FBI cautions healthcare organizations of cyberattacks

If you think you’re free from cyberattacks, the FBI has news for you.

The Federal Bureau of Investigation has issued a private industry notification to medical and dental facilities regarding the looming dangers of cyberattacks.

The notification points out that cybercriminals have been targeting File Transfer Protocol servers to gain access to patients’ protected health information and personally identifiable information. The criminals access FTP servers operating in “anonymous” mode and use the information gained to “intimidate, harass and blackmail business owners,” according to the FBI.

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“Cybercriminals could also use an FTP server in anonymous mode and configured to allow ‘write’ access to store malicious tools or launch targeted cyberattacks,” the FBI notification said.

FTP servers are commonly used to transfer data between network hosts. A 2015 study out of the University of Michigan in Ann Arbor noted FTP has mostly been replaced by HTTP, SCP and BitTorrent. However, the study also found about 1.1 million extant FTP servers allow anonymous access. “These anonymous FTP servers leak sensitive information, such as tax documents and cryptographic secrets,” the study said. “More than 20,000 FTP servers allow public write access, which has facilitated malicious actors’ use of free storage as well as malware deployment and click-fraud attacks.”

To combat this growing threat, the FBI suggests healthcare organizations double-check their networks to ensure FTP servers aren’t running in anonymous mode. If organizations must use anonymous mode, the FBI recommends administrators refrain from storing PHI and PII on the FTP server.

This isn’t the first time the FBI has spoken out about the issue of cybersecurity. Earlier this month, FBI Director James Comey gave the keynote speech at the Boston Conference on Cyber Security. During his address, Comey said cyberthreats are “too fast, too big and too widespread for any of us to address them alone.”

He noted that cybercriminals come from all over and use various means to gain what they want. “And we’re not only worried about loss of data, but corruption of that data and lack of access to our own information,” Comey said.

When asked to elaborate on the number one cyberthreat to healthcare providers, Comey replied with one word: ransomware, according to The National Law Review. On that front, Comey advised healthcare leaders not to pay ransom and to maintain backup systems to protect valuable data. Additionally, Comey urged healthcare organizations to collaborate and work with the FBI in situations involving a cyberattack.

Photo: Epoxydude, Getty Images

The biggest takeaway from the annual meeting of orthopedic surgeons (AAOS)

If you walked through the sprawling exhibit floor of the San Diego Convention Center last week, you would have noticed products galore. Mannequins being pretend treated on hospital beds, and all kinds of medical devices being touted for surgeons and other buyers.

And yet the annual meeting of the American Academy of Orthopaedic Surgeons was less about rods and screws and the latest techniques in surgery, and more about bundled care and the shift from volume to value. And this despite the fact that the Trump administration appointees are putting a temporary pause on programs that expand or implement bundled care.

This is an important shift given that device vendors in the past would dazzle surgeons with the latest technologies as physician preference and large egos would rule hospital purchasing decisions. All of it without a thought placed on how much those shiny objects cost.

And now the pendulum has swung to where device manufacturers are casting themselves as partners to help solve hospital’s problems.

Take Johnson & Johnson’s DePuy Synthes for instance.

“We have more than 25 people in supply chain that goes to the hospital and help hospital management looking at end-to-end supply chain to look for opportunities for efficiencies and in inventory management,” declared Juan-Jose Gonzalez, president of DePuy Synthes, in an interview at AAOS in an enclosed area of its exhibit. “And outside you will see the Johnson & Johnson Care Advantage that are looking at supporting patients before a procedure, during a procedure, and in the recovery phase.

Care Advantage is J&J’s services business and this year at AAOS, all the major orthopedics players were eager to flex their services muscle.

In fact, even when Stryker launched its total knee on the reportedly million-dollar Mako surgical robot — that a Zimmer-Biomet executive dismissed as a “showbot” without directly naming it — the Kalamazoo, Michigan company was stressing the economic evidence and value to surgeons rather than a feat of engineering.

Here’s Stuart Simpson, vice president and general manager, Stryker, explaining how doing a partial knee replacement using the Mako robot has proved value, in a phone interview last week.

“We have seen the 30-day complication rate reduced by 36 percent with Mako versus nonMako. And we have seen the cost of complications and readmissions for Mako cases 66% lower than nonMako cases in the 90-day period,” he said. “And that’s even accounting for the additional cost of using Mako.”

The hope is the economic value will extend to the robotic use of total knee replacements as well.

Plus, just as J&J DePuy Synthes has its Care Advantage services platform and its own strategy to gain market share, Stryker has its Performance Solutions business aimed at improving hospital and OR efficiency, among other things.

Not to be outdone, the biggest hip and knee company by market share — Warsaw, Indiana-based Zimmer-Biomet — has also tweaked its consulting business to highlight its services chops. It’s called Signature Solutions. At AAOS, the company’s exhibit contained an impressive circular zone that showed off how the company is leveraging both new technology and partnerships to stay with the patient and the hospital from before a joint replacement or orthopedic procedure all the way to recovery at home.

