Cybersecurity

The FDA is in a constant state of working to optimize regulatory requirements for advancing technology. Digital health has been a hot topic for the agency over the past year due to increases in remote healthcare amidst the COVID-19 pandemic...

Continuously growing elements of the Industry 4.0 are the bits and bytes, or data. With platforms like Internet of Things and Cloud, on average, an individual is producing 1.70 megabytes of data every second.1 With such massive dataflows which also...

The COVID-19 pandemic is still creating headlines in the health care domain. Around the world, governments, and organizations such as World Health Organization (WHO), European Medical Agency (EMA), and FDA are working together to eliminate lockdowns and get our society...

The interoperability of medical devices is an important factor to consider especially with the increase in the digital health medical devices coming into the market. Medical devices should be able to safely and effectively exchange and use information or health...

In today’s modern era of the internet, it is a given that as medical device technology continues to develop, so will the number of devices that rely on network connectivity. The biggest market for these devices is healthcare clinics and...

On April 2, 2019, FDA released their proposed regulatory framework for modification to Artificial Intelligence / Machine Learning (AI / ML) based Software as a Medical Device (SaMD) and is taking public comments on the proposal until June 3, 20191....

Outstanding innovations come with the heavy burden of dealing with new risks and threats. Especially when public health is at risk, FDA and other regulatory agencies attempt to provide guidance for companies to develop safe and effective products. With all...