Policy on Cybersecurity

Medical devices are increasingly connected to the Internet, hospital networks, and other medical devices to provide features that improve health care and increase the ability of health care providers to treat patients. These same features also increase the risk of potential cybersecurity threats. FDA recognizes that medical device cybersecurity is a shared responsibility among stakeholders and effective cybersecurity risk management incorporates pre-market, and post-market lifecycle phases and addresses cybersecurity from medical device conception to obsolescence.

The values of patient safety and integrity long associated with healthcare require a strong focus on cybersecurity to protect the promises inherent in an interconnected, data-driven healthcare model. At PENTAX Medical, our mission is to improve the standard of patient care and quality of healthcare delivery by providing the best endoscopic products and services with a focus on the improving clinical outcomes, reducing the cost of care delivery, and enhancing providers’ and patients’ experiences. Our goal is to ensure our devices, products, and systems meet the highest security standards and that governs how we approach cybersecurity across our business.

To protect our devices, products, and systems, we take a comprehensive approach to ensuring safety and security. Our cybersecurity program is built on four pillars. Because technology and threats continue to evolve, we are frequently evaluating and updating security measures with the goal of ensuring our patients receive the highest quality care.

  1. Cybersecurity-embedded design – When we develop new products, or update existing products or systems, we conduct a cybersecurity review and analysis to ensure that we are actively considering security and including appropriate control measures as we build our products.
  2. Constant threat and risk analysis – Threats and associated risks continue to evolve. Through collaboration with external experts, information sharing with specialists in the healthcare and cybersecurity fields, and our continuing analysis, we quickly identify new threats and deploy cybersecurity controls to improve patient safety.
  3. Software Product Lifecycle Management – To maintain the trust of our patients, we manage the cybersecurity of our products throughout their lifecycle. PENTAX proactively monitors the support of Operating Systems (OS) and plans availability of upgraded OS platforms for our products.
  4. Partnering for Security – The risks posed by cyberattacks are felt by the entire industry. Working together with industry partners, security experts, academic institutions and the Cybersecurity research community, we are able to assess trends, share threat information, and establish standards that protect patients. Working together on cybersecurity challenges is critical to maintaining patient trust in our industry.


For further cybersecurity information on applicable products, visit the links below.

Video Processor Cybersecurity and Antivirus Software

Informatics, Speech, Voice and Swallowing Products Cybersecurity