1. Medtech Insight
  2. >>Policy & Regulation
  3. >>Legal & IP

Medtech Cybersecurity Whistleblowers: Traditional Protections, Incentives Apply

As the medical device industry enters a brave new world of connected products, cybersecurity vulnerabilities and hacking threats have surfaced, raising many questions. Among them: what protections are available to employees who raise the alarm about cybersecurity problems with a device sold by their company. Attorney Alexis Ronickher addresses this question in this article and in a Medtech Insight podcast interview.

lock security businessman protect concept whistleblower cybersecurity

Cybersecurity vulnerabilities that have required a US FDA safety alert and remediation from manufacturers have surfaced for several devices during the past year. (For example, Also see "FDA Recommends Security Patch For St. Jude Wireless Cardiac Devices" - Medtech Insight, 9 January, 2017.) While there’s been no clear indication that any manufacturer has tried to cover up vulnerabilities that have reached the public view so far, employees who believe their employers are holding back information from the public about cybersecurity risks are entitled to the same protections and incentives as other whistleblowers, according to a legal expert.

Alexis Ronickher, a partner at the law firm Katz, Marshall and Banks, recently published a “Cybersecurity Whistleblower Protections” guide that looks at protections afforded to those who disclose cybersecurity vulnerabilities in different industries

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Legal & IP

State And International Enforcement Agencies May Step Up Amid Uncertain Federal Environment

 
• By Elizabeth Orr

States and international regulatory bodies may increase their US enforcement role following federal staff cuts, Hyman Phelps & McNamara attorneys said in a recent webinar. The attorneys also expect False Claims Act enforcement and public health to remain key areas of focus at the federal level.

FDA And Boston Scientific Face Legal Action Over Spinal Device Safety

 
• By Elizabeth Orr

A patient, Dena Lawler, is suing Boston Scientific and the US FDA over alleged harm from a spinal stimulator device. Lawler claims inadequate regulatory review allowed dangerous modifications to the device, which then caused her pain and other health issues. She is calling for reconsideration of the device approvals.

California Medtech Firms Resolve Patent Dispute Over Delivery Catheters

 
• By Brian Bossetta

Route 92 says it has reached a settlement with Q’Apel Medical over patent claims concerning its Tenzing delivery catheters.

US Medtech Tariffs: How Will EU Navigate Unchartered Territory?

 
• By Amanda Maxwell

US President Trump has imposed sweeping tariffs that encompass medtech. These are expected to drive up costs, disrupt supply chains and hinder innovation, likely driving the EU to seek new trade partnerships to mitigate the impact.

More from Policy & Regulation

Consumer Healthtech Investment Totaled $4.5BN In 2024, But Bar Is High Amid Economic Uncertainty

 
• By Marion Webb

Global investment in consumer healthtech increased by 9% year-over-year in 2024, totaling $4.5bn, with significant interest in mental health solutions, according to Galen Growth. While the first quarter of 2025 saw raised confidence and investments, the Trump administration’s new tariffs and sweeping changes to healthcare have introduced new uncertainties.

FDA And Boston Scientific Face Legal Action Over Spinal Device Safety

 
• By Elizabeth Orr

A patient, Dena Lawler, is suing Boston Scientific and the US FDA over alleged harm from a spinal stimulator device. Lawler claims inadequate regulatory review allowed dangerous modifications to the device, which then caused her pain and other health issues. She is calling for reconsideration of the device approvals.

California Medtech Firms Resolve Patent Dispute Over Delivery Catheters

 
• By Brian Bossetta

Route 92 says it has reached a settlement with Q’Apel Medical over patent claims concerning its Tenzing delivery catheters.