Background

On May 16, 2025, the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ASTP/ONC) issued a Request for Information (RFI) on the Health Technology Ecosystem.  The RFI is gathering input from all healthcare stakeholders on how to modernize the digital health ecosystem for Medicare beneficiaries, focusing on improved patient empowerment, interoperability, and value-based care (VBC).  

CMS and ASTP/ONC are especially interested in practical ideas, evidence-based suggestions, and real-world examples to guide potential policy updates, future rulemaking, and digital health innovation that is patient-centered, cost-effective, and outcome-driven.  Key CMS objectives include:

• Reduce provider and patient burden related to data access, reporting, and administrative workflows.
• Encourage development and widespread adoption of real-time, personalized, and secure digital tools.
• Improve access for patients and caregivers to their health data.  Develop secure digital identity credentials for such access.
• Eliminate barriers to using digital tools in clinical workflows.  Standardize and automate documentation and quality measurement.  Develop strategies for supporting small/rural practices.
• Simplify data exchange between providers and payers.
• Align technology with Alternative Payment Model requirements.  Promote adoption of digital tools measuring and improving outcomes.  Support VBC organizations with scalable, interoperable infrastructure.

This RFI marks a pivotal step in shaping how digital tools and real-world data can transform U.S. healthcare.  CMS and ASTP/ONC emphasize transparency, patient empowerment, ecosystem-wide participation, and practical policy refinements to make digital health technology work better — for everyone.  These are precisely the goals and capabilities of RegenMed’s technical platforms and associated processes.

RegenMed Summary Response

The Company’s flagship solution, Circles, is a digital platform designed to collect, structure, and analyze longitudinal health data in a secure and patient-centric way.  Key capabilities include:

• Low-cost, clinically relevant data collection with minimal burden on providers.
• Supports value-based care by correlating treatments with long-term patient outcomes.
• Allows patients to access and compare their personal outcomes with similar cohorts.
• Provides cloud-based, real-time access to longitudinal datasets from any device.
• Incorporates both conventional and Complementary and Alternative Medicine (CAM) practices, addressing gaps in traditional clinical trial data.  See this Article.
• Empowers clinicians — especially in non-academic settings — to engage in high-quality, outcomes-driven research.
• Avoids shortcomings of “big data” systems such as clinical irrelevance, poor interoperability, algorithmic opacity, and data ownership disputes.  See this Article.
• Clinically and statistically significant datasets based on verifiable physician-patient interactions, structured around specific anatomical regions, pathologies, treatment protocols, and standardized outcomes assessments.
• Enabling faster, lower-cost and more impactful medical innovation, especially critical today due to declining public research funding and bias concerns in peer-reviewed literature.
• Provide high-quality, verifiable data for training reliable AI healthcare models.
• Supports SODH and health equity through use by any sized provider group, any specialty, in any location.
• Supports deep and sustained collaboration on any clinical topic among providers and medical scientists across institutional and regional borders.
• Innovative patient health tokens for highly secure digital access to, and control over, individual longitudinal health records.  (See this White Paper.)
• Ethical, clinical, reputational, and financial motivation to providers to generate clinically and statistically significant real-world evidence.  (Physicians-Owned Circles.)

This summary captures RegenMed’s overarching position: that real-world, patient- and provider-validated data, structured around long-term outcomes and specific clinical contexts, is the foundation for effective digital health transformation.  Their Circles platform is proposed as a model framework for CMS and stakeholders to achieve these goals at scale.

The full texts of the CMS RFI and RegenMed Response can be found here and here respectively.