committed to align with the ACCESS payment approach, with many beginning in 2026.", "CMS describes a ten-year model, rolling start dates, outcome-aligned payments, public reporting of aggregated risk-adjusted results, physician clinical oversight, clinical and data safeguards, and lifestyle/behavioral, diagnostic, medication, care-coordination, and technology-supported services." ], "does_not_establish": [ "CMS endorsement of an accepted organization.", "Guaranteed final participation, participant-specific effectiveness, coverage, outcomes, or performance." ], "boundary": "Inclusion on the accepted-applicant list is not CMS endorsement and does not guarantee final participation; participation remains contingent on Medicare enrollment, an executed agreement, final approval, and other requirements.", "related": { "stable_object": "/signals/cms-access/", "proof": "/proof/access-accepted-organizations/", "graph": "/intelligence-graph/" }, "verified_at": "2026-09-03", "source_updated_at": "2026-08-17", "next_review_due": "2026-09-10", "change_detected_at": null, "freshness": "Current", "authoritative_sources": [ "https://www.cms.gov/priorities/innovation/access-model-accepted-applicants", "https://www.cms.gov/priorities/innovation/innovation-models/access" ] }, "uscdi": { "record_id": "VOL-USCDI-001", "entity": "United States Core Data for Interoperability", "current_status": "Latest release: USCDI v7; 2026 SVAP Approved Version: USCDI v6", "verified_on": "2026-09-03", "authoritative_source": "https://healthit.gov/standards-and-technology/onc-standards-bulletin/onc-standards-bulletin-2026-2/", "current_claim": "USCDI v7, released July 23, 2026, is the latest released USCDI version. USCDI v6 remains the 2026 SVAP Approved Version eligible for voluntary certified-health-IT updates beginning August 29, 2026.", "establishes": [ "USCDI v7 is the latest released USCDI version.", "USCDI v6 remains the 2026 SVAP Approved Version eligible for voluntary certified-health-IT updates beginning August 29, 2026." ], "does_not_establish": [ "That every certified health IT product has implemented USCDI v7.", "That the continuing 2026 SVAP relevance of USCDI v6 makes it the latest released version.", "That the v6 source record should be erased or presented as the latest release." ], "boundary": "Use v7 for latest-release questions and v6 for the 2026 SVAP-approved-version context; label and link both precisely.", "related": { "proof_v7": "/proof/uscdi-v7-release/", "proof_v6": "/proof/uscdi-v6/", "graph": "/intelligence-graph/" }, "verified_at": "2026-09-03", "source_updated_at": "2026-07-23", "next_review_due": "2026-10-03", "change_detected_at": null, "freshness": "Current", "authoritative_sources": { "latest_release": "https://healthit.gov/standards-and-technology/onc-standards-bulletin/onc-standards-bulletin-2026-2/", "2026_svap_approved": "https://healthit.gov/certification-health-it/certification-criteria/standards-version-advancement-process-svap/" } }, "rpm_rtm": { "record_id": "VOL-RPMRTM-001", "entity": "Medicare RPM/RTM — CY 2027 Physician Fee Schedule", "current_status": "Proposed — comments due September 14, 2026", "verified_on": "2026-09-03", "authoritative_source": "https://www.cms.gov/newsroom/fact-sheets/calendar-year-cy-2027-medicare-physician-fee-schedule-proposed-rule", "current_claim": "CMS's CY 2027 PFS proposal includes material proposed changes to RPM/RTM delivery and payment requirements. The public comment period closes September 14, 2026.", "establishes": [ "CMS proposed changes affecting RPM/RTM for CY 2027.", "The public comment period closes September 14, 2026." ], "does_not_establish": [ "Final Medicare policy or final payment requirements for CY 2027." ], "boundary": "Treat every CY 2027 RPM/RTM change described here as proposed until a final rule establishes otherwise. September 14, 2026 is the comment deadline, not an effective date.", "related": { "proof": "/proof/cms-2027-rpm-rtm/", "graph": "/intelligence-graph/" }, "verified_at": "2026-09-03", "source_updated_at": "2026-07-14", "next_review_due": "2026-09-14", "change_detected_at": null, "freshness": "Current proposal" }, "medicare_app_library": { "record_id": "VOL-MAL-001", "entity": "CMS Medicare App Library", "current_status": "Current published requirements · voluntary participation pathway", "verified_on": "2026-09-03", "authoritative_source": "https://www.cms.gov/initiatives/health-technology-ecosystem/overview/submit-your-app/requirements-medicare-app-library", "current_claim": "CMS publishes a voluntary Medicare App Library pathway for patient-facing apps that integrate with CMS Aligned Networks and meet one of three initial use cases. The pathway includes CMS-approved identity verification, independent vetting, interoperability, application materials, and CMS validation before listing.", "establishes": [ "CMS publishes a voluntary participation, evaluation, application, and listing pathway for patient-facing apps serving people with Medicare.", "The initial use cases are Kill the Clipboard, Conversational AI Assistants, and Diabetes & Obesity Prevention and Management.", "Published requirements address identity, interoperability, third-party evaluation, CMS review, and launch.", "ACCESS has a separate and conditional relationship to App Library review, designation, and payment." ], "does_not_establish": [ "Approval, acceptance, clinical effectiveness, Medicare coverage, payment, or CMS endorsement of a particular app.", "That the public pages checked contain every product-specific technical or evaluation threshold.", "That current requirements, partners, application access, listings, or