FDA regulation of remote patient monitoring

By Dr Nicola Davies

The global remote patient monitoring (RPM) market is advancing at a significant rate across the entire healthcare industry, notes Dr Nicola Davies in her exclusive column for the Pharma Letter. This has most recently been driven by the COVID-19 pandemic1 and the US Food and Drug Administration’s guidance for the expanded use of certain approved RPM devices during this period.2

Despite the clear benefits of RPM, particularly for helping the elderly and those with chronic conditions to effectively monitor their own, there are several risks associated with the use of such technology. These threats include data breaches, device malfunctions, and application vulnerabilities to ransomware, malware and viruses. Understandably, patients might have privacy concerns about how sensitive RPM data is collected, processed and deleted. Dr Nicola Davies discusses the role of the FDA in ensuring the safety and efficacy of RPM technology.