Blockchain has the potential to transform healthcare in general and the pharmacy supply chain in particular.

The distributed ledger technology could offer legislative, logistical and patient safety benefits for pharmaceutical supply chain management. From a regulatory perspective in the United States, blockchain technological and structural capabilities, in fact, extraordinarily map to the key requirements of the Drug Supply Chain Security Act.

The DSCSA outlines a 10-year timeframe that will require elements including medication track-and-trace, product verification and notification of stakeholders about illegitimate drugs. A shared ledger of information to enable each of these steps is a foundational aspect of blockchain technology.

[Also: Blockchain beyond EHRs: Transforming value-based payment, precision medicine, patient-centric care]

“Logistically, blockchain aligns well with federal efforts like the National Strategy for Global Chain Security,” said Kevin Clauson, Associate Professor in the College of Pharmacy and Health Sciences at Lipscomb University. “One of the most promising benefits of blockchain from a patient safety perspective is to help stem the tide of the so-called SSFFC medicines – substandard, spurious, falsely labeled, falsified and counterfeit – that continue to plague the pharmaceutical supply chain.”

Counterfeit drug prevention

Counterfeit drug prevention is a major use-case for blockchain in healthcare, said Tapan Mehta, market development executive, healthcare and life sciences services practice, at DMI, a mobile technology and services company.

“With an estimated global annual loss of $200 billion due to counterfeit drugs, pharmaceutical supply chain integrity may be one of the most relevant and demanding use-cases for blockchain,” Mehta said. “A blockchain-based system could ensure a chain-of-custody log, tracking each step of the supply chain at the individual drug or product level.”

Potential applications for blockchain in the pharmaceutical industry already are being explored. Take the BlockRX initiative, for example, that has been set up to address the drug supply chain integrity problem by leveraging the distributed digital ledger to support and manage the drug development lifecycle.

“Add-on functionality, such as private keys and smart contracts, could be leveraged as part of this process for seamless supply chain integrity,” Mehta said. “Smart contracts feature software on a blockchain that defines agreement terms and execution that could help to mitigate fraud and lower costs.”

Mehta also said transparency and traceability are key to blockchain in the pharmacy supply chain.

“In the event that a drug shipment is disrupted or goes missing, the data stored on the common ledger provides a rapid way for all parties to trace it, and determine who handled the shipment last,” Mehta explained. “The public availability of the ledger would make it possible to trace every drug product all the way back to the origin of the raw material used to make it.”

The decentralized structure of the ledger would make it impossible for any one party to hold ownership of the ledger and manipulate the data to their own advantage, Mehta added.

Four significant use-cases

Shahram Ebadollahi, vice president of innovations and chief science officer at IBM Watson Health, said he sees four use-cases for blockchain that are especially well suited for the pharmacy supply chain.

“First, Drug Quality and Security Act compliance and track-and-trace,” he said. “DSCSA regulation requires an electronic, interoperable system to identify and trace prescription drugs distributed in the United States. Other countries are implementing similar programs. All manufacturers, distributors and dispensers of prescription drugs in the U.S. market are required to comply.”

Second, controlled substance monitoring. The federal government increasingly is holding the pharmaceutical industry responsible for monitoring the supply chain for the illegal and out-of-pattern ordering of Schedule II drugs (opioids) and is penalizing distributors. Manufacturers are concerned that they, too, will soon be held accountable.

“Third, Cold Chain monitoring,” Ebadollahi said. “Ensure the temperature integrity of pharmaceuticals across the supply chain according to the FDA, USP-NF, EU GDP and WHO guidelines and regulations. Cold Chain shipments are projected to grow 52 percent between 2014 and 2020.”

And fourth, active pharmaceutical ingredients. Monitoring the source and provenance of active pharmaceutical ingredients from raw materials through active pharmaceutical ingredients stage manufacturing and final product manufacturing. The active pharmaceutical ingredients process ends where the processes covered in the Drug Supply Chain Security Act begin.

Two critical opportunities

Blockchain offers two critical opportunities for the pharmaceutical supply chain, according to Maria Palombini, director of emerging communities and initiatives development at the IEEE Standards Association. Those being combatting counterfeits and supply chain optimization.

“The U.S. distribution model is comprised of three key trading partners – manufacturers, wholesalers and pharmacies,” Palombini said. “The current supply chain infrastructure is siloed and fragmented and trying to utilize a patch-fix approach by integrating track-and-trace and other technologies over an outdated approach. The fragmented infrastructure has created an opportunistic market for the growth of Internet pharmacies and the overall counterfeit drug trade. No one patient or entity can truly verify the source of the drug.”

The nature of the drug distribution model compels all three trading partners to have equal transparency into the auditing and tracking of inventory as one depends on the other to ensure medicine is delivered to patients as securely and quickly as possible.

Therefore, again, there are three trusted partners who need visibility of the supply chain and verifying the journey of the drug from manufacturing to the patient. If every entity on the supply chain can have visibility of inventory and audit the distribution of the medicine, that certainly makes it more difficult for counterfeits to reach the market.

Doing what other tech cannot

Manufacturers, wholesalers and pharmacies currently use a variety of tools to help with all of these processes. But there are simply things that blockchain can do that other technologies cannot.

Big pharma, for instance, currently uses several different software programs and databases to manage drug supplies. The introduction of a blockchain system – in which each participant controls a node on the network, and each transaction requires a consensus – would revolutionize the drug supply chain, said Mehta of DMI.

“The decentralization of blockchain also sets it apart from other technologies,” Mehta said. “Most pharmaceutical companies use central databases to manage their supply chains that have systems administrators who can edit, modify or delete records. With blockchain, records are permanent and cannot be altered in any way, ensuring the most secure transfer of data possible. As a result, a company could prevent human error, logistical delays and costs.”

Blockchain is unique because all permissioned users are working with one original, immutable source of information where every chronologically stamped transaction is replicated in every block of the chain that can never be altered, IEEE’s Palombini explained.

“This allows for all parties to verify the source of the information without doubt,” she said. “The very fact that information on the blockchain is immutable enables all the partners on the chain to know they are working with one single record of truth.

True end-to-end supply chain management

Blockchain offers the potential as a unifying solution for management of the pharmaceutical supply chain. Its distributed construct would enable true end-to-end supply chain management and allow participation by multiple stakeholders, rather than being architected as the vulnerable patchwork database approach currently in place, said Clauson of Lipscomb University.

“However, one of the greatest challenges in doing so is around interoperability with legacy systems, which remains a necessity for the near-term,” he added. “This is why work like that by the Center for Supply Chain Studies in simulating models of compatibility will be so interesting to monitor.”

Today, pharmacy supply chains are a series of linked but separate events. Participants often end up buying back data to gain a view of how their products are used or consumed.

By allowing all parties to a transaction access a common record, the veil is lifted, said Giles Ward, executive director at Hashed Health, a consortium of healthcare companies focused on accelerating innovation using blockchain and distributed ledger technologies.

“Blockchain is a network solution. A company does not build their own blockchain – they assemble a network of participants around a problem or process and build a common solution,” Ward said. “If the rules are agreed upon at inception, trust is moved to the protocol level, and transparency is the enforcer.”

Unlike with other solutions, Blockchain participants retain control over their data, including who can see it. Trading partners can share data necessary to complete transactions while keeping priority information confidential.

Streamlining processes, enhancing data

A big question is, how can blockchain help streamline processes or enhance data in the pharmacy supply chain? There are many ways.

