AdvaMed Digital Health Tech Board Approves Best Practices to Advance Responsible Data Access and Patient Care
WASHINGTON, D.C.—AdvaMed, the Medtech Association, today announced that its Digital Health Tech Board of Directors has approved voluntary Data Access Principles & Best Practices to help medical technology companies and health systems collaborate on responsible data access, use, and protection. The framework puts patient trust at the center of efforts to improve care, support research, and advance innovation, including artificial intelligence.
“To optimize the performance and clinical outcomes associated with a surgical technology, for example, we may need appropriate access to relevant information about what happens before, during and after a procedure, not just what happens in the operating room,” said Robert Cohen, chair of the AdvaMed Digital Health Tech Board of Directors and vice president, innovation and technology, orthopaedic group at Stryker. “High-quality data help us develop, validate, and improve AI-enabled tools.
“These best practices give companies and health systems a common starting point for that collaboration, with clear expectations for privacy, transparency, and responsible use. The goal is to learn more from technology so we can do more for patients.”
“Putting patients first means making technology work for each individual, wherever they receive care,” said Mick Farrell, chair of the AdvaMed Board of Directors and chairman and CEO of Resmed. “Responsible access to data can help us personalize each health journey and learn how technology performs in the real world. These best practices are an important step toward turning more of those insights into better care, while respecting the trust patients place in us. Digital transformation succeeds when patients, clinicians, and innovators can move forward together.”
“Protecting patient privacy and advancing innovation must go hand in hand,” said Scott Whitaker, president and CEO of AdvaMed. “These best practices give medtech companies and health systems a practical way to build trust, work through data-sharing questions, and keep the focus where it belongs: better care for patients. I thank our Digital Health Tech Board and the member company experts who brought this work forward. Their collaboration reflects our industry’s commitment to helping more patients benefit from medtech and health tech innovation.”
The framework, formally titled AdvaMed Data Access Principles & Best Practices for Introducing Technology into a Health System, focuses on introducing and supporting medtech products and services in U.S. health systems. It establishes common expectations for the data needed to implement technology, integrate it into clinical workflows, optimize performance, monitor safety and quality, and improve products and services. It addresses both health information covered by federal health privacy law and other relevant clinical, device, and operational data.
The best practices are organized around four principles:
- Transparency and Clear Expectations. Clearly explain what data are collected, how they will be used and protected, and the responsibilities of each party through agreements, documentation, and privacy disclosures.
- Responsible Data Stewardship. Follow applicable laws, limit identifiable data use to permissible purposes, address retention, and support accountability through governance, training, and oversight.
- De-identification as a Foundation for Innovation. Use recognized de-identification methods, regularly assess their effectiveness, and apply safeguards to reduce the risk that individuals could be identified again. Support lawful, responsible uses of de-identified data consistent with agreed terms.
- Use AI and Advanced Analytics Responsibly. Promote patient benefit through transparent data practices and risk-based oversight, including evaluation of performance, safety, and potential bias throughout the technology’s lifecycle.
The framework also supports reciprocal sharing of data and insights, including appropriately safeguarded benchmarking, quality, and safety information, and real-world data that health systems can use to improve care. By establishing clearer expectations, the best practices aim to reduce contracting and implementation delays while supporting productive, trusted partnerships.
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