Health Record Connect

Medidata Health Record Connect is an EHR integration and interoperability engine designed for securely and compliantly acquiring, transforming, and exchanging electronic health record data across the clinical research and healthcare ecosystem. Built for life sciences organisations, clinical trial sites, and care teams, it powers a new level of collaboration and visibility into a patient's critical healthcare information by leveraging a multi-pronged approach to connectivity — ensuring the right data from the right site and patient is securely acquired, transformed, and presented to the appropriate users within a single user experience.

As the boundaries between lifelong healthcare data and the subset required in a clinical trial continue to blur, Health Record Connect addresses the imperative to manage a greater variety of complex data from a broader range of sources. The platform reflects a commitment to advancing research and healthcare as quickly and safely as possible by utilising every part of the available data ecosystem, including supporting Clinical Research as a Care Option (CRAACO) — where interventional clinical trials may represent the only remaining treatment option for some patients.

Key Features and Capabilities

• Connectivity to any healthcare system: Health Record Connect connects to any healthcare system using whatever protocol or standard is appropriate for each site, enabling quicker startup times and higher adoption rates without requiring complex, bespoke integrations.
• Health Information Exchange (HIE) support: Out-of-the-box scalability through connectivity to a wide range of healthcare organisations and physician practices via national and local HIEs and networks, eliminating the need to create one connection at a time.
• Support for FHIR, CCDA, DICOM, and HL7: Works with any format or protocol, including those most commonly used to communicate healthcare information across the USA.
• Bi-directional data transformations: Enables site healthcare data to be leveraged across all Medidata applications, regardless of the original communication format.
• Longitudinal patient insights: By pulling in data from multiple sources, users gain a full view of a patient's history — not just information from their own site — enabling richer, more informed clinical decision-making.
• EHR-to-EDC data entry acceleration: Integrates with Rave Companion to present matching EHR data to clinical trial sites as they complete Rave EDC forms, dramatically speeding up data entry where trial forms require data already present in the patient's healthcare record. Sites retain full control, as nothing is submitted to Rave EDC until the site saves the form.

Supported Workflows and Use Cases

• Clinical trial data collaboration: Facilitates data collaboration within interventional clinical trials using Rave Companion, with the requirement that all users are employed by the institution in which data is accessed, under the supervision of a physician or principal investigator, and involved in monitoring safety events and study outcomes.
• Medidata Surgical Planning: Powers surgical planning workflows by making relevant patient health record data available within the Medidata platform.
• Real-world data (RWD) aggregation and insights: Supports the aggregation of real-world data from multiple sources to generate broader insights across the clinical development lifecycle.

Integration and Interoperability Approach

1. Health Record Connect connects to healthcare systems using the appropriate protocol or standard for each site, avoiding the need for complex per-site integrations.
2. Data is acquired from multiple sources — including HIEs and direct connections — and transformed into formats compatible with Medidata applications.
3. Matching EHR data is surfaced to clinical trial site users via Rave Companion as they complete Rave EDC forms, keeping the site's attention on the data throughout the process.
4. Transformed data is made available across the broader Medidata platform to support a wide range of downstream workflows and use cases.

Health Record Connect is part of the broader Medidata platform and is designed to integrate with Medidata solutions including Rave EDC, Rave Companion, and Medidata Surgical Planning. Medidata also provides training options for clients and partners, including self-paced and instructor-led courses, available through the Medidata Global Education and Training programme.