In a linear, transparent process, it becomes very clear who is adding value to a transaction and who are merely “rent seekers,” Hashed Health’s Ward said.

“Intermediaries are going to be forced to prove their value or they will be circumvented,” he explained.

Large pharmaceutical companies function through complex and often outdated centralized systems that impede optimal supply chain efficiency, DMI’s Mehta added.

“With blockchain, companies can streamline the development, testing and distribution of drugs, allowing supply chain management to be much more flexible, transparent and secure,” Mehta said. “The future of blockchain in the industry involves highly efficient decentralized structures that enable high transactional throughput and programmability of complex relationships of a large number of users, and therefore can handle a large volume of product and transaction data.”

Simply put: The ability for blockchain to track and distribute data throughout the chain delivers visibility to inventory that was never present before.

“With blockchain, manufacturers can better anticipate drug shortages and better target drug recalls,” IEE’s Palombini noted. “The autonomous and decentralized nature of blockchain streamlines the operations of the pharmacy supply chain removing the manual process of payments, invoicing and routine human error.”

Improving data integrity

Depending on the specific blockchain protocol employed and its accompanying features, the immutable nature of blockchain could enhance data integrity, thereby reducing the load on data stewardship functions.

Acknowledging that the aforementioned benefits are still theoretical in nature, Lipscomb University’s Clauson said that half-a-dozen companies have for the past few years been working on blockchain-enabled Drug Supply Chain Security Act compliance platforms. Those include BlockVerify, iSolve/BlockRx, Chronicled, The LinkLab, Modum, and Vechain.

Blockchain holds great promise for the pharmacy supply chain, as it does for other healthcare applications. It’s early days, but the great potential of blockchain may move more companies into the fold.

As the United State’s national healthcare expenses keep rising, “most ideas are adding cost or nibbling around the edges of the existing cost structure,” Hashed Health’s Ward said. “Blockchain is a once in a generation opportunity to cut up to a third out of the middle. Nothing else comes close to blockchain’s potential.”

Twitter: @SiwickiHealthIT
Email the writer: bill.siwicki@himssmedia.com

Hospital IT and security executives should know that hackers are by no means finished with slicing and dicing healthcare. Ransomware strains such as WannaCry, Petya and NotPetya were only shots across the bow -- there are sure to be many more such cyberattacks to come.

If hospitals have become used to this new reality, the healthcare industry may need to start paying more attention to protecting physician group practices. A colossal 83 percent of U.S. physicians have suffered some form of cybersecurity attack, according to new research from Accenture and the American Medical Association.

[Also: 2018 is primed for blockchain, big data and cloud computing advancements, all with a better security plan]

Fifty-five percent of the 1,300 physicians surveyed said they were very or extremely concerned about future cyberattacks against their practice. Further, 74 percent of physicians were most concerned that future attacks could interrupt their clinical practices and the same percentage worried about the compromise of patient records. Fifty-three percent worried cyberattacks' impact on patient safety.

The most common type of attack against physician practices is phishing, cited by 55 percent of those who experienced an attack. Phishing is followed by viruses at 48 percent. Physicians from medium and large practices are twice as likely as those in small practices to suffer these types of attacks, the survey found.

Sixty-four percent of all physicians who suffered a cyberattack experienced up to four hours of downtime before they resumed operations, and 29 percent of physicians in medium-sized practices that suffered a cyberattack said they experienced nearly a full day of downtime, the survey said.

In this era of non-stop cyberattacks on healthcare organizations, 85 percent of physicians believe it is very or extremely important to share personal health data outside of their health system – they just want to do it safely, the Accenture/AMA survey found.

Two-thirds believe that greater access to patient data both inside (67 percent) and outside (65 percent) their health system would help them provide quality patient care more efficiently. However, the vast majority (83 percent) of physicians said that HIPAA compliance alone is insufficient and that a more holistic approach to assessing and prioritizing risks is needed, the survey found.

“The important role of information sharing within clinical care makes healthcare a uniquely attractive target for cyber criminals through computer viruses and phishing scams that, if successful, can threaten care delivery and patient safety,” said AMA President David Barbe, MD, in a statement. “More support from the government, technology and medical sectors would help physicians with a proactive cybersecurity defense to better ensure the availability, confidentiality and integrity of healthcare data.”

Twitter: @SiwickiHealthIT
Email the writer: bill.siwicki@himssmedia.com

Global Healthcare Exchange, which develops technology for healthcare supply chain management, has launched what it said is a first-of-its-kind tool to help clinicians with the documentation of supplies and implants at the point of care.

The cloud-based Clinical ConneXion offers a single source of truth for item information to support clinical documentation and patient billing, officials say – enabling better accuracy and increased efficiency in the OR, fewer missed charges and improved tracking of supplies.

[Also: The next big thing in pharmacy supply chain: Blockchain]

Clinicians in procedural areas are often required to document supplies and implants at the point of use directly into the EHR, but clinical care often calls for more products than are available in the item master list. Supplies that can't be located on the list must be entered manually as one-time items – which is disruptive workflow and a drag on efficiency, according to GHX. It also diminishes the value of the data in the EHR when its accuracy is in question.

Clinical ConneXion connects supply chain and the electronic health record, linking to GHX's large repository of enriched and validated data, linking directly to the EHR by using the provider’s item master and other data sources to reduce one-time supplies and associated charge reconciliation.

This enables more accurate supply documentation and improved efficiency in supply tracking and case costing insights, allowing hospitals to eliminate the unnecessary expansion of the supply chain item master.

[Also: Supply chain needs security, visibility to stem billions in product loss for healthcare]

“Clinical ConneXion allows organizations to focus on supply chain data while GHX provides the heavy lifting on clinical attributes needed for revenue integrity and downstream systems, such as the electronic health record,” GHX senior vice president Tina Murphy said in a statement. "Accurate, enriched item data is fed directly to the EHR by leveraging the item master and other data sources.”

GHX pointed to the example of Baton Rouge, Louisiana-based Franciscan Missionaries of Our Lady Health System, a 1,799-bed network, which uses the tool in tandem with bedside barcode scanning and has been able to all-but eliminate manual entry of commonly used supplies into the EHR by clinicians (reducing such instances from 50 percent to .05 percent) and improve charge capture (from 40 percent to 95 percent).

"Having good, quality data has enabled the supply chain organization to gain the trust of our clinical teams, because they value the data we are providing," said Bill Mosser, vice president, materials management at the health system. He said the more efficient data capture process has meant that "clinicians are now able to find and select items with confidence and speed so they can spend more time at the bedside with patients."

Clinical ConneXion is now available for Epic, but partnerships with other EHR vendors are soon to come, according to GHX.

Twitter: @MikeMiliardHITN
Email the writer: mike.miliard@himssmedia.com

Just a little more than a month after a judge dismissed its lawsuit against the federal government for the U.S. Department of Veterans Affairs-Cerner EHR deal, CliniComp has fueled a new legal war against the EHR giant.

This time, the California-based EHR developer is claiming that Cerner directly infringed upon its 1997 patent.

Filed this week with the U.S. District Court of the Southern District of California, the suit claims CliniComp CEO Chris Haudenschild filed a patent for an enterprise healthcare information management system that gives users access to remote-hosted healthcare applications through a public network.

