NHC Responds to Joint CMS–ASTP/ONC RFI on Improving Health Technology (PDF)

June 16, 2025

Mehmet Oz, MD, MBA
Administrator
Centers for Medicare & Medicaid Services Department of Health and Human Services
7500 Security Boulevard
Baltimore, MD 21244

RE: Request for Information; Health Technology Ecosystem [CMS-0042-NC]

The National Health Council (NHC) appreciates this opportunity to respond to the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC)/Assistant Secretary for Technology Policy (ASTP) Request for Information (RFI) on the Health Technology Ecosystem.

Created by and for patient organizations over 100 years ago, the NHC brings diverse organizations together to forge consensus and drive patient-centered health policy. We promote increased access to affordable, high-value, equitable, and sustainable health care. Made up of more than 180 national health-related organizations and businesses, the NHC’s core membership includes the nation’s leading patient organizations. Other members include health-related associations and nonprofit organizations including the provider, research, and family caregiver communities; and businesses and organizations representing biopharmaceuticals, devices, diagnostics, generics, and payers.

As a unified voice for people with chronic diseases and disabilities, the NHC supports the federal government’s continued efforts to build a patient-centric, digitally enabled health care ecosystem. We commend CMS and ONC for using this RFI to examine how federal infrastructure can evolve to support accessible, secure, and interoperable digital health products for Medicare beneficiaries, with particular attention to innovation, accessibility, and real-world implementation.

Digital health tools hold tremendous promise to empower patients, improve access to care, streamline administrative functions, and reduce disparities. However, the ecosystem must be designed in collaboration with those it seeks to serve. This includes consideration of digital literacy, internet access, health literacy, and existing structural inequities. It also includes acknowledgement of the evolving landscape of patient needs, especially for individuals living with multiple chronic conditions, disabilities, and complex care coordination challenges.

General Recommendations

The NHC offers the following overarching recommendations:

    1. Patient-Centered Design and Evaluation: All digital health policies, infrastructure investments, and technology standards must center the lived experiences and needs of patients and caregivers. Digital tools should be co-developed with patient organizations and tested with populations representing various abilities, literacy levels, geographies, and chronic conditions. Patient-centered evaluation metrics must be used to measure the real-world utility of these tools.

    2. Advancing Whole-Person Interoperability: The scope of data interoperability must extend beyond traditional medical claims and lab results to include social needs, behavioral health, assistive technologies, and care coordination activities. Blue Button 2.0 and other CMS application programming interfaces (APIs) should evolve to integrate richer data sets such as social determinants of health (SDOH), disability accommodations, and longitudinal care pathways.

    3. Reducing Patient Burden through Consolidated Access: The current landscape often requires Medicare beneficiaries to navigate multiple portals, data silos, and login credentials.[1] CMS should prioritize development of patient-centric digital tools that unify access to Medicare claims, provider records, lab results, and care navigation services. Usability, accessibility, and ease of onboarding should be prioritized alongside security and functionality.

    4. Equity in Digital Identity Access: While we support efforts to enhance security and data protection, digital identity requirements (e.g., ID.me, Login.gov) must not become a barrier to participation. CMS should ensure inclusive credentialing pathways that do not penalize individuals lacking smartphones, government-issued IDs, or broadband access. Paper and caregiver-assisted alternatives should be preserved.[2]

    5. Aligning Certification and Payment Policy: ONC certification standards should reflect not only technical interoperability, but also the downstream usability of tools by patients and providers. Certification must be meaningful and accompanied by reimbursement strategies that incentivize provider and health system adoption of certified digital tools. Program alignment across Medicare, Medicaid, and the Innovation Center should be pursued to avoid fragmentation.

Specific Recommendations
Patients and Caregivers

PC-1. What health management or care navigation apps would help you understand and manage your (or your loved ones’) health needs, as well as the actions you should take?

Medicare beneficiaries and caregivers often express a need for digital tools that can simplify and integrate the fragmented components of their care journey. Health management and care navigation applications (apps) should provide a unified experience that allows users to track medications, manage appointments, communicate with care teams, and receive tailored health education. Tools that integrate clinical data, claims data, and real-time alerts about care gaps or follow-up needs would be particularly helpful.

PC-1a. What are the top things you would like to be able to do for your or your loved ones’ health that can be enabled by digital health products?

Among the most valued capabilities are:

    • Medication management, including refill reminders and drug interaction alerts;
    • Care coordination, with the ability to synchronize data from multiple providers into a single longitudinal view;
    • Personalized health guidance, based on the patient’s conditions and social context, not just general health information;
    • Real-time benefits checks that indicate whether a service is covered and estimate the associated out-of-pocket cost; and
    • Integrated scheduling tools that can book appointments across systems or provider networks.

For caregivers, access to such features on behalf of the patient—ideally through designated proxy access—is essential.

PC-1b. If you had a personal assistant to support your health needs, what are the top things you would ask them to help with? In your response, please consider tasks that could be supported or facilitated by software solutions in the future.

A digital personal assistant should offer:

    • Automated interpretation of lab results, highlighting changes or concerns in layperson terms;
    • Reminders for preventive screenings and vaccinations;
    • Connection to community-based services, such as transportation or nutrition assistance, based on location and eligibility;
    • 24/7 symptom triage tools, integrated with electronic health records (EHRs) to support clinical follow-up if needed;
    • Secure messaging capabilities, allowing real-time communication with health care providers or care managers.

