FDA calls on medical device makers to focus on cybersecurity

cybersecutiry

Medical device makers should take new steps to protect their products from malware and cyberattacks or face the possibility that U.S. Food and Drug Administration won’t approve their devices for use, the FDA said.

The FDA issued new cybersecurity recommendations for medical devices on Thursday, following reports that some devices have been compromised.

Recent vulnerabilities involving Philips fetal monitors and in Oracle software used in body fluid analysis machines are among the incidents that prompted the FDA to issue the recommendations, a spokeswoman for the agency said.

In one case reported in October, malware slowed down fetal monitors used on women with high-risk pregnancies at a Boston hospital, and in another case, the FDA in January issued a warning about Oracle software that could allow remote access to the databases of Roche Cobra analysis devices, she said.

Representatives of Philips and Oracle didn’t immediately respond to requests for comment on the FDA recommendations.

“Many medical devices contain configurable embedded computer systems that can be vulnerable to cybersecurity breaches,” the FDA said in its recommendations. “As medical devices are increasingly interconnected, via the Internet, hospital networks, other medical device, and smartphones, there is an increased risk of cybersecurity breaches, which could affect how a medical device operates.”

Under proposed rules issued by the FDA, the agency is recommending that device makers provide it with their plans for providing updates and patches, said Erica Jefferson, an FDA spokeswoman.

“Once the guidance is finalized, the agency might consider withholding marketing clearance or approval for medical devices that fail to appropriately address cybersecurity risks,” she said.

The FDA is not aware of any patient injuries or deaths associated with cybersecurity incidents, the agency said. The agency doesn’t have “any indication that any specific devices or systems in clinical use have been purposely targeted at this time,” it said.

The FDA has seen medical devices infected or disabled by malware, and the presence of malware on hospital computers, smartphones and tablets, the agency said. The agency has also found health care providers with “uncontrolled distribution of passwords” and disabled passwords in software designed to have limited access, it said.

Other health care providers have failed to apply software updates and patches in a timely manner, the agency said.

The agency wants medical device makers to “take appropriate steps to limit the opportunities for unauthorized access to medical devices,” the FDA said in its recommendations. Manufacturers should review their cybersecurity practices to assure that appropriate safeguards are in place to prevent unauthorized access, the agency said.

Health care providers should also take steps to limit access and to improve cybersecurity, the agency said.

 

 

Source : Grant Gross, IDG News Service | June 13, 2013

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About thomasdinnocenzi

Thomas D'Innocenzi is a highly accomplished, results-focused senior international executive with extensive experience in global sourcing and market development worldwide to meet evolving business needs. Tom has proven ability in implementing and managing profitable global sourcing operations worldwide. Extensive experience in international market development operations to accommodate rapid growth. Skilled in building top-performing teams, benchmarking performance, and restricting organizations to improve efficiency, productivity, and profitability. Experienced transition leader and change agent. As principal of Nova Advisors, LLC I’ve assembled an exemplary team that brings with them the knowledge and experience gained from starting up a Global Sourcing program with multiple Fortune 500 companies as well as the largest supplier network throughout the Asia-Pacific region. We have experience and expertise in more than a thousand medical and pharmaceutical products in manufacturing and sourcing at the best value. The right product, the right price point and the right branding fueled these successes that resulted in double-digit growth for top line sales and bottom line net margins for our customers. What sets us apart: • Our reach includes a large network of suppliers & manufacturers spanning 13 countries in Asia-Pacific region • We understand the manufacturing process and the business of the supplier and the buyer • Our company culture is based on quality assurance and our process is based on local quality control Our commitment is to be your partner offering the best products and services at the lowest cost. Contact me to discuss how we can make the global marketplace work for you. thomas@novaadvisors.com In addition, I am open to discussing opportunities in global sourcing, international marketing & sales, logistics and medical/pharma in Thailand, Vietnam, Malaysia, Philippines & Japan. Aside from my work I enjoy piano, astronomy, physics, and assisting my daughters with their studies. SPECIALTIES: Global Sourcing, Supply Chain Management, Business Development, Marketing, Logistics, Global Networking, Market Development, Healthcare Solutions, Pharmaceuticals, Medical Devices, Technology, Asia, Southeast Asia, US and Canada
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