The suit alleges Cerner’s remote hosting capabilities on its Millennium architecture mirror the technology described in CliniComp’s patent. Clinicomp is asking for permanent injunctive relief and treble damages as a result of Cerner’s “willful infringement.”

Further, the company is asking for an award of prejudgment and post-judgment interest, costs and other expenses, in addition to other and further relief judged by the court.

“In 1999 [the CEO] recognized the challenge facing healthcare enterprise and conceived of a system that would take advantage of the emerging power of the internet to solve the IT infrastructure dilemma,” the suit reads.

“Rather than have each healthcare enterprise host its own IT infrastructure and be saddled with the burden of maintain and upgrading that infrastructure, Haudenschild envisioned a system where the primary components of the IT infrastructure… would be hosted remote from the healthcare enterprise.”

This is not CliniComp’s first battle with the EHR giant. The company filed suit against the government this summer for the no-bid contract VA gave to Cerner to replace its legacy EHR. A judge dismissed that case in late November based on jurisdiction -- but further details explained CliniComp couldn’t have competed for that contract.

CliniComp later told the VA it would drop its lawsuit if the VA would allow the EHR developer to prove to the agency it could handle the contract for less. So far, there’s been no public response as to whether the VA will take the company up on its offer.

This suit could signal more lawsuits against other EHR vendors, given similarities in the technology.

"Cerner disagrees with the allegations and will aggressively defend the lawsuit," a Cerner spokesperson said in an emailed statement.

CliniComp did not respond to a request for comment before time of publication. We will update this story if more information becomes available.

Twitter: @JessieFDavis
Email the writer: jessica.davis@himssmedia.com

Cincinnati-based Mercy Health, with nearly two dozen hospitals and 500 care sites across Ohio and Kentucky, has joined the AVIA Innovator Network.

AVIA is an alliance of more than 24 leading-edge health systems who share strategies and technologies to deliver higher-quality and more efficient care.

[Also: Slavitt takes on senior advisor role with healthcare innovation network AVIA]

It employs a field-tested methodology, what AVIA calls an innovation blueprint, featuring customized organizational structures and repeatable processes to help health systems drive process improvements.

Mercy, the largest health system in Ohio, said it hopes to harness those innovative approaches and learn from its peers.

"Building an ecosystem of innovation partners is critical to achieving our vision of transforming care delivery across our ministry," Mercy CEO John Starcher said. "We recognize that some of the most innovative solutions may come from outside our organization and have joined the AVIA Innovator Network to accelerate the identification, adoption and dissemination of high-impact digital innovations.

Twitter: @MikeMiliardHITN
Email the writer: mike.miliard@himssmedia.com

Progress in genomic sequencing has led to some exciting breakthroughs in clinical therapies. And now, information about those therapies is becoming available for use within the EHR.

Marc S. Williams, director of the Genomic Medicine Institute at Geisinger, reported in a HIMSS Learning Center webinar today that integration between databases of genomic findings and most EHRs is now possible due to work based on funding by the National Human Genome Research Institute.

Williams demonstrated how EHR Info-Buttons are being used to provide information about genomic data at the point of care in the webinar  Lessons Learned from the eMERGE Network in Preparing the EMR for Precision Medicine.

“Context-sensitive links embedded in EHR systems,” Williams said, “can be used to provide links to online clinical resources to help anticipate clinicians' information needs.” He said the capability is available for addition to any Meaningful Use compliant system.

The work is a collaboration between two NHGRI projects, the eMERGE network and ClinGen. eMERGE is a national network which studies and pilots genomic medicine translation through discovery, implementation, tools, and policy; it is working on EHR integration. ClinGen is building an authoritative central resource that defines the clinical relevance of genes and variants for use in precision medicine and research.

[LEARN MORE: Lessons Learned from the eMERGE Network in Preparing the EMR for Precision Medicine]

Williams said these EHR integrations have enabled pharmacogenomic information to be made clickable, allowing clinicians to navigate directly to a view of guidelines on recommended therapies. 

“We have res-useable reliable algorithms that can be used across almost any EHR,” he said. “It also provides links to guidelines on CLIA certified genetic testing, which is helpful to clinicians who may struggle with where to send out for genetic tests.”

NHGRI was established in 1989 to carry out the role of the National Institutes of Health (NIH) in the International Human Genome Project. The eMERGE Network is comprised of 13 sites, including 2 central sequencing and genomic centers (CSG) and one coordinating center. Each site maintains its own biorepository where DNA specimens are linked to phenotypic data contained within EMRs.

It has a goal to identify 25,000 participates with 100 clinically relevant genes.

The member organizations are Children’s Hospital of Pennsylvania, Cincinnati Children’s Medical Center, Columbia University, Geisinger, Kaiser Permanente Washington with University of Washington and the Fred Hutchison Cancer Research Center, Harvard University, Mayo Clinic, Meharry Medical College, Northwestern University, Vanderbilt University, University of Washington, Baylor College of Medicine, and Partners/Broad.

Twitter: @GusVenditto
Email the writer: gus.venditto@himssmedia.com

Healthcare IT giant Cerner is challenging a contract awarded to competing EHR maker Epic Systems. Cerner is alleging the bidding process was unfair and raises the possibility of conflict of interest.

At issue is a seven-year $62 million contract UI Health signed with Epic for an EHR system to replace a variety of legacy technology. UI Health is an academic medical center associated with the University of Illinois in Chicago.

[Also: New Year's resolution: Dust off that EHR contract to make sure you're as protected as you think]

Go-live was planned for the fall of 2019, Michael Zenn, chief financial officer of UI Health, told Healthcare IT News in mid-September. He anticipated the rollout would take 21 months. Zenn said the Epic system would replace the various technologies in place today, including pieces of Epic, Cerner, Allscripts, McKesson and Midas -- some of which date back to the 1990s.

Cerner filed a protest with the state's Chief Procurement Office for Higher Education claiming the bidding process was unfair and tainted by a possible conflict of interest, according to the News-Gazette, which also reported the project is now on hold.

The News-Gazette, which obtained the details of the Cerner protest through the Freedom of Information Act, also reported Cerner said it was denied a chance to demonstrate its product and Epic was the only bidder to provide a demonstration.

In assessing which vendor would suit UI Health best, a 17-member committee helped develop a process and set technology criteria, Zenn said in September. The team also oversaw development of the RFP – request for proposal – and an evaluation of the responses.

UI also considered technology demonstrations from several vendors.

“For Epic, we had 460 participants in our demo. And we received back 745 evaluations,” Zenn said. “We had a large number of people looking into the process.”

Twitter: @Bernie_HITN
Email the writer: bernie.monegain@himssmedia.com

The Pew Charitable Trusts and American Medical Informatics Association are pressing Congress on its cuts to the Office of the National Coordinator, which will prevent the agency from implementing the EHR reporting program required by the 21st Century Cures Act.

The Cures Act requires the U.S. Department of Health and Human Services to establish an EHR reporting program to measure a platform’s usability, security and interoperability – among other functions. The mandate was designed to help providers choose the right EHR platform for their organizations.

[Also: CMS chief medical officer: We must develop new skills for EHR usability and human-centered design]

However, in October, Deputy National Coordinator for Health Information Technology Jon White, MD, told the U.S. Senate Committee on Health, Education, Labor and Pensions that ONC won’t be able to meet that requirement.

The letter – sent by AMIA Vice President for Public Policy Jeffery Smith and Pew Manager of Health IT Ben Moscovitch – asks Congress to make sure ONC has the required funds to implement these provisions.

