Via FierceHealthcare »

The Senate approved the 21st Century Cures Act Wednesday afternoon in a majority vote. President Barack Obama could sign it into law as early as tomorrow.

The final vote was 94 to 5.

The act covers a broad range of medical reforms and innovations, including fixes to the Food and Drug Administration’s process for approving drugs, funding for the “Cancer Moonshot” and precision medicine initiatives, and expanded access to mental health services.

RELATED: 3 ways hospitals must prepare for 21st Century Cures Act

It also aims to support health information technology goals, including electronic health record (EHR) interoperability and data privacy and security.

Language in the bill could force technology vendors to make their systems talk to one another, prohibiting information blocking and other practices that interfere with data-sharing that would benefit patients. In addition to EHR interoperability, it also addresses product standards and certification.

The act will help dig doctors out of the “ditch” that EHRs have put them in, Sen. Lamar Alexander (R-Tenn.), chair of the Senate Health, Education, Labor and Pensions Committee, said from the floor just before the vote.

FDA fears 

Detractors, including Sens. Elizabeth Warren (D-Mass.) and Bernie Sanders (I-Vt.), say the act gives too much away to pharma companies and weakens FDA oversight.

Sanders, who voted against the act, noted in Senate floor debate yesterday that even President-elect Donald Trump was shocked to learn how much more Americans pay for prescriptions than people in other countries and that the federal government is restricted by law from negotiating drug prices. He urged fellow senators to vote against the bill.

Pharma’s bounty

A Los Angeles Times headline calls the act a “huge handout to the drug industry disguised as a pro-research bounty.”

If universal praise for a measure “makes your B.S. detectors twitch, you’re on the right track,” writes columnist Michael Hiltzik. “The 21st Century Cures Act is a huge deregulatory giveaway to the pharmaceutical and medical device industry, papered over by new funding for those research initiatives. The punchline is that the regulatory rollback is real, but the funding may not be—it’s subject over the next decade to annual appropriations by Congress that might never come.”

A PBS NewsHour piece, meanwhile, lists the “winners and losers” under 21st Century Cures. Not surprisingly, big pharma and medical device manufacturers make the “winners” list. Real-world evidence for approval of new indications for FDA-approved drugs lands in the win column, along with patient advocacy groups.

Losers include randomized clinical trials: “Currently the gold standard for testing drugs and devices for safety, the adoption of real-world evidence standards may indicate that randomized clinical trials will become less important for drug and device approval,” the article notes.

Biden’s ‘Moonshot’

On Monday, the Senate voted to rename the part of the bill that will provide $1.8 billion over 7 years to fight cancer after Joe Biden’s son, Beau Biden, who died of cancer in 2015. The vice president, presiding over the session, teared up as he responded to the formal motion: “Without objection.” He later told reporters he didn’t know of the plan.

“This is one of the last times I’ll preside over an actual vote count,” Biden said on a video shot before the session and posted to Twitter. “This is the beginning of a fundamental change … the urgency with which we treat the need to cure cancer and to turn some cancers into chronic diseases.”

A broad scope

The House voted 392 to 26 in favor of the landmark legislation last week. Rep. Erik Paulsen (R-Minn.) said the legislation is an “innovation game-changer … a once-in-a-generational transformational opportunity to change the way we treat disease. It expedites the discovery, the development, and the delivery of new treatments and cures and ensures that America will be a leader in the global fight for medical innovation.”

The wide-ranging measure (PDF) includes these and other healthcare provisions:

• It provides $4.8 billion to the National Institutes of Health, which includes $1.8 billion to fund the “Cancer Moonshot” to accelerate cancer research; $1.4 billion for the Precision Medicine Initiative to drive research into the genetic, lifestyle and environmental variations of disease; and $1.6 billion for the BRAIN Initiative to improve understanding of diseases like Alzheimer’s and speed diagnosis and treatment.
• It gives $500 million to the FDA to streamline the clinical trial process and hire new staff.
• It provides $1 billion in grants to states to prevent opioid abuse.
• The bill also aims to improve mental health programs, including integrating mental health services into primary care settings and expanding access to mental health treatment and services.

Via Health Data Management »

The new 21st Century Cures Act is about to change healthcare IT, and most of the industry never saw it coming.

