Cybersecurity Regulations in a GxP Environment

March 4th, 2014 by

Medical Device Cyber SecurityModern medical devices bear an increased capacity for advanced data processing. In addition to being able to store far greater quantities of patient information than they once could, many metering and diagnostic devices can be accessed through common computing tools like smartphones or Wi-Fi networks.

While such functionality makes usage easier for medical professionals, it opens up a whole new realm of information security compliance requirements for device manufacturers. Maintaining secure architectures within your firm is more important than ever and in some cases, more difficult than ever.

New Cybersecurity Frameworks

On June 14, 2013, the FDA released a new guidance document addressing general principles and controls that medical device manufacturers should implement to ensure information security with regard to cybersecurity and the medical device in question.

These guidelines focused heavily on three key topics:

  • Confidentiality
  • Integrity
  • Availability

As with all FDA Draft Guidance’s for Industry and FDA Staff the guidance for cybersecurity is not legally binding. The draft guidance represents FDA’s current thinking on this topic.

The document applies to the controls to be implemented for certain pre-market submissions including de novo submissions, 510(k) submissions, PDP and HDE submissions. These included requirements for various forms of cybersecurity documentation dealing with hazard analysis, traceability and device instructions for continued secure usage. While it’s unclear whether failure to adhere to these new suggestions will completely preclude firms from bringing their devices to market, compliance is sure to make the process easier.

Helping Your Clients Maintain Compliance

Medical device manufacturers aren’t alone in being subject to cybersecurity regulations. The day before releasing the aforementioned guidelines, the FDA also published a safety communication pertaining to hospital networks as well as medical devices.

In short, these alerts mean that the FDA isn’t just directly blocking non-compliant devices from reaching the market; the agency is ensuring that hospitals and clinics participate as well. Care providers that want to use your devices won’t be able to do so if they represent potential security vulnerabilities. Similar rule-making trends on the international stage indicate that cybersecurity compliance is becoming critical to maintaining profitable client relationships.

The Broad Scope of Cybersecurity

Finally, remember that cybersecurity goes beyond hardware. The firmware and application software that your devices use must be compliant with a number of previously established rules devised by the FDA and European Regulatory Authorities alike.

Faulty software can lead to forced product recalls, sale prohibitions or, at worst, loss of sensitive patient information and lawsuits. In some cases, such as that of a late-2013 network hack that affected the FDA itself, these defects may even result in the potential loss of sensitive trade secrets and other corporate information.

Comprehensive computer system validation and information security implementations are critical on multiple fronts. While these actions and methodologies make it easier for consumers and care professionals to utilize devices safely, they also ensure that device manufacturers can sell their products in a range of markets and maintain a better public image by preventing breaches.

For help meeting organizational objectives and regulatory compliance when it comes to your information security, contact GxP-CC. These global experts help companies meet and maintain compliance with guidelines set forth by the FDA and European Regulatory Authorities for the medical device, pharmaceutical and dental lab industries.

About this author:


For over 15 years Mr. Francum has worked in regulated environments directing and orchestrating the various components involved in assuring compliance of the most stringent regulatory requirements. He is an internationally recognized expert and has extensive experience in over 25 countries including, but not limited to, the regions of North America, Latin America, Europe and the Middle East.

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