Nashville is home to more than 400 health care companies, but the Fab Five are HCA Holdings (HCA), Community Health Systems (CHS), LifePoint Hospitals, Vanderbilt University Medical Center and Saint Thomas Health. Each is a multibillion-dollar organization that employs thousands of health care professionals. It is rare to see the CEOs of all of Nashville’s Fab Five committing their time and energy to a common cause, but that is what happened earlier this month. The cause? Figuring out how different health IT systems can communicate and exchange data.

In 2004, President George W. Bush created the Office of the National Coordinator for Health Information Technology (ONC) with a mandate to implement a “nationwide … interoperable information technology infrastructure.” Now, more than a decade later, only 11 percent of health care chief information officers indicate they are able to routinely exchange electronic patient information with other providers. Our health care data that are supposed to be so useful are stuck in artificial silos created by the different health IT systems that we use. In fact, HHS issued a report this month admonishing the health information community, indicating that “information blocking” by health IT vendors and providers is widespread. Dr. Karen DeSalvo, head of the ONC, noted problems including vendor strategies to obstruct information downloading, competitors’ excessive charges for information sharing, collusion between vendors and providers regarding information transfer, and restrictive terms in vendor contracts. In all, a scathing report that the national investment in “meaningful use” of electronic health records was being deliberately and unintentionally obstructed for commercial gain.

Over the years, several health information companies have attempted to respond by creating the CommonWell Health Alliance. The alliance was designed to promote data sharing, but a number of the largest health IT vendors, including industry leader Epic Systems, are not participating.

Enter the Center for Medical Interoperability and its newest board members: HCA CEO Milton Johnson, CHS CEO Wayne Smith, LifePoint CEO Bill Carpenter, Vanderbilt Vice Chancellor of Health Affairs Dr. Jeff Balser and Saint Thomas Health CEO Dr. Michael Schatzlein. The goal of the Center for Medical Interoperability is to connect these health information silos so that different platforms and providers can communicate and share data freely. The new health information technologies are keys to the paradigm shift to coordinate care across health sectors and among all health providers. This shift will require the ready access and seamless transfer of health data to the point of care without compromising quality or safety.

In addition to the Nashville Fab Five, the center’s board includes representatives from Northwestern University Medical Center, the Robert Wood Johnson Foundation, Cedars-Sinai Medical Center, Johns Hopkins University Medical Center and other national leaders in health services. As the health care industry continues its march through major reform, the ability to share data across platforms and providers is essential. Let’s hope Nashville’s Fab Five can help create a path through the health IT maze.

Richard Cowart is chairman of the health law and public policy departments at Baker Donelson law firm. Reach him at dcowart@bakerdonelson.com.

Via The Tennessean

Prior to flying to Chicago for the annual Healthcare Information and Management Systems Society (HIMSS) Conference, I had a lot to do. More than 40,000 health IT professionals, vendors, policy makers, investors and other stakeholders gather for educational sessions, speeches, exhibits, interviews and social events. And lots and lots of walking.

Along with preparing my presentations, packing and sorting through various meeting requests, I had one critical priority: band practice. My band is preparing for a large (for us) gig at the end of May for our high school reunion.

As with prior events, we welcome guest performers to sit in with the band and as a result, we’ve had a range of people showing up to practice in my basement. Each comes with a guitar or bass, plugs into one of my amplifiers and we start making music. Given the distinctive sounds of some of the songs, we will often use effects pedals with our guitars to get the right tone. Each pedal contributes to the overall sound, easily swapped depending on who is playing what, simply by re-routing cables. While we may obsess over the sound, the one thing we don’t fret over is the setup. We just plug and play.

A few days later I found myself in Chicago, walking the exhibit halls and touring the Interoperability Showcase, where vendors highlight the flow of information from one application to the next. To the casual observer, one would think that the industry had fully embraced interoperability.

But, the truth is actually more complicated.

Earlier this month, the Office of the National Coordinator for Health Information Technology (ONC) released a report saying it is “increasingly concerned about” what it views as unreasonable interference and information blocking coming from both vendors and providers. It noted in particular that a few entities had too much control over electronic health information.

The report said that “current economic and market conditions create business incentives” for certain entities to control electronic health information and limit its availability. It pointed to 60 reports of this practice in 2014. Though no specific companies or “bad actors” were named, the report also included several recommendations to increase the exchange of EHR information. The ONC’s recommendations include creating new transparency obligations for developers and new certification requirements that strengthen surveillance of health IT capabilities and pushing for a national governance framework for health IT exchange with clear principles regarding interoperability and information sharing.

