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FDA Cybersecurity Guidance For Medical Device Companies

Thursday, October 26th, 2017

The Food and Drug Administration (FDA) is responsible for regulating food, drugs, and medical devices. This responsibility enables the organization to create regulations, enforce safety standards, and issue recalls. The administration can also release guidelines to help medical device manufacturers confront cybersecurity threats.

Hackers exploit companies, governments, and systems because there are gaps in security layers. For instance, a hacker does not need to break into hospital databanks to access patient information. A hacker only needs to gain access to the email of a single employee with access. Coordinating security protocols within companies is crucial to beating these threats. The following is a detailed look at how the FDA guidelines can help prevent security threats at your medical device company.

Understanding the FDA guidelines

The FDA guidelines are voluntary, but they are intended to educate healthcare entities and medical device manufacturers on the realities of cybersecurity threats. The guidelines recommend that manufacturers consider threats in both the design and development of their medical devices. Manufacturers are also advised to conduct their own security sweeps to identify any weak points in their systems.

Although medical device manufacturers cannot anticipate every threat, they can determine risk levels and take steps to reduce those levels. Finally, the guidelines advise manufacturers to test all types of equipment, not just those that connect to other medical devices or portable media.

Recovering from cyberattacks

The FDA recommendations that companies take a case-by-case approach to ensure that each medical device’s particular vulnerabilities are discovered and corrected. Some medical devices contain sensitive patient information, so manufacturers should emphasize those devices in their review and recovery plans.

The FDA also provides some examples of increased security protocols. Stronger passwords, two-step authentication, locks, automatic logouts for inactive users, and data encryption are recommended. The FDA also proposes that companies introduce systems that detect security breaches and permit continued functionality of the medical devices. Companies should utilize data backup procedures to ensure that patient data is recoverable.

Handling cybersecurity threats

The FDA guidelines provide a framework, but not the answers to complex problems in cybersecurity. Each company must find its own solution based on its own unique experiences. Dealing with the increase in cybersecurity threats not only prevents hacking, but it also helps keep your company in compliance with federal law. If patient information is leaked, your medical device company or healthcare entity could be at risk of legal consequences.

If you have questions about compliance and cybersecurity, call the experienced healthcare attorneys at Brown & Fortunato in Amarillo, Texas today. You can reach us at 806-345-6300 or Contact Us by email to learn more about our practice areas. We welcome you to visit our offices located at 905 S. Fillmore, Suite 400, Amarillo, TX 79101.