The requirement “will provide greater transparency to clinicians and hospitals that the technology they purchase is interoperable and usable,” Smith and Moscovitch wrote. “This provision also has the potential to reduce clinician burden, support care coordination among healthcare providers and improve patient safety.”

Further, the reporting program will give developers and providers better information to improve EHR development purchasing implementation and customization.

AMIA also sent a letter to Congress earlier this week, expressing concern that the Republican tax overhaul could dissuade graduate students from pursuing careers in healthcare informatics due to tuition waivers.

The concern with the Tax Cuts and Jobs Act are provisions that would whittle the stipend for graduate students majoring in health informatics down from $30,000 a year to less than $20,000 under the bill.

The amount would make “graduate studies impossible for many students who have no other means of financial support,” AMIA President and CEO Douglas Frisma, MD, and AMIA Board Chair Thomas Payne, MD, wrote.

“As health informatics students graduate from highly respected schools in biology, medicine and computing-related fields, we anticipate that a disincentive of this magnitude would drive potential students from pursuing graduate research,” they wrote.

The result of which would be “a deleterious effect across both academia and industry, which increasingly relies on high-quality graduate training,” they added. As the health industry increasingly relies on IT, the profession requires a supply of well-trained professionals.

Healthcare IT staffing already is facing a shortage, much like the rest of the country. Security positions are facing an even greater workforce shortage, as the recent HHS Cybersecurity Task Force report found one out of three organizations don’t have a dedicated security leader.

Twitter: @JessieFDavis
Email the writer: jessica.davis@himssmedia.com

The Office of the National Coordinator for Health IT published the Patient Demographic Data Quality Framework of best practices for data management processes that enable hospitals to more effectively match patient records.

Developed in conjunction with Pittsburgh-based CMMI Institute and the Department of Health and Human Services, the tool arrives after CHIME announced in November it would abandon its two-year effort to resolve this issue with its National Patient ID Challenge.

[Also: Best Hospital IT Departments 2017: The winners are in]

ONC’s goal is to boost patient safety by accurately and consistently matching patient data internally as well as between organizations.

The framework consists of five categories: Data governance, data quality, data operations, platforms and standards, and supporting processes. Hospitals can start by evaluating their own organization across those categories.

“When patient data is not accurately matched, treatment and diagnosis decisions are made in the absence of valuable information, and patients could be subject to adverse events and significant harm,” ONC said.

Eighty-six percent of healthcare providers, in fact, know of a medical error caused by patient misidentification, according to the 2016 National Patient Misidentification Report from Ponemon Institute.

“Patients and practitioners alike need to have the assurance that medical errors do not occur due to improperly recorded data,” CMMI Institute CEO Kirk Botula said.

Defining and adopting standards, as well as implementing sound data management processes, requires increased awareness and effective collaboration – nothing short of cultural evolution toward shared responsibility, both within and across healthcare organizations, Botula added.

PDDQ provides an evaluation of data management practices for patient data through all healthcare process areas, including registration, patient care, laboratory, pharmacy, claims and billing.

The PDDQ Framework is available here.

Twitter: @Bernie_HITN
Email the writer: bernie.monegain@himssmedia.com

The new age of precision medicine and genetic testing demands a steep learning curve – for patients and physicians alike. Patients need to be aware of what tests they might benefit from, what the results might mean and what, if anything, can be done in light of them.

Physicians, many of whom learned little about genomics in their medical training, need to know what genetic tests to order and when – and, just as crucially, often how and where.

Technology may still have some ground to gain when it comes to truly enabling precision medicine techniques. But at NorthShore University HealthSystem careful calibration of electronic health records, provider workflows and clinical decision support tools have led to some useful strategies for helping physicians better prescribe genetic tests for their patient.

"One of the key challenges is that genetic and genomic information is rapidly coming at us from all different angles," said Peter Hulick, MD, director of the Center for Personalized Medicine at NorthShore University HealthSystem.

"Even today, traditional medical education cannot address it in enough detail to make every single provider an expert," he added. "Fortunately, we're also in an era where we're able to leverage tools like the EHR and really get doctors up to snuff for the genomic era of medicine – we can put the right amount of information in front of the busy clinician, at the right time, so that they have what they need to incorporate this information right at their fingertips."

Leadership at the Chicago-area health system recognized this is an important direction and allocated resources to modernize the electronic health record, said Hulick. 

The aim, he explained, was to tweak the system to better enable things that might sound easy straightforward but in practice are complicated. Hulick pointed for example to the ability to track a genetic result in the EHR so clinicians know what the patient has been tested for and what the result is as a discrete variable. 

When that data is trackable, "that means you have what we call in genomics a variant repository," he said. "Once you have that, you can start to link it to other information that's known about the patient: family history status, etc. And you can start to build an infrastructure around it and use some of the tools for clinical decision support that are used in other areas: drug/drug interactions, reminders for flu vaccinations, and you can start to build on those decision support tools but apply them to genomics."

Toward that end, NorthShore recently incorporated two new genetic testing programs that primary care docs could use during their annual visits with their patients.

"We're not trying to make all of our primary care physicians into genomic experts… we're giving them enough tools to help them feel comfortable."

Peter Hulick, MD, NorthShore Research Institute

One, called MedClueRx, is pharmacogenomics testing kit that can be mailed to patients in advance of the appointment to evaluate and identify genes they may have that impact how they metabolize certain drugs. The data from that test is integrated into NorthShore's Epic EHR and can help inform the patients' care plans.

Its Genetic & Wellness Assessment, meanwhile, takes stock of health and family history as a means to better indicate need (or not) for either preventative or specialty-based genetic testing. The results of the form, which is completed by patients, are integrated into the EHR.

So far, NorthShore has seen physicians appreciating the chance to learn more about pharmacogenomic testing and how it can be applied to clinical decision-making. The new kits are helping the PCP order up more precise – and relevant – tests, while also helping patients do better with medication adherence and treatment plans.

"We're not trying to make all of our primary care physicians into genomic experts," said Hulick. "That is a difficult strategy that isn't really scalable. But we're giving them enough tools to help them feel comfortable, recognizing when further investigation, such as a referral to one of our personalized medicine clinics."

NorthShore has about 10 clinics based around expertise in different areas, he said, "whether it be inherited cancer, cardiomyopathies, aortopathies, certain arrhythmias – different areas where there are genetic components and a champion in our group may have expertise but a primary care physician may not realize that or understand how to get that patient to the clinics."

Before their annual physical patients fill out some basic yes/no questions to help the PCP get a better understanding of their genetic background and family history.

"When the primary care physician reviews this information, they get what's called a best practice alert – right where they also see things like a flu vaccine reminder, a colonoscopy reminder – to let them know that this patient answered yes to these questions and that they may benefit from a referral or potentially a targeted genetic testing if it's indicated," said Hulick.

"And because most PCPs aren't going to know what tests to order, we've actually gone a bit further," he added. "We're starting to partner with labs who offer testing to make it more seamless in terms of teeing up the specific order based on the questions that are answered. So the primary care doctor just has to basically click on the suggestion."

The key is to do all in the normal workflow of the physician, of course. 

"That's been one of our main goals,” Hulick said, “to bring genetics and genomics into routine care flow."

