A millionaire’s mission: Stop hospitals from killing their patients by medical error

Via Fox News »

IRVINE, Calif. — Joe Kiani likes to point out that the most worn spot on most medical monitoring devices is the mute button.

He’s out to change that — and, he hopes, to stop the epidemic of preventable hospital death that kills tens of thousands of Americans each year.

It’s not a glamorous cause. And Kiani is not a household name. But he is a multimillionaire with a proven track record of using engineering smarts to fix dogged problems; he made his fortune improving the humble pulse oximeter, which measures oxygen saturation in the blood. Now, he’s pushing a nerdy, but elegant, idea for saving lives: prodding manufacturers of medical devices and electronic records to open their platforms so all the systems can talk to each other.

His tech fix — if widely implemented — could bring order to the cacophony of beeps, buzzes, and blaring alarms that can so overwhelm nurses and doctors that they push “mute” and miss true emergencies. It could make it easier for staff to monitor patients with complex needs. And it could flag, in advance, potentially fatal errors like incorrect dosing and drug allergies.

Manufacturers, naturally, aren’t so eager to share their computer code. But Kiani is not one to give up.

He stages a glitzy patient safety summit each year, attracting big-name speakers like Bill Clinton and Joe Biden to pound home the need for hospitals to stop killing their patients. “If President Clinton or Vice President Biden says it, it has far more weight,” Kiani said. “When I say it, it’s like a flea screaming.”

In the past five years, Kiani has encouraged — some would say browbeat and publicly shamed — 70 companies to sign a pledge to open their platforms. The group includes some of the biggest medical device manufacturers — who also happen to be some of his most bitter corporate rivals.

“It’s really surreal when I look at where we are,” Kiani said. “People who were our mortal enemies like Medtronic and Philips are now joining us.”

Of course, making a pledge is one thing. Carrying it out is another. While smaller companies have been eager to open up their data, many heavyweights are moving slowly. Some cite concerns about patient privacy; others are working on big integrated systems to sell to hospitals and aren’t interested in cooperating with competitors. Makers of electronic health records have been especially reluctant.

Yet outside experts such as Dr. Peter Pronovost of Johns Hopkins University, a world leader in patient safety, see glimmers of hope.

Pronovost once thought it would take federal regulation to force companies to make their devices talk to one another, which he calls a crucial safety feature, akin to making sure a pilot can can check on the plane’s landing gear from the cockpit. He’s heartened by Kiani’s progress.

“When Joe first stood up and said he’d make data open, he was the lone wolf in the industry,” Pronovost said. “Most of the others put their heads down and stayed silent. He’s been a visionary.”

Zoll, which manufactures defibrillators and data systems in ambulances, was one of the first to open its data. Patient information captured in Zoll-equipped ambulances can now flow directly into the patient’s electronic health record, for review by hospital staff.

As a next step, CEO Rick Packer is pressing the health records companies to send data to his ambulance devices, so paramedics have crucial background on the patients they’re transporting.

“I use the data pledge as a moral high ground” in negotiations, Packer told a panel at Kiani’s patient safety summit last year. “Eventually it’ll come around and we’ll get what we need.”

A science geek hits it rich

Kiani runs his own medical device company, Masimo, from a building so airy and modern it stood in for Stark Enterprises in the first “Iron Man” movie.

With a volleyball court in the lobby and hemp milk and artisanal chocolate served in the employee cafeteria, the building pulses with California startup vibe.

Kiani, 51, a father of three with slightly silvering hair and a penchant for wearing dark tailored suits with no tie, lives in nearby Laguna Beach. But his life wasn’t always so easy.

When Kiani arrived in the US from his native Iran at the age of 9, he spoke three words of English. His family settled in tiny Albertville, Ala., because his father, a technician, had a friend there. (Many who admire Kiani note he’s the kind of successful immigrant who might be barred from the US under President Donald Trump’s temporary immigration ban.)

Kiani raced through high school, finishing at 15, and planned to become a doctor. But chemistry at San Diego State  University foiled him. Instead, he turned to engineering.

“It’s probably better he didn’t become a doctor,” mused Dr. Steven Barker, a professor emeritus of anesthesiology and aeronautical engineer at the University of Arizona who now works as chief science officer for Masimo. “He wouldn’t have saved nearly as many lives.”

Soon after graduating, Kiani got a chance to work on pulse oximeters.  The geek in him was captivated. “I couldn’t believe you could shine light in your finger and measure oxygen in your blood,” he said. “I just loved the idea.”

But devices being used in the mid-1980s were terrible. Just about any patient movement caused the devices to sound a false alarm that oxygen levels were low. Patients would then be blasted with too much oxygen, which often led to blindness in premature babies.

Drawing on what he’d learned from fields like submarine warfare and satellite communication, Kiani and colleagues came up with adaptive algorithms that helped the oximeters ignore signals that made no physiological sense. That cut down on false alarms and improved reliability. In 1989, Kiani and engineer Mohamed Diab launched Masimo. It began, as so many of California’s great companies have, in a garage.

The next decade was tumultuous. Bigger companies were trying to steal his ideas. Kiani couldn’t seem to get hospitals to look at his device. At times, his sales reps were even physically escorted off hospital grounds.

“It was so frustrating. I can’t even tell you,” he said.

Kiani had stumbled into the scandalous world of hospital GPOs, or group purchasing organizations. His pulse oximeter was being locked out by larger competitors who paid hefty fees to hospital purchasing agents in order to land exclusive sales contracts.

Kiani was initially afraid to get involved, not wanting his young company to be blackballed. “It wasn’t in my personal interest to try to change this industry,” he said. But he did speak out, in a series of high-profile articles and in testimony before the Senate in 2002.

“He really helped open up the market for smaller companies that had better, disruptive technologies,” said Ronald Newbower, an MIT-trained physicist who’s spent decades using technology to improve patient safety at Massachusetts General Hospital.

