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FDA Releases Draft Premarket Cybersecurity Guidance for Medical Device Manufacturers

October 19, 2018
by Heather Landi, Associate Editor
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The Food and Drug Administration (FDA) has released draft guidance to the healthcare industry that updates cybersecurity recommendations for medical device manufacturers with the aim of addressing vulnerabilities and evolving cybersecurity threats.

The draft premarket cybersecurity guidance, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, identifies issues related to cybersecurity that manufacturers should address in the design and development of medical devices to ensure better protection of devices against cybersecurity threats that could interrupt clinical operations and delay patient care.

The new guidance is intended to provide recommendations to the medical device industry regarding cybersecurity device design, labeling and that FDA recommended documentation be included in pre-market submissions for devices vulnerable to cybersecurity threats. The recommendations build on the framework that the FDA created in its 2014 guidance for manufacturers.

According to the FDA, these updated recommendations also will facilitate an efficient premarket review process and help ensure that medical devices are designed to sufficiently address cybersecurity threats before the devices are on the market.

“Cybersecurity threats and vulnerabilities in today’s modern medical devices are evolving to become more apparent and more sophisticated, posing new potential risks to patients and clinical operations,” FDA Commissioner Scott Gottlieb, M.D., said in a statement. “The FDA has been working to stay a step ahead of these changing cybersecurity vulnerabilities, including engaging with external stakeholders. In this way, we can help ensure the health care sector is well positioned to proactively respond when cyber vulnerabilities are identified in products that we regulate.”

“Today’s draft premarket cybersecurity guidance provides updated recommendations for device manufacturers on how they can better protect their products against different types of cybersecurity risks, from ransomware to a catastrophic attack on a health system,” Gottlieb said in his statement, noting that the rapidly evolving nature of cyber threats necessitated an updated approach “to make sure [the guidance] reflects the current threat landscape so that manufacturers can be in the best position to proactively address cybersecurity concerns when they are designing and developing their devices.”

“This is part of the total product lifecycle approach to device safety, in which manufacturers must adequately address device cybersecurity from the design phase through the device’s time on the market to help ensure patients are protected from cybersecurity threats,” Gottlieb said.

As part of its focus on strengthening medical device cybersecurity, the FDA also announced this week an agreement with the Department of Homeland Security to increase collaboration on medical device security. The agreement, between the FDA’s Center for Devices and Radiological Health and DHS’ Office of Cybersecurity and Communications, is meant to encourage even greater coordination and information sharing about potential or confirmed medical device cybersecurity vulnerabilities and threats. Such collaboration can lead to more timely and better responses to potential threats to patient safety, the agencies said.

“Our strengthened partnership with DHS will help our two agencies share information and better collaborate to stay a step ahead of constantly evolving medical device cybersecurity vulnerabilities and assist the health care sector in being well positioned to proactively respond when cyber vulnerabilities are identified. This agreement demonstrates our commitment to confronting cybersecurity risks and the unscrupulous cybercriminals who may seek to put patient lives at risk,” Gottlieb said in a statement about the partnership.

With regard to the draft guidance issued this week, it incorporates new recommendations, including a “cybersecurity bill of materials,” which is a list of commercial and/or off-the-shelf software and hardware components of a device that could be susceptible to vulnerabilities. Depending on the level of cybersecurity risk associated with a device, this list can be an important resource to help ensure that device users are able to respond quickly to potential threats, the FDA said.

The draft guidance also introduces two tiers of devices—those with higher cybersecurity risk, including implanted devices such as pacemakers or neurostimulation devices, and standard cybersecurity risk, which includes devices that contain software—based on potential harm to patients from cybersecurity threats. The draft guidance outlines the documentation for inclusion in a premarket submission to the agency to demonstrate that the design of the medical device has adequately mitigated risk.

The FDA will hold a public workshop Jan. 29-30 to discuss the newly released draft guidance.

 

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Health First Data Breach Exposes Information of 42K Patients

November 15, 2018
by Rajiv Leventhal, Managing Editor
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A data breach at Florida-based Health First exposed the personal information of some 42,000 patients, according to various industry media reports this week.