EHRs aren't typically designed to do this sort of thing out of the box, of course. "Fortunately we have a very innovative IT department and they've helped us maximize what Epic can do and customize it to get genomic data as a discrete variable, build a questionnaire that's deployed electronically, get that FHIR best practice alert that has the information embedded, so the clinician can see more recommendations behind it," said Hulick. "And then actually take action on it. You make this all seamless and minimize the clicks in Epic so it doesn't bog down the clicks for the primary care physician."

Close engagement with the docs has been key to making this work. "We had many educational meetings, brainstorming meetings, planning sessions with our physician leaders in the different areas of content. I myself am a geneticist, and there was administrative support from the medical group in terms of how do we practically deploy this,” Hulick said. “And a huge commitment from our health IT group to how we actually build it."

Amy Lemke, PhD, senior research scientist at NorthShore's Center for Personalized Medicine, said the work began with an exploratory implementation assessment to determine what physicians view as common challenges and perceived benefits of pharmacogenomics.

"That allowed us to use that feedback early on to modify and make some changes prior to full-scale rollout," Lemke said. "The same type of assessment, we're hoping to conduct with the genomic wellness assessment to get some of the provider and patient feedback so we can make the modifications and meet the needs of both."

Lemke added that the work also contributes to the evidence base.  

"We'll look at these findings and see what some patients do – and that's going to feed back into physicians' experiences and they'll see the relevance to their practice and care," she said. 

NorthShore is still at the very beginning of the project – it launched just in the past six months – but the hard work is already paying off.

"We've had more than 20,000 people complete this hereditary assessment," Hulick said. "We are identifying patients who wouldn't have necessarily been identified otherwise as having an indication, for example, for BRCA1 or BRCA2 testing. Some primary care physicians were looking for more structure, and so here we're making it more systematic.

That has proven advantageous at the physician- and enterprise-level particularly when it comes to identifying at-risk patients and understanding why some of they did not complete the appropriate screening or make it to the clinical referral. 

As a large academic medical center, NorthShore is clearly better positioned than many to try a project like this. But Hulick hopes health systems of all sizes can learn from some of their experiences making smarter and more targeted use of genetic testing.

"If you try to design the perfect solution, you will never try anything," he said. "We took initial steps knowing it wasn't going to capture every patient we needed to capture. But if we keep moving the needle in increments we can make real headway. Real world experience can give you a lot more understanding of where are the potential breakdowns of the process and how do you fix them?"

Twitter: @MikeMiliardHITN
Email the writer: mike.miliard@himssmedia.com

The U.S. Department of Veterans Affairs released its report on the functional requirements expected of Cerner with the EHR modernization project.

Typically, these documents are provided to vendors attempting to bid on government contracts. However, VA Secretary Shulkin issued a sole source contract to EHR giant Cerner in June, in an effort to work alongside the Department of Defense and their Cerner install.

The VA has yet to sign the contract with Cerner. 

According to the documents, interoperability is top of mind for the agency. Along with requiring Cerner to provide a level of secure information exchange, interoperability must be far better than the industry standard.

“The Contractor is required to collaborate with VA affiliates, community partners, EHR providers, healthcare providers and vendors to advance seamless care throughout the healthcare provider market,” according to the work statement.

The idea is to create “a design architecture that allows for access to and sharing of common data and an enabling security framework that supports end-to-end healthcare related clinical and business operations.”

By the time of initial operating capability, the platform must enable the VA, DoD and community providers to share interactive care plans and collaborative communication between providers.

Further, within two years of signing the contract, the new system should let the agency share complete referral management activities, along with discharge and admission data.

Cerner will also be required to provide a “computable dataset” for population health, research analytics, clinical decision support and workflow integration, as well as create a tool to identify and manage veterans who are at high risk of suicide.

The work plan further outlined the need to ensure VA services continue without interruption throughout the duration of the project. Cerner will need to provide a transition plan to support the outgoing transition for 90 days, along with staff to support the agency during the “phase-in, phase-out period.”

Cerner will also be required to provide bi-weekly check-ins.

Last week, in response to a Government Accountability Office report that found the VA wasted $1.1 billion on its EHR modernization efforts, House Committee on Oversight and Government Reform leaders said they’re concerned as to whether the VA is equipped to handle the EHR modernization project.

Specifically, Robin Kelly, D-Illinois, was concerned about the VA hiring, firing and rehiring 34 contracts during the GAO study.

The committee said it was reluctant to provide more money for the Cerner contract without an increased VA budget, which may also hinder finalizing the contract.

Twitter: @JessieFDavis
Email the writer: jessica.davis@himssmedia.com

Moving into 2018, hospitals and health systems continue to face many challenges in implementing, maintaining and upgrading their electronic health record systems. These challenges range from technical to security to strategy to human interaction.

Kris K. Wilson, chief information officer at Hilo Medical Center, a Hawaii hospital that has achieved the top HIMSS Stage 7 ranking for its IT work, says cybersecurity will be a top challenge hospitals must face in 2018 when it comes to their EHRs.

"As EHRs mature and collect vast amounts of data, keeping this data safe as adept cybersecurity threats increase must remain at the forefront," said Wilson. "Educating staff on the proper use of hospital systems and placing safeguards within your EHR to limit the amount of data accessible is a good start to overcoming this challenge."

[Also: Want to save hundreds of lives and millions of dollars? Integrate clinical pathway tools with your EHR]

To staff, having only limited access to Internet sites and applications may seem restrictive, but CIOs should see this measure as necessary, she added.

Another major challenge facing EHRs in 2018 is the continued focus on interoperability. Systems need to be able to talk with one another to successfully gain the complete picture of a patient as possible. But as hospital and health system CIOs have discovered over the years, that’s a tall order. Technology and strategies exist to help tackle this challenge, however.

"The major challenge that all of us face is the development of interoperability," said David Ratto, MD, a pulmonary and critical care specialist and hospitalist at Methodist Hospital of Southern California who has been directly involved with the hospital’s EHR. "Whether we are trying to accomplish meaningful use or improve the overall care of our patients, we need improved functional interoperability. Data must be available and needs to be seamlessly transferred from one source to the next."

[Also: EHRs in the cloud: Why smaller healthcare providers are making the leap]

How to take on the challenge of interoperability? Ratto said he'd like to see a scale-back on Stage 3 meaningful use – except for the interoperability segment.

"That should not be pushed out to later dates, and in fact it should be mandated that all vendor products meet interoperability standards," he said. "Some of the standards definitely should be made simpler."

On the interoperability front, Mustafa Ozkaynak, assistant professor in the college of nursing at the University of Colorado Anschutz Medical Campus, pointed to the need for hospital and health system EHRs to play nice with information systems from other types of care provider locations.

"EHR systems should be open to accept data from outside resources such as daily living settings and nursing homes," Ozkaynak said. "As more and more health-related activities take place in daily living settings – home, work, restaurants, etc. – EHRs should be able to use the data collected in daily living settings."

To overcome this challenge, hospital and health system CIOs and other executives should develop strategies for how data from nursing homes, for example, can be integrated into their EHRs, he said.

“The starting point should be reviewing current interoperability strategies and revise them to be more inclusive so that nursing home data can be utilized by hospitals,” he added.

On another front, there is the rise of value-based care in the healthcare industry. And this change in healthcare reimbursement from volume to value will have an impact on EHRs.

"Most EHRs continue to be cumbersome with features driven toward reimbursement for which they were developed, rather than toward value-based care, and that focus is shifting,” said Kurt Hegmann, MD, director of the Rocky Mountain Center for Occupational and Environmental Health at the University of Utah and a partner with Kaiser Permanente, working on their EHR. 

