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

Digital health arrived to society and it generates data which is growing exponentially. Pharma and medical device industry recently embarked on this journey. Digital tools became everyday experience both in development as well as post-market settings. These non-traditional data sources may contain relevant safety, efficacy, effectiveness and other knowledge, which are valuable for understanding and further characterizing safety profile of a given medicinal and medical device product. It is however unclear what new responsibilities are associated with the use of such tools and data generated / collected by them. Current regulatory framework does not provide very clear guidance on it. Teams are struggling to interpret expectations originated from regulations, ethics and patients. We present practical approaches for data management and we suggest that a detailed assessment of projects is conducted to identify obligations for screening digitally-sourced data. Compliance with regulations is obligatory, but it is also incumbent on the sponsor to define a data management strategy covering the purpose of the activities, and the value of the data gathered. Decisions thereafter should be aligned with the mission, vision, and objectives defined by the sponsor.

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