Medical device cybersecurity seems to have taken a back seat to the COVID-19 pandemic, but a new internet connection protocol vulnerability has been identified that affects health care along with a wide range of other industries.
Startup Brightinsight Inc. is working to make the infrastructure behind digital health easily accessible to pharma and med-tech companies. To aid it on this path, the San Jose, Calif.-based company has raised a $40 million series B round to expand its capabilities and global reach.
Hospitals may be providing patient care outside of normal clinical settings during the COVID-19 outbreak, but this raises the question of how to access patient data systems in these makeshift settings. Arthur Young, president and CEO of Interbit Data Inc., of Natick, Mass., told BioWorld that the company’s solution is to add Internet-based access to its Netsafe system.
The device industry is quite familiar with whistleblower lawsuits, but Cisco Systems Inc., of San Jose, Calif., was recently forced to pay more than $8 million in connection with a qui tam lawsuit over cybersecurity lapses for video surveillance equipment sold to state and federal government agencies. The case suggests device makers will have to be up to speed on cybersecurity if they wish to avoid suffering a similar fate, particularly given a recent warning the FDA posted regarding a widespread cybersecurity vulnerability.
PERTH, Australia – The Therapeutic Goods Administration (TGA) has unveiled final guidance that details how the Australian regulator considers cybersecurity risks over the life of a medical device, including whose responsibility it is to assess and communicate risk, as well as the expectations for manufacturers under the Essential Principles. Industry had voiced concerns in reaction to the draft version of the guidance – released last December – that related to proposed changes to the Essential Principles and the use of standards. The TGA had proposed two separate guidances – one for device and in vitro diagnostic manufacturers and those that develop software for medical devices and another guidance for users.