As hospital purchasing rules began to change, Kiani’s company began selling huge numbers of pulse oximeters. It is now one of the top sellers in a market estimated at $1.5 billion globally.

The company is moving into other areas, including brain monitoring. Kiani is extremely proud of Masimo’s technology and the sleek, iPhone-like devices he’s been creating of late. But the company took dings — and received an FDA warning letter in 2014 — for not adequately responding to complaints about some of its devices. Kiani said the company has since overhauled that process.

Masimo went public in 2007, and Kiani, still at the helm, is rich beyond his dreams. (Masimo’s board balked at his lucrative contract a few years ago and renegotiated, but he still takes in more than $5 million a year.)

“His life story,” said retired California Senator Barbara Boxer, a close friend, “reads like a fairy tale.”

But his business success wasn’t enough. The fight to open up hospital purchasing practices had stirred an activist bent in Kiani. He soon found his target.

Turning patient safety into a glitzy cause

After years of working in the medical field, Kiani knew the grim statistics: Some 100,000 patients in the US die each year of medical errors, according to a 1999 Institute of Medicine report. Some researchers, using newer screening tools, think the number could be four times higher. Others say it’s lower.

But everyone agrees these deaths can and should be prevented.

When Kiani began to put faces to the statistics, he was shaken.

One of those faces belonged to 11-year-old Leah Coufal, who died in December of 2002 at Cedars-Sinai Medical Center in Los Angeles. She’d had routine surgery to correct a mild chest deformity and apparently received a massive dose of fentanyl to control pain — enough to stop her breathing.

Her mother, Lenore Alexander, couldn’t talk about Leah’s death for a decade. When she started speaking out, Kiani listened. He was shocked to realize his own daughter — who is fine now — had surgery in the same hospital, with the same surgeon, in the same week as Leah.

“That could have been me,” Kiani told the people gathered at his first patient summit in 2013. “It could have been you.”

He was also shocked to find Leah had not been monitored after surgery, not even with a simple pulse oximeter. Another name Kiani couldn’t keep out of his mind at the time was Rory Staunton, a 12-year old from New York who scraped his arm in gym class, then died from a sepsis infection that simple screening tools could have detected.

“He wondered: “Why are people going into hospitals and not coming out?’” said Frederic J. Harris, an electrical engineering professor at San Diego State University who taught Kiani and remains close to him.

Kiani decided to tackle such senseless deaths through engineering.

“God bless him. He’s working on this and he’s got people all over the place working on it,” said Alexander, Leah’s mom, who has spent years pressing to get patients monitored after surgery. “I believe he’s a really good man. He’s not doing this for his own pocket.”

Critics, however, look askance at the high glitz content of Kiani’s annual summits, run through his Patient Safety Movement Foundation.

Held at beachside hotels, with splashy staging and tickets priced at $500 to $1,000 apiece, the summits rely heavily on political star power. (This year, for instance, the foundation is dangling a private fishing trip with Jimmy and Rosalynn Carter as a prize; health care institutions can enter to win by committing to specific steps to reduce patient deaths.)

Some critics also raise questions about the money Kiani has handed out to politicians. His foundation, which is funded by Masimo and other corporations, paid $315,000 to Clinton for a 2014 speech (though the former president has waived his fee for the past three years, Kiani said). Another of Masimo’s foundations has contributed $2.5 million to the Clinton Foundation.

“That’s a lot of money. You wonder if it’s a way to legally channel money to a candidate,” said Beth Waldron, a patient safety advocate and consultant in Chapel Hill, N.C. She once hoped to work with Kiani on her key issue — death from venous thromboembolism, or blood clots — but grew concerned after looking at how the foundation operates.

“I’ve seen very little substantive action coming from this particular patient safety organization,” said Waldron. She notes that plenty of other groups also work on patient safety and, in her view, get more done. “I don’t see the results to justify the costs,” she said.

Kiani said he resents any implication that he’s trying to buy access to promote his company or alter tax policies that affect his industry.

And many in the field, even competitors, say Kiani’s work is making a difference, by turning a spotlight on the uncomfortable topic of patient death and also by reshaping market forces.

“The pledge for open data does make an impact. Customers are starting to demand it,” said Stefan Dräger, the CEO of Germany’s Dräger, a medical technology manufacturer which signed up early on. He predicts more and more companies will jump in: “They have to,” he said. “It would look awkward if they refused.”

Medtronic, a medical device giant, has started to embrace open platforms, including in some of its insulin pumps and glucose monitors. Another powerhouse, Philips, has been working to develop industry-wide standards so devices can talk to each other.

Electronic medical records makers also need to come aboard, noted Johns Hopkins’s Pronovost, or they risk becoming “dumb data entry and billing systems” without access to the streams of data coming in from monitors and devices — or the powerful analytic tools used to make sense of it all.

Ed Cantwell, who runs the nonprofit Center for Medical Interoperability, said it’s a national embarrassment that companies have been allowed to own patient data instead of sharing it.

He’s working to create the architecture that hospitals could use to network their tens of thousands of devices into what he calls a “truly neutral, two-way plug and play” system. Once those standards are in place, he said, “I’m going to call vendors on their data pledges — very publicly.”

That can’t come too soon for Kiani. He’s already revved up about what it could all mean: Once more devices are linked and data is flowing, he said, computers should be able to predict in advance which patients are headed for trouble and alert clinicians. All that’s needed, he said, are a few good algorithms.

“It’s easy for a computer to do,” Kiani said. “It’ll be phenomenal.”

CEO Ed Cantwell Featured in InCharge Healthcare 2017: The Continuum of Care

Via Nashville Medical News »

View the 2017 edition of InCharge Healthcare »

As our healthcare delivery system continues to evolve and transform, there is an increasing focus on communication, connection and engagement at every point along the continuum of care.