How do we reconcile the seemingly contradictory views between the ONC and the broader health IT industry? Health care is evolving quickly, and the requirements many sought when implementing systems have changed dramatically in the last few years. When Meaningful Use (MU) was born out of the Health Information Technology for Economic and Clinical Health (HITECH) Act in 2009, users sought systems to help document visits between providers and patients. Accountable care organizations (ACOs) did not exist, and outside of integrated delivery networks, few engaged in alternative payment methods (APM) that focused on value or outcomes. Even some of the MU Stage I requirements, such as the requirement to share data with patients by burning them a CD, appear quite dated now.

With value-based care, new priorities have emerged: data sharing, care coordination, patient engagement, and predictive analytics. In addition, consolidation among providers and overall convergence in the industry has accelerated the need for interoperability, not just for electronic health records (EHRs), but also for medical devices, wearables and more.

Ultimately, the broader question is, “How can systems keep pace amid such rapid change?” ONC has said it will work with the US Department of Health and Human Services (HHS) to explore whether creating new conditions of participation in federal health programs is feasible or if a more traditional enforcement agency should take a leading role. The ONC also said in the report that requiring more transparency from developers regarding business practices that could interfere with the exchange or use of electronic health information “would be an effective, market-based approach to preventing many types of information blocking.” In particular, it highlighted enabling customers to access, discuss and share information on vendors.

While there is a role for government to set and enforce rules and point the industry in the right direction, I believe market forces will likely dominate. I can pull any guitar off my wall and plug it into any combination of amplifier and effects to suit my needs. If something does not sound right, I can quickly swap it out. If something goes wrong, I can easily identify and fix malfunctions. Therefore, I don’t buy products that don’t harmonize with the other elements of my system.

Health systems are beginning to shop for technology the same way, both for EHRs and medical devices. The Center for Medical interoperability will assist hospital and health systems as they and broader health care stakeholders advance interoperable practices across the system. With greater needs to connect applications and facilities to meet new payment models and operational challenges, hospitals and health care systems are sending a message to the industry that they intend to buy products that are proven to be interoperable and, in some cases, interchangeable. Industry efforts, such as the CommonWell Health Alliance, which is creating a vendor-neutral platform to advance effective health data exchange, are responding as well.

While I cannot predict how soon health care technology will play well together, the good news is that our band is sounding pretty good. I am also confident that if my friend Pete shows up with his Telecaster, or Dave arrives with his 1949 Gibson J-45, they can join in without missing a beat.

—By Harry Greenspun, M.D., Director, Deloitte Center for Health Solutions, Deloitte LLP

via Health Care Current

During a joint FCC/FDA meeting, stakeholders disagreed on who should be tasked with developing standards for the environments in which wireless medical devices are tested. Some said it’s time for the government to step in, while others warned federal regulations could stifle innovation.

Stakeholders seem to be at odds over who should set standards for proper testing environments for wireless medical devices. While some say it is time for regulatory agencies to step in to provide more certainty for industry and patients, others are concerned government regulation could hamper innovation.

Industry, government officials and standards groups converged in Washington, D.C., at the Federal Communications Commission (FCC) headquarters on March 31 to talk about developing “test beds” for medical wireless devices. The meeting, co-hosted by FCC and FDA, exposed some of the confusion, frustration and rifts that stakeholders have on test beds that would be a platform to test wireless devices so they function securely and safely in different environments.

While some groups, in particular standards organizations, called for more government involvement to standardize test bed requirements, others were more wary and wanted industry to be able to develop its own standards.

“We have isolated test beds doing good work in their own entities but I think the industry needs a common place to go,” said Mick Conley, development manager for industry programs at the safety-standards group Underwriters Laboratories Inc. “I think there needs to be a critical sponsor, possibly the FDA, getting together a collection of member consensus-driven people that start prescribing use cases.”

Some attendees pointed to the Wifi Alliance and its work to develop test beds for wireless devices more generally, but Conley noted that it took 15 years for the alliance to develop those standards. He said the alliance’s work to cover the large spectrum of manufacturers is a model that should be looked at but also points out it is important to develop test bed standards as soon as possible to support device safety. In addition, implementing standards sooner could save industry money, he suggested.

