DIME PROJECT

Patient-generated health data
Building the next generation of real-world evidence

Providing a more timely, continuous, and patient-centered view of health than traditional data sources

The evidence systems regulators and payers rely on today for AI-enabled medical device approvals are built on 20th century evidence systems. They were not designed to track products that continue to change after approval and market delivery.

As we rapidly digitize healthcare, this new generation of medical technology requires an evidence infrastructure that supports current-day decision-making. Patient-generated health data (PGHD), collected through connected medical devices, remote monitoring and smart home technologies, smartphones, and other digital tools, provides a more timely, continuous, and patient-centered view of health than traditional data sources.

Read the Policy Brief

In partnership with

Explore the work

DiMe has spent the past two years building policy-focused analysis examining how PGHD, alongside other forms of real-world data and evidence (RWD/E), can strengthen oversight of AI-enabled medical devices after deployment to help regulatory decision-makers move from reactive oversight to evidence-informed intervention.

DiMe’s PGHD work included a gap analysis of the regulatory, policy, and technical landscape that surfaced barriers around PGHD validation and interoperability, lays out what that foundation should look like, and gives regulators a near-term path to build it without requiring new legislation.

Policy Brief | July 31, 2026

This brief explains why electronic health records and claims data became trusted sources of evidence and how patient-generated health data has reached the same inflection point. It includes five near-term federal actions for coordinated implementation:

Establish national standards for trusted patient-generated health data
Modernize post-market surveillance for software and AI-enabled medical products
Develop shared methods for identifying meaningful safety and performance signals
Build interoperable infrastructure for bidirectional data exchange
Align measurement strategies for regulation and payment

Read the Policy Brief

Educational Briefing

Written for congressional staff and anyone who needs the policy brief’s argument without the technical density. This briefing opens with a plain-language explainer of real-world evidence, AI-enabled devices, and patient-generated health data, then walks through what the government is already piloting (FDA’s TEMPO and RAPID programs, CMS’s ACCESS model and Medicare App Library) and where the operational gaps remain.

It closes with a full plain-terms appendix that unpacks every technical term in the policy brief, organized by the five recommendations they support, from provenance and version tracking to predetermined change control plans and measure isolation.

Use this when you need the argument to land with a non-technical audience.

Read the Educational Briefing

Why now

The gap in patient-generated health data touches nearly every conversation happening in digital health right now:

Real-world evidence. Every discussion about the limits of current RWE infrastructure eventually runs into the same wall: patient-generated data is abundant, but there is no trusted way to bring it into regulatory or payment decisions yet.

Clinical trial innovation. Decentralized and hybrid trials depend on data generated outside the clinic. Without shared standards for that data, sites and sponsors are left building one-off solutions.

Reimbursement and outcome-aligned payment. As payment shifts from covering services to covering outcomes, the question becomes what data that determination is based on. Patient-generated health data is a natural fit, but almost no one has a clear starting point for using it.

AI in healthcare. Structuring the data patients generate so it can actually be used in a clinical workflow is a prerequisite for most AI applications in health.

Public workshop

This work was preceded by a public workshop that brought together more than 2,000 stakeholders to explore how PGHD can support medical device development, regulatory decision-making, and post-market oversight.

45
Speakers

9
Patients/Patient Advocates

15 +
Government Leaders

2000 +
Participants

The bottom line

Patient-generated health data is ready for strong investment, and getting there does not require new legislation. FDA, CMS, ONC, and the CMS Innovation Center already have the authority to act, and DiMe’s PGHD work is built to support that effort with evidence and a practical starting point.

Want to talk about this work? Whether you’re thinking about this from an RWE, clinical trials, reimbursement, or AI governance angle, we’d like to help with what you’re working on.

Contact DiMe

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