"CIOs and other executives should put themselves in the physician’s shoes; spend a day following physicians and see how they work with their EHR tools, understand the pain points, and hear their suggestions on improving value-based care."

Looking forward a bit, Michelle C. Lardner, RN, deputy CIO, clinical informatics, in the department of clinical research informatics at the National Institutes of Health, said genomics functionality in the EHR is not necessarily a major challenge at most hospitals going into 2018; however, as this practice grows, the need will show itself

"For those organizations that offer precision medicine, the need is certainly there," Lardner said. "That is the challenge. Data such as family history and genetic test results become information and knowledge that can tailor patient treatment and could improve outcomes."

This data must be readily accessible by the nurses, doctors, geneticists and researchers that practice in this field. "We championed this requirement and partnered with our vendor to develop the integrated tools we need for our clinicians and researchers," she added.

And finally, there is the age-old problem of information overload and clinician burnout with EHRs. Technology teams need to get a grip on this challenge to help clinicians do their jobs without tiresome and tedious technical work.

"EHRs are great for gathering information into one tool, but the workflows to manage this are sometimes confusing and overwhelming for the staff, causing burnout," said Matthew Ernst, director of training, documentation and support for digital innovation and consumer experience at Thomas Jefferson University. "When staff get overwhelmed and start to feel burnout, their productivity goes down and possible patient safety issues can creep in."

One of the ways to overcome this challenge is to fund a team that is dedicated to working with the staff to help them understand the workflows, build out shortcuts, and report back to the EHR analysts on any issues – call this the EHR consumer experience team, Ernst suggested.

"This team would partner with the staff, super-users, and designated department contacts, and would give the staff a sense of ownership into its use," he explained. "The goal would be for the staff to become more proficient in its use and be freed for additional tasks."

Revenue recovery can be a logical outgrowth of this approach, he added. Executives can set up a few metrics to measure this.

"One could be the number of patients a doctor sees in a day," he explained. "For example, a doctor becomes more proficient in documenting in the EHR and is able to see an additional patient a day, three days a week. For a hospital with 500 physicians – 1,500 patients a week – 78,000 patients a year. There would be other revenue opportunities with these patients."

Twitter: @SiwickiHealthIT
Email the writer: bill.siwicki@himssmedia.com

Karen DeSalvo, MD, who served as National Coordinator for Health Information Technology from 2014 to 2016 and U.S. Assistant Secretary for Health from 2014 to 2017, will join the faculty at the Dell Medical School at The University of Texas at Austin.

A longtime leader in public health and information technology, DeSalvo was commissioner of health for the City of New Orleans (she worked to help the wire the city's healthcare infrastructure following Hurricane Katrina), before being appointed by President Obama to lead ONC – and, later, coordinate HHS' response to the 2014 Ebola outbreak.

[Also: Karen DeSalvo lays out vision for 'Public Health 3.0,' focuses on social determinants of health]

When she joins the UT faculty in January, DeSalvo will work in the Division of Primary Care and Value-Based Health, with professorships in both the Department of Internal Medicine and in the Department of Population Health.

Dell Med officials say DeSalvo will focus on an array of initiatives that make use of work being done at UT on community health, medical care and research related to the social determinants. She'll also look for innovations in applying technology and digital health to traditional public health programs and strategies.

"Karen is an absolute star who is defining the future of medicine," said Clay Johnston, MD, dean of the Dell Medical School, in a statement. "She recognizes that data is the key to improving the health of populations. This also demonstrates the important role Dell Med can play in vital ongoing policy conversations, at every level of government, about ways to move the system’s focus toward health, not healthcare.

"Awareness that health means more than healthcare cuts across the Dell Medical School," added DeSalvo, in a statement. "As a brand-new institution, it has a unique opportunity to design an educational, clinical and community approach to health."

Twitter: @MikeMiliardHITN
Email the writer: mike.miliard@himssmedia.com

More than a decade ago, healthcare information technology leaders – concerned about electromagnetic interference (EMI) from mobile electronics – banned cellphones in patient care areas. While there was little empirical evidence documenting such interference with medical devices, apocryphal anecdotes and a precautionary attitude led to the bans.

Today, following studies by the Mayo Clinic and other researchers that showed almost no harmful effects from interference, those bans have largely disappeared. Cellphones have become ubiquitous, and they now share the patient room with a host of healthcare IT devices: Computers, monitors, peripherals, smartphones and tablets are all frequently operating within 6 feet of the bedside and exam table, according to a recent study by HIMSS Media¹.

As IT devices in the hands of patients and providers crowd the point of care, the question of EMI and its potential impacts on nearby medical devices – and patients – is being raised once again. There are new concerns about the impact of wireless technologies such as Wi-Fi and Bluetooth. And experts are also resurrecting worries about the risks of leakage currents when non-FDA-approved equipment is not properly grounded.

Consumer-grade concerns

Unlike medical devices that undergo rigorous electronics instrumentation testing to meet the International Electrotechnical Commission’s 60601 and, more specifically, 60601-1-2 standards, commercially produced desktops, laptops and tablets are not required to meet similar emissions standards.

“These products are designed for consumers and office environments, not clinical settings,” explained Raja Bhadury, head of HP’s care delivery portfolio. “The risk of electrical shock, burns and even cardiac arrhythmias due to leakage current from improperly grounded IT products is not fully understood.” As such, these IT devices are usually not rigorously tested for clinical environments. “Besides, considerable investment is needed to design products to meet these higher emissions standards, and it takes time to go through the certification testing.”

Juuso Leinonen, project engineer at the nonprofit ECRI Institute, said the patient safety-focused organization is aware of only isolated incidents in which high-powered radio transmitters (namely, two-way radios) interfered with the function of some fluid warmers operated in close proximity.

“Overall, most consumer-grade equipment is low-powered, which seems to mitigate the concern with EMI,” Leinonen said. “At least at present, we do not have reports to support this being a significant issue in the healthcare setting.”

But leakage current, on the other hand, poses a threat for certain types of patients, as it has for decades. In 2004, authors Leonard Eisner, Robert M. Brown and Dan Modi provided a primer on leakage current standards for Medical Device + Diagnostic Industry readers. “Leakage current is one of the most stringent, yet telling, parameters of possible danger to patients or caregivers,” they wrote more than a decade ago. “This is especially true for patients with weakened immune systems.”

Proactively weighing the risks

Good data on any negative impacts caused by leakage current have been hard to come by. One reason for the lack of empirical evidence is patients’ vulnerable state at the onset. It can be difficult to determine whether leakage current or an already weakened organ causes problems with immune-compromised or cardiac patients.

Despite the lack of firm research in this area, healthcare providers would be wise to proactively weigh the risks of EMI in their current IT equipment infrastructure, especially with a growing fleet of consumer IT equipment residing in patient rooms, edging ever closer to patient beds. That review includes assessing purchasing plans and guidelines, scrutinizing potential equipment and working with vendors to ensure patient safety at all times. 

Specifying a “minimum separation distance” (MSD) between IT devices with radio transmitters and sensitive medical devices can also help reduce risk. Researchers from Concordia University in Montreal found that when hospital staff comply fully with a MSD policy of even one meter, they can operate devices in the same room as the patient and medical equipment without posing a danger².                             