Certainly, the top executives featured on this year’s cover represent not only excellence in their own particular part of the continuum but a willingness and ability to reach across silos to make healthcare’s triple aim a reality. There has been a transformative shift across the country as the industry expands focus to include prevention and maintenance of health as a central part of the mission to deliver care to the communities being served, and our local healthcare industry has played an integral role in those national efforts.

It’s evident while flipping through the pages of the 2017 edition of InCharge Healthcare, Middle Tennessee is blessed with a wealth of impressive leaders – and each impacts the continuum at different inflection points. While providers and facilities operators are certainly a central part of the equation, so are the venture capitalists, bankers and mentors who fund and nurture innovative young companies … the healthcare attorneys and accountants who help facilitate connections while keeping industry clients on the right side of state and federal regulations … the association executives advocating for thoughtful reforms … and the HIT experts and industry consultants figuring out the most effective, efficient ways to deliver care and share information in a secure manner.

As part of Middle Tennessee’s healthcare community for more than two decades, we hope that Nashville Medical News is also an integral part of that continuum by delivering news and insights on clinical, business, research and regulatory matters of interest to our readers. Through nearly 25 years of continuous publication, the paper has seen various ownership groups, but the constant always has been a desire to serve the city’s robust healthcare industry by providing meaningful local and national news.

Trusted Wireless Health – A New Approach to Medical Grade Wireless

Via ICT Today »

Several current trends give cause to rethink the design of wireless systems in medical buildings.

Increasingly, patients are bringing in their connected smart devices and expecting the hospital to provide wireless internet services for free. Studies conducted over the last six years show that guest traffic in these facilities has risen from less than 10 percent of all Wi-Fi traffic to as much as 95 percent of the total airtime and bandwidth.

Within the hospital, advances in medical technology bring greater demand for more wireless devices, in large part so that patients can be mobile while being treated and also eliminate wires that can cause hazards. The Internet of Things (IoT) is arriving in medical care in the form of wearable sensors, which must communicate data affecting the safety of the patient regardless of where they are and despite adverse local radio frequency (RF) conditions.

Procurement of new technology is often driven by specific medical departments based on their needs for improved products, but without consideration of how it will coexist with current equipment and guests. Often, purchase decisions consider only the cost of the device itself, not the total cost including risks brought on by incompatibility to other wireless-based systems.

In addition, there is an increased need for medical devices designed to work not only in the hospital, but also in the patient’s home. Away from the medical facility, these devices must communicate reliably and securely back to the caregivers’ systems. What if the patient could be discharged, freeing up valuable resources, with the assurance that the medical data was reliable and secure and that the patient could be located as needed?

These trends combine into a perfect storm of high growth in user demand for wireless services. The healthcare community is ill-prepared to manage this challenge alone. Exacerbating growing demand are the potential for co-channel interference, device makers’ calls for proprietary networks, and a lack of vendor-neutral best practices or standards against which network infrastructure can be installed and measured. These factors contribute to high costs and low network reliability.

Can a single solution be found to these varied concerns and objectives? This article proposes an integrated plan for Trusted Wireless Health (TWH). In TWH, choices made in one area can affect, and in turn are affected by, those made in other areas under consideration. All must coexist.

A Determined Policy 

The wireless healthcare environment is characterized by inconsistent and widely varying practices, as well as a lack of design and implementation standards. The hospital setting in particular faces explosive growth in consumer and medical wireless devices. Left unchecked, it is almost impossible for clinicians’ tablets or computers on wheels to work simultaneously with patients’ smartphones, wireless ventilators, monitors and infusion pumps at the level of assurance required in a medical setting.

A starting point is to consider the risk of action or inaction, the residual risk, and possible methods of risk mitigation. A guide to these sorts of consideration is the standard documented in ISO-80001-1 and other associated standards, which ask the hospital to consider risks, mitigate what risks they can and thoroughly document and accept the risks that remain.

TWH is part of a complete, hospital-wide risk assessment to understand the vulnerabilities of a wireless system (Figure 1). Risk analysis consists of hazard identification: the risky situations and root causes, an estimate of the potential harm of each hazard and its severity, and an estimate of the probability of harm. Risk acceptability must be evaluated and a risk versus benefit versus cost analysis performed. Risk control measures must be identified, documented and implemented, and their efficacy evaluated. Residual risk must be reported and accepted at the C-level and constantly iterated.

As a result, the hospital quickly comes to realize that allowing wireless in the hospital to be driven by the needs of individual departments carries such great risk that a determined policy on wireless services, purchases, implementation and ongoing use must take place. The policy creates a constancy of purpose toward the improvement of the provided medical services as a whole, and reminds everyone that wireless is a critical component of those improvements. It ends the practice of awarding vendor business on the basis of a lone price tag or discrete needs and focuses on the goal of minimizing total costs, which include the costs of medical risk.

How Does TWH Differ from MGWU? 

Medical Grade Wireless Utility (MGWU) was a valuable starting point from which the TWH geometric RF design evolved. TWH RF continues the concept of providing separate layers of traffic and expands on it. It starts with a listing of a dozen changes a hospital can do in a few hours to provide some immediate relief, buying time to more thoroughly revamp the RF environment.

TWH RF differs from MGWU in a few aspects. First, it is not solely concerned with pushing as much signal out over as large an area as possible. Instead, it concerns itself with many access points (APs) operating at a relative RF whisper. This provides several advantages, including large increases in capacity and lower RF noise levels.

A key consideration is that today’s client devices have very low power. Symmetry in the downstream/ upstream requires that APs be designed, not at the maximum permitted power of 17-20 decibels per millwatt (dBm), but with the 5-11 dBm that the end device can provide. This, in turn, rapidly shrinks the coverage area of each AP. This higher density increases system capacity. The necessity is for more, lower power APs. But it also provides a challenge—how to prevent interference between all the APs?

