Welcome to the sDHT Adoption Library, featuring NaVi
NaVi is a closed-environment AI research assistant that leverages a carefully curated library of more than 300+ vetted documents, including FDA guidance and industry best practices. NaVi helps you search and explore content across the sDHT Adoption Library and Roadmap using natural language questions.
The Library is intended to serve as a living resource. Content is added periodically as new guidance, standards, and peer-reviewed research are released.
Meet NaVi: Your AI-Powered Research Assistant
Library scope and selection
To ensure high-quality, relevant results, the Library follows a predefined scoping approach:
- Inclusions: FDA guidance, non-commercial standards, and peer-reviewed research (2018–Present) focused on sDHTs being used as measurement tools for medical products in U.S.-based clinical trials.
- Exclusions: Materials from single commercial entities, non-U.S. regulatory bodies (except select EMA guidances with direct U.S. cross-relevance), and conference proceedings, and conference proceedings.
Inclusion in the Library does not imply endorsement, completeness, or regulatory acceptability.
Library Resources
Library scope
Resources in the sDHT Adoption Library are identified using a predefined scoping approach and include publicly available FDA guidance, non-commercial standards and guidance, and peer-reviewed research relevant to sDHT use in U.S.-based clinical trials. Materials from single commercial entities, non-U.S. regulatory bodies, conference proceedings, and studies conducted exclusively outside the United States are excluded; inclusion does not imply endorsement or regulatory acceptability.
Last updated 2026: Library content is reviewed and updated on a periodic basis as new eligible materials become available.
Showing 3 of 3 results
Embedded Pragmatic Clinical trials Iniative
This iniative aims to support organizations in planning and conducting embedded pragmatic trials by leveraging resources, proposing efficient practices, and fostering collaborations within the healthcare ecosystem. The initiative focuses on bringing clinical research and care together, resulting in meeting patients where they are and strengthening the real-world relevance of clinical trials
Embedded Pragmatic Clinical trials Iniative
TransCelerate
Recommendations / best practices
Authors
TransCelerate
This iniative aims to support organizations in planning and conducting embedded pragmatic trials by leveraging resources, proposing efficient practices, and fostering collaborations within the healthcare ecosystem. The initiative focuses on bringing clinical research and care together, resulting in meeting patients where they are and strengthening the real-world relevance of clinical trials
NA
Keywords
Technologies
Open Resource
Some summaries are generated with the help of a large language model; always view the linked primary source of a resource you are interested in.
Collaborative Communities: Addressing Health Care Challenges Together
This FDA webpage discusses Collaborative Communities, which are continuing forums where public and private sector members proactively work together on medical device challenges to achieve common objectives and outcomes. These communities are convened by external stakeholders, not the FDA, and may exist indefinitely, tackling challenges with broad impacts across the healthcare ecosystem. The CDRH participates as a member in several of these communities to contribute its knowledge and perspective on public health challenges and help advance regulatory science and innovation.
Collaborative Communities: Addressing Health Care Challenges Together
2025
FDA
FDA - informational resource
Authors
FDA
This FDA webpage discusses Collaborative Communities, which are continuing forums where public and private sector members proactively work together on medical device challenges to achieve common objectives and outcomes. These communities are convened by external stakeholders, not the FDA, and may exist indefinitely, tackling challenges with broad impacts across the healthcare ecosystem. The CDRH participates as a member in several of these communities to contribute its knowledge and perspective on public health challenges and help advance regulatory science and innovation.
Findings
Collaborative Communities are sustained, multi-stakeholder forums (including patients, industry, academia, and the FDA) dedicated to solving shared challenges in the medical device ecosystem. These communities are not intended to replace formal regulatory mechanisms. They are equipped to perform activities such as:
Developing best practices and strategies.
Generating and evaluating evidence to support novel approaches.
Clarifying ill-defined challenges and generating consensus on definitions.
Addressing issues related to product quality and safety.
Recommendations
The FDA/CDRH does not establish or fund these communities. Instead, the FDA recommends that interested stakeholders convene and lead these groups. The FDA reviews opportunities on a case-by-case basis for participation, considering:
The community's potential public health impact.
Alignment with the CDRH mission, priorities, and resources.
The existence of a formal governance structure, a convener, a plan to measure success, and a mechanism for sustained engagement.
Regulatory Considerations
The FDA's participation in these communities is a strategic priority for advancing regulatory science and fostering responsible medical device innovation. Examples of digital health-related collaborations include those focused on AI/ML, Digital Biomarkers, Digital Health Technologies (DHTs), and Real-World Data (RWD). The outcomes developed by these groups can inform and accelerate the development of science-based solutions to policy and scientific challenges.
Collaborative Communities are sustained, multi-stakeholder forums (including patients, industry, academia, and the FDA) dedicated to solving shared challenges in the medical device ecosystem. These communities are not intended to replace formal regulatory mechanisms. They are equipped to perform activities such as:
Developing best practices and strategies.
Generating and evaluating evidence to support novel approaches.
Clarifying ill-defined challenges and generating consensus on definitions.
Addressing issues related to product quality and safety.
Recommendations
The FDA/CDRH does not establish or fund these communities. Instead, the FDA recommends that interested stakeholders convene and lead these groups. The FDA reviews opportunities on a case-by-case basis for participation, considering:
The community's potential public health impact.
Alignment with the CDRH mission, priorities, and resources.
The existence of a formal governance structure, a convener, a plan to measure success, and a mechanism for sustained engagement.
Regulatory Considerations
The FDA's participation in these communities is a strategic priority for advancing regulatory science and fostering responsible medical device innovation. Examples of digital health-related collaborations include those focused on AI/ML, Digital Biomarkers, Digital Health Technologies (DHTs), and Real-World Data (RWD). The outcomes developed by these groups can inform and accelerate the development of science-based solutions to policy and scientific challenges.