ACCESS rules will remain unchanged." ], "boundary": "These are published participation and listing requirements, not proof that a particular app is clinically effective, CMS-endorsed, covered by Medicare, accepted into the library, or eligible for ACCESS payment. Requirements and listings can change.", "related": { "stable_object": "/signals/medicare-app-library/", "graph": "/intelligence-graph/" }, "source_last_updated": "2026-08-24", "verified_at": "2026-09-03", "source_updated_at": "2026-08-24", "next_review_due": "2026-09-10", "change_detected_at": null, "freshness": "Current; weekly source check", "supporting_sources": [ "https://www.cms.gov/initiatives/health-technology-ecosystem/overview/submit-your-app", "https://www.cms.gov/priorities/innovation/innovation-models/access" ], "requirements_decision_object": { "object_id": "MAL-REQ-2026-09-03", "source_checked_on": "2026-09-03", "source_last_modified": { "cms_requirements": "2026-08-24", "cms_submission_overview": "2026-08-20", "cms_access_model": "2026-08-12" }, "primary_sources": { "cms_requirements": "https://www.cms.gov/initiatives/health-technology-ecosystem/overview/submit-your-app/requirements-medicare-app-library", "cms_submission_overview": "https://www.cms.gov/initiatives/health-technology-ecosystem/overview/submit-your-app", "cms_access_model": "https://www.cms.gov/priorities/innovation/innovation-models/access" }, "fields": { "use_case_pathway": "The app must integrate with a CMS Aligned Network and meet at least one of three initial use cases: Kill the Clipboard; Conversational AI Assistants; or Diabetes & Obesity Prevention and Management. Kill the Clipboard includes CMS-approved identity, FHIR transmission, FHIR visit-summary retrieval, and network connectivity. Conversational AI includes personalized support from clinical records, clear AI-result labels and disclaimers, and separation of education from clinical guidance. The diabetes/obesity pathway includes clinical-record integration, coaching, reminders and alerts, prevention and active management, prediabetes resources, and HIPAA compliance when applicable.", "target_user": "The directory is for people with Medicare seeking patient-facing digital health care options. CMS invites health app developers, tech-enabled organizations, and innovators to apply.", "identity_requirements": "Patient-facing apps must support secure identity verification using CMS-approved IAL2 and AAL2 standards. CMS directs applicants to ID.me or CLEAR.", "third_party_review_route": "Complete independent evaluation through either the DiMe Seal route or CARIN Consumer-Facing Applications accreditation through DirectTrust; CMS also states that applicants sign the CARIN Code of Conduct. CMS describes review across clinical evidence, privacy, security, usability, equity, and technical standards.", "clinical_evidence": "Third-party evaluation covers clinical evidence. The CMS pages checked do not publish a detailed clinical-evidence threshold or required study design.", "privacy_security": "Third-party evaluation covers privacy and security. CMS review includes data handling, privacy disclosures, disclosure of data sources and terms or agreements, and a security checklist. HIPAA applies when the app operates as a covered entity or business associate.", "usability_accessibility": "Third-party evaluation covers usability. The CMS pages checked do not name a separate accessibility standard or accessibility test.", "equity": "Third-party evaluation covers equity. The CMS pages checked do not publish a detailed equity scoring rubric.", "cms_aligned_network_fhir_connectivity": "Apps connect to a CMS Aligned Network directly or through a Personal Health Record. CMS's submission overview specifies FHIR R4 and SMART on FHIR; use-case requirements add functions such as FHIR exchange and visit-summary retrieval where applicable. CMS also lists enabling Medicare.gov beneficiary notifications, including notices, EOBs, and fraud alerts, as a core patient-facing-app requirement.", "cms_review_access": "CMS validates use-case alignment, CMS Aligned Network connectivity, data handling, and legal agreements. A fee-charging app must provide trial access for Medicare patients. CMS says ACCESS participants are exempt from CMS Review and Trial Access because those requirements are addressed through ACCESS participation.", "launch_discovery": "After the pledge, identity implementation, network connection, third-party vetting, application, and CMS review, an approved app can be featured in the Medicare App Library on Medicare.gov. Submission materials include developer and integration details, vetting and privacy documentation, and listing assets.", "access_payment_relationship": "App Library inclusion is not itself a Medicare payment pathway. CMS says organizations offering qualifying technology-supported chronic care may separately apply to ACCESS; ACCESS participants that also pledge to the Health Tech Ecosystem are featured with a special designation indicating ACCESS participation and Medicare coverage status. ACCESS tests outcome-aligned payments in Original Medicare.", "unknowns": "The CMS pages checked do not publish detailed scoring thresholds for clinical evidence, usability, accessibility, equity, or technical standards; a complete public application link; decision timelines; category-level acceptance counts; or product-specific coverage and payment determinations.", "next_source_check": "P4L operational control: recheck the official CMS requirements, submission, and ACCESS pages on 2026-09-10, or sooner if CMS changes the pages or application access." } } } } }