FDA Cybersecurity Playbook is out – so what?

The FDA’s long-awaited playbook on cybersecurity for medical devices is out, and while it covers critical topics related to preparedness and response, we hope it’ll soon be followed by efforts that focus on threat prevention.  The Playbook thoughtfully covers fundamental concerns for Healthcare Delivery Organizations  (HDOs) in managing cyber attacks on Healthcare and Public Health infrastructure and follows other valuable reads on Premarket and Postmarket guidelines for submissions by Medical Device Manufacturers for effective cybersecurity management.  Clearly, cybersecurity has become a key, sustained focus for the FDA over the past few years.

At Thirdwayv, we welcome the attention of the FDA on cybersecurity.  Discussions on cybersecurity preparedness, response, threat identification and risk assessment are valuable, however, threat prevention is perhaps the biggest, potentially latent issue that needs emphasis.  In this regard, the development of industry standards that address the unique needs of this sector are critical.  Additionally, leveraging the learnings from the communications technology industry can greatly accelerate the FDA efforts.  Today, Thirdwayv is working with Healthcare leaders to solve the IoT security challenge utilizing its decades of experience in the communications technology arena.  We look forward to sharing this expertise to help the FDA in its efforts.

Connected. Protected. Thirdwayv.

Related Posts

Popularity of Remote Patient Monitoring Skyrockets — Is it Secure?

A recent report from commercial intelligence platform provider Definitive Healthcare revealed that remote patient monitoring insurance reimbursement claims rose 1,294% from January 2019 to November 2022. It’s likely that a desire to minimize contact during the pandemic drove much of this demand.  But remote patient monitoring claims continued to grow even after people resumed face-to-face…

Countdown to Safer Medical Devices

A six-month clock started ticking late last year, counting down to the FDA’s new deadline for updating its public-facing guidance for improving the cybersecurity of medical devices. This requirement became law on Dec. 29, 2022, as part of a $1.7 trillion Omnibus Appropriations Bill that also includes new rules for submitting applicable medical devices to…

Getting Real about Real-Time Location Systems

Real-Time Location Systems, or RTLS, emerged in the 1990s for use by government and military entities. The technology has been adopted in manufacturing, logistics and aerospace applications for years. Now it is coming into its own in a growing variety of other applications, from healthcare consignment inventory management to retail item tracking. It’s time to…