Keywords
& inclusion (DEI)
Artificial intelligence (AI) / Machine learning (ML)
Best practices
Cybersecurity
Digital biomarkers
Digital health policy
Digital health technologies (DHTs)
Diversity
equity
FDA
Healthcare ecosystem
International regulatory harmonization
Medical device development
Medical device development tools (MDDTs)
Patient-centered outcomes
Real-world data (RWD)
Stakeholder collaboration
Technologies
Open Resource
Some summaries are generated with the help of a large language model; always view the linked primary source of a resource you are interested in.
Digital technologies for medicines: shaping a framework for success
This article outlines strategies for successfully integrating digital technologies into medicines development and regulatory decision-making, focusing on EMA qualification processes and marketing authorization applications (MAAs). It emphasizes early engagement with regulators, iterative validation processes, and comprehensive documentation to address the reliability, accuracy, and clinical validity of digital technologies. The authors highlight the importance of distinguishing between aspects of digital health technologies under EMA's remit and those requiring compliance with broader regulatory frameworks like MDR and GDPR.
Digital technologies for medicines: shaping a framework for success
2020
Nat Rev Drug Discov
Framework or roadmap
,
Lessons learned
,
Recommendations / best practices
Authors
Francesca Cerreta, Armin Ritzhaupt, Thomas Metcalfe, Scott Askin, João Duarte,Michael Berntgen, Spiros Vamvakas
This article outlines strategies for successfully integrating digital technologies into medicines development and regulatory decision-making, focusing on EMA qualification processes and marketing authorization applications (MAAs). It emphasizes early engagement with regulators, iterative validation processes, and comprehensive documentation to address the reliability, accuracy, and clinical validity of digital technologies. The authors highlight the importance of distinguishing between aspects of digital health technologies under EMA's remit and those requiring compliance with broader regulatory frameworks like MDR and GDPR.
Findings
Early and iterative engagement with EMA helps developers refine data generation plans, identify multidisciplinary expertise, and ensure the adequacy of early-stage data.
Clearly defining the concept of interest, context of use, and clinically meaningful change is essential for qualifying digital measures.
Comprehensive documentation should cover benefit-risk impacts, reliability, and validity of digital health technologies, avoiding overly detailed technical specifications that could invalidate qualification during updates.
Risk assessments of technology changes and updates, akin to approaches used for manufacturing changes, are crucial during regulatory reviews.
Support for collaborative groups, such as consortia and trade associations, helps aggregate and harmonize data to progress regulatory applications.
Recommendations
Establish early contact with EMA to align on regulatory requirements, optimize data generation, and ensure continuity in assessment teams.
Identify the digital technology's impact on benefit-risk assessment, specifying its purpose as a novel measure or alternative to traditional methods.
Provide evidence of reliability, accuracy, repeatability, and clinical validity, ensuring sufficient detail for regulatory assessment without risking qualification during updates.
Conduct comprehensive risk assessments for changes to technology or software, following principles of ICH guidelines (Q8, Q9, Q10, Q12).
Develop user manuals and training materials to optimize implementation in clinical trials and ensure patient compliance.
Regulatory Considerations
EMA’s Remit: Focus on aspects affecting the benefit-risk assessment of medicinal products, while providing high-level information on unrelated technical parameters.
Alignment with MDR and GDPR: Ensure digital tools comply with applicable legal frameworks, including medical device regulations and data protection requirements.
Treat software and technology updates with a risk-based framework, evaluating their impact on clinical data validity and performance.
Collaborate with consortia to aggregate diverse data sources for confidential regulatory discussions, maximizing evidentiary value.
For medical devices, ensure CE marking or equivalent regulatory compliance before marketing, though it is not required during development.
Early and iterative engagement with EMA helps developers refine data generation plans, identify multidisciplinary expertise, and ensure the adequacy of early-stage data.
Clearly defining the concept of interest, context of use, and clinically meaningful change is essential for qualifying digital measures.
Comprehensive documentation should cover benefit-risk impacts, reliability, and validity of digital health technologies, avoiding overly detailed technical specifications that could invalidate qualification during updates.
Risk assessments of technology changes and updates, akin to approaches used for manufacturing changes, are crucial during regulatory reviews.
Support for collaborative groups, such as consortia and trade associations, helps aggregate and harmonize data to progress regulatory applications.
Recommendations
Establish early contact with EMA to align on regulatory requirements, optimize data generation, and ensure continuity in assessment teams.
Identify the digital technology's impact on benefit-risk assessment, specifying its purpose as a novel measure or alternative to traditional methods.
Provide evidence of reliability, accuracy, repeatability, and clinical validity, ensuring sufficient detail for regulatory assessment without risking qualification during updates.
Conduct comprehensive risk assessments for changes to technology or software, following principles of ICH guidelines (Q8, Q9, Q10, Q12).
Develop user manuals and training materials to optimize implementation in clinical trials and ensure patient compliance.
Regulatory Considerations
EMA’s Remit: Focus on aspects affecting the benefit-risk assessment of medicinal products, while providing high-level information on unrelated technical parameters.
Alignment with MDR and GDPR: Ensure digital tools comply with applicable legal frameworks, including medical device regulations and data protection requirements.
Treat software and technology updates with a risk-based framework, evaluating their impact on clinical data validity and performance.
Collaborate with consortia to aggregate diverse data sources for confidential regulatory discussions, maximizing evidentiary value.
For medical devices, ensure CE marking or equivalent regulatory compliance before marketing, though it is not required during development.
Keywords
Open Resource
Some summaries are generated with the help of a large language model; always view the linked primary source of a resource you are interested in.