In May 2025, the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC) issued a Request for Information (RFI) on “Building the Health Technology Ecosystem” (CMS-0042-NC). Rune Labs submitted a formal comment highlighting how real-world, longitudinal, patient-generated data, especially in complex conditions like Parkinson’s disease, can power earlier intervention, improve outcomes, and support equitable, value-based care. Our full response is shared below.

June 12, 2025

Parkinson’s disease affects an estimated 1.2 million Americans today and is projected to double by 2040. Over 60 % of these individuals are Medicare beneficiaries, driving more than $25 billion in annual direct medical spend. Yet objective, longitudinal data on motor fluctuations, medication adherence, and functional outcomes remain sparse. We therefore appreciate the opportunity to comment on CMS/ONC’s Request for Information: Health Technology Ecosystem. 

Below, we provide detailed evidence, recommendations, and implementation considerations below and stand ready to serve as a real‑world test case as CMS and ONC operationalize these new policies.

Unlocking Value Through Digital Health and PGHD

Rune Labs strongly supports the goal of improving health outcomes by expanding access to digital capabilities and actionable data. Drawing from our work with StrivePD, a digital care management platform for Parkinson’s disease, we offer the following key insights:

• Passive, consumer‑grade sensors meaningfully reduce acute‑care utilization. Today’s wearables contain sophisticated sensors that can generate the data needed to identify high-risk events for patients. We encourage CMS to recognize such digital biomarkers as legitimate measures for Alternative Payment Models (APMs) and expand Remote Therapeutic Monitoring (RTM) codes beyond musculoskeletal use cases.

• Application programming interfaces (API)‑first data exchange should explicitly include Patient‑Generated Health Data (PGHD). This ensures modern health IT systems are built to handle both clinician-entered data, but also the rich, continuous stream of information patients generate themselves.

• Digital identity rules must preserve consumer‑friendly sign‑on methods. Medicare’s digital systems should allow secure, user-friendly third-party login methods (like Apple ID) that meet federal identity standards. This would prevent older adults from being excluded due to complex authentication requirements and help ensure equitable access to digital health tools.

• Value‑Based Care models need timely, device‑collected outcomes. Such models require timely, objective, and meaningful health data that could detect changes in disease progression 3–6 months earlier than traditional in-clinic assessments.

• Early engagement with specialty‑specific digital platforms de‑risks Trusted Exchange Framework and Common Agreement (TEFCA) adoption. To support successful TEFCA adoption without stifling innovation, CMS and ONC should collaborate early with specialty digital platforms and implement a phased path for PGHD exchange.

Accelerating Patient Access, Engagement, and System Innovation

Below are several directly annotated responses. They represent responses informed by multiple stakeholder perspectives and are intended to offer clear, actionable input across the RFI.

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?

Achieving sustained Medicare patient engagement in digital health requires a combination of passive data capture, simplified identity verification, caregiver delegation, and device-agnostic cloud analytics. Automatically collecting health data through wearables or smartphones reduces patient burden and ensures consistent, real-world insights without manual input. Streamlined authentication, such as third-party logins or biometrics, removes access barriers, especially for older adults. Enabling caregivers to securely act on a patient’s behalf supports those with cognitive or physical limitations. Finally, cloud-based analytics that work across devices ensure broad compatibility and scalability. Solutions using these strategies have demonstrated over 80% weekly engagement by prioritizing ease of use and integration into daily life.

PA-4. What would be the value to payers of a nationwide provider directory that included FHIR end points and used digital identity credentials?

Insurers should accept patient-submitted health data using Fast Healthcare Interoperability Resources standards that clearly identify the patient as the data source, and to adopt modern, secure authentication protocols (OAuth 2.1 + Proof Key for Code Exchange) that work with popular consumer login tools. Together, these steps support secure, scalable, and patient-friendly data exchange across the healthcare ecosystem.

VB-3. What are essential health IT capabilities for value-based care arrangements?

Essential health IT capabilities for value-based care include the ability to capture, analyze, and act on Patient-Generated Health Data (PGHD) in real time. PGHD enables earlier detection of disease progression, more precise medication management, and reduced acute-care utilization.

• Acute-care utilization: In a 9-month prospective cohort (n = [138]), users of Rune Lab’s digital health platform StrivePD experienced a 42% relative reduction in ED visits (p < 0.05) compared to matched claims-based controls at Kaiser Permanente.

• Disease-progression sensitivity: Mobility metrics captured passively via iPhone detected step length decline 6 months earlier than standard in-clinic assessments (MDS-UPDRS III).

• Medication titration: A subgroup analysis from a real-world ABBV-951 cohort demonstrated a 30% improvement in gait speed over 4 weeks and a concomitant decrease in fall risk, supporting PGHD’s role in optimizing therapy.

These findings highlight the importance of integrating device-collected PGHD, remote monitoring tools, and real-time analytics into health IT infrastructure to support effective, proactive value-based care.

Implementation Safeguards: Ensuring Security, Privacy, and Equity

As demonstrated by Rune Lab’s StrivePD AI-based platform, digital tools must be built with strong privacy and security protections that meet industry and regulatory standards. They need to be SOC 2 Type II certified, HIPAA-compliant, and adhere to GDPR requirements, ensuring that sensitive health data is handled responsibly. A zero-trust architecture adds another layer of protection by verifying every access request, while data minimization practices ensure that only essential information is collected, reducing exposure to unnecessary risk.

To promote equity, the digital ecosystem should include targeted efforts to serve under-resourced populations. For example, our StrivePD software ecosystem was provided in partnership with community clinics in rural Oregon and South Texas, where access to digital health tools is often limited. A device-loaner program also ensures patients without smartphones or wearables can still participate. Additionally, the user interface should be tested to meet a Flesch–Kincaid Grade 6 reading level, making it accessible to users with a wide range of literacy levels.

Overall Recommendations Summary

• Include neurological conditions in remote monitoring programs: Let people with conditions like Parkinson’s or MS use data from their phones or wearables to qualify for remote care and support.

• Make patient-generated data part of standard health records: Add things like step counts, sleep data, and symptom tracking to the official list of health info patients can access and share.

• Roll out new health data-sharing rules gradually: Test how patient-collected data can be safely shared through national networks by starting with pilot programs and providing support during the transition.

• Use easy, secure logins people already know: Let patients sign in with tools like Apple ID or Google in a way that meets government security standards, without making the process harder.

Rune Labs appreciates CMS and ONC’s leadership in creating a modern health‑technology ecosystem. We believe Parkinson’s disease is an ideal proving ground for the policies outlined in this RFI and welcome the opportunity to collaborate as a test‑bed partner.

‍