MGWU was heavily dependent on a distributed antenna system (DAS) for RF propagation. With today’s prevalence of multiple input, multiple output (MIMO) technologies, which require multiple separate RF sources and receivers, a DAS would need to consist of as many individual RF distribution systems as there are contemplated streams of MIMO. Essentially, if there is one DAS for a single stream legacy system (SISO), a 2x MIMO would require two complete DAS systems, a 3x MIMO would require three, and so forth. The space and cost requirements to create a DAS-based MGWU become prohibitive. TWH RF implements the MGWU using precise geometry and spatial separation. The result offers lower costs of infrastructure installation, which help offset the additional AP counts required by the lower power settings.

Consider also that advances in miniaturization have created a range of small radios for carrier-based services, also called small cells or femto cells. For the purposes of this article, these radio sources shall be referred to as tiny cells. Their chief characteristic is that they can bring in carrier signals from the outside without the need for a DAS to distribute the signals. They function as base stations with or without coordination to the macro cells in the outside world, communicating via industry-standard Ethernet provided by the carriers or sublet traffic on the building enterprise network structured wiring.

Advances in unlicensed spectrum continue with the addition of technologies such as Bluetooth® low energy (BLE), LTE in unlicensed spectrum (LTE-U)—which brings carrier traffic out from the licensed bands into Wi-Fi space—and other users of the spectrum. All this occurs under the Federal Communications Commission mandate that all users within unlicensed spectrum must coexist.

Fundamentals of TWH 

TWH is a vendor-neutral, future-ready wireless and wired infrastructure able to transport wireless signals from medical devices of established vendors and new and startup vendors alike. It consists of a design that allows for up to seven independent wireless services across eight wireless networks, which together constitute an infrastructure shaped to the building and engineered to deliver appropriately assured wireless service

at the locations in the healthcare enterprise as required by need. TWH RF provides for the future placement of new technologies, such as LTE-U, without the need to completely redesign each layer of previously installed service.

TWH creates up to seven completely independent wireless networks at the critical 5-6 gigahertz (GHz) band and one additional wireless network in the 2.4 GHz band. The first three of seven independent 5-6 GHz networks are referred to here as the Red, Green, and Blue networks. While each color layer can be assigned at will, normally the Red network layer at 5-6 GHz will constitute services for the enterprise itself—the doctors, nurses, and devices providing patient care. At 2.4 GHz, the Red network will provide for enterprise legacy devices that do not have 5-6 GHz capabilities. The Green network at 5 GHz will constitute services for guests, the patients and their visitors. The Blue network is designed to be used at 5-6 GHz for new services on otherwise incompatible technology, such as LTE-U, and at 2.4 GHz for services such as BLE for wayfinding and other applications that develop.

Figure 2 is an excerpt from a ceiling plan design by a major architectural firm specializing in hospital design. Following TWH RF rules, the architect was able to create a MGWU out of individual APs, placing APs out of the way of various ceiling obstructions, yet correctly positioning them to provide excellent RF coverage. The three (or more) layers discussed are all located in advance, so Ethernet category 6a (or otherwise specified) cables can be pulled to each location, even if all layers are not implemented in all areas of the hospital. For example, an operating room might not need the Blue layer, but might wish to implement both the Red and Green layers as a set of redundant services for hospital medical personnel and devices. In other areas of the hospital (for example, in patient rooms), the Red and Green layers would exist as two separate networks, one for hospital services and one for guests, while the Blue layer would represent the locations of a carrier-supplied tiny cell network.

Each large circle represents a gross AP location, while the actual AP is indicated by a small square. Note that the squares are located directly in the middle of a reflected ceiling plan 2×2 grid, allowing for the AP to be located in a tamper-resistant decorative panel consistent with the ceiling layout. This simplifies installation.

The additional four layers (above and beyond the three in the example above) derive from a lattice arrangement suggested by the packing of atoms in a crystal. The Center for Medical Interoperability has developed the methodology and will be licensing it free of charge to providers working with their membership.

A wireless network designed around the principles of TWH will provide the critical underpinning for: u Dense, low-signal level RF coverage u Trusted and verified design for capacity and coverage

  • w Licensed at no cost to architects working on member projects w Architect ensures APs are integral to all systems w Allows for multiple frequency segregated traffic networks
  • Elevator, stairwell and difficult access areas considered
  • w AP RF design power matched to clients, not max permissible
    • A wired network designed to support wireless needs
    • Detailed implementation and configuration procedures
    • Wireless 100 percent verified and validated after install and configuration

Trusted Interoperable Devices 

Trusted Interoperable Device certification needs to guide both vendor product development and enterprise procurement. Validation of devices to the TWH RF design will consider aspects beyond the Wi-Fi alliance certification.

When evaluating a device, the questions asked should include: How does it react to higher data rates? How much power does it send out? How does it behave in roaming?

Device behavior concerning roaming is a particularly important question. Does the device stay put when RF conditions are good enough, and does the device move to a new AP when RF conditions become adverse? There are many devices today which, despite being placed in an environment with several good signals all more than adequate to communicate, constantly hop from one AP to the next, with each jump causing a roam event. Certification will examine how a device behaves when the signal degrades below a certain threshold. Does the device actively seek a new link, or does it hold on to the existing AP?

Client radios are ever smaller, with smaller battery capacities. Thus, the RF design of the client changes accordingly. The transmit power is lower and, coupled with some increase in data rate, the time the radio needs to be on is less, which increases battery life. With the lower transmit power, it is not sufficient that the enterprise sources (APs) be designed to blanket an area at high power that the clients can hear; it is instead required that the APs be placed at a sufficient design density so that, when matched to the power of the client, both sides can hear each other (symmetric power). Even at the low power, the signal-to-noise ratio must be high enough that the data rate is sufficient to send a message in a quick burst and then turn off the power-draining radio.