These features would allow patients and caregivers to proactively manage health needs rather than reactively respond to problems, improving both engagement and outcomes.

PC-4. What features are missing from apps you use or that you are aware of today?

Despite growing innovation in the digital health marketplace, a number of critical features remain absent or underdeveloped in apps that aim to support Medicare beneficiaries and caregivers. Many apps still lack interoperability across health systems, leaving patients to manage multiple portals and interfaces. Very few tools offer comprehensive medication reconciliation across all prescribers, which is especially vital for older adults who often see multiple providers. Caregiver-specific modes—allowing designated proxies to manage appointments, access test results, and communicate with providers on the patient’s behalf—are inconsistently implemented or too difficult to configure.

Further, few apps provide integrated social services navigation, despite growing recognition that SDOH affect health outcomes. For instance, an app that could identify local food assistance programs, transportation services, or language-access resources—based on the patient’s ZIP code and health status—would provide meaningful support yet remains rarely available.

PC-4a. What apps should exist but do not yet? Why do you believe they do not exist yet?

A truly integrated Medicare navigation tool could provide a unified view of medical, pharmacy, and social services data, alert patients to out-of-pocket exposures, recommend preventive services, and track progress toward care goals. The absence of such a tool reflects both technical and policy barriers: lack of universal APIs across provider systems, uncertainty around data sharing policies, and limited financial incentives for vendors to invest in older adult–focused tools. Additionally, tools that combine longitudinal care planning with end-of-life preferences, helping families understand and record wishes for care transitions, palliative services, or advance directives, remain scarce.

PC-4b. What set of workflows do you believe CMS is uniquely positioned to offer?

CMS could play a unique role in enabling apps that offer:

    • A complete, longitudinal record of claims and coverage information across all Parts (A, B, D, and Advantage);
    • Tools for plan comparison and benefit optimization using personalized, real-time eligibility data; and
    • A care gap notification system, alerting beneficiaries when they are overdue for recommended screenings, medications, or follow-ups.

By enabling these workflows through APIs and promoting standards for vendor participation, CMS could drive innovation that is uniquely targeted to the needs of Medicare patients and their families.

PC-5. What can CMS and its partners do to encourage patient and caregiver interest in these digital health products?

CMS and its partners must prioritize trust, relevance, and usability to increase adoption of digital health products among Medicare beneficiaries and caregivers. Digital tools are more likely to be used when patients see clear benefits and feel confident in their ability to navigate the technology safely.

CMS should lead a national awareness campaign—modeled on the success of previous Medicare Part D and Marketplace outreach efforts—highlighting the benefits of digital tools and educating beneficiaries and caregivers about their rights to access and control their data. This campaign should use plain language, culturally tailored messaging, and partner with community organizations trusted by older adults and individuals with disabilities.

CMS can increase visibility and credibility of tools by creating an endorsement program. Tools that meet specified criteria (e.g., accessibility, usability, security, caregiver support, and integration with CMS data) could display a CMS-backed badge, helping patients distinguish high-quality apps from unregulated commercial products.

PC-5a. What role, if any, should CMS have in reviewing or approving digital health products on the basis of their efficacy, quality, or impact or both on health outcomes (not approving in the sense of a coverage determination)? What criteria should be used if there is a review process? What technology solutions, policy changes, or program design changes can increase patient and caregiver adoption of digital health products (for example, enhancements to data access, reimbursement adjustments, or new beneficiary communications)?

While CMS should not function as a regulatory gatekeeper, it can serve as a certifying or vetting body, establishing voluntary review criteria for tools aimed at Medicare users. Criteria should include:

    • Demonstrated accessibility (e.g., Section 508 compliance, multilingual support);
    • Proven usability across diverse demographic groups;
    • Clear data stewardship policies, including opt-in consent and transparent sharing practices; and
    • Evidence of positive patient or caregiver outcomes, including reduced administrative burden, enhanced satisfaction, or more effective care coordination.

To incentivize adoption, CMS could integrate certified tools into the Medicare Plan Finder or display them prominently on MyMedicare.gov. CMS should also consider reimbursement adjustments to reward providers who offer training or support for certified tools, especially in underserved areas. 

PC-5b. What changes would enable timely access to high-quality CMS and provider-generated data on patients?

 CMS can accelerate access by:

    • Expanding Blue Button 2.0 to include additional data elements beyond claims and coverage, such as social risk factors, care plans, and assessment data;
    • Mandating real-time data availability from certified APIs used by Medicare providers and payers;
    • Standardizing data definitions across programs and vendors to reduce ambiguity and facilitate interoperability;
    • Creating developer sandboxes with synthetic CMS datasets that simulate real-world data access for testing and certification purposes.

Improving data accessibility will support a more vibrant ecosystem of tools tailored to Medicare populations and create more seamless care experiences for beneficiaries and caregivers alike.

PC-6. What features are most important to make digital health products accessible and easy to use for Medicare beneficiaries and caregivers, particularly those with limited prior experience using digital tools and services?

To ensure access and usability that is responsive to the needs of all users, digital health tools must be designed with the specific needs of Medicare beneficiaries and their caregivers in mind, particularly those with limited digital experience, cognitive impairments, or physical disabilities. Accessibility is not merely a feature—it is a precondition for meaningful engagement and adoption.

