Adverse Events in the Digital Age: Finding the Sharpest Tool in the Box.

Area of Science:

• Digital Health
• Regulatory Science
• Data Management

Background:

• Digital health tools are increasingly used in pharmaceutical and medical device development and post-market surveillance.
• Exponential growth in digital data presents opportunities and challenges for industry stakeholders.
• Existing regulatory frameworks lack clear guidance on managing responsibilities associated with digital health data.

Purpose of the Study:

• To explore the new responsibilities associated with digital health tools and their generated data.
• To provide practical approaches for data management in the context of digital health.
• To guide sponsors in assessing project obligations for screening digitally-sourced data.

Main Methods:

• Review of current regulatory landscape and industry practices.
• Development of practical data management strategies.
• Proposal for project-based assessment of data screening obligations.

Main Results:

• Identification of ambiguities in regulatory expectations for digital health data.
• Presentation of a framework for assessing responsibilities and defining data management strategies.
• Emphasis on the sponsor's role in aligning data management with organizational objectives.

Conclusions:

• Compliance with regulations is mandatory, requiring a proactive approach to data management.
• Sponsors must define clear data management strategies, considering the purpose and value of digitally-sourced data.
• Strategic alignment of data management decisions with organizational mission, vision, and objectives is essential.