Passed easily on Wednesday by the House of Representatives, the bill is expected to sail through the Senate next week. It is supported by President Obama, who undoubtedly will sign it.

Much of the bill focuses on significant FDA regulatory changes, support of mental and substance abuse-related healthcare, and funding for programs such as Vice President Biden’s Precision Medicine Initiative, the Brain Research Through Advancing Innovative Neurotechnologies Initiative, cancer research and regenerative stem cell-based medicine. It also includes mandates to improve healthcare IT—most notably, in relation to nationwide interoperability and information blocking. Suddenly, those “Interoperability Pledges” that EHR vendors signed earlier this year will not be toothless expressions of good will.

Certain sections of the 996-page Cures bill are focused on “improving quality of care for patients” in the area of information technology, with interoperability the front and center concern. HHS will receive $15 million in funding to change ONC’s certification process to help push interoperability and fight information blocking by EHR vendors.

Specifically, HHS will change the conditions of Meaningful Use certification of healthcare IT to include interoperability. To be certified, vendors will not have taken “any action that constitutes information blocking” or “take any action that may inhibit the appropriate exchange, access, and use of electronic health information.” They may not prevent HIT interoperability and must develop application programming interfaces (APIs) or other technologies to enable the application to be “accessed, exchanged and used without special effort.” The vendors also must have successfully tested the “real world use of the technology for interoperability.”

The act also places strong emphasis on providing patients’ access to their electronic health information in a single longitudinal format that is “easy to understand, secure and updated automatically.” It recommends that ONC include this in Health IT certification, as well as providing the ability for patients to electronically communicate their health information to providers. HHS will convene with industry stakeholders to develop regulations that provide specific definitions and criteria. Vendors found to be blocking information are subject to penalties of as much as $1 million per violation.

The act also provides for greater support of networks exchange to advance an interoperable health information technology infrastructure, “for the purpose of ensuring full network-to-network exchange of health information.” The focus will be on establishing public-private partnerships to build consensus and develop a “trusted exchange framework, including a common agreement among health information networks nationally.”

Also See: Is information blocking finally on its last leg?

While no private or public health information network will be required to adopt the trusted exchange framework, federal agencies may require adoption within their networks. Health information exchanges are prohibited from information blocking, as are providers, and are subject to penalties of as much as $1 million.

Within three years of the Cure Act’s enactment, HHS must establish a “provider digital contact information index” for access by healthcare professionals and facilities.

The act also establishes a Health Information Technology Advisory Committee that will unify and replace the existing HIT Policy Committee and the HIT Standards Committee, to provide recommendations and report to ONC. Priority target areas for HHS and the HIT Advisory Committee, working with private and public healthcare stakeholders, will be:

• “Achieving a health information technology infrastructure, nationally and locally, that allows for the electronic access, exchange, and use of health information, including through technology that provides accurate patient information for the correct patient, including exchanging such information.”
• The promotion and protection of privacy and security of health information in health information technology, especially in the area of accounting of disclosures and protections of sensitive information. The act includes “the segmentation and protection from disclosure of specific and sensitive individually identifiable health information with the goal of minimizing the reluctance of patients to seek care.” This emphasis on segmentation of information is significant in the mental health / substance abuse world, where the existing inability of IT systems to separate out data that has not been authorized for disclosure inhibits data exchange and analysis.
• The facilitation of secure access to health information by individuals, family members, caregivers and guardian including when related to age or other disability, cognitive impairment, or dementia.

The committee is authorized to determine other targets, and indeed, the act appears to be recommending specific emphases. It suggests considering targets related to population health, improving child healthcare, and use of telemedicine and “self-service” technologies, and patient matching, among others.

If you were at HIMSS’ 2016 Conference, you couldn’t miss the 20-feet long banners and overall chatter about “The Interoperability Pledge.” Software vendors were challenged by ONC to pledge voluntarily that they would facilitate communication of health information between providers, patients and other healthcare stakeholders. ONC appeared to be preparing for a combined industry/government initiative to get us over the long-time hump of non-interoperability between our many varied EHR systems. Indeed, vendors representing 90 percent of EHRs used by hospitals nationwide signed up.

And then? Nothing. Little has changed. Pledges were voluntary.

But now, with the new 21st Century Cures Act, compliance is going to be the name of the game, once again—and this time, for HIT vendors. It’s about to be time for them to step up and follow through.

