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Regulation + Payment + Digital Health2026-07-22Historical
FDA selected Dexcom's Glucose Health Program for the TEMPO pilot. The intended use is tied to ACCESS clinical use areas and will be evaluated using real-world data while the program is offered through ACCESS participants. FDA states that effectiveness for the participating intended uses has not yet been evaluated.
Decision implication: Digital-health companies should evaluate whether product evidence, use case, outcome measures, and care model can align with ACCESS/TEMPO-style pathways.
Digital Health Ecosystem + AI2026-07-29Current
CMS's August 24 Medicare App Library requirements page publishes a voluntary evaluation-to-listing pathway for patient-facing apps, including three initial use cases, CMS-approved identity, CMS Aligned Network connectivity, third-party vetting, CMS review, and launch requirements.
Decision implication: Before seeking listing, map the product to one CMS use case and document identity, network/FHIR connectivity, independent review, CMS review or applicable ACCESS exemption, and the evidence, privacy, usability, and equity controls. Reverify the current source before a product-specific decision.
Regulation + Digital Health2026-08-21Current
FDA's maintained TEMPO participant table currently lists four participants. FDA states that effectiveness for the participating intended uses has not yet been evaluated. The table lists SonderMind / SACA, Limbic / Unpacked, Cadence / HypertensionOS, and Dexcom / Dexcom Glucose Health Program. FDA's CDRH update log identifies the participant page as updated August 21, 2026.
Decision implication: For current TEMPO participation, use and timestamp the maintained FDA table. Keep TEMPO selection separate from clinical effectiveness, device-specific authorization, ACCESS participation, Medicare coverage, endorsement, and scaled adoption.
Interoperability + Ecosystem2026-08-11Current
CMS maintains category-specific early-adopter and pledge lists plus a showcase of demonstrations described as live or close to launch. The showcase is a demonstration space, not a rating; inclusion does not establish CMS endorsement, validation, uniform availability, or equal maturity.
Decision implication: Track implementation maturity by named organization and use case rather than assigning one blanket general-availability status to the ecosystem.
Reimbursement + Remote Monitoring2026-07-14Current
The CY 2027 PFS proposed rule would require established patients and an initiating visit for RPM/RTM, restrict payment when monitoring is delivered by contractors rather than practice-employed clinical staff, and seeks comment on bundling codes into new HCPCS G-codes. The public comment period closes September 14, 2026.
Decision implication: Assess the proposal now and, if submitting public comment, meet the September 14, 2026 deadline; keep scenario work explicitly contingent on the final rule.
Payment + Adoption2026-08-03Current
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.
Decision implication: Separate accepted-applicant status from final participation, map payer-alignment commitments, and monitor model implementation and aggregated risk-adjusted results.
Agentic AI + Clinical Care2026-01-13Changed
ARPA-H describes ADVOCATE as intended to develop clinical AI agents for cardiovascular-care tasks plus supervisory post-deployment monitoring. The submission window closed April 1, 2026; the source reports no selected performer, validation, authorization, or result.
Decision implication: Create a dedicated agentic-AI adoption standard covering authority boundaries, human escalation, post-deployment monitoring, evidence, liability, workflow, and regulatory status.
Clinical Trials + AI2026-04-28Changed
FDA announced two initiated real-time endpoint/data-signal reporting proofs of concept. Separately, FDA requested information on a proposed AI-enabled early-phase-trial pilot; that RFI closed June 29, 2026, and the cited source does not establish a later selection or broader-pilot launch outcome.
Decision implication: Monitor whether real-time trial methods become reusable regulatory infrastructure for digital health, therapeutics, and healthspan studies.
AI + Biomedical Discovery2026-05-05Current
ARPA-H describes IGoR as an AI-enabled research ecosystem intended to generate hypotheses, run experiments, refine biological models, and accelerate discovery. The 10× language is a target; the stated full-proposal deadline passed August 13, 2026, and the cited page establishes neither awards nor results.
Decision implication: Track standards, shared protocols, validated speed/quality gains, and whether the model becomes transferable to aging biology and preventive science.
Payment + Outcomes + Interoperability2026-07-20Current
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.
Decision implication: Treat clinical oversight, outcome reporting, safeguards, interoperability, and care coordination as operating requirements rather than downstream integrations.
AI Safety + Postmarket Evidence2025-09-30Historical
In a September 2025 discussion-only request, FDA asked about post-deployment performance and drift, evaluation infrastructure, clinical outcomes and user feedback, and human-AI interaction. Comments closed December 1, 2025; the request is not guidance or policy.
Decision implication: Add real-world monitoring, drift detection, human-AI interaction, and response protocols to P4L's AI adoption/evidence standard.
AI + Information Blocking + Interoperability2025-12-22Current
The HTI-5 proposed rule would establish a FHIR-oriented foundation for future API requirements and proposes revising information-blocking definitions to emphasize automated means, potentially including autonomous AI systems. Comments closed February 27, 2026; HTI-5 is not final.
Decision implication: Track final-rule language and design P4L's agentic-AI adoption framework around explicit data-access rights, governance, authentication, provenance, and human authority.
Healthspan Research + Clinical Translation2026-02-24Current
ARPA-H lists seven PROSPR awards and up to $144 million over five years for work on early aging markers, healthspan measures, interventions, and accelerated trial designs. Continued funding is milestone-contingent; the source reports no program outcome.
Decision implication: Track biomarkers, endpoint qualification, trial methods, regulatory precedents, and commercialization pathways created by PROSPR.
