COLLECTION OF AES IN THE NEW DIGITAL ERA
While the amount of available digital data is growing, and we will soon reach 44 trillion gigabytes, pharma and medical device industries use digital tools collecting vast amount of health-related data in conjunction with research, development, and commercial activities. These non-traditional data sources may contain safety, efficacy, effectiveness, and other knowledge, valuable for understanding and further characterizing safety profile of a given medicinal and medical device product. However, it is unclear what responsibilities are associated to the use of such tools and data generated/collected by them.