Via HealthLeaders Media »

Making patients the stewards of their own health data could result in better access, despite a business environment where health systems do not make sharing a patient’s data with each other a top priority.

The barest outlines of the Trump Administration’s healthcare policy were not yet clear on the morning after Donald Trump’s upset presidential victory, but the CIO of a New York City health system was already looking forward to resolving issues unresolved by the election.

“If we were all on a common shared data platform and could easily access one another’s patient data, I think we would do a much better job of keeping people healthy,” said Daniel Barchi, senior vice president and chief information officer of New York Presbyterian Hospital in New York.

Speaking at the inaugural Techonomy Health conference last week in Half Moon Bay, CA, Barchi expressed hopes that the industry can agree to make patients the stewards of their own data moving forward.

In this way, he believes, patients can be at the center of sharing data in a business environment where health systems still do not make sharing a patient’s data with each other a top priority.

“The standard [in the 2009 American Recovery and Reinvestment Act] was so low,” he said.

“I can send a couple of packets of data. You can send me a couple of packets of data and check the box. That’s it. It’s not really interoperable in any way. And the EMR vendor was really not incented in any way. They were just helping everybody get live on all these new systems.”

No Incentive to Share Data

As a result, healthcare CIOs find themselves having built “really great complex systems within our own health systems, but aren’t incented to share data in any way, and so we’re doing it through a lot of back-door work,” Barchi said.

He equated continuity of care (CCD) documents to “electronic faxes, a couple-of-page PDF version of somebody’s care. Sure you can shoot it back and forth electronically, but you’re not going to interact with it.”

Barchi said he forward to accelerating innovation on the care coordination front.

“There’s an expectation in the technology industry that we have absolute huge airplane hangars full of people at desks making phone calls and checking up on people at home,” he said.

“Even in a $7 billion health system, I might be able to introduce you to our 17 care coordinators individually by name, so we’re not at the level where large health systems have these workforces that are incented to keep people healthy.”

Rooting Out Inefficiencies

Speaking at the same event, another speaker said technology is showing promise to squeeze inefficiencies out of back-office work.

“The provider is the main deliverer of healthcare,” said Jim Dougherty, who serves as CEO and co-founder at Madaket Health, a cloud-based service startup, which automates provider enrollment in payer plans.

“We’ve said we’re going to focus on making their lives better,” said Dougherty, a former member of the board of directors of Beth Israel Deaconess Medical Center in Boston.

Such enrollment still relies too often on laborious fax-based workflows. Via Madaket, a process that used to take a provider and payer 45 days “now takes two days, which benefits everybody,” he said.

Such cloud-based technology platforms can also be extended to accelerate other workflows.

“We at New York Presbyterian have this issue,” Barchi said, commenting on Madaket’s technology. “Mass General has this issue. Mayo has this issue. We all have this credentialing and payer issue with vendors. This is the kind of solution that will get in and solve a problem that occupies anywhere from 10 to 30 full-time employees on this kind of issue.”

One concern is whether to implement such point solutions in a piecemeal fashion, or to looking “to change the way that we’re running the healthcare system.”

Barchi said part of the answer will come from the next generation of electronic medical records.

“There are always upgrades that are happening to get better and better at sharing data,” Barchi said.

Via Vanderbilt University News »

It is the ultimate invasion of privacy: An unscrupulous hacker gains access to a network of interconnected medical devices and then, with a few quick keystrokes, remotely delivers a fatal electric shock to some unsuspecting victim’s pacemaker. This may sound like the plot of a spy novel, but such a scenario, at least from a technological standpoint, is not out of the realm of possibility.

As today’s health care industry relies increasingly on devices and systems that collect and share data between one another, cybersecurity breaches have become a troubling new reality. In fact, just last month, two device manufacturers—St. Jude Medical and Johnson & Johnson—issued separate warnings that their respective cardiac implants and insulin pumps were vulnerable to hackers.

While other industries, like the financial sector, have made cybersecurity a priority for 20 years or more, health care has been relatively late to the game and is now behind the curve in addressing such threats, according to M. Eric Johnson, dean of Vanderbilt Owen Graduate School of Management and Bruce D. Henderson Professor of Management.

