The U.S. Food and Drug Administration (FDA) opened a probe in August to investigate claims that heart devices made by St. Jude Medical, a medical device manufacturer, were defective and vulnerable to fatal cyber attacks.
The FDA probe was launched following a security vulnerability report from MedSec, a cyber security research company, and Muddy Waters, a due diligence based investment firm, claiming that St. Jude’s pacemakers and defibrillators were vulnerable to cyberattacks. These attacks, according to the report, could result in battery drain or manipulations of the pacemaker beat rates, putting patient lives in jeopardy.
St. Jude Medical fought back, filing a suit against MedSec and Muddy Waters in September. St. Jude claimed the report used false and misleading tactics and was created for the sake of a short-selling scheme. In such schemes, investors sell a stock if they think its value will soon drop. In turn, they can buy back shares at a lower price and make money.
The medical device manufacturer recently announced that it would set up a medical advisory board focused on cybersecurity issues affecting patient care and safety. The group will be known as the Cyber Security Medical Advisory Board and will provide advice on cybersecurity standards for medical devices.
St. Jude Chief Medical Officer Mark Carlson released a statement saying the newly created advisory board demonstrates St. Jude’s ongoing commitment to advancing standards of patient care around the world without compromising safety and security.
The board’s membership has not yet been finalized, but it will work with both St. Jude’s technology experts as well as external researchers to maintain and enhance cybersecurity standards and patient safety.
St. Jude Medical, a St. Paul, Minnesota-based company, agreed in April to sell for $25 billion to Abbott Laboratories in a deal that will be finalized at the end of 2016. The company has announced it will recall some of its 400,000 implanted heart devices due to the risk of premature battery depletion, which was linked to two deaths in Europe.
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