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Patricia O'Connell
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Sonali Gunawardhana Moderates FDLI Panel on Regulation of Mobile Health Technologies

Bloomberg BNA’s Medical Devices Law & Industry Report
December 15, 2015

Sonali P. Gunawardhana, of counsel in Wiley Rein’s Food & Drug Law Practice, moderated a December 10 Food and Drug Law Institute (FDLI) panel on the regulation of mobile health (mHealth) applications. Ms. Gunawardhana’s comments were covered by Bloomberg BNA’s Medical Devices Law & Industry Report.

The U.S. Food and Drug Administration (FDA) has said it will exercise enforcement discretion over mobile apps that may meet the definition of a medical device but pose a low risk to the public, according to the article. But the FDA is “being proactive” regarding cybersecurity threats in the medical technology arena, Ms. Gunawardhana said.

Malware threats, uncontrolled distribution of passwords, and lagging security patches and updates are among the potential vulnerabilities the FDA has identified with respect to medical device cybersecurity. “They’re very concerned with this area,” Ms. Gunawardhana said.