Healthspan Measurement2026-02-24Current
The Stanford-led THRIVE team is expected to harmonize existing health datasets, generate a PROSPR-IC score, and test its accuracy and intervenability in a one-year lifestyle intervention. The award page reports prospective work, not a validated score or result.
Decision implication: Track the construction, validation, endpoint properties, and public availability of the PROSPR-IC score.
Healthspan Therapeutics + Trial Design2026-02-24Current
The VITAL-H team plans a phase 3 hybrid trial of three repurposed FDA-approved drugs. Existing approvals do not establish an aging/healthspan indication, and the source reports no trial result.
Decision implication: Track protocol, endpoints, regulatory interactions, safety management, and whether results support an aging/healthspan indication pathway.
Digital Health + Clinical Research2026-07-23Historical
FDA announced a funding opportunity that was open from July 20 through August 20, 2026, for projects exploring digital health technologies in drug development, including actigraphy, photography, and contactless sensors. The application window is closed. P4L is now watching for awardees, selected modalities, endpoint methods, validation work, and resulting guidance or precedents.
Decision implication: Monitor for awardees, selected modalities, endpoint methods, validation work, and resulting guidance or precedents.
Interoperability Standards2026-06-30Changed
ASTP/ONC announced 2026-approved SVAP standards including USCDI v6, expanding the standardized data available for exchange across health IT systems.
Decision implication: Update data-readiness requirements in P4L's Adoption Diagnostic and monitor which data classes become practically available through certified systems and aligned networks.
Interoperability Standards2026-07-23Current
ASTP/ONC's Standards Bulletin records the July 23, 2026 release of United States Core Data for Interoperability Version 7 (USCDI v7).
Decision implication: Update 'current standard' references, re-run interoperability-readiness mappings against v7, and preserve the v6 record as a prior-version/provenance record rather than overwriting it.
RPM Oversight + Compliance2026-05-14Current
CMS highlighted OIG's finding that, in 2022 claims and encounter data, about 43% of enrollees receiving RPM lacked a record for at least one component. CMS did not require billing for all three components, so the finding is neither a current rate nor proof that an unbilled component was not furnished.
Decision implication: Track documented component delivery and claims/encounter ascertainment separately; do not infer care quality or current prevalence from the 2022 finding alone.
AI + Drug Development2026-05-01Current
FDA states that CDER has seen significant growth in drug-application submissions using AI components across nonclinical, clinical, postmarketing, and manufacturing phases. This is a submission trend, not an approval count or endorsement of a method or output.
Decision implication: Track where FDA expectations become more explicit by phase and build those requirements into evidence/adoption readiness for AI-enabled life-science products.
AI Medical Devices + Transparency2026-06-16Current
FDA maintains a non-comprehensive, periodically updated list intended to identify AI-enabled medical devices authorized for marketing in the United States. Omission does not establish lack of authorization, and inclusion does not establish comparative effectiveness or adoption.
Decision implication: Ingest the authorized-device list into P4L's Intelligence Graph and compare authorization with real-world adoption, evidence, workflow, and postmarket monitoring.
Healthspan Therapeutics2026-02-24Current
ARPA-H awarded Linnaeus Therapeutics up to $21.9 million to test whether a GPER agonist improves aging outcomes. The work is investigational; the award does not establish an aging or healthspan benefit.
Decision implication: Track outcome selection, human trial design, safety, biomarker changes, and whether results support broader healthspan claims.
Interoperability + Administrative Adoption2026-08-04Current
Under CMS-0057-F, impacted payers have API compliance dates generally beginning January 1, 2027, including a Prior Authorization API for medical items and services (excluding drugs). Under the FY 2027 IPPS/LTCH PPS final rule, the Electronic Prior Authorization measure is an optional bonus measure for eligible hospitals and critical access hospitals in the CY 2027 EHR reporting period and becomes mandatory in CY 2028. CMS has proposed—not finalized—a similar CY 2027 optional/bonus and CY 2028 required schedule for MIPS-eligible clinicians.
Decision implication: Include electronic-prior-authorization readiness in adoption diagnostics for technologies that depend on coverage of non-drug medical items or services; assess drug workflows separately because CMS's 2026 drug-related changes remain proposed.
Geroscience + Research Agenda2026-07-29Current
NIA plans the Fifth Geroscience Summit for December 2-3, 2026 to assess progress, knowledge gaps, and future directions in geroscience with a focus on health.
Decision implication: Create a pre-summit issue map and post-summit change analysis for P4L Brief and Evidence Explorer.
Innovation Funding + Wearables + AI2026-04-22Current
ARPA-H announced contract awards of up to $28 million to 15 small businesses across wearables, AI, diagnostics, and gene therapies. Exact amounts and continued funding are milestone-contingent; awards do not establish validation or adoption.
Decision implication: Add funded companies to the Intelligence Graph and track which technologies cross from R&D into clinical validation and institutional adoption.
Telehealth + Medicare2026-01-22Current
CMS states that starting in CY 2026 it will add services to the Medicare telehealth services list only on a permanent basis after removing the provisional/permanent distinction. This does not make every flexibility permanent or guarantee payment in every setting.
Decision implication: For telehealth products, distinguish temporary flexibilities from durable coverage and map each use case to permanent service eligibility.
Digital Health + Historical Observation2026-08-11Historical
On August 11, 2026, FDA's maintained TEMPO participant table listed Cadence Solutions, Inc. / HypertensionOS and Dexcom, Inc. / Dexcom Glucose Health Program. FDA states that effectiveness for the participating intended uses has not yet been evaluated.
Decision implication: For current TEMPO participation, use and timestamp the maintained FDA table. A historical observation does not establish why a source later changed.