Patient engagement is part of the new focus at Zimmer-Biomet’s services business. The company has partnered with a firm called HealthLoop for better supporting patients who have to deal with information overload as they get ready for a joint replacement

“What HealthLoop does is really two key components – no. 1, it helps to break down that information so the patient gets messages before the stay and then also afterwards. So their care plan is sent to their phone, tablet or computer,” explained Joe Tomaro who leads the go-to-market strategy of the Signature Solutions business, in a booth interview at AAOS. “The other part that Health Loop does is that it collects patient-related outcomes information as well as information post-surgery as to the number of physical therapy visits, home care visits, when did home care start – all of which is real important to estimate how much [the procedure] costs and all of that information you don’t get from the payer until six months later.”

The latter becomes exceedingly important in the Comprehensive Care for Joint Replacement Program which reimburses hospitals for collecting patient-reported outcomes. Zimmer-Biomet has also acquired a virtual rehab company called RespondWell to help joint replacement patients perform their daily physical therapy at home, thus reducing the need to go to a physical therapist.

Meanwhile, all this focus on services and value-based care by all the major players have not gone unnoticed by surgeons at AAOS.

“If you go out to the floor right now in Technical Exhibits, the big booths within all the large total joint companies — Zimmer, DePuy, Smith & Nephew — are all taken up with their programs to manage the bundles because they have now seen that managing the bundle is really important,” declared Thomas Barber, an orthopedic surgeon with Kaiser Permanente and chair of AAOS’ Council on Advocacy

And that’s a sea from just being focused on titanium and steel implants and products.

Photo: Gregory Kramer, Getty Images

Stryker launches expensive Mako robot for knee replacement in cost-conscious era

As value-based care and bundled payments begin to take hold in the orthopedics industry and healthcare overall, Kalamazoo, Michigan-based Stryker is doing something counterintuitive.

It is launching an expensive piece of equipment. Coinciding with the first day of the annual meeting of the American Academy of Orthopaedics Surgeons (AAOS) in San Diego, the orthopedics company announced Tuesday that the MAKO robot is now officially launched in the U.S. to perform total knee replacements. (MAKO has been available to perform total hip knee replacements and partial knees in the U.S. up until now.)

Why introduce a reportedly million-dollar piece of new technology at a time when hospitals and orthopedics practices are racing to reduce the cost of hip and knee replacements?

In a phone interview, Stuart Simpson, vice president and general manager, Stryker, shared his confidence that the Mako robot with the total knee application would have both clinical and economic benefits that hospitals would find compelling.

To step back a bit, Stryker made a bold acquisition of Mako for nearly $1.65 billion in 2013. Bold because none of the larger ortho players had envisioned joint replacement procedures to be done by a robot. The company has also bucked the consolidation trend in the marketplace – think Zimmer buying Biomet; Wright Medical buying Tornier – although there leaked reports showed that it was exploring a merger with Smith & Nephew. The bet was new, innovative technology backed by proper clinical and economic validation would win the future.

Mako’s total knee application — where the Mako robot would implant Stryker’s Triathlon knee — won FDA approval back in August 2015. But Kevin Lobo, the company’s CEO made the rather atypical decision to delay a wide sales roll out nationwide until 2017. [ I reported on that decision for a different publication last year].

In that two years, Mako’s total knee application has been used on a limited basis in 65 hospitals in the U.S., U.K., Australia and Germany, Simpson said and more than 1,400 cases have been performed.

Now it’s ready for full launch and the hope is that the clinical benefits noticed in the partial knee application by using the Mako robot will extend to the total knee as well.

Simpson said that the company used the commercial payer databases to do a study on how Mako’s partial knee application stacks up against partial knees performed manually without the use of a robot.

Stuart Simpson, vice president and general manager, Stryker

Stuart Simpson, VP, and general manager, Stryker

“What we have seen in two years, you’re seeing revision rates of partial knees with Mako of about half a percent versus revision rates of nonMako procedures of about 3.5 percent,” Simpson said. “That is a big, significant clinical quality improvement.”

There is a clear economic benefit as well when Mako’s partial knee applications were studied, according to Simpson.

“We have seen the 30-day complication rate reduced by 36 percent with Mako versus nonMako. And we have seen the cost of complications and readmissions for Mako cases 66% lower than nonMako cases in the 90-day period,” he said. “And that’s even accounting for the additional cost of using Mako.”

Simpson declined to comment on the price of Mako though it is reportedly upwards of $1 million, only noting that there are a variety of financing options that are available to hospitals who need only to say that they are interested in one.

“Once we’ve established that physicians want a Mako, we can typically find a way that works for hospitals given all the different financial strategies that these hospitals tend to have,” he said.

One small survey of orthopedic surgeons undertaken by RBC Capital Markets seems to suggest that Stryker is poised to take market share away from the likes of Zimmer Biomet and Johnson & Johson Depuy partly because of high interest in robotics.

“U.S. orthopedic surgeons expect strong demand for new robotics systems and believe that [Stryker] will be the leader in the U.S. robotic hip/knee market,” according to a research note published Monday by Brandon Henry, an analyst with RBC Capital Markets. “Surgeons expect Stryker’s Mako to capture ~90% of the U.S. robotic hip/knee market. Separately, surgeons expect strong ~82% and ~56% year-on-year growth in their robotic hip/knee procedures in 2017 and 2018, respectively. Surgeons expect the fastest growth in robotic total and partial knees.”

All of which should be sweet music to Simpson, Lobo, and the Stryker sales team that have waited to sell the device far and wide.

Photo: Stryker 

Correction: An earlier version of the story incorrecrtly stated that the total knee application on Mako was available in Japan. It is available in U.S., U.K.., Australia and Germany.