Consumer-mediated exchange refers to the process where patients share their health data directly with healthcare providers, payers, and researchers. This model inverts the landscape of healthcare data sharing. Patients become the conduits for their health data, actively participating in its exchange. This paradigm shift can address several longstanding issues in healthcare data interoperability, making patient information more accessible to providers, payers, and researchers.

In this blog, we explore the mechanics, challenges, and potential solutions for consumer-mediated exchange of health information.⁠⁠⁠

Actors of Consumer-Mediated Exchange

Senders: Patients or custodians of patients
Receivers: Healthcare providers, payers, and researchers

Consumer-mediated exchange involves patients (senders) sharing their health data with healthcare providers, payers, and researchers (receivers) to enhance care, streamline payments, and support research.

Types of Data Shared

Clinical Data: Medical records, lab results, and imaging studies
Billing Data: Billing codes, insurance claims, and payment information
Device Data: Data from wearable devices (e.g., heart rate monitors, glucose meters) and medical equipment
Patient-Generated Data: Information from patient surveys, diaries, and self-reported data

Growing Importance of Consumer-Mediated Exchange

Access to complete patient information is crucial for improving care, but it has long been a challenge. Traditionally, efforts have focused on interoperability between organizations to facilitate data exchange for patients. However, recent developments have made it more viable for patients (consumers of health care) to share their health data directly with providers, researchers, and payers.

Regulatory Changes: Recent regulations, such as the 21st Century Cures Act and CMS Interoperability and Patient Access Final Rule (CMS Rule 9115-F), have created new opportunities for patients to access their health data. This data is available in the FHIR format. Since it originates from the payer and provider EHR systems, it is verified and trustworthy.
Increase in Device Data: With the proliferation of health monitoring devices, there is a surge in available health data that can be shared and used for improving patient care.
Billing Incentives: New billing codes for remote monitoring have made it financially feasible for providers to incorporate patient-shared data as part of care.
Complexity of Traditional Methods: Business-to-business (B2B) and Health Information Exchange (HIE) models often require extensive setup and coordination. The consumer-mediated exchange is a much simpler alternative.
TEFCA Progress: The current rate of adoption of the Trusted Exchange Framework and Common Agreement (TEFCA) has created an information gap that consumer-mediated exchange can fill in the interim. As TEFCA adoption accelerates, it will introduce more consumer-mediated exchange options by giving patients greater access to their data.

Receivers of the Patient Data and Potential Benefits

Healthcare Providers Using EHRs
- Data shared by patients can be integrated with EHR data to construct comprehensive longitudinal records, improving care quality and billing processes.
- Data from patients can streamline the pre-registration process by accessing existing health records and insurance information.
Research, Clinical Trials, and Registries
- Data shared by patients can streamline clinical trials and research by simplifying data acquisition and enabling access to a large and diverse pool of patient data.
- Data from a diverse population in disease registries allows for a better understanding of diseases and, hence, their effective management and treatment.
Payers and Other Population Health Analytics
- Data from patients can help payers identify preventive care initiatives and timely treatments to facilitate more cost-effective care.
- Patient data can also enable payers to offer personalized health plans to improve healthcare service delivery and outcomes.

Data Formats

FHIR (Fast Healthcare Interoperability Resources): Data from providers and payers under Cures Act and CMS 9115 is predominantly available as FHIR.
Proprietary Convertible Formats: Structured data from devices and other apps that can be converted to FHIR or other formats.
Unstructured Data: Data available as PDFs, images, and text documents.

Patient Data-Sharing Models

At a high level, patients can use two approaches to share their data. The best solution would depend on the use case and other factors, as discussed further below.

Push by Patient: In this model, the patient pushes data directly into the receiving system. This method would usually require the incoming data to be in some structured format. This approach is currently being discussed in an Argonaut project using FHIR.
- Pros: Using FHIR or other structured formats provides a simple way to map and merge incoming data into the existing system.
- Cons: This approach can cause data integrity concerns in the receiving system. These can still be addressed using the Provenance of the incoming data and some other options. However, the major issue is the security of the receiving system (typically an EHR). This is where the sender's authentication becomes critical, as discussed in the authentication section below.
*NOTE: Argonaut CGM Write Initiative is working on addressing this problem. In a recent video, we proposed a solution for combining Continuous Glucose Monitoring (CGM) data with Epic data.
Pull by Patient (Drop and Pick up): This is another approach that can be adapted to receive patient data. In this approach, the patient drops off the data at a secure location in response to a code or a secure link that they receive. The receiver can then import this data into their system. This allows the receiving system to perform data validation and patient-matching before data is imported.
- Pros: This method maintains data integrity and confidence, as the receiving system reviews all data in the system.
- Cons: Manual steps may be required for patient matching and validation, which can be automated and improved with algorithms such as natural language processing.