“The reality is, there’s always some risk,” Bhadury concluded. “PC vendors must work with their healthcare customers and regulatory agencies to assess the risk and make thoughtful design choices to address the risk.”

References

1. HIMSS Media, Creating a Patient-Safe Technology Environment: a HIMSS Custom Research Report. Prepared for HP. October 2017.
2. “Can personal devices interfere with hospital care?” Science Daily, June 16, 2015, https://www.sciencedaily.com/releases/2015/06/150616123921.htm

When it comes to technology on the front lines of healthcare data security, data loss prevention software is one of the key defenses to safeguard protected health information – nearly as important as firewalls and antivirus.

A new report from KLAS looks closely at DLP technology from various vendors, from full-suite to niche, assessing their performance based on interviews with security professionals, mostly chief information security officers. CISOs weighed in the capabilities they're most focused on deploying, the tools they need to support and optimize, and the security insights their DLP tech offers them and more.

DLP software is able to identify protected health information and prevent it from escaping the confines of a health systems's network, whether by hacker or human error.

The technology can safeguard data at rest (scanning servers and hard drives to see where PHI is located, and encrypting it when it's not authorized), data in motion (monitoring of network traffic to filter or encrypt PHI when found in emails or IMs) and data in use (a hospital can monitor how staffers interact with PHI – saving, copying/pasting, etc.).

KLAS examined how various DLP technologies manage with data encryption, email encryption, email filtering, web filtering, file-sharing encryption, device lockdown and identification of high-risk behaviors. It polled CISOs about full-suite vendors (Digital Guardian, Symantec), limited data vendors (Cisco, Forcepoint, McAfee, Microsoft) and niche technologies (Proofpoint, Zix).

Among KLAS' findings: Symantec’s and Digital Guardian’s wide array of offerings have led to their technologies being most widely adopted among those surveyed; Proofpoint earned-high-marks for intuitive functionality and high capacity for optimization, and Symantec customers liked the alerting and reports it gave them, enabling more actionable insights.

"For larger organizations that prefer a one-stop-shop vendor capable of meeting a variety of needs, Symantec and Digital Guardian offer solutions that are proven to be consistently deployed across multiple capabilities," according to KLAS. "Many smaller organizations prefer to start with a limited DLP scope, such as email filtering/encryption, and then build out the business case for further DLP capabilities."

Optimization is key to a well-running DLP system, and providers want a tool that works well from the get-go but also lends itself well to tailoring to their own specific needs, the report finds.

"All DLP solutions require a period of fine-tuning in order to effectively identify PHI and reduce false positives," researchers said. "Proofpoint’s limited scope of mainly email filtering/encryption capabilities allows them to deliver a product with good baseline rules out of the box and easy optimization through instructive webinars and on-site staff.

"Digital Guardian excels at accurately identifying PHI through their robust fingerprinting/rules capabilities," they added, "though satisfaction is hindered by the timeliness and quality of support staff during and after the initial optimization process."

Once DLP technology has been fine-tuned, the focus turns to the analytics it provides – via dashboards, alerts and other notifications – enabling staff to take preventative action for at-risk PHI, without interfering with clinical workflows

In that area, Symantec earned high mark from CISOs, who said its "robust reporting and configurable alerts enable them to highlight security vulnerabilities and drill down into incidents when sensitive PHI is at risk," according to KLAS. "Forcepoint clients are frustrated by having to create their own reports and dashboards, while Microsoft clients share challenges in pulling reports that support their security programs, though feedback is limited."

Twitter: @MikeMiliardHITN
Email the writer: mike.miliard@himssmedia.com

Epic Systems just revealed that its new EHR, dubbed Sonnet, will be available in March 2018 and its new implementation tool Utility is already being used.

Epic CEO Judy Faulkner first mentioned Sonnet at HIMSS17, when she described it as a slimmer version of the Epic EHR one might see in many large healthcare systems today.

Sonnet has fewer modules and a reduced feature scope, Epic spokeswoman Meghan Roh said. “Sonnet provides the benefits of a robust, integrated EHR at a lower price point.”

[Also: Epic CEO Judy Faulkner reveals two new EHR versions are in development]

That lower price means Epic will now be effectively competing with smaller electronic health records vendors, most notably athenahealth and eClinicalWorks, in that market segment.

Sonnet is designed for small hospitals, small physician groups, post-acute care facilities, and some international organizations, she said. It uses what Epic refers to as the short Compact Method for install.

Utility has been in play since the fourth quarter of 2017, with those projects slated to go live in 2018. The goal is to give customers a choice that is right for them, she said.

 “It is for organizations that want fast installs that utilize our best practice ready-to-use designs with minimal modification.”

Faulkner explained during an interview at HIMSS17 that Epic is a long poem and Sonnet is a shorter poem, and that she personally names all the products, including the full Epic offering “all-terrain.”

Twitter: @Bernie_HITN
Email the writer: bernie.monegain@himssmedia.com

Artificial intelligence is starting to make its mark on healthcare in a big way. That's got a lot of people really excited – and not a few are a little nervous.

For all the promise AI holds, after all – the chance to reshape clinical workflows and enable big advances in data analytics and precision medicine, to name just a few – some experts are raising concerns that such automation will start to edge out the human beings who are so crucial to care delivery.

[Also: As AI spreads through healthcare, ethical questions arise]

A report from Infosys earlier this year, for instance, suggested that as health systems forge ahead with their AI deployments, they should also be careful to "establish ethical standards and obligations for the organization" as some people are inevitably displaced from their healthcare roles by automation.

A new study in the Journal of the American Medical Association takes a close look at how AI could lead to big improvements in the way information and technology are leveraged in healthcare, specifically with regard to electronic medical records. But it also makes the case that humans have an indispensable role to play along the way.

"The redundancy of the notes, the burden of alerts, and the overflowing inbox has led to the '4000 keystroke a day' problem and has contributed to, and perhaps even accelerated, physician reports of symptoms of burnout," researchers wrote. "Even though the EMR may serve as an efficient administrative business and billing tool, and even as a powerful research warehouse for clinical data, most EMRs serve their front-line users quite poorly."

[Also: Machine learning will replace human radiologists, pathologists, maybe soon]

Moreover, as has been often noted, the arrival of technology in the exam room and radiology suite has led to "unanticipated consequences," sometimes, such as a depersonalization between the patient and a physician hunched over a computer screen and "important social rituals" such as conversation among clinicians to discuss potential diagnoses.

The authors warn about other unintended consequences as AI and machine learning continue to make inroads across healthcare. Both offer big opportunities to help providers "process and creatively use the vast amounts of data being generated," but care must be taken to do it right.

AI's ability to automate the the repetitive tasks that occupy so much of a clinicians' time would be welcome, the Stanford researchers write, noting that "automated charting using speech recognition during a patient visit would be valuable and could free clinicians to return to facing the patient rather than spending almost twice as much time on the 'iPatient'—the patient file in the EMR."

But automation has its perils too, of course. For instance, when developing predictive models, "there is nothing more critical than the data. Bad data (such as from the EMR) can be amplified into worse models." Simply allowing machine learning to run without human intervention presents clear risks.

"Instead, clinicians should seek a partnership in which the machine predicts (at a demonstrably higher accuracy), and the human explains and decides on action," the authors write. "The 2 cultures – computer and the physician – must work together."

Despite the very real apprehensiveness about how unfettered AI could distort data models when improperly applied, and "legitimate concerns that artificial intelligence applications might jeopardize critical social interactions between colleagues and with the patient," the authors are skeptical of some other oft-voice worries about AI.