Tools should offer multi-modal interfaces, including:

    • Large text, adjustable font sizes, and high-contrast visual design for individuals with low vision;
    • Voice-guided navigation and text-to-speech functionality for users with limited literacy or vision impairments; and
    • Touch-friendly controls and simplified layouts for individuals with reduced dexterity or motor function.

User interfaces must be intuitively organized, avoiding jargon and layering complexity only where necessary. Navigation should follow standard conventions, minimizing cognitive load. Tools should include “help” prompts, FAQs, and live support chat options tailored for users who may be accessing digital tools for the first time.

Accessibility should be validated through real-world testing with target populations. Developers should be required to:

  • Conduct inclusive usability testing with older adults, people with disabilities, caregivers, and individuals with limited English proficiency;
  • Share documentation of feedback collection and integration; and
  • Comply with Section 508 and WCAG 2.1 accessibility standards at a minimum, with additional Medicare-specific accessibility guidance to be developed by CMS.

Tools should incorporate onboarding modules: brief, guided walkthroughs that introduce users to key features and reinforce navigation pathways. These modules can build user confidence and reduce abandonment rates.

Finally, offline functionality or low-bandwidth optimization is crucial, particularly in rural and underserved areas where internet connectivity may be limited. CMS should incentivize development of tools that include offline data storage, asynchronous data upload, and telephone-based backup systems where feasible. By embedding these features into certification requirements and procurement guidelines, CMS can help ensure that digital health tools are inclusive, practical, and tailored to the real-world needs of Medicare beneficiaries and caregivers.

PC-7. If CMS were to collect real-world data on digital health products’ impact on health outcomes and related costs once they are released into the market, what would be the best means of doing so?

To evaluate the impact of digital health products on health outcomes and related costs, CMS should establish a national framework for collecting real-world evidence (RWE) that includes standardized, patient-reported outcomes, longitudinal cost analyses, and utilization metrics. This framework should incorporate data collection mechanisms that are embedded in both clinical and patient-facing workflows to minimize administrative burden and maximize representativeness. For example, digital tools used in the Medicare program should be required to include integrated feedback loops, such as in-app surveys or user experience dashboards, that capture beneficiary input on usability, engagement, and self-reported health status over time. These data should be complemented with claims-based outcome measures and quality indicators to triangulate effectiveness and cost trends.

Additionally, CMS should partner with entities experienced in digital health evaluation—such as the Agency for Healthcare Research and Quality, National Institutes of Health, and academic health centers—to pilot real-world assessments of specific digital interventions. These pilot studies should prioritize a broad range of patient populations, including older adults, individuals with limited digital literacy, and those facing barriers to care. Data collection protocols should include stratification by demographic variables to identify any variations in effectiveness or access. Public reporting of aggregated findings would foster accountability and allow patients, caregivers, and clinicians to make more informed decisions about digital health tool adoption.

PC-8. In your experience, what health data is readily available and valuable to patients or their caregivers or both?

In practice, patients and caregivers most commonly access demographic information, basic Medicare coverage data, and historical claims summaries, especially via tools like the Blue Button 2.0 API.[1],[2] These data are valuable for understanding general patterns of care and ensuring coverage accuracy. However, they fall short in meeting the full spectrum of patient and caregiver needs, particularly for care coordination and clinical decision-making. High-value but less accessible data types include detailed clinical notes, diagnostic images, encounter-level information, real-time provider availability, operative reports, appointment schedules, and patient-facing quality ratings.[1]

Access to encounter notes and narrative assessments is especially critical for understanding a patient’s health trajectory and context-specific provider recommendations, yet these are often unavailable or fragmented across portals. Moreover, caregivers frequently report difficulties in accessing medication lists, care plans, and lab results due to insufficient proxy support or interface barriers.[2] App developers also face challenges in retrieving structured, normalized data across different systems, hindering innovation in patient-facing applications.[3],[4]

To improve meaningful access, CMS should support the development of APIs that expose these high-value data types in consistent formats, while also promoting broader integration of SDOH and behavioral health information where permissible under privacy laws. This would enable richer patient experiences and support more effective self-management and caregiving.

PC-9. Given that the Blue Button 2.0 API only includes basic patient demographic, Medicare coverage, and claims data (Part A, B, D), what additional CMS data sources do developers view as most valuable for inclusion in the API to enable more useful digital products for patients and caretakers?

Developers and patient advocates alike consistently identify additional data sources that would meaningfully enhance the functionality of the Blue Button 2.0 API.[5] Key priorities include access to encounter-level data from Medicare Advantage (MA) plans, prior authorization status, durable medical equipment (DME) utilization, behavioral health claims, and data related to home and community-based services (HCBS). Including pricing and cost-sharing information at the line-item level—both projected and historical—would further empower patients to make informed decisions.

Obstacles to expanding Blue Button API functionality include both technical limitations (such as data normalization challenges) and regulatory ambiguities regarding what information may be shared under current privacy frameworks.[1] CMS should convene a technical advisory panel of patients, developers, and privacy experts to establish best practices for safe, consent-based data sharing beyond current Blue Button capabilities.

