Med-Tech Innovation November 25, 2020
Marta Dunphy-Moriel, partner, and Alexander Dittel, senior associate in the commercial technology team at Kemp Little LLP, look at how medical device & mhealth products must meet cybersecurity standards.
We have seen an exponential growth in a variety of medical devices and mHealth devices over the last 10 years. Many modern devices rely on “hyper-connectivity” to deliver medical services in new ways and to monitor and diagnose patients remotely. However, this comes at the cost of increased cybersecurity risk.
A medical device will include any instrument, apparatus, software, material or other article intended for diagnostic or therapeutic purposes for humans which does not predominantly rely on pharmacological, immunological or metabolic processes. mHealth products such as fitness, lifestyle...