As an integral part of TWH, the procurement process for wireless devices needs to be reconsidered. It is not sufficient to purchase a device that meets some standards in an antiseptic environment. The device must be able to coexist with all other devices found in the environment, including those carried by guests. Devices that can pass some sort of certification scheme as to interoperability must be clearly and correctly identified, and then be placed on a network of their own, while the rest must be segregated in some way so as to permit the certified devices some guarantee of service.

Trusted Traffic Design 

TWH traffic design considers transaction frequency and volume effects on the allocation of wireless resources.

Additional capacity in a given area can only come from an increased density of APs of an existing technology, or an introduction of a new, possibly incompatible, technology. Knowing how much traffic a given device or application generates and how often it does so provides the architect designing the AP placement a basis on which to adjust the density of APs. The IT department and the wireless management system are then afforded the opportunity to adjust wireless services accordingly.

Until and unless the air-time arbitration scheme moves to something other than the decades-old 802.11, wireless will always have some chance of packet loss. Thus, there can never be any absolute guarantee of service. The potential loss of packets must be considered in the overall risk assessment within a hospital facility. The risk of failure can be mitigated by providing overlapping services, but that ability must have devices which do not hop from AP to AP as noted above.

Trusted Location-Finding Abilities 

The ability to find people and objects will be made possible by tags that use both Wi-Fi and precision guidance of non-Wi-Fi sources. In the unlicensed bands, location is done at 2.4 GHz rather than at 5 GHz by necessity—it propagates most easily. Actively chirping tags associated with equipment and personnel need to do so more than once per occurrence. It has been demonstrated that a tag that chirps three times on each of the three channels is highly effective. Tags that only chirp once (or only once per channel) tend to give false readings. TWH geometric RF design provides a guarantee of three APs within approximately a 7.6 meter (25 feet) line of sight to each tag or radio source, which results in superior location resolution (Figure 3). Time difference of arrival (TDoA) and angle of arrival (AoA) systems from devices at the existing locations will further improve the location-finding methods. Another current trend is to invert the BLE beaconing system, using BLE not as a source, but rather by placing a high density of receivers looking for BLE sources in motion. The TWH geometric design provides for the specific locations of a nearly ideal grid for such a system.

Privacy and Security Considerations 

TWH considers that privacy is a requirement for medical data whether the devices are within the hospital or outside the hospital grounds. Medical devices certified as interoperable at the device and application levels both must be identified uniquely and securely. There is no need to reinvent the process; there are multiple solutions in the market that allow for assigning a unique certificate per verified component. Identified and authenticated devices and applications will be allowed access to virtual local area networks (VLANs), which in turn permit access to servers containing the requisite information. Those who fail access control will be shunted to general access on the outside. Patients and other guests inside the building will be provided an easy method by which to obtain a temporary certificate, all the while holding at bay those living in the area or commuting by the building.

Trusted Applications and Interchange of Data

While today’s devices communicate well with their own servers, and via graphical user interfaces (GUIs) to the humans who consume the data, there is a marked lack of ability for devices to exchange information among themselves. Would it not be good if the infusion pump and the respiratory machine connected to the patient utilized only one sensor for each vital sign in common, rather than requiring one per device? Common application programming interfaces (APIs) should allow each vendor to concentrate on what they do best while both accepting and providing information to other medical systems in a trusted manner. Disparate vendors are working together on a trusted interchange gateway.

Considerations for the Future 

Wireless is advancing rapidly, with considerable leaps in technology. The impacts of further new technologies will quickly make legacy systems and devices obsolete. 802.11 is a poor method for allocation of air time. As one possible alternative, LTE operates much like an arbitrated bus of a switch or a modern computer backplane and is widely available today. The hindrance to LTE is the tight control exercised by the patent owner, so it may not itself be the future, but some mechanism will come to the forefront. Being backwards compatible has served 802.11 till now, but at some point the switch to an incompatible technology must be made. The frequencies in use (the unlicensed ISM bands) will most likely remain the same but the use of that space will need to change. The concept underlying TWH geometric RF design is to permit the introduction of a new technology on independent pre-planned frequency spans within the medical RF system while permitting legacy devices and applications to continue to work. Medical devices will need to be licensed with the understanding that the low layer protocols will be swapped out from 802.11 to something more efficient—there will be no need to replace the physical infrastructure wholesale, nor to change the way the rest of the medical applications work.


TWH is a fusion of concepts, which together can deliver trust and assurance to a medical wireless system. The goal is to provide medically needed data, delivered wirelessly in a timely, certain and private manner, all the while removing unintended consequences from the use of disparate tech-nologies which often do not work together. With TWH in place, the medical community can rely on trusted wireless transport to provide new advances in medical care.

AUTHOR BIOGRAPHY: Mitchell Ross is the principal for Trusted Wireless Health at the Center for Medical Interoperability in Nashville, TN. He has more than 40 years of experience in machine-to-machine communications and has worked at NASA, Xerox, Pratt & Whitney, General Motors and Digital Equipment Corporation. Beginning with the wide-scale adoption of IEEE 802.11b in the late 1990s, he has spent the last 18 years working to optimize Wi-Fi installations. He can be reached at mitchell.a.ross@Center4MI.org.


Blockchain and health care’s future

Via Nashville Post »

Disruptive database technology could be industry savior

Beyond the country music tropes and Bible Belt platitudes, Nashville should be best known for its place in the health care industry.

Headquartered in the city are 16 publicly traded health care companies with a combined $73 billion in global revenue, according to an impact study the Nashville Health Care Council conducted last year.

It was not surprising, then, that Distributed: Health picked iconic local structure Schermerhorn Symphony Center to host in September its first-ever conference on blockchain databases for the industry. Specifically, blockchains involve widely distributed databases that live on many individual devices instead of existing on central hubs. The innovative technology was on full display in a day of panel discussions and presentations, all exploring a step forward for health care in its hotbed.