“Health care is behind for several reasons,” he said. “It’s a very fragmented industry—you have countless clinical operations, and many of them are quite small and don’t invest in information security. And then at the other end of the spectrum, there are these hospitals that are, in effect, high-tech islands. They have these amazing surgical robots and other technology, but only in the last five years has there been a push to build a more integrated IT backbone with security.”

Johnson, who studies information technology’s impact on the extended enterprise, has co-written a new article examining the chronology of medical device security. Published in the October 2016 issue of Communications of the ACM, “A Brief Chronology of Medical Device Security” is the result of an interdisciplinary project, known as Trustworthy Health and Wellness(THaW), which is funded by the National Science Foundation. A.J. Burns, assistant professor of computer science at the University of Texas–Tyler, and Peter Honeyman, research professor of computer science and engineering at the University of Michigan–Ann Arbor, collaborated on the article.

In the article Johnson and his co-authors identify four major inflection points that span the evolution of medical devices and their security: (1) “Complex Systems and Accidental Failures” (1980s–present), (2) “Implantable Medical Devices” (2000–present), (3) “Unauthorized Parties and Medical Devices” (2006–present), and (4) “Cybersecurity of Medical Devices” (2012–present). The authors also lay out a timeline of important legislation aimed at regulating and/or enhancing security and privacy in the health sector. In the end, they arrive at several conclusions:

• The future of medical device security will be defined by the steps that the health sector takes today.
• Security trade-offs characterize the design and deployment of medical devices.
• Discussions of cybersecurity and medical devices often are distorted by misinformation and frightening language.

With regard to the latter, the authors wrote, “We must resist the temptation to sensationalize the issues related to cybersecurity in the health sector, and instead apply sober, rational, systematic approaches to understanding and mitigating security risks.”

What then should be the appropriate course of action for health care professionals and their patients? Is there one risk they should be concerned about above all others? Johnson and his co-authors offer a clear answer in that regard.

“It is safe to say that patients’ reluctance to accept medically indicated devices due to concerns about security poses a greater threat to their health than any threat stemming from medical device security,” they wrote.

In other words, the biggest danger to patients’ health is not the security threats themselves but rather the irrational decisions that might result from these perceived threats. While users of medical devices may be vulnerable to hackers in theory, there is not enough of a risk, according to the authors, to discourage use of the devices altogether. A hijacked pacemaker makes for an interesting plot twist in a novel, but it is not very likely to happen in real life.

“Unless you’re the president of some country,” Johnson said, “or someone with a lot of enemies, I wouldn’t worry about being personally targeted.”

Via Wall Street Journal »

Dr. Peter Pronovost (@PeterPronovost) is a practicing anesthesiologist, critical-care physician, professor, Johns Hopkins Medicine senior vice president and director of the Armstrong Institute for Patient Safety and Quality. He blogs fromVoices for Safer Care.

If we want to rein in the costs of the U.S. health-care system – now equal to nearly 18% of the nation’s gross domestic product – we cannot ignore the fragmented technologies used to help heal and save lives.

At first glance, the devices, monitors, electronic health records and machines found in today’s hospitals might inspire awe. Look beyond the slick displays with blinking lights, however, and the picture is less reassuring. Rather than working as an integrated whole, these technologies rarely “speak” to one another, reducing productivity and increasing costs. As a result, time that clinicians might spend at the bedside or discussing patient cases with colleagues is used to fill in the gaps between uncoordinated technologies.

For example, nurses scribble down a physician’s instructions for a drug infusion from one computer screen, do math to find the right dose, and then walk to the medication pump and enter the order. Every high-risk medication requires a second nurse to double-check that the pump is programmed accurately — a task that drains staff time. On a 12-bed intensive care unit, these double-checks add up to two full-time nursing positions, we found at Johns Hopkins. Yet if the electronic orders communicated with the pump, this extra work would not be needed, and the risk of entering the wrong dose would diminish.

Clinicians who want to gauge a patient’s progress and risk of complications need to make hundreds of clicks on computer screens, check devices and eyeball the settings on the patient’s bed. In one of our ICUs, the work of ensuring that patients received steps to prevent seven common harms – such as blood clots and infections – takes nearly 20 minutes. Integrate systems and that time can be cut by two-thirds, we found in a pilot project.