Furthermore, CMS should consider integrating select non-CMS datasets through partnerships or federated access models. For example, incorporating immunization registries, social service data, and SDOH risk factors from trusted third-party sources would support holistic patient engagement tools. Expanded APIs should be backed by robust documentation, sandbox environments for developers, and a transparent roadmap for iterative enhancements based on user feedback.

PC-10. How is the Trusted Exchange Framework and Common Agreement (TEFCA) currently helping to advance patient access to health information in the real world?

TEFCA has the potential to be a transformative force for patient data access by promoting standardized, nationwide interoperability among health information networks. However, its real-world impact on patient access remains limited to date. Patients and caregivers often encounter delays, data gaps, or inconsistent availability when attempting to access health information through participating networks.[2] These limitations stem in part from uneven participation among providers, lack of uniform implementation of the Data Exchange Framework, and limited awareness of TEFCA’s existence and benefits.

To strengthen TEFCA’s utility for patients and caregivers, CMS should require certified health IT developers and Medicare-participating providers to demonstrate TEFCA-compatible data exchange capabilities as a condition of participation or reimbursement. Additionally, TEFCA governance bodies should create a consumer advisory group to help guide patient-facing priorities and identify pain points. CMS can further enhance TEFCA’s relevance by supporting use cases that prioritize patient-directed data exchange, such as seamless transfer of full EHRs between providers and access to longitudinal health histories for caregiving families.

TEFCA’s success also hinges on harmonizing standards, eliminating redundant protocols, and consolidating overlapping frameworks. CMS and ONC should lead efforts to align TEFCA with Fast Healthcare Interoperability Resources (FHIR) APIs, reduce duplicative consent procedures, and integrate TEFCA access with digital identity tools that enable authenticated, real-time data retrieval by patients and caregivers.

PC-11. How are health information exchanges (HIEs) currently helping to advance patient access to health information in the real world?

Health Information Exchanges (HIEs) vary widely in effectiveness, but the most successful models play a vital role in facilitating real-time access to longitudinal patient data, care coordination across provider networks, and public health reporting.[1] In regions with robust HIE infrastructure, patients benefit from improved care continuity, fewer duplicative tests, and streamlined transitions between providers.[2] Some HIEs also offer patient-facing portals that aggregate data from multiple sources, although these tools are inconsistently adopted and often under-publicized.[3]

Nonetheless, significant barriers persist. Many HIEs do not offer direct patient access, and even those that do may suffer from usability issues, incomplete records, or delays in data availability.[4],[5] Additionally, not all providers participate in regional HIEs, and variability in governance models leads to gaps in data sharing practices.[6] To address these shortcomings, CMS should establish minimum patient-access performance standards for federally supported HIEs and incentivize broader provider participation.

CMS could provide grant funding or technical assistance for HIEs to develop patient-facing tools with multilingual support, mobile accessibility, and caregiver proxy features. It should also define the ongoing role of HIEs relative to TEFCA, private networks, and EHR vendor platforms, ensuring that patients receive consistent, high-quality access regardless of where they receive care.

PC-12. What are the most valuable operational health data use cases for patients and caregivers that, if addressed, would create more efficient care navigation or eliminate barriers to competition among providers or both?

Operational health data can be a powerful enabler of patient-centered navigation yet remains underutilized in digital tools available to Medicare beneficiaries.[7] The ability to generate binding cost estimates before care episodes would provide meaningful transparency and reduce financial uncertainty. Access to real-time provider scheduling data—preferably integrated with third-party appointment management platforms—would allow patients to coordinate care more efficiently and reduce no-shows or delays.[1] Similarly, exposure to patient-facing quality metrics, particularly when stratified by condition and patient demographic, would support informed decision-making and incentivize competition among providers on value rather than volume.[2],[3],[4]

Other valuable use cases include integrated referral tracking, care plan visualization tools, and the ability to compare providers based on performance measures relevant to chronic conditions or geriatric populations. These functionalities would not only support more efficient care navigation but also align with broader CMS goals around competition and health system transformation.

To realize these use cases, CMS should invest in standardization of underlying data elements, enforce interoperability requirements for provider directories and scheduling systems, and require digital tool vendors to incorporate consumer-tested interfaces for displaying cost, access, and quality information.

PC-13. How can CMS encourage patients and caregivers to submit information blocking complaints to ASTP/ONC’s Information Blocking Portal?

To enhance enforcement of information blocking provisions, CMS should launch a targeted educational campaign directed at patients and caregivers, informing them of their rights to health data and the mechanisms available for redress. Publicizing the Information Blocking Portal across Medicare communications—such as Explanation of Benefits (EOBs), enrollment packets, and Medicare.gov—would improve awareness and normalize reporting of access barriers.

Additionally, CMS could require certified digital health tools to include in-app prompts or feedback buttons that link directly to the complaint portal. These prompts should be context-aware, triggering when users encounter missing data, denied requests, or unexplained delays. Feedback collected through these channels should be aggregated and used to inform oversight priorities and policy refinements.

While encouraging greater reporting, CMS must also ensure that complaints are triaged promptly, transparently investigated, and result in meaningful consequences for repeat offenders. Patients and caregivers who submit complaints should be updated on the status of their case and provided with additional resources or support if needed. These steps would build trust in the system and promote a culture of data access accountability.

PC-14. Regarding digital identity credentials (e.g., CLEAR, Login.gov, ID.me, etc.): What are the challenges, benefits, and strategies for wider adoption among patients and caregivers?

