This year, the medical device industry expects to see changes from consumer demographics to digital personalization across the board. As digitalization and technological innovation expands, the medical device industry must place a greater focus on risk management, cybersecurity, and data privacy to protect its consumers.  

In 2022, the amount of medical data obtained will increase by 100% every 73 days, and by 2027, the wearables market alone is expected to reach $195 billion. The increasing number of cyberattacks parallel the growth in consumer data, as the adoption of EHRs, wireless devices, and telemedicine provide hackers with an easy access point. As a result, the FDA continues to hold manufacturers of medical devices accountable for security breaches, forcing manufacturers to control and protect consumer information with strategic risk management plans.  

Recent News 

The medical device industry continues to face cybersecurity threats as digitalization saturates the landscape. In 2019, Medtronic’s MiniMed Insulin Pumps were recalled after the FDA identified cybersecurity risks. By 2020, ransomware attacks had cost the U.S. healthcare industry over $20 billion, and more than 18 million patient records were compromised. By 2021, an average of 1.95 healthcare data breaches were reported daily.  

In November, the Cybersecurity and Infrastructure Security Agency (CISA) issued an advisory related to the multiple vulnerabilities found in Siemens software. All versions of Capital VSTAR, Nucleus NET, Nuclear Source Code, and more were at risk, potentially impacting millions of medical devices. Ultimately, cybersecurity and data privacy threats are increasingly prevalent in the medical device industry, requiring manufacturers to prioritize their risk management plans. 

The Importance of Data Privacy and Cybersecurity in Medical Device

Cybersecurity and data privacy are necessities for both the manufacturer and consumer. While some measures are required by law, organizations like the FDA, ENISA, and NIST have enacted guidelines to hold manufacturers accountable. Preventative measures are essential in medical device manufacturing, as they can identify risks before distribution. This not only eliminates costs, but it minimizes recalls and liability damage while protecting the consumer. As digitalization expands, so does the amount of consumer data, requiring manufacturers to continually prioritize cybersecurity, data privacy, and risk management. 

By instilling risk management into the larger business plan, with cybersecurity and data privacy taking precedence, manufacturers prevent the unauthorized use of data. Most medical devices provide essential care, and security breaches could disrupt device functionality and potentially result in life-threatening altercations.  

When looking at a specific device, most copies are identical to one another technologically, so the attack on one may bleed into each individual make of that one model. Ultimately, consumer data is highly sensitive, and most of this data is protected by HIPAA. Medical device manufacturers and healthcare organizations may be found responsible for privacy violations or health risks and face serious repercussions.  

Protecting Patient Data 

Taking preventative measures to protect consumer data is critical as we move into an increasingly digital landscape. Following guidelines set in place by government organizations and enacting a risk management plan helps minimize vulnerabilities. Manufacturers and healthcare organizations alike must define responsibilities and accountability when creating a risk management plan. Appointing the appropriate individuals throughout the process is vital, ensuring that these individuals have proper training and skills to produce a safe and efficient product. Maintaining documentation of policies and procedures, along with cross-checking system output, solidifies that the device is functioning correctly. 

Medical device manufacturers and healthcare organizations must remain vigilant in identifying cybersecurity and data privacy risks by evaluating device and network security and mitigating safety risks. Protecting patient information on the backend through antivirus software and encrypted data can also reduce vulnerabilities. The FDA constantly releases and updates its guidelines related to the cybersecurity of medical devices, including protecting personal information with passwords and necessary software updates, following up on alerts, and sharing information with family or caregivers.  

Moving Forward: Prioritizing Risk Management 

With the continued growth of digitalization and technological advancement, the medical device industry faces increased cybersecurity and data privacy threats. To avoid any shortcomings, manufacturers must instill preventative measures into the business model early on, such as cross-checking functionality and maintaining written documentation. While combating potential security breaches, medical device manufacturers and healthcare organizations must put risk management plans in place to minimize vulnerabilities and protect patient information.  

Contributions by Rachel Ruth