What Does the Receiver Need?

The requirements for the receiver system will vary depending on the type of receiver. As most incoming data will be in FHIR format, the receiver system should support storing FHIR data. In EHR, as in the receiver scenarios, these could be the FHIR APIs provided by the EHRs. In non-EHR scenarios, it could be any kind of data management system based on the receiver type.

An ideal receiving system should support the following:

Storing FHIR and/or other structured data
Storing unstructured data
An easy method to export data (if this is not the primary system)
Authentication options as outlined below based on the use case

Authentication Options for Patients with the Receiving System

For implementation of any of the above models, patients will need to authenticate with the receiving system before they can submit the data. It’s important to clarify that we are referring to patient authenticating to the receiving system. When sharing data from their providers or payers, patients will authenticate with those systems using credentials assigned to them from those systems. Here are the different options:

No Authentication: The receiver shares a generic link that anyone can use to upload data. The patient logs in to a provider or payer health system where they already have an account, downloads their data, and then submits it to the receiver. This option can be used with both the “Pull” and “Push” models outlined above, for example, a patient submitting data from CMS Blue Button 2.0 for a clinical trial.
- Pros: The patient does not need to set up an additional account in the receiver system, and it’s quick.
- Cons: Manual processes are required on the receiver side to match and import the data.
Patient Portal Credentials: This option is only available to providers using EHRs where the patients already have an account assigned by the EHR. The patient logs in using the receiving system's patient portal credentials.
- Pros: The patient does not need to set up an additional account. Incoming data can be automatically mapped to the patient as they are authenticated.
- Cons: It is dependent on the EHR supporting it.
  The Argonaut CGM Write Initiative mentioned above, has outlined this as one of the proposed flows. In the recent video, we also outlined a way to accomplish this.
Patient-Specific Code: This option is similar to the “No Authentication” option above. However, in this option, the link has an embedded code specific to a patient.
- Pros: Data is automatically mapped to the patient, simplifying mapping and import on the receiver’s end.
- Cons: Individual patient invites need to be created, delivered, and managed.
Patient Account in the Receiver System: In this option, the receiver requires the patient to create an account in their system. The patient uses that account to log in and share their data.
- Pros: The patient is authenticated, which simplifies the process of mapping and importing the data into the receiver system.
- Cons: It involves a one-time process for sending and accepting invites, which requires additional support to manage patient accounts.

A successful consumer-mediated exchange solution requires secure data sharing, patient authentication, and integration with existing systems. It should handle data securely, support different authentication methods, work with various data formats, and be compatible with both EHR and non-EHR environments. This level of comprehensive capabilities is essential for a simple implementation and effective data exchange.

A Solution to Facilitate Consumer-Mediated Exchange: MeldRx

MeldRx is an integrated platform that enables developers to build, test, and launch healthcare IT solutions that support a variety of use cases. We have developed a framework within MeldRx that makes it simple to integrate consumer-mediated exchange features in your apps. Here are some of the key features of the framework:

FHIR First Backend System - MeldRx workspace provides all the features required to implement a receiver system. It is designed to handle FHIR data along with other structured and unstructured data, ensuring a reliable data management solution.
Comprehensive Integration: MeldRx offers comprehensive support to seamlessly integrate data from providers, payers, and devices.
Support Both EHR and Standalone Solutions: MeldRx workspaces are suitable for both EHR and non-EHR environments, offering the flexibility to either integrate with existing systems or operate as a standalone solution. MeldRx Linked Workspace allows you to integrate patient shared data with EHR data in your apps even where the EHR might not support importing data.
Flexible Authentication for Patients: MeldRx supports various authentication methods, including anonymous access, code-based verification, patient portal login, and MeldRx account-based authentication.
Data Sharing Options: MeldRx allows both push and pull methods for data sharing, featuring unique functionality for secure drop-off and pick-up of information.
Customizable Platform: MeldRx offers SMART on FHIR capabilities for tailored solutions, ready for plug-and-play use or as a foundation for building your applications from scratch.
If you're working on implementing a consumer-mediated exchange solution, we'd love to discuss it with you.