Digital identity credentials play an important role in enabling secure, scalable access to personal health data, yet they remain underutilized among Medicare beneficiaries and caregivers.[1] The primary barriers include unfamiliarity with identity verification protocols, limited digital literacy, language or accessibility issues, and a general lack of trust in third-party credentialing services.[2] These challenges are compounded in rural and underserved areas, where access to broadband and support infrastructure may be limited.[3]

Despite these barriers, the benefits of widespread digital identity credential adoption are considerable.[4] These systems facilitate secure authentication across platforms, reduce reliance on redundant logins or paper forms, and enable caregivers to access records through delegated permissions rather than shared passwords. Broader use of digital identity also supports interoperability by enabling consistent identity matching across systems and reducing record duplication or fragmentation.

CMS should take an active role in advancing adoption. This includes integrating credential sign-up processes into Medicare enrollment and MyMedicare.gov workflows, offering multilingual technical support, and subsidizing credentialing for beneficiaries with limited financial resources. CMS could also establish partnerships with community health centers to provide in-person digital identity assistance. By embedding identity services into existing touchpoints and offering tiered levels of access based on need, CMS can promote both security and inclusion.

Providers 
The success of digital health transformation is inextricably tied to provider adoption, trust, and seamless workflow integration. Many clinicians remain skeptical of digital tools due to usability concerns, fragmented systems, and additional administrative burden.[1] To build a sustainable digital infrastructure, CMS must prioritize technologies that support provider-patient communication, reduce documentation fatigue, and improve care coordination—particularly in under-resourced and rural settings.

CMS should standardize and expand access to APIs and FHIR-based interoperability tools, streamline quality reporting through bulk data capabilities, and ensure that provider-facing tools are modular and specialty-adaptable. Providers must be supported with technical assistance, implementation toolkits, and clear guidance around proxy access, liability, and data-sharing responsibilities when using third-party applications. CMS should also align digital health investments with broader value-based care frameworks, incentivizing adoption through financial levers and quality program integration.

Additionally, CMS must address fragmented identity verification systems, enabling secure, federated digital identity solutions that reduce intake friction and support both patients and caregivers. Trust communities, such as Qualified Health Information Networks (QHINs), can further reduce administrative overhead by standardizing credentialing and access governance. To support transparency and accountability, CMS should revise overly broad information blocking exceptions, provide educational resources for submitting complaints, and phase in proportional disincentives linked to noncompliance.

Ultimately, CMS’ digital health policies should enable providers to focus on what matters most: delivering timely, informed, and compassionate care to patients without undue technological burden.

Payment and Coverage
Payers are integral to the successful realization of a nationwide interoperable health data ecosystem, and CMS must address several policy and technical limitations to ensure their full engagement. TEFCA is promising, but its current design lacks full bidirectional functionality and does not yet accommodate payer needs for real-time utilization data, behavioral health integration, and SDOH information.[2],[3] Clear governance mechanisms, improved alignment with state data sharing laws, and a defined payer role in TEFCA must be established to mitigate participation barriers.

To accelerate interoperability, CMS should expand API requirements beyond Patient Access and Provider Directory APIs to include Prior Authorization and Payer-to-Payer data exchange capabilities. Support for HL7 FHIR standards should be bolstered through grants, implementation tools, and public-facing transparency metrics. Digital identity credentialing also remains fragmented; CMS should establish federal-level certification of acceptable credentials (e.g., CLEAR, Login.gov) and promote their consistent use across MA plans and payer systems. Doing so will reduce access friction and enhance beneficiary trust and usability.

A nationwide provider directory that includes FHIR endpoints and supports digital identity integration would increase administrative efficiency, streamline credentialing, and enable more secure data exchange across payers and providers. Similarly, enabling bulk extraction of clinical quality data via FHIR APIs can reduce reporting burdens on providers while improving the consistency and accuracy of quality measurement by centralizing analytics on the payer side. CMS should pilot and evaluate models that allow payers to assume responsibility for quality calculations, especially for smaller or resource-limited providers.

Efforts to consolidate provider reporting across programs must be grounded in shared standards (FHIR, CQL, QRDA III) and synchronized reporting cycles. Payers can enhance real-time provider decision-making by deploying dashboards that integrate claims and clinical data and support quality improvement efforts. CMS should consider funding or incentivizing these tools, particularly when they support small or rural providers.

Finally, payer engagement in combating information blocking should be strengthened through formal guidance, educational toolkits, and a secure, structured complaint submission process. CMS must ensure that participation in the complaint system does not penalize smaller payers or inhibit collaborative problem solving. Transparent reporting on the nature and outcomes of complaints will build stakeholder confidence and improve compliance across the health data exchange landscape. With structured support and aligned incentives, payers can play a vital role in reducing administrative burden, advancing interoperability, and enhancing patient access to high-value care.

