Background: Mobile phone apps capable of monitoring arrhythmias and heart rate (HR) are
increasingly used for screening, diagnosis, and monitoring of HR and rhythm disorders such …

Real-time high-quality data on the performance of digital health applications is needed for
feedback-led optimization and to ensure safety and performance, particularly if they will …

Background Multimorbidity raises the number of essential information needed for delivery of
high-quality care in patients with chronic diseases like rheumatoid arthritis (RA). We …

Wearable sensor technology could have an important role for clinical research and in
delivering health care. Accordingly, such technology should undergo rigorous evaluation …

Background In nursing practice, flushing the catheters pre and post-drug administration is
considered an important clinical procedure to prevent complications, and requires the use of …

Background: After years in the making, on April 5, 2017, the European Parliament and
Council finally adopted Regulation (EU) 2017/745, the new Medical Devices Regulation …

This article provides a primer on medical device regulations in the United States, Europe,
and Canada. Software tools are being developed and shared globally to enhance the …

The COVID-19 public health crisis has accelerated the transformation of health systems to
become more closely tied to citizens/patients and increasingly dependent on the provision …

Regulation of medical devices has been one of the most prominent initiatives of the
European Union in the health domain. The recent Medical Device Regulation …

This chapter maps out the different EU legal frameworks regulating IoT cybersecurity, taking
into account insights from IoT industry stakeholders, including manufacturers, cybersecurity …