?DIGITS: DIGital health Interoperability Technology Standards - Summary This project addresses the need for standardized digital health data formats through five integrated aims. Aim 1 focuses on forming a multidisciplinary consortium of stakeholders, including clinicians, researchers, industry representatives, regulators, and patient advocates, to develop a governance framework that supports the collaborative development of sustained standards. This includes establishing various working groups and an ethical advisory board, with clear role definitions, onboarding procedures, and a structured decision-making process modeled after successful prior efforts with the American Psychiatric Association. Aim 2 involves building the standard through an iterative, evidence-driven development cycle. It includes a comprehensive review of existing data standards (e.g., HL7 FHIR, Open mHealth), creation of draft schemas, and stakeholder consensus via Delphi processes. Three versioned releases will iteratively refine the standard using structured feedback, benchmark data, and technical implementation testing. Aim 3 validates the proposed standard in a real-world clinical study of anxiety disorders across seven smartphone and wearable platforms. A 338-participant decentralized study will empirically test harmonization techniques for sensor data (e.g., steps, heart rate), ensuring the standard’s ability to support device-agnostic, clinically meaningful metrics. Aim 4 focuses on building adoption pathways by partnering with major device manufacturers and organizing technical workshops to co-develop API mapping layers, demonstrate value propositions, and facilitate incremental integration of the standard. It also includes pathways for journal and funder uptake. Finally, Aim 5 ensures long-term sustainability by transitioning stewardship to the APA, publishing tools and standards as open-source, launching a validation toolkit and training ecosystem, and establishing a financially viable operating model through consortium fees and ongoing stakeholder engagement. Together, these aims will enable scalable, secure, and interoperable digital health data infrastructure that advances both mental health research and care.