Technology Vendors, Data Providers, and Networks
To foster a thriving digital health ecosystem for Medicare beneficiaries and their caregivers, CMS should adopt an approach that addresses both short-term needs and long-term structural changes. In the near term, CMS can accelerate developer interest by expanding access to high-value CMS datasets through open APIs, improving the clarity and usability of data use agreements, and providing developer-focused resources such as technical documentation, open-source code, and real-time sandbox environments. Targeted funding through challenge grants or public-private innovation partnerships would further encourage developers to address the unique needs of underserved populations, including individuals with chronic illnesses, disabilities, or limited digital access. Over the longer term, CMS should establish a centralized hub—analogous with the FDA’s Digital Health Center of Excellence—that supports iterative development, user testing, and integration of patient-facing tools into Medicare workflows.[1]

Greater access to meaningful data is essential to innovation in the Medicare space. CMS should prioritize the release of de-identified Part D data, MA encounter data, and cost-sharing breakdowns disaggregated by geography, language preference, disability status, and other equity-related variables. Developers would benefit from complementary integration with public sources such as the Area Deprivation Index and immunization registries. Obstacles such as fragmented data formatting, burdensome legal review, and lack of onboarding support limit participation by smaller developers. CMS should respond by issuing standardized data dictionaries, curating use case repositories, and streamlining access pathways. In addition to improving data availability, CMS and ASTP/ONC should expand and mandate APIs that expose real-time provider directories, care team composition, prior authorization status, and price transparency. These functions, built on HL7 FHIR and SMART on FHIR standards, would allow a secure, inclusive, and user-centered approach to identity verification would streamline access to digital health tools while strengthening cybersecurity and reducing fraud. CMS should adopt a federated credentialing model that accepts multiple providers, such as Login.gov, CLEAR, and ID.me, provided they meet NIST IAL2 and AAL2 standards. However, CMS must ensure accommodations for patients who face challenges with conventional identity proofing methods, including those with no credit history or stable residence. Mandating use of OpenID Connect protocols would facilitate consistent and secure access across platforms, but CMS must also ensure the interface is intuitive, multilingual, and compatible with assistive technologies. Broad adoption will depend on addressing the needs of digitally underserved populations while maintaining robust security and transparency standards.

To promote interoperability, CMS should require vendors and networks participating in federal programs to use open, publicly documented APIs rather than proprietary systems. Incentivizing the use of HL7 FHIR, OAuth 2.0, and other standards through certification and reimbursement policies would reduce vendor lock-in and enhance competition. CMS should also publish transparency dashboards detailing API conformance, usability, and endpoint availability, encouraging accountability among vendors and empowering developers and provider organizations to make informed choices. A national provider directory of FHIR endpoints would complement this effort, simplifying endpoint discovery and improving care coordination across networks. CMS or ONC should manage this directory as a free public good, ensuring equitable access for developers, providers, and patients.

TEFCA plays a distinct role in promoting secure, scalable, nationwide data exchange by creating a uniform governance and technical framework. Although regional HIEs and proprietary networks continue to serve localized functions, TEFCA’s potential to unify disparate systems and support consistent data sharing across state and program boundaries is unmatched. CMS and ONC should provide clear guidance for migrating redundant or overlapping protocols—such as XCA or ad hoc FHIR exchanges—toward TEFCA-compatible interfaces. Doing so will reduce fragmentation and establish a more reliable backbone for longitudinal patient data access.

While the US Core Data for Interoperability (USCDI) standard has been instrumental in advancing structured exchange, its current scope omits critical patient-centered data elements, such as functional status, social risk factors, and patient-reported outcomes. These limitations stem from both definitional exclusions and inconsistent implementation. Expanding USCDI to include these elements would improve care quality, but CMS and ONC must manage scope by offering modular data element tiers to reduce implementation burden. In parallel, CMS should fund pilot projects that explore the utility of less structured, but more comprehensive formats—especially those supported by natural language processing or generative models—to assess trade-offs in semantic clarity, usability, and user-centered effectiveness.

Certification remains a vital mechanism for driving industry alignment. Among the most impactful criteria are FHIR API conformance, patient-facing data access, and NIST-aligned security protocols. However, certification must evolve to emphasize real-world usability, including caregiver proxy access, price transparency, and multilingual support. CMS should also prioritize the inclusion of capabilities for bulk data transfer to streamline quality reporting and reduce burden on providers. Such capabilities would enable continuous performance tracking and data aggregation at scale but must be supported by robust privacy protections and common payload standards to prevent misuse and ensure equitable benefit.

In implementing the 21st Century Cures Act API conditions, CMS and ONC should move beyond mere technical compliance to require unrestricted access to all EHR data elements—structured and unstructured—and prohibit contractual practices that limit access. Certification must include performance testing, real-world usability evaluations, and transparency in access restrictions or fees. Similarly, EHI export functionality must be revised to include FHIR-based automation tied to clinical workflows, such as discharge or transitions of care. CMS can further encourage adoption through reimbursement incentives and by integrating export functionality into conditions of participation.

To reduce documentation burden and support high-quality clinical workflows, CMS should encourage the development of modular, standards-based applications that integrate voice recognition, natural language processing, and ambient sensing. These tools should be certified for usability and clinical appropriateness, particularly in low-resource settings. CMS can promote innovation in this space through targeted funding, quality incentives, and public API repositories.

Security and privacy protections are foundational to patient and caregiver trust. CMS should require all certified and uncertified digital health tools to meet minimum security standards—including encryption, multifactor authentication, audit logging, and breach detection—and should align these standards with NIST guidance. Transparent security attestations should be publicly accessible, and vendors should be subject to third-party audits. Similarly, APIs and digital applications must include consent management features that allow users to set, monitor, and revoke data sharing permissions with specificity. CMS should also require that all tools include clear, plain-language privacy notices and offer opt-in transparency dashboards that show who has accessed data and for what purpose.