Hospital beds typically come with alarms that alert staff when a patient starts to get out of the bed on his or her own. Yet sometimes staff forget to turn the alarm back on — for instance, after the patient returns to the bed following an X-ray. An integrated system would quickly flag patients who are deemed a high fall risk but whose bed alarms aren’t activated. Instead, in many hospitals, staff still must walk from room to room to visually check that bed alarms are on for patients who need them.

Other fields have used systems integration approaches to become high-performing, less costly and ultra-safe. In aviation, for example, controls, instruments and mechanical systems communicate with each other, enhancing pilots’ situational awareness. Pilots don’t spend time poring over topographical maps to make sure they don’t fly the plane into a mountain; the plane gets that data and warns them if they are approaching a cliff. Yet health care has not embraced similar approaches.

Such a change is overdue. There are certainly other solutions to improve health-care productivity and decrease costs. Complications and substandard care make hospital stays longer or lead to readmissions. Staff spend too many hours on required documentation. Hospitals devote enormous administrative resources to working with hundreds of different insurers. Drug prices are constantly rising. Yet we cannot ignore the dysfunctional systems at the heart of how we care.

If we improve productivity by integrating technologies and extracting their data, we can do more than reduce costs. We can transform the patient experience: fewer complications, more “quality time” with their care team, and more opportunities to engage in their care.

Via Medical Economics »

For urgent care physician John Kulin, DO, interoperability of electronic health records (EHRs) has long been a dream—one that remains unfulfilled.

In his Manahawkin, New Jersey, practice, he and his staff of 17 physicians have access to complete medical records for fewer than 5% of all patients despite significant investments in interoperability software. With 60,000 patient visits annually, he gets the patient information he needs electronically from only 3,000. For the rest, the practice relies on paper records. 

“Interoperability is a huge problem,” he says. “Yet, it’s one of the holy grails of actually engaging patients more and using our EHRs to make patient care better so that we’re not operating in different silos. But so far, it’s not happening well at all.”

The federal Office of the National Coordinator for health information technology (HIT) defines interoperability as the ability of information systems to exchange patients’ electronic health information and use information from other EHR systems without any special effort from the user.

For many patients, Kulin has a semblance of interoperability because he benefits from data on prescription medications and lab test results sent directly to his EHR . 

“When we get lab results back through our lab interface, it all comes right into the chart, so now we can compare and graph that data against prior lab work,” Kulin says. “That’s one of the few systems where we have prior data from other providers. That gives us a much better understanding of what’s going on with patients and enhances care.”

Kulin shares patient records via Direct secure messaging (Direct), a protocol for exchanging clinical messages and attachments such as patient records. In the second quarter of this year, physicians and other providers sent 24 million Direct exchange transactions via this secure email system, which complies with federal privacy standards under the Health Insurance Portability and Accountability Act (HIPAA). 

But when it comes to getting patient information from area hospitals and other physicians or imaging test results, Kulin is mostly operating blind. “From an urgent care perspective, I want access to every one of our patients’ medical records, particularly from primary care physicians,” he says.

When he does get medical records from hospitals or physicians, they come mostly via fax. “That’s problematic because it’s a hard copy that we need to read and put into a PDF that goes into the chart,” he explains. 

Interoperability still out of reach

Certainly paper is inconvenient, but for Kulin it’s also a sign that true interoperability is still years away, a factor that drives up costs needlessly. Without access to records, for example, he can’t compare a current EKG with an earlier one, making it impossible to know what’s normal for a patient, he adds.

Not knowing what’s normal means Kulin or someone on his staff may need to send a patient to the nearest emergency department. “Without that information, we’re just operating in a vacuum, and that’s something we never want to do,” he says.

Earlier this year, physicians were optimistic when the Senate Health Education Labor and Pensions (HELP) Committee unanimously passed S. 2511, the Improving Health Information Technology Act, to reform the rules governing federal standards for health information technology and EHR systems. Finally, Congress seemed to be addressing the problems that resulted after it passed the Health Information Technology for Economic and Clinical Health (HITECH) Act in 2009.

But despite the unanimous committee vote and support from members of both houses and both parties, the bill has not come up for a vote. Action on S. 2511 may have slowed because physicians and the Centers for Medicare & Medicaid Services (CMS) are preparing to implement new payment systems next year under the Medicare Access and CHIP Reauthorization Act (MACRA) of 2015. Physicians and HIT vendors have expressed concerns to Congress that the U.S. Department of Health and Human Services (HHS) may be changing too many of the requirements they impose on how  physicians practice all at once. 