The website DataBreaches.net reported that in early October, the healthcare provider Health First notified the Department of Health & Human Services (HHS) of a breach that affected 42,000 patients.  The breach actually occurred earlier in the year, however, between February and May 2018, according to the report, which received a statement from the organization’s senior vice president, consumer and retail services.

The Health First executive noted that “a small number of our employees were the victims of a phishing scam which compromised some of our customers’ information. The criminals were able to gain access of these employees’ email accounts for a limited period of time.”

Health First officials also told Florida Today this week that the data breach “was fairly low-level, though it could have included some customers' Social Security numbers. Mostly it appears to have involved information such as addresses and birth dates. No medical information was compromised,” according to this report.

Phishing attacks continue to plague the healthcare industry; the single largest breach this year was a hacking incident affecting 1.4 million patient records that involved UnityPoint Health, an Iowa-based health system. That said, cybersecurity professionals are still looking for more advanced ways to get out in front of these attacks, as healthcare has traditionally lagged behind other industries in in phishing resiliency.

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4.4M Patient Records Breached in Q3 2018, Protenus Finds

November 7, 2018
by Rajiv Leventhal, Managing Editor
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There were 117 disclosed health data breaches in the third quarter of 2018, leading to 4.4 million patient records breached, according to the Q3 Protenus Breach Barometer report.

Published by Protenus, a cybersecurity software company that issues a Breach Barometer report each month, the most recent data shows that although the number of incidents disclosed in Q3 decreased somewhat from Q2, the number of breached records increased from Q2 to Q3. Also, the number of affected patient records has continued to climb each quarter in 2018—from 1.13 million in Q1 to 3.14 million in Q2 to 4.4 million in Q3.

In Q3, the report noted that the single largest breach was a hacking incident affecting 1.4 million patient records that involved UnityPoint Health, an Iowa-based health system. Hackers used phishing techniques, “official-looking emails”, to gain access to the organization’s email system and capture employees’ passwords. This new incident follows one that took place at the same organization in April when 16,400 patient records were breached as a result of another phishing attack.

For incidents disclosed to HHS (the Department of Health & Human Services) or the media, insiders were responsible for 23 percent of the total number of breaches in Q3 2018 (27 incidents). Details were disclosed for 21 of those incidents, affecting 680,117 patient records (15 percent of total breached patient records). For this analysis, insider incidents are characterized as either insider-error or insider-wrongdoing. The former includes accidents and other incidents without malicious intent that could be considered “human error.” 

There were 19 publicly disclosed incidents that involved insider-error between July and September 2018. Details were disclosed for 16 of these incidents, affecting 389,428 patient records. In contrast, eight incidents involved insider-wrongdoing, with data disclosed for five of these incidents.

Notably, when comparing each quarter in 2018, there has been a drastic increase in the number of breached patient records as a result of insider-wrongdoing. In Q1 2018, there were about 4,600 affected patient records, in Q2 2018 there were just over 70,000 affected patient records, and in Q3 there were more than 290,000 affected patient records tied to insider-wrongdoing.

What’s more, the report found that hacking continues to threaten healthcare organizations, with another increase in incidents and affected patient records in the third quarter of 2018. Between July and September, there were 60 hacking incidents—51 percent of all Q3 2018 publicly disclosed incidents. Details were disclosed for 52 of those incidents, which affected almost 3.7 million patient records. Eight of those reported incidents specifically mentioned ransomware or malware, ten incidents mentioned a phishing attack, and two incidents mentioned another form of ransomware or extortion. However, it’s important to note that the number of hacking incidents and affected patient records have dropped considerably when comparing each month between July and September 2018.

Meanwhile, of the 117 health data breaches for which data was disclosed, it took an average of 402 days to discover a breach from when the breach occurred. The median discovery time was 51 days, and the longest incident to be discovered in Q3 2018 was due to insider-wrongdoing at a Virginia-based healthcare organization. This specific incident occurred when an employee accessed thousands of medical records over the course of their 15-year employment.

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