Managing risk in the digital health age
With the new European Medical Device Regulations coming into force in May 2021 and the recent appointment of a medtech cybersecurity chief at the US Food and Drug Administration (FDA) in February 2021, cyber security of medical IoT devices is now at the centre of attention for much of the healthcare industry and has witnessed a number of innovative revolutions to address the coronavirus.
The new EU regulation aims to improve the safety, security and traceability of devices. While the onus is principally on manufacturers to ensure compliance, healthcare providers are obliged to adhere to general cyber security best practices and report any serious safety or security issues to the manufacturer and to the local regulator.
Growing risk awareness
Similarly in the US, the appointment of the first Director of Medical Device Cybersecurity at the FDA is recognition by the regulatory body of the increasing cyber threats to medical devices and patient safety.
The cyber security Director has signaled that updated guidance on security for new medical devices will be produced later in 2021. The FDA cybersecurity guidelines cover the entire device lifecycle and are made available for both Medical Device Manufacturers and Healthcare delivery organizations.
A need for understanding and action
The medical device industry is growing and has become an essential element linked to the healthcare domain given rising incidence of chronic diseases and surging geriatric population. It is forecasted that, by 2030 the medical devices market will be worth $795 billion, based on a compound annual growth rate of 5.2% for the 2015-2030 period.[1] Market research firm IDC estimates close to 42 billion connected devices will generate 79.4 zettabytes of data by 2025. To compare, 1 zettabyte is equal to as much information as there are grains of sand on all the world’s beaches.
Therefore, it becomes essential for all healthcare players to understand the risks derived from the cyber security of medical IoT devices and to implement and maintain processes to mitigate those risks.
Read the full Cyber Security of Medical IoT Devices Report to gain insights on the current cyber threat landscape for medical IoT devices and to learn what organizations should do to help manage their cyber security.
