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Medical device sector hopes to avoid hacking lawsuits

It’s been true for centuries. The makers of medical devices keep working hard to take advantage of new technology’s potential to extend and improve lives and make themselves a profit. They’ve now created networked, smart computers tiny enough to comfortably fit inside your body.

Today, hackers are working to compromise such devices. As a result, legal and medical experts, regulators, and medical tech companies are scrambling get ahead of whatever happens next.

Healthcare sector said to be taken by surprise

While some other sectors had the problem almost as soon as digital technology was available, experts say healthcare was slow in getting hit with hacking activity.

In 2015, the data of 80 million customers of a major managed health company was compromised by hackers. A ransomware attack in 2017 locked 16 hospitals in the UK out of their patients’ records, forcing their emergency rooms to go into “diversion status.”

The executive director of the quasi-governmental Healthcare Sector Coordinating Council told the Washington Post, “Quite frankly, it caught a lot of the health-care sector flat-footed. It was a bit of a slow-motion ambush.” He’s seeing a gradual recognition that “the circular finger pointing should end.”

Creative hackers in a target-rich environment

The nightmare scenario is a hacker controlling a device you need to survive. As Vice President, Dick Cheney’s pacemaker was temporarily taken offline to ensure it wasn’t used for a terrorist or assassination attack. Hacking a similar device in a carefully chosen individual might conceivably be used for ransom or blackmail.

But implantable devices are often connected to networks, potentially making hacking an even greater threat.

Insulin pumps, pacemakers, defibrillators and dialysis devices exchange data with networks of computers, databases and sometimes consumer mobile devices. A hacking attempt on your device may be aiming at a company or an entire industry, not you individually.

Government now beginning to set some standards

Lawmakers and regulators have now begun setting the cybersecurity standards that companies, hospitals and doctors must meet. This ongoing effort may help consumers hold the health industry accountable for how responsibly it meets these technological challenges.

The Food and Drug Administration has already recalled some medical devices for vulnerability to hacking. Early this year, the FDA also began educating manufacturers and others in the industry on getting devices through FDA approval, including a review of “software validation and risk analysis.”

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