“Nashville is blowing up,” John Bass, CEO of medical data company InVivoLink, said as he gave the event’s opening address to hundreds of attendees in the symphony hall. “We’re in a great position to be an epicenter for health care technology. I’m proud to have watched that emerge and I’m excited about the blockchain community forming, because I think it’s a key to positioning Nashville as a hub of health care technology.”

As much as the health care industry depends on Nashville, the city depends on the revenue the sector generates even more. Almost 400 health care companies operate here, accounting for 250,000 local jobs and $1.5 billion in state and local taxes, per the health care council. And as problems with the current health care system continue to emerge, there is cause for concern.

“There’s this perfect storm going on where in 2022, we’re going to reach $5 trillion in health care spending,” Bass said. “The numbers are simply getting too big. We all hope that technology — and hope specifically that blockchain technology — has a big role to play in flattening that prosperity and getting health care under control.”

An industry in poor health

Aside from the concerns of increasingly exorbitant spending, there are other causes for anxiety in health care. The industry is designed for episodic care, addressing illness and injury as they occur. As we’ve increasingly become a nation with unhealthy habits and lingering illnesses, it’s done little to adapt itself.

“The state of being healthy being hard has made us a nation with chronic conditions,” Chris Kay, chief innovation officer at Humana, said in a presentation following that of Bass. “[The health care] mindset doesn’t work anymore when you have people suffering from longtime conditions. That requires a relationship.”

In an age where information is more readily available than ever, data regarding the cost of care still remains perplexing for consumers.

“The complexity inside an insurance company about claims and payments is profound,” Kay said. “Health care is one of the few markets where the service we receive — the patient and the doctor — is disconnected from the payment.”

Finally, the caregivers themselves often lack data on patients and it can be frustratingly difficult to pass relevant patient files between doctors and information systems, Kay said.

“Doctors want to have a full record of our data but they don’t,” he said. “Interoperability is a core problem in health care.”

But hundreds of health care and technology innovators didn’t gather at the Schermerhorn to hear the things they probably already knew to be problematic in their field. Rather, they were drawn by the promise of a new technology with the potential to address these problems and revolutionize the industry. They wanted a closer look at blockchain.

A disruptive promise

Blockchain technology was popularized by the bitcoin market, with companies like Deloitte and Microsoft recently having invested in it.

In a blockchain, security is guaranteed as each piece of data is blocked with others and then verified at each point in the network of connected databases. As blocks are increasingly chained together, the data gets buried and harder to manipulate. This system replaces the need for single-point, third-party fiduciaries.

“At its core, the reason why blockchain is valuable and interesting is that you trust users in the network less and the system more,” Jeff Garzik, an original developer for bitcoin, told the opening audience. “Data in transactions is fully verified by every single network participant… Every node in that network is checking the rules.”

This level of security could make blockchains a method for storing health data, one that would be easily tapped and transferred by those with permission. Proponents argue this could be a way to give patients constant access to their wellness data and promote healthy habits in the face of chronic maladies.

“Fundamentally knowing your score as an individual, as a consumer, is the root of our ability to control our own health,” Kay said. “Imagine having your own health and wellness records available throughout your life and being able to control who sees what.”

Kay went on to paint a future where the navigability of data on blockchains leads to “zero friction points between the time a patient sees a doctor and the time the payments and settlements are made.”

On the caregiver side, blockchain is most promising in its potential to transfer relevant patient data from one place to another and provide interoperability.

“Health care is the only vertical market that has not agreed upon an interoperability program at this point,” Ed Cantwell, executive director of the Center for Medical Interoperability, said during an afternoon panel session. “If they put their money where their mouth is and they adopt platforms that are standards-based… and trust-worthy, then that’s the foundation for blockchain to be wonderful.”

Potential pitfalls

There are, of course, obstacles to blockchain becoming widely adopted throughout health care.

Perhaps the main barrier will be the industry itself, which is notoriously resistant to major change. The most prominent insurance companies have little financial incentive to make the marketplace more navigable for patients as it stands now, as they benefit from the treatment of individual illnesses rather than the full spectrum of health.

Then there are the stringent regulations regarding matters as sensitive as health care. The Health Insurance Portability and Accountability Act may not account for a major disruption in the way patient information is stored before it is thoroughly vetted.

“If we were to wait for the U.S. government to mandate specific technology around blockchain, it would be at glacial speed,” said Stephanie Fetzer, a project architect at IBM and conference panelist.

Lastly, it might be the patients themselves who are most resistant to the adoption of blockchains. It will be hard for average people to put the faith of their medical records into something they don’t understand.

In short, blockchains may have to establish themselves in smaller capacities before igniting a full-scale health care revolution.

Nashville Health Care Council Panel Calls for Leadership, Accountability in Addressing Cyber Threats

Via Businesswire »

NASHVILLE, Tenn.–(BUSINESS WIRE)–With cyber security breaches becoming an ever-growing issue for health care companies, the Nashville Health Care Council welcomed a panel of experts to discuss strategies for preventing such attacks. Though data invasions can be disastrous for health care organizations, the industry has so far struggled to put processes into place that will effectively reduce the negative consequences of cyber crime.

The discussion was moderated by Kerry McDermott, vice president, public policy and communications, Center for Medical Interoperability; and featured panelists Samar Ali, attorney, Bass, Berry & Sims and former White House Fellow; Paul Connelly, vice president and chief information security officer, HCA, and former chief information officer, the White House; Noah Kroloff, principal and co-founder, GSIS, and former chief of staff, U.S. Department of Homeland Security; and Mark Sullivan, principal and co-founder, GSIS, and former director, U.S. Secret Service.

The conversation explored the current and emerging threat landscape, identifying the “bad actors,” which include international terrorists and nations infiltrating American entities, hackers who feel they are exposing data to protect public interests, and criminals who are looking for financial gain. The panelists agreed that the government has a role in data security to some extent, but that, in large part, effective security rests with the private sector.