So how long will it be before we achieve true interoperability? HIT experts tell Medical Economics that HHS will need to provide more incentives to HIT vendors to make their systems truly interoperable and that HHS has the power to do so now.

In its October, 2015 report, “Connecting Health and Care for the Nation. A Shared Nationwide Interoperability Roadmap,” ONC predicted it would be 2021 to 2024 before the nation’s health system achieves interoperability, which it defines as one that would “enable a learning health system, with the person at the center of a system that can continuously improve care, public health, and science through real-time data access.”

Our experts agree, predicting that true interoperability will be in place by the ONC’s target date. “We definitely want a system where information moves around seamlessly,” says Robert M. Wachter, MD, author of “The Digital Doctor: Hope, Hype, and Harm at the Dawn of Medicine’s Computer Age”and a practicing hospitalist.

It would be best, he adds, if EHR vendors would allow physicians to move patient data easily from one system to another. But that seems unlikely given the restraints physicians face under HIPAA, the fear of system breaches that can—and do expose patients’ records to hackers, and the fact that vendors have little incentive to promote interoperability.

“There’s not a great market advantage for vendors to share. In fact, you could say there’s a market disadvantage to sharing information,” explains Wachter, a professor and interim chair of the Department of Medicine at the University of California, San Francisco. Some EHR vendors for hospitals and health systems don’t share patient information with physicians who are out of network, for example.

To address this problem, the federal government should use its clout as the nation’s largest purchaser of healthcare to get HIT vendors to enable patient data to flow more freely among systems, Wachter says. If necessary, he adds, the government should threaten that “interoperability will be forced on you if you don’t do it yourself.”

A combination of actions such as those called for in S. 2511 and government steps  to require HIT vendors to achieve interoperability will force those organizations standing in the way of interoperability to begin to do so, he explains. 

The double-sided coin of sharing data

But for now, even though all HIT vendors are not working toward true interoperability, Wachter says, “I don’t see any villains here.” He cites the problem of information blocking, which occurs when one EHR system does not allow providers working with another system or working for a different healthcare organization to access patient data. Information blocking is generally not malicious, says Wachter. 

Instead, most IT vendors working for physician groups, hospitals, and health systems serve the needs of their customers—healthcare providers–rather than the needs of the larger healthcare system. In these situations, committing scarce IT resources to sharing with other systems falls to a lower place on the priority list, Wachter says. Moreover, sharing patient data across multiple systems increases the risk that patients’ records could be hacked or stolen, he adds.

What’s more, if patient information leaks out due to a breach, leading to a $1 million fine, then a provider organization might be conflicted about data sharing, he says. “On the one hand, the provider might say, ‘Yes, we want to share information,’ but, on the other, they’re really saying, ‘No, we can’t do this because we don’t feel completely safe with that kind of risk,” he explains. 

The way Farzad Mostashari, MD, former National Coordinator for Health IT, sees it, physicians and other providers bear some of the responsibility for allowing hospitals and health systems to block information and should demand more, he says. 

Not only should physicians demand more from hospitals and health systems, they need to ask more from their EHR vendors, says Mostashari, the founder of Aledade, a company that helps primary care physicians form and operate accountable care organizations. Those vendors are required to meet specific certification requirements, and, previously, these systems were tested against the ONC’s certification standards and showed they could meet those requirements, he adds. But when Aledade evaluated 33 EHR systems to determine if they could meet those certification requirements, most of them failed, he says.

“Only 38% of those EHRs could actually give us an electronic download of the patient’s summary records in standard form,” he says. But when most don’t perform in the field, then neither legislation nor new regulations will solve the problem. “What we need is enforcement of the laws and the regulations we already have on the books,” he says. 

To ensure that their physician clients get the data they need from hospitals, Aledade pays EHR developers and interface vendors to improve the flow of patient information. “That’s a tax on physicians that we pay in order to ensure the success of population health,” he says. 

“Patient data shouldn’t be held hostage,” he adds. “If a physician has a certified EHR and that EHR can’t get the data physicians need, then physicians should complain to the certification body and to the ONC.” 

What’s the solution?

