ARTICLE SUMMARY:
While regulatory submissions are a well-defined process, they are becoming more complex, particularly in view of new and evolving regulatory standards and the pandemic-driven increase in data from digital health, telehealth, and remote patient monitoring. IQVIA’s Phil Johnson advises how to incorporate these patient-controlled datasets into regulatory submissions.
The proliferation of patient health data has increased in recent years. This was especially the case in 2020, when medical technology and digital health became the new normal in place of in-person doctor visits. The growth in new devices and increased usage of devices for remote and virtual patient-doctor meetings as well as online discourse surrounding healthcare, is ushering in a shift toward patient-centric and technology-driven practices that is redefining the way medtech companies approach regulatory compliance and health outcomes.