“It’s not lost on the government that this is a huge challenge, one of the biggest threats we have. The government does realize they need to support you and be in a partnership with you, but that’s not going to be the silver bullet,” Sullivan said. “We all have to individually protect ourselves. It’s a technology challenge, but it’s also a people challenge and a leadership challenge.”

“Cyber is both a security issue and a philosophical issue. It’s both about how we are protecting our institutions, and how we are doing business. This is not going to be static; this is going to change every single day, every single week, every single month, every single year. We as a nation are going to need to evolve at the same speed as the evolution of the threat,” Kroloff said.

Speaking to the room full of top health care executives, the experts stressed the need for organizations to have a detailed action plan around security breaches, and the importance of addressing threats from a comprehensive team perspective, not just from the IT department. They emphasized that dramatic changes will need to occur within organizations to effectively protect themselves.

“No matter what your job is, cyber security is your job too. As leaders, you set the tone. If your staff thinks this is important to you, it will become important to them,” Connelly said. “If we can make our employees savvy on how they use technology, not only will they protect themselves but they’ll carry it forward with them in their job as well.”

When it comes to cyber security, much is at stake for the health care industry and the country as a whole.

“Cyber terror is what keeps me up at night. A primary goal of terrorism is to cause chaos, but I think it’s also to create fear of the unknown. People who are trying to cause terror know that America’s optimism and unity are what set us apart as a country,” Ali said. “The answer for cyber security is actually in this room, and among all those living in America. It’s a cultural shift and we have to take the responsibility of how we are sharing our information.”

“The Council presents content that will help our members understand the most pressing issues that our industry faces, so that they can make informed business decisions,” said Hayley Hovious, president of the Nashville Health Care Council. “We are pleased to offer this discussion today, and hope that each of our members walked away with a better understanding of the challenges and solutions that our business faces in cyber security.”

Today’s program was presented by BlueCross BlueShield of Tennessee. Supporting sponsors were Bass, Berry & SimsCressey & CompanyKPMG, and LifePoint Health.

About the Nashville Health Care Council

The Nashville Health Care Council is a premier association of health care industry leaders working together to further establish Nashville’s position as the nation’s health care industry capital. Supported by nearly 300 corporate members, including local and national health care companies, the Council serves as a trusted source for information on trends that influence the health care industry. The organization provides members with one-of-a-kind networking opportunities and access to Nashville’s elite health care business community.

Worldwide, Nashville’s health care industry generates more than 500,000 jobs and $78 billion in annual revenue. The industry is Nashville’s largest and fastest-growing employer. For more information on the Council, please visit www.healthcarecouncil.com.

Center for Medical Interoperability names CEO

Via Nashville Post >>

A local health industry group aiming to overhaul how medical technologies talk to each other has named a new CEO.

The Nashville-based Center for Medical Interoperability has announced the promotion of Ed Cantwell (pictured) to chief executive officer.

Involved since the center’s founding, Cantwell previously served as its executive director. Prior to joining the center, he served as senior vice president at the West Health Institute and president and CEO of InnerWireless and of SpectraPoint. In addition to his 25 years of experience leading advanced technology businesses and developing communications systems, Cantwell served as an Air Force fighter pilot for over a decade.

See the complete article here.

Center for Medical Interoperability names Ed Cantwell as CEO


cantwellNashville, TN (October 27, 2016) – The Center for Medical Interoperability, an organization of health systems dedicated to improving health care by advancing the seamless flow of information among medical technologies, is pleased to announce the promotion of Ed Cantwell to Chief Executive Officer.

Involved since the Center’s founding, Cantwell previously served as its Executive Director, helping establish the initial board and strategic direction. Prior to joining the Center, he served as Senior Vice President at the West Health Institute and President and CEO of InnerWireless and of SpectraPoint. In addition to his 25 years of experience leading advanced technology businesses and developing communications systems, Cantwell served as an Air Force fighter pilot for over a decade.

“After a national CEO search, the board concluded that Ed’s knowledge and understanding of the Center’s mission, the key stakeholders, and the technology architecture and infrastructure needed to achieve interoperability make him uniquely suited to lead the Center,” said Mike Schatzlein, MD, Chairman of the Board of Directors. “This promotion is a testament to the vital role Ed has played in advancing the comprehensive interoperability efforts of the Center.”

“I’m honored to serve as CEO of the Center and help our members holistically address their clinical, business and technical needs. The support of our board and the greater Nashville community for achieving our mission has been tremendous,” said Cantwell.

The Center’s board includes CEOs from the following health systems:  Ascension Health, Carilion Clinic, Cedars-Sinai Health System, Community Health Systems, Hospital Corporation of America, Hennepin Healthcare System, LifePoint Health, Northwestern Memorial HealthCare, RWJBarnabas, Scripps Health, UNC Health Care System, and Vanderbilt University Medical Center. As a cooperative research and development arm for health systems, the Center collaborates with vendors to improve real-time information flow among medical devices and applications, such as electronic health records and research databases, to enable better decision-making by clinicians and improved patient safety.

About the Center for Medical Interoperability

The Center for Medical Interoperability is a 501(c)(3) organization led by health systems to advance data sharing among medical technologies and systems. Members are committed to compelling change and improving patient safety, care quality and outcomes, and reducing clinician burden and waste.

ONC offers help navigating complex EHR contracts, post-go-live usability

Via Healthcare IT News »

The Office of the National Coordinator for Health IT has put out new guidance for choosing EHRs and understanding the fine print of vendor contracts.

The EHR contract guide – subtitle: Selecting Wisely, Negotiating Terms, and Understanding the Fine Print – aims to help providers that are purchasing new systems better understand the intricacies of contract language and negotiate good terms with their vendors.

The guide points toward key rights and vendor obligations that providers can stipulate in their EHR contracts, and also advises about terms to avoid. It also covers patient safety and security risks, data integrity, downtime and other scenarios that can arise after go-live. It seeks to arm providers with the knowledge necessary to enable constructive relationships with vendors  handle disagreements with vendors.