Caregivers are an underserved group in the digital health landscape. Current systems lack standardized proxy access mechanisms, consistent recognition of caregiving roles, and the technical infrastructure to support shared access to digital tools. CMS must establish uniform proxy credentialing frameworks, require caregiver support in all certified applications, and mandate legal recognition of caregivers across Medicare programs. Caregiver-facing tools must be accessible, multilingual, and optimized for diverse caregiving arrangements.

Developers building tools for patients, caregivers, and providers would benefit from centralized technical support—including sandbox environments, API reference libraries, and curated datasets—as well as legal and compliance templates to navigate regulatory complexity. CMS should provide grant funding to early-stage developers and establish an ongoing digital innovation consortium to facilitate peer learning and policy co-design.

Finally, CMS should follow several guiding principles when designing digital health policies: prioritize real-world usability and accessibility; ensure equity across language, income, disability, and caregiving status; promote open standards and modular design; embed transparency and user control into all tools; and align requirements with clinical and patient workflows. These principles must be informed by ongoing stakeholder engagement, particularly with patients and caregivers who navigate the system daily.

As use of digital health tools increasingly extends beyond clinical settings, CMS should clarify expectations and protections around non-clinical data use. Community-based organizations, legal services, public health agencies, and caregiver networks can all benefit from structured data access, but consent must be explicit, revocable, and transparent. APIs supporting these functions should include safeguards to ensure appropriate use, with annual transparency reports summarizing patterns of access and key risk mitigations. CMS must strike a careful balance between innovation and accountability to ensure that expanded use of patient data meaningfully benefits those it is intended to serve. 

Value-Based Care Organizations
To support patients in value-based care arrangements, CMS should strengthen its alignment of financial and operational incentives for providers participating in alternative payment models (APMs), such as accountable care organizations (ACOs). Specifically, the agency can encourage the adoption of digital tools—like patient engagement platforms, care navigation apps, and remote monitoring systems—by offering infrastructure grants, enhanced shared savings, or quality scoring advantages. These tools are especially important for populations with complex care needs, including individuals with disabilities, chronic conditions, and limited digital literacy.

However, broader adoption remains hampered by systemic barriers, including inconsistent interoperability, a lack of digital inclusivity, and resource constraints among smaller or rural ACOs. CMS should address these challenges by expanding technical assistance, supporting platform-agnostic certification, and facilitating usability testing across diverse patient populations to ensure equitable access and effectiveness.

For APMs to deliver high-value care, CMS must also ensure the integration of health IT capabilities that prioritize real-time care planning, longitudinal patient tracking, caregiver access, and feedback loops for patient-reported outcomes. The agency should advance data standards that include not only clinical and claims data, but also patient experience, functional status, and social determinants of health—ensuring patients are treated holistically and that care is coordinated across all touchpoints.

Finally, CMS should reevaluate certification criteria under the ONC Health IT Certification Program to better reflect the practical needs of APM participants. Tools such as integrated social risk screening, multilingual portals, and patient identity resolution systems should be incorporated to close gaps in care and support seamless care transitions. CMS must ensure that digital infrastructure for APMs is not only technically capable but also patient-centered, equitable, and responsive to the lived realities of those receiving care.

Conclusion

Thank you for the opportunity to provide input on this RFI on the health technology ecosystem. Please do not hesitate to contact Kimberly Beer, Senior Vice President, Policy & External Affairs at kbeer@nhcouncil.org or Shion Chang, Senior Director, Policy & Regulatory Affairs at schang@nhcouncil.org, if you or your staff would like to discuss these comments in greater detail.

Sincerely,

Randall L. Rutta
Chief Executive Officer


[1] Shakera Moreland, “Bridging the Gap in Healthcare Information Access for Caregivers,” Journal of AHIMA, December 18, 2023. https://journal.ahima.org/page/bridging-the-gap-in-healthcare-information-access-for-caregivers.

[2] Dan Lips, Michael Tanner, and Avik Roy, “Improving Access to—and Integrity of—Federal Benefits Using Digital ID Technology,” Foundation for Research on Equal Opportunity, October 29, 2024. https://freopp.org/whitepapers/improving-access-to-and-integrity-of-federal-benefits-using-digital-id-technology/.

[3] Centers for Medicare & Medicaid Services, “Blue Button 2.0,” CMS.gov, last modified March 31, 2022, https://www.cms.gov/bluebutton.

[4] Mona Omar Mohsen and Hassan A. Aziz, “The Blue Button Project: Engaging Patients in Healthcare by a Click of a Button,” Perspectives in Health Information Management 12 (Spring 2015): 1d. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4696090/.

[5] Jan Walker et al., “OpenNotes after 7 Years: Patient Experiences with Ongoing Access to Their Clinicians’ Outpatient Visit Notes,” Journal of Medical Internet Research 21, no. 5 (May 2019): e13876, https://doi.org/10.2196/13876.

[6] Jennifer Dickman Portz et al., “Characteristics of Patients and Proxy Caregivers Using Patient Portals in the Setting of Serious Illness and End of Life,” Journal of Palliative Medicine 24, no. 11 (October 27, 2021): 1697–1704, https://doi.org/10.1089/jpm.2020.0667.

