In simpler times, the U.S. Food and Drug Administration (FDA) mostly concerned themselves with food and drugs. These days, the proliferation of medical devices means the agency needs a robust technology department that includes both hardware and software. These medical devices, like anything else connected to the internet, come with cybersecurity concerns. Learn Cybersecurity Risks: The Future of Medical Device Recalls.
HIPAA Journal reports an average of 1.4 healthcare data breaches occurred in 2019, in comparison to 18 total incidents in 2009. The number of records exposed in these breaches peaked in 2015 at 113.27 million patient records either stolen, exposed, or otherwise disclosed without patient permission. When it happens, a medical device recall may be instituted, leaving your company facing even more expenses.
Thankfully, there’s a seamless solution available in MockRecalls’ Saas based recall training and implementation solution.. Here’s everything you need to know about the cybersecurity risks involved in healthcare.
Pre-Existing Healthcare Cybersecurity Conditions
Our healthcare system is at the forefront of technological innovation. Not only are patient medical records, appointment scheduling, and even the appointments themselves increasingly digitized, but consumers are using more wearable technology, including wearable fitness trackers and smartphones. These provide a gateway into medical devices used to monitor blood pressure, heart rate, temperature, and more.
In fact, the FDA’s first medical device recall occurred in 2017 in implantable RF-enabled cardiac pacemakers that required a firmware update. This was due to hackers exploiting vulnerabilities in the on-board computer’s embedded software. And it didn’t stop at the device level – by the end of 2019, the agency uncovered 11 cybersecurity vulnerabilities in IPnet.
Because IPnet is so widely used as a third-party component in medical devices, it impacted a wide range of health tech companies. Even worse, the attacks are continuing to escalate with cybercriminals potentially exploiting IoT security loopholes to attack unprotected IoT devices connected to hospital networks. Although computer workstations are often secured through OS updates, medical devices often require manual updates.
Everything from your desktop computer to your printer, lab equipment, and smartphone is a potential security vulnerability. Things get even more complicated when you’re running a multi-location business, especially one with a global footprint. Maintaining secure device communications is vital to protecting patients (and your business), and it’s a full-time job.
Making matters worse, the novel Covid-19 coronavirus caused a worldwide pandemic amid all this, putting even more strain on an already cracking technology infrastructure.
Healthcare Cybersecurity in a Global Pandemic
If anything, the 2020 novel coronavirus outbreak shined a spotlight on the technology infrastructure and problems that may occur. Secure, remote technology is more important than ever, as everyone from therapists to medical doctors and nurses are working on providing telehealth and telemedicine services. In-home healthcare can be revolutionized in 2020…but only if it’s secure.
As President Trump removes telehealth barriers, more at-risk Americans will be able to access professional medical advice and even diagnostics. Imagine a world where your doctors and nurses can finally use data collected from a variety of medical sensors to properly analyze and diagnose your condition based on activity, diet, and lifestyle history. The future of medical technology is bright, but it comes with risks.
Everyone staying home means encrypted and secure communications needs to occur between doctors and patients. Stuck at home with schools closed and many facing unemployment, cybercrime is surging, and everyone is at higher risk of attack. Hackers are using the pandemic to fuel phishing scams, and they’re working harder than ever to expose large data caches with big payouts.
Meanwhile, property crime against hospitals is increasing. Reports around the country are popping up of everything from respirator masks, gloves, and hand sanitizer to coronavirus testing kits and patient data being stolen. The healthcare industry is the front lines of everything happening in 2020. You’re consistently being targeted by crime, despite being in business to help people. So, what can you do?
Securing the Future of Healthcare Through Automation
More medical technology on the market means higher risk across more platforms. While it’s great that we have the hardware capability for more advanced health tech, software development is a continuous cycle. Hospitals and other healthcare companies need to become more tech-savvy, just like the FDA did. This means implementing a scalable, on-demand way to manage medical device recalls.
Healthcare companies trust Mock Recalls to assess their current recall readiness and develop a mock recall plan that can be thoroughly tested and retested with its Saas based recall management solution.
MockRecalls is a mock recall planning, training and consulting program to test your recall readiness. We are purely focused on protecting your product investment by working with you to create a new recall plan or analyze your current recall plan and then put it through a mock recall or recall simulation test to insure you are prepared for a possible product recall. We use our on-demand SaaS based recall management platform that eliminates common mistakes manually conducting recalls, by automating the most tedious steps of a product recall. It is a simple to use platform that just focuses on handling product recalls quickly and efficiently. Through our mock recall training using our dedicated recall platform, companies can improve the recall process, increase response rates, and document and communicate with all stakeholders.
Our program can analyze your company’s readiness in many of the typical elements of the recall process including:
- Initiation, investigation, and communication process
- Recall working team and decision team composition and dynamics
- Team roles and responsibilities
- Process flow and lot traceability
- And retrieval capability and effectiveness checks
Our recall simulation program is conducted as an escalating model using real product facts and potential issues, with multiple inputs such as consumer complaints, social media, FDA/USDA/local health department and law enforcement. Conducting a recall simulation will also allow the recall team and all involved personnel to become familiar with their responsibilities throughout the recall procedure. This gives them time to effectively communicate any concerns about the plan while the company isn’t dealing with the pressure of an actual recall.
Looking to test your product recall readiness across your organization? MockRecalls will help create and/or test your recall program. Click here to learn more or call us!