“Purchasing processes and contracts have an important role in ensuring information can move freely and securely across all the devices and IT systems used in patient care,” said Ed Cantwell, executive director of the Center for Medical Interoperability. “This guide can help foster the dialogue between buyers and sellers to achieve that shared goal.”

ONC’s accompanying Health IT Playbook, meanwhile, is a web-based tool that offers clinicians guidance on specific usage topics as they put EHRs to work. It highlights best practices and success stories for system implementation; gives advice for workflow, usability and other optimization challenges, and offers guidance on HIPAA, data exchange, quality reporting and more.

“It is great to see ONC stepping up and creating the Health IT Playbook,” said Steven Waldren, MD, director of American Academy of Family Physicians’ Alliance for eHealth Innovation. “They have engaged family physicians to offer input during the development and we are excited to see it has launched.

“Physicians can find it difficult to keep up to date on the changing requirements for and breadth of information on health IT,” he added. “The simple structure and the interactive tools provided in the Playbook will be an asset to family physicians and their practices as they continue their journey of selecting, implementing, optimizing, and switching EHRs.”

Will MACRA spark interoperability advancements?

The Center for Medical Interoperability introduced a new maturity model and HIMSS publicly commented that focusing on technical interoperability is not enough in the industry-wide move toward value-based care and alternative payment models.

MACRA interoperability advancements

Kerry McDermott, vice president of public policy and communication at the Center for Medical Interoperability said the organization’s recenlty released maturity model can be used to assess interoperability progress.

The rule on the Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) will be released early this fall. But even before it hits the street, the hefty law is having an impact.

MACRA, designed to overhaul how physicians are paid under Medicare and how they must use health IT to achieve value-based care, relies on a definition of interoperability written in 1990 by the Institute for Electrical and Electronics Engineering (IEEE), which calls for “the ability of two or more systems or components to exchange information and to use the information that has been exchanged.”

Under the Merit-Based Incentive Payment System (MIPS) portion of MACRA, an eligible clinician must allow a single unique patient to view, download or transmit their patient record, within a performance period, or allow them to use an application programming interface (API) to access their record–or a combination of both.

Indeed, value-based care cannot be achieved without the interoperable exchange of data and the analysis of the data, to improve care and lower costs.

Todd Cooper, principal of Breakthrough Solutions Foundry, a member of the IEEE Personal Devices Workgroup, said that when trying to implement HIT architectures and solutions, it helps to have a definition.

But he concedes that it would help to have one “with a bit more flesh on the bones to help direct roadmap and development planning” than the one ONC has been using. Whereas ONC has been using the IEEE definition, Cooper recommended a new one by The Center for Medical Interoperability.

The Center, which defines itself as “a united a group of industry leaders to change the status quo,” in fact, recently published an Interoperability Maturity Model.

The model includes five dimensions focusing on infrastructure, syntactic information exchange, terminology semantics, orchestration and the dynamic contextual ability of apps and devices to share patient data based on clinical workflow.

Kerry McDermott, vice president of public policy and communication at the Center said the model can currently be useful to assess progress toward interoperability.

Healthcare IT News parent Health Information Management and Systems Society (HIMSS), meanwhile, earlier this summer encouraged officials from the Office of the National Coordinator for Health Information Technology (ONC) to expand its view of interoperability.

“To simply focus on technical interoperability is not enough,” HIMSS said in its comments to ONC.

ONC should look at how much information is flowing and the extent to which clinicians make decisions by incorporating exchanged data, HIMSS said. That kind of analysis and guidance “could have a greater impact on care delivery than simply looking at the technical capabilities between interoperable systems.”

All of these dimensions, Breakthrough’s Cooper said, “should be addressed in parallel if you want the interoperability tide to raise all ships.”

Via Healthcare IT News »

From the Editor: How Nashville will save health care

HCA Holdings Inc. and Community Health Systems Inc. control a large chunk of the nation’s hospital beds. That gives them significant power to change the health care industry.

So when the two Middle Tennessee hospital giants — and rivals — come together on something, the industry takes notice.


That’s why a new nonprofit group formed to solve health care’s tech woes has courted Milton Johnson and Wayne Smith to join its effort. The CEOs signed on, along with a host of other Nashville and national health care power players, putting serious influence behind the Center of Medical Interoperability that’s building its offices here in Nashville.

Interoperability essentially means the ability of different tech systems to communicate and share data. Technology is rapidly changing health care. And the push for electronic medical records has led to an onslaught of new tech vendors, each with their own proprietary software.

The problem is those systems don’t work together, meaning hospitals and doctors can’t seamlessly share information — which kind of defeats the purpose of going digital in the first place.

The government likely will play a role in solving this dilemma, but health care providers may be in a better position to drive change. They can demand more from their tech vendors by using their checkbooks. When two of the nation’s largest hospital companies say they won’t buy your software if it doesn’t work a certain way, it certainly limits your market share.

That’s the goal of the interoperability center. The center’s director moved the group here to stack its board with the biggest names in health care. And it has, from HCA and CHS to Vanderbilt and Ascension, the parent company of Saint Thomas Health.

Nashville is in a perfect position to lead on this effort. In fact, we have to. The region’s largest industry depends on it, if we want all eyes to stay on Nashville when it comes to health care.

Nashville had long led the way in the world of health care services, largely because we’re home to the two largest for-profit hospital companies in the nation, along with hundreds of other industry players. But larger tech cities are challenging us in the world of health care technology. This center could give us an edge in charting the industry’s future in the world of tech, while holding on to our mantle as the nation’s health care leader.

In today’s cover story, reporter Eleanor Kennedy talked with the man behind the interoperability center and why he chose Nashville to launch this initiative. It’s all about influence and purchasing power.

Via Nashville Business Journal »