[7] Centers for Medicare & Medicaid Services, “Blue Button 2.0 Developer Documentation,” CMS.gov, accessed June 4, 2025, https://bluebutton.cms.gov/developers.

[8] Sahalu B. Junaid et al., “Recent Advancements in Emerging Technologies for Healthcare Management Systems: A Survey,” Healthcare 10, no. 10 (2022): 1940. https://doi.org/10.3390/healthcare10101940.

[9] Pew Charitable Trusts, How to Improve Electronic Health Record Usability and Patient Safety (fact sheet, August 2016), https://www.pewtrusts.org/en/research-and-analysis/fact-sheets/2016/08/how-to-improve-electronic-health-record-usability-and-patient-safety.

[10] Mohsen and Aziz, “The Blue Button Project,” 1d.

[11] Moreland, “Bridging the Gap.”

[12] Office of the National Coordinator for Health Information Technology. How APIs in Health Care can Support Access to Health Information: Learning Module. U.S. Department of Health and Human Services, December 2017. https://www.healthit.gov/sites/default/files/page/2018-05/privacy-security-api.pdf.

[13] Nir Menachemi, Saurabh Rahurkar, Christopher A. Harle, and Joshua R. Vest, “The Benefits of Health Information Exchange: An Updated Systematic Review,” Journal of the American Medical Informatics Association 25, no. 9 (2018): 1259–1265, https://doi.org/10.1093/jamia/ocy035.

[14] LeadingAge and the Strategic Health Information Exchange Collaborative (SHIEC), Health Information Exchange (HIE): A Primer and Provider Selection Guide, accessed June 9, 2025, https://leadingage.org/health-information-exchange-hie-a-primer-and-provider-selection-guide/.

[15] LeadingAge and SHIEC, HIE: A Primer and Provider Selection Guide.

[16] Nir Menachemi et al., “The Benefits of Health Information Exchange: An Updated Systematic Review,” Journal of the American Medical Informatics Association 25, no. 9 (2018): 1259–1265. https://doi.org/10.1093/jamia/ocy035.

[17] LeadingAge and SHIEC, HIE: A Primer and Provider Selection Guide.

[18] Sahalu Balarabe Junaid et al., “Recent Advancements in Emerging Technologies for Healthcare Management Systems: A Survey,” Healthcare 10, no. 10 (October 3, 2022): 1940, https://doi.org/10.3390/healthcare10101940.

[19] Katherine Rose, Joseph S. Ross, and Leora I. Horwitz, “Advanced Access Scheduling Outcomes: A Systematic Review,” Archives of Internal Medicine 171, no. 13 (April 25, 2011): 1150–59, https://doi.org/10.1001/archinternmed.2011.168.

[20] Amy Abernethy et al., The Promise of Digital Health: Then, Now, and the Future, NAM Perspectives, Discussion Paper (Washington, DC: National Academy of Medicine, 2022), https://doi.org/10.31478/202206e.

[21] Elizabeth W. Woodcock, “Barriers to and Facilitators of Automated Patient Self-scheduling for Health Care Organizations: Scoping Review,” Journal of Medical Internet Research 24, no. 1 (2022): e28323. https://doi.org/10.2196/28323.

[22] Rose, Ross, and Horwitz, “Advanced Access Scheduling Outcomes,” 1150–59.

[23] Boon Peng Ng, Georgianne Tiu Hawkins, McKayla Massey, Jacqueline B. LaManna, and Chanhyun Park, “Digital Divide Among Medicare Beneficiaries and the Diabetes Prevention Program,” American Journal of Preventive Medicine 67, no. 5 (November 2024): 746–752, https://doi.org/10.1016/j.amepre.2024.07.013.

[24] Lips, Tanner, and Roy, Improving Access to Federal Benefits.

[25] Meena Seshamani, Douglas Jacobs, Jean Moody-Williams, and Lee Fleisher, “Addressing Rural Health Inequities in Medicare,” Centers for Medicare & Medicaid Services (blog), February 10, 2023, https://www.cms.gov/blog/addressing-rural-health-inequities-medicare.

[26] Lips, Tanner, and Roy, Improving Access to Federal Benefits.

[27] Kelly J. Thomas Craig et al., “The Burden of the Digital Environment: A Systematic Review on Organization-Directed Workplace Interventions to Mitigate Physician Burnout,” Journal of the American Medical Informatics Association 28, no. 5 (May 2021): 985–997, https://doi.org/10.1093/jamia/ocaa301.

[28] Ron Southwick, “TEFCA Has Moved beyond Hype, but There’s Room for Progress in Exchanging Health Data,” Chief Healthcare Executive, June 4, 2025, https://www.chiefhealthcareexecutive.com/view/tefca-has-moved-beyond-hype-but-there-s-room-for-progress-in-exchanging-health-data.

[29] Mike Cordeiro, “Why TEFCA Offers a Promising Future for Interoperability,” Health Data Management, April 2, 2025, https://www.healthdatamanagement.com/articles/why-tefca-offers-a-promising-future-for-interoperability.

[30] Elizabeth Kunkoski, Anindita Saha, and Maria Matilde Kam, “FDA Perspective on the Importance of Digital Health Technologies in Clinical Trials,” JAMA Health Forum 6, no. 4 (April 11, 2025): e250165, https://doi.org/10.1001/jamahealthforum.2025.0165.

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