The two main applications of test beds are to provide assurance of interoperability between wireless medical devices and to allow other devices to coexist without interference, speakers at the meeting explained. “Test beds will provide us and consumers the assurance a device won’t break our system,” said Chris Riha, senior director at the Technology Services Group at Carilion Clinic Health System. “It’s not going to be a plug and play; it will hopefully be a plug and don’t break.”

Ed Cantwell, chief operating offering with the Center for Medical Interoperability compared current medical wireless systems to a “seven-dimension chess game” that have to take into consideration factors such as radio frequency, signal type and human behavior.

“The question is can we rise up, and is it time for U.S. healthcare to have a point of view on what wireless really means in a hospital,” he added. “[Regulators have] defined building automation, they’ve defined electricity, they’ve defined every other basic utility but wireless is still like this orchestra where there is no testing whether all the instruments play together.”

Riha said he would like to see a seal of approval similar to the European CE mark that states that a device follows certain approved protocols. But he shied away from endorsing government development of test bed standards, stating he is “philosophically opposed to government regulations.”

Rick Hampton, wireless communications manager with Partners Healthcare System, which includes Massachusetts General Hospital, argued that government regulation is sometimes necessary, especially when industry hasn’t come together to develop its own standards. Even internet providers want to see uniform standards because they are afraid of liability issues when medical devices connect to their portals.

Steven Baker, senior principal engineer with Welch Allyn, which has prioritized development of wireless capabilities for its hospital devices, says he stands somewhere on the spectrum between Riha and Hampton, and cautioned that while stakeholders are discussing developing test beds for wireless medical devices, new companies are continuously entering the healthcare system with devices that often fail in the hospital setting.

“I think we all agree we need a plan, so far industry hasn’t come together to create a plan,” he said. “So while I prefer the industry would do it, maybe there needs to be some government incentive to do it.”

Baker says he doesn’t want to see FDA and FCC to come up with test bed requirements without industry input but also noted getting that input is like herding a thousand cats.

Surjit Ahluwalia, director of Advanced Services at Cisco Systems, says he doesn’t think any single company can address the transformation of wireless medical devices on the market and suggests the answer may be to develop industry partnerships to come up with solutions in specific product areas.

“I believe this is a shared problem we all have to work together to address,” he said. “We can’t just put this on the regulators…because frankly if you overregulate it you’ll have companies stay away from it, you will stifle and stop the innovation that’s happening. And if you leave it open you’ll have all these other problems to deal with.”

The sentiments were echoed by Robert Jarrin, senior director of government affairs at Qualcomm Inc, who said he’d like to see the creation of a public-private partnership that FDA and FCC should oversee. The entity would gather information from companies on what testing tools they currently use and what issues are they facingandreport on how to improve wireless test beds, he proposed.

“The next step should be creating [a national medical wireless test bed] center which could be housed in many different places and the idea would be it would have expertise, it would have access to experimental licenses and tools to help those [who] are developing converged wireless medical devices,” Jarrin added.

Despite the contention over who should set test bed standards, speakers seemed to agree that manufacturers need access to a wide range of techniques to test their wireless medical devices in environments they are likely to be used in and based on risk level. Test beds also need to account for use of wireless medical devices by patients at home and the need for devices to be simple enough for use by people who are not tech savvy, some pointed out.

Test beds should also take into account how wireless medical devices are updated over time and any methodology used should be based on the lifecycle of the device, attendees stated.

Several speakers also emphasized the importance of not making standards too burdensome for smaller medical device companies.

Julius Knapp, head of FCC’s Office of Engineering and Technology, said he and Bakul Patel, associate director for digital health at CDRH, had absorbed the day’s discussion, emphasizing that the agencies do not want to overregulate the industry.

Via The Gray Sheet

By Ferdous Al-Faruque

Technology vendors, hospitals, and health systems restrict data access under the guise of security and confidentiality, but it can be challenging to identify and differentiate information-blocking from more benign impediments, says an ONC report.

The federal government’s $28 billion investment in health information technology interoperability is undermined by vendors and providers who don’t want to share data with perceived competitors, a new study says.

In a report requested by Congress, the Office of the National Coordinator for Health Information Technology said that “information blocking” is a significant problem that is likely to get worse as expectations and the capabilities for HIT mature and improve.

Because of gray areas that include contract restrictions on the disclosure of relevant evidence, and unavoidable technology glitches and snafus, ONC said it can be challenging to identify and differentiate information blocking from more benign impediments.