Still, it would be unfair to level all of the blame on providers and IT vendors, because regulators also bear some responsibility for the failure of HIT systems to achieve what physicians want, Wachter adds. “To a large degree we have not created a regulatory environment that promoted the development of an infrastructure for sharing,” he says. 

Congress anticipated that interoperability would reduce redundant services and lower costs, but that hasn’t happened. Realizing the benefits of interoperability will require Congress and regulators at HHS to urge vendors and health systems to allow a more unrestricted flow of patient data. “But exhortation is only the first step,” Wachter says, adding that HHS needs to flex its market power as a buyer and threaten to require interoperability.  

For John D. Halamka, MD, chief information officer of the Beth Israel Deaconess Medical Center in Boston, Massachusetts, interoperability requires technology standards and policies and a business case for sharing data, he says. 

Via Healthcare Informatics »

A new Health Affairs blog by Drs. DeSalvo and Washington shares thoughts on what will be needed to create an interoperable future

The immediate past National Coordinator for Health IT and the recently appointed National Coordinator for Health IT on Sep. 29 co-authored a blog online in Health Affairs touting the gains made in the adoption of electronic health records (EHRs) made in the years since the passage and implementation of the HITECH (Health Information Technology for Economic and Clinical Health) Act in 2009, and laying out their vision of a more digitally interoperable healthcare system. Writing on Sunday in the Health Affairs Blog,Karen DeSalvo, M.D. and Vindell Washington, M.D., the immediate past and current National Coordinators, highlighted the near-universalization of EHR adoption among U.S. hospitals and physician practices, while sharing thoughts on what elements will be needed to push forward the interoperability of healthcare information going forward.

Drs. DeSalvo and Vindell wrote that, “Over the past seven years, the United States has seen a historic health IT transformation, moving from a primarily paper-based health system to one where virtually everyone has a digital footprint of their care because of the dramatic uptake of electronic health records (EHRs). Recent data have helped quantify just how rapidly technology has transformed clinical settings. Today,” they noted, “nearly all hospitals (96 percent) and nearly eight in 10 (78 percent) physicians use certified EHRs. This transformation is the result of 2009’s Health Information Technology for Economic and Clinical Health (HITECH) Act, when fewer than one in 10 hospitals and 17 percent of physicians used EHRs. This rapid uptake of technology reflects the unyielding effort by clinicians and health systems across the board who helped usher in this new era of medicine. The result of this effort is a vast amount of electronic health data now exists which simply did not seven years ago.”

What’s more, DeSalvo and Vindell wrote in Health Affairs, “This transformation represents more than simply digitizing paper health records. It also puts us at a global competitive advantage and is leading to real-world impacts in the clinical setting. Systematic reviews of academic literature found that 84 percent of studies showed that certified EHRs had a positive or mixed positive effect on quality, safety, and efficiency of care. Other recent studies found that EHRs can reduce adverse events among cardiovascular, surgery, and pneumonia patients and that switching EHRs did not result in adverse safety events.”

As the federal officials noted, “These results reflect the vision we laid out in two key documents last year when we collaborated with more than 35 federal partners to develop the Federal Health IT Strategic Plan 2015-2020, and joined forces with the private sector to develop A Shared Nationwide Interoperability Roadmap, which outlines milestones, calls to action, and commitments that public and private stakeholders should focus on achieving, particularly in the near-term, to continue making progress.”

Moving forward, DeSalvo and Vindell wrote, it is the goal of federal officials at the Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS), and Office of the National Coordinator for Health IT (ONC) to create a “learning, person-centered health system,” one that helps the healthcare system to shift from the initial-adoption phase of the past few years to a more advanced phase involving “improving patient experiences and health outcomes” through EHR and other clinical information systems.

To do this, they write, ONC will focus on partnering with public and private partners to accelerate true interoperability of health information, via the following means: “the use of common, federally recognized, national standards; changing the culture around access to information—including combating data blocking; and, building the business case for interoperability.” They add that, “To achieve these goals, the Administration is leveraging impactful tools: delivery system reforms that drive a business case for interoperability; new guidance on the Health Insurance Portability and Accountability Act (HIPAA) to make providers and individuals aware of patients’ rights to access and transmit their data; and requiring publishing application programming interfaces (APIs) to enhance the connectivity between EHRs and provider and consumer applications.”