Digital Interventions and Their Unexpected Outcomes - Time for Digitalovigilance?

Area of Science:

• Digital health interventions
• Software as a medical device (SaMD)
• Healthcare technology regulation

Background:

• Digital interventions in healthcare are increasingly developed as Software as a Medical Device (SaMD).
• Existing medical device regulations necessitate adverse event assessment for post-market surveillance.
• Ensuring proper use and patient safety requires appropriate labeling of digital health interventions.

Purpose of the Study:

• To raise awareness within the research community about challenges in digital health interventions.
• To highlight the neglect of unexpected consequences of digital health interventions in current literature.
• To propose proactive measures for ensuring patient safety with digital health technologies.

Main Methods:

• Literature review and conceptual analysis of digital health interventions and adverse event reporting.
• Identification of gaps in current research regarding unexpected consequences.
• Development of a framework for future research and surveillance.

Main Results:

• Unexpected consequences of digital health interventions are often overlooked or undocumented.
• There is a critical need for systematic assessment and monitoring of adverse events.
• Current practices do not adequately address the unique challenges posed by digital health interventions.

Conclusions:

• A new research field, digitalovigilance, is proposed to address these challenges.
• Systematic assessment and monitoring of adverse events should be integrated into clinical trials.
• Reporting of adverse events and meta-analyses are crucial for advancing digital health safety.