“However, based on the evidence and knowledge available, it is apparent that some healthcare providers and health IT developers are knowingly interfering with the exchange or use of electronic health information in ways that limit its availability and use to improve health and health care,” ONC said.

“This conduct may be economically rational for some actors in light of current market realities, but it presents a serious obstacle to achieving the goals of the HITECH (Health Information Technology for Economic and Clinical Health) Act and of healthcare reform.”

Most complaints about information blocking target HIT developers, ONC said.

“Many of these complaints allege that developers charge fees that make it cost-prohibitive for most customers to send, receive, or export electronic health information stored in EHRs, or to establish interfaces that enable such information to be exchanged with other providers, persons, or entities,” the report says.

“Some EHR developers allegedly charge a substantial per-transaction fee each time a user sends, receives, or searches for (or “queries”) a patient’s electronic health information. EHR developers may also charge comparatively high prices to establish certain common types of interfaces—such as connections to local labs and hospitals. Many providers also complain about the costs of extracting data from their EHR systems for their own use or to move to a different EHR technology.”

Providers were not exempt from criticism, particularly hospitals and health systems that ONC said were blocking data access under the guise of security and confidentiality to control referrals and enhance market dominance.

“Such constraints are not information blocking insofar as they are consistent with the requirements and policies established by federal and state law that protect patients’ electronic health information,” ONC said. “But it has been reported to ONC that privacy and security laws are cited in circumstances in which they do not in fact impose restrictions.”

For example, ONC said providers cite HIPAA privacy rules when denying the exchange of electronic protected health information for treatment purposes, even though HIPPA specifically permits such disclosures.

ONC said it has also received complaints and anecdotes about some providers and vendors in cahoots to block information exchanges with unaffiliated providers.

“A developer may have the requisite trust relationships and technological capabilities to exchange secure messages using the federal Direct standard with a large network of providers,” ONC said.

“But the developer and provider may implement this capability so as to restrict the exchange of information to physicians who are members of the provider’s care network (e.g., by preventing users from entering a recipient’s Direct email address and requiring instead that users select recipients from a pre-populated drop-down list).”

Who Owns the Data?

Chris Van Gorder, president/CEO of San Diego-based Scripps Health, says the healthcare sector has mostly come to understand that health records belong to the patient.

“I’m sure a few providers are concerned about patients getting access and not understanding the information in the record, but I suspect there are people in the world that get access to their financial information from banks and don’t completely understand that data either. It is still readily available to them,” Van Gorder says.

The only legitimate concern providers have with patient data exchanges is confidentiality, Van Gorder says, because providers are liable for any release of confidential patient data to anyone other than the patient.

He says a bigger obstacle than information blocking is the lack of interoperability of the data.

“We have no standards and requirements for interoperability and that is a huge problem,” he says. “We are at the point now where we are connecting medical devices to electronic patient records, except that the makers of medical devices have not yet done what the makers of USB sticks have done.”

“Each of our thousands of medical devices that can move patient information straight to the patients’ electronic medical record has to be done through a unique connection. This results in a very expensive and complex system. Keep in mind that medical decisions are based on that information so we have to get it right.”

Van Gorder, who last week was named to the board of directors at the Center for Medical Interoperability, says the nation’s healthcare grid needs to develop “a plug-and-play system of medical interoperability that will feed timely and accurate patient information into the EHR. We can improve quality and lower costs at the same time. This effort will need to be adopted and supported by the major EHR vendors as well.”

Via HealthLeaders Media

Several of Nashville’s best-known health care leaders will help lead an effort to improve interoperability in medical technology systems. Milton Johnson, chairman and CEO of HCA Holdings Inc.; Wayne Smith, president and CEO of Community Health Systems; William Carpenter III, chairman and CEO of LifePoint Hospitals; Dr. Jeffrey Balser, vice chancellor for health affairs and dean of the Vanderbilt University School of Medicine; and Dr. Michael Schatzlein, CEO of Saint Thomas Health and a market leader for St. Louis-based Ascension Health, have been named to the board of directors of the Center for Medical Interoperability. They’re part of a 14-member board which includes representatives from other leading medical systems.

Via HealthLeaders Media

The Center for Medical Interoperability has announced its board of directors, which officials say is the next step to jumpstart the creation of a platform to achieve integration of medical technologies in a plug-and-play manner.

The Center was launched with $10 million in funding from the Gary and Mary West Foundation, in conjunction with personnel and technology from the La Jolla, Calif.-based Gary and Mary West Health Institute. Its board of directors consists of executives of some of the largest health systems in the U.S., including Johns Hopkins University, Cedars-Sinai Health System, Robert Wood Johnson Health System, Northwestern Memorial HealthCare, and others.

A key element of the Center’s strategy will be a research and development lab where solutions are collaboratively developed, tested and certified. The Center will aim to work with its members to understand business, clinical and technical requirements, and with the healthcare marketplace in a vendor-neutral manner to develop solutions and share performance results to help drive adoption.

“It is vital that all forms of healthcare technology, including medical devices and electronic health records, be able to seamlessly exchange information so that the quality and safety of care can be improved and costs can be reduced,” Michael M.E. Johns, M.D., the founding chairman of the board of directors, said in a press release statement.

Via Healthcare Informatics

Five executives from Nashville-based hospital operators have joined the board of a new initiative advocating for “plug-and-play” hospital technology — a move that underscores the importance of integrated technology.

The Center for Medical Interoperability, which will have offices in Nashville and San Diego, will try to find ways to bridge the technological divide that plagues the sharing of information between providers and health systems. Medical interoperability would allow systems to exchange and use information rather than the current situation, where information is unable to move between incompatible systems.

The center will have a research and development lab to test and certify solutions that meet the industry’s business, clinical and technological requirements.

The center is funded by a $10 million grant from the Gary and Mary West Foundation, a foundation with a focus on lowering health care costs and senior wellness. Of the 14 board members, five work in the Nashville area.

“It is vital that all forms of health care technology, including medical devices and electronic health records, be able to seamlessly exchange information so that the quality and safety of care can be improved and costs can be reduced,” said Michael M.E. Johns, M.D., the founding chairman of the board of directors, in a prepared statement.

“The current lack of plug-and-play interoperability between medical devices, applications, enterprise systems and electronic health records hinders physicians from quickly and easily being able to access information that aids in making the best decisions for patients. It can materially compromise patient safety, and result in repeated manual entry of data and other inefficiencies that waste billions of dollars each year,” Johns said.

The board of directors:

• Michael M. E. Johns, MD, founding chairman, Center for Medical Interoperability

• Jeffrey Balser, MD, PhD vice chancellor for Health Affairs and dean, Vanderbilt University School of Medicine

• William Carpenter III, chairman and CEO, LifePoint Hospitals

• Dean Harrison president and CEO, Northwestern Memorial HealthCare

• Milton Johnson chairman and CEO, Hospital Corporation of America

• Stephen Jones president and CEO, Robert Wood Johnson University Hospital and Robert Wood Johnson Health System

• Thomas Priselac president and CEO, Cedars-Sinai Health System

• Jon Pryor, MD, MBA CEO, Hennepin Healthcare System

• Paul Rothman, MD CEO, Johns Hopkins Medicine and Dean, Johns Hopkins University School of Medicine

• Michael Schatzlein, MD market leader, Indiana and Tennessee Ministries, Ascension Health

• Joseph Smith, MD, PhD, chief medical and science officer, West Health Institute

• Wayne Smith Chairman, president and CEO, Community Health Systems

• Nicholas Valeriani chief executive, West Health

• Chris Van Gorder president and CEO, Scripps Health

Via The Tennessean

The center, which aims to be a test lab of sorts for providers seeking to integrate patient records, medical devices and other health technology, is announcing its board of directors and $10 million in funding from the Gary and Mary West Foundation today. The center wants to help hospitals and doctors develop, test and certify standards for device and EHR interoperability, and would evaluate standard-setting bodies like HL7 and vendor-driven initiatives like the CommonWell Health Alliance. The goal is to give providers more control over what an interoperable system looks like. “These are the health systems, the entities buying, deploying and using the technology to take care of patients stating what their needs and requirements are and then working with vendors to address that,” said Kerry McDermott, the center’s vice president of public policy and communications.

— Board members include leaders from the Hospital Corporation of America, Community Health, Ascension Health and others including Johns Hopkins, Cedars-Sinai, Vanderbilt and Northwestern, which collectively make up more than 10 percent of hospitals in the country.

The board chair will be Michael Johns, a former vice president of the University of Michigan Health System and chancellor of Emory University. Press release here: http://politico.pro/1NdiAjl

Via Politico