"Concerns about physician 'unemployment' and 'de-skilling' are overblown," they said.

Instead, when well-deployed, AI could "bring back meaning and purpose in the practice of medicine while providing new levels of efficiency and accuracy." But as they embrace the technology, physicians must "proactively guide, oversee, and monitor the adoption of artificial intelligence as a partner in patient care." 

The JAMA article, "What This Computer Needs Is a Physician: Humanism and Artificial Intelligence," Abraham Verghese, MD; Nigam H. Shah and Robert A. Harrington, MD, all of Stanford University School of Medicine, see lots of room for improvement in EMRs.

Twitter: @MikeMiliardHITN
Email the writer: mike.miliard@himssmedia.com

EHR vendors Epic, Cerner and eClinicalWorks dominated the most-read articles throughout the last 12  months -- with news both good and bad. Also in the mix: patient safety struggles, artificial intelligence, blockchain and next generation of electronic health records that vendors are collectively agreeing will be CHRs, as in comprehensive health records. 

Here are the 10 most-read Healthcare IT News articles of 2017. 

1. These 10 hospitals scored an 'F', pose the greatest risk to patients, Leapfrog says

Hospital watchdog Leapfrog released its Spring 2017 Hospital Safety Grade on April 12. It highlights hundreds of hospitals that are leading in preventing deadly medical errors at their facilities. The national healthcare rating is focused on errors, accidents and infections. It assigns ‘A’ through ‘F’ letter grades to hospitals.  Leapfrog rated 2,639 hospitals, and 823 hospitals earned an A, 706 earned a B, 933 earned a C, and 167 earned a D.

2. Epic CEO Judy Faulkner reveals two new EHR versions are in development

Epic Systems founder and CEO Judy Faulkner at HIMSS17 in February told us in an exclusive that the company is building two new versions of EHRs, each with a lyrical name. “We’re finding that people need different things,” she said. A critical access hospital, for instance, doesn’t need the full Epic iteration. The two forthcoming versions of Epic can provide a pathway to adding all the features at a later time. They are designed for smaller organizations and will be lower in cost.

3. eClinicalWorks to pay $155 million to settle suit alleging it faked meaningful use certification

At the end of May, the United States Department of Justice charged EHR vendor eClinicalWorks false claims for federal incentive payments under the government’s Meaningful Use Program. The whistleblower suit alleged that the company’s software failed to accurately record user actions with audit log functionality, did not always accurately record diagnostic imaging orders or conduct drug-drug interaction checks and did not satisfy data portability requirements designed to enable doctors to transfer patient data to vendors’ EHRs.

4. Epic CEO Judy Faulkner is standing behind switch from EHRs to 'CHRs'

Faulkner said in late Septmeber at Epic’s user group that the time has to come to drop the ‘E’ from electronic health records and replace it with a C. ‘E’ has to go away now. It’s all electronic,” Faulkner said. CHRs would include more types of data, such as social determinants, about what people eat, how much they sleep, if they are obese or live in a food desert (or both), and whether they are lonely, because all of those factors can have an enormous impact on an individual’s health. 

5. PwC's top 10 healthcare industry issues for 2017

“Top health industry issues of 2017: A year of uncertainty and opportunity” is how the consulting firm PWC characterized the healthcare landscape as 2017 neared. PwC viewed the fate of the Affordable Care Act as unclear. The firm saw pharma’s business relationships with Washington and with its customers might undergo major changes. “New technologies will alter many of our preconceptions about healthcare delivery,” PwC concluded. The shift towards value-based care would continue its development, altering the healthcare landscape.

6. Top 10 healthcare technology advances for 2017, according to ECRI

ECRI Institute created its “Top Ten Hospital C-Suite Watch List” at the start of 2017. Among the developments, the nonprofit organization saw in its crystal ball are the upsurge of artificial intelligence. Also, it forecast genetic testing and biosensors for opioid addiction. ECRI anticipated fluorescent endoscopic imaging. Indocyanine – green imaging that highlights malignant tissue during an endoscopy. It is normally undetectable under regular light. Green imaging lets physicians easily distinguish malignant tumors from healthy tissue and Type 1 diabetes vaccines.

7. Epic to jump into medical billing, currently hiring for new unit

A want ad recently appeared on the website of Verona, Wisconsin-based electronic health record colossus Epic Systems Corp. for "bright, motivated individuals to join our new billing services team as we enter the world of medical billing." Epic explained that it will take on some of the billing work and associated IT functions, for Resolute Professional Billing customers, when announcing the new service at the end of June. 

8. Cerner sued for $16 million over revenue cycle rollout

Wisconsin-based Agnesian Healthcare is suing Cerner for fraud and breach of warranty, claiming issues in its billing software resulted in losses of over $16 million. Also, the hospital said in the suit, filed Septmber 15, that the issues have tarnished its reputation and claims $200,000 a month in damages.The hospital went live with Cerner’s revenue cycle software in 2015 and paid $300,000 for the platform. In the suit, Agnesian said problems with the software began almost immediately after the installation that resulted in “pervasive errors” in billing statements to patients. “Cerner disagrees with the allegations and will aggressively defend the case,” Cerner responded. This one may or may not be settled in 2018. 

9. How AI is transforming healthcare and solving problems in 2017

Artificial intelligence is more than just a promising future state. It’s here, machine learning are  startups like Augmedix, BrainQ, Byteflies and Cytovale are sprouting up. Augmedix is working to cut the time doctors spend on a computer during patient visits by leveraging Google Glass. Another example: Nuance recently introduced a AI virtual assistant for healthcare. Nuance’s new Dragon Medical Virtual Assistant is designed to streamline a variety of clinical workflows for the 500,000 clinicians that already use Dragon Medical for their clinical documentation.

10. How does blockchain actually work for healthcare?

Hospitals need to understand blockchain. The so-called digital ledger technology was developed in 2008 by Satoshi Nakamoto, a possibly pseudonymous person (or perhaps multiple people) who designed it as the underpinning for the exchange of the digital cryptocurrency known as Bitcoin. While the two most commonly cited examples of how blockchain can be used in healthcare are data interoperability and security, the stream of new possibilities is flowing as well, including as a master patient index, claims adjudication, supply chain and clinical trials. Today, Hospitals currently have as many as 20 different ways to enter a simple date-of-birth and no real way to standardize that once it’s been done.

Twitter: @Bernie_HITN
Email the writer: bernie.monegain@himssmedia.com

Epic Systems, and its founder and CEO Judy Faulkner were the subjects of well-read news throughout 2017. Here are the top 10 Epic Systems news stories as gauged by our readers' interest:

1. Epic CEO Judy Faulkner reveals two new EHR versions are in development

"We're developing some really nifty new software," Epic founder and CEO Judy Faulkner told Healthcare IT News at HIMSS17 in Orlando this past February.

Epic is ready to make good on its promise to provide new versions of the EHR technology, she said, including Sonnet, which has a lower price point, and is aimed at hospitals that don't require all the bells and whistles of the full Epic EHR

"We're finding that people need different things," said Faulkner. "If you are a critical access hospital, you don't need the full Epic. The two new versions of Epic in development can provide a pathway to adding all the features at a later time."

Earlier this month, Epic announced that Sonnet would be available starting in March.

2. Epic CEO Judy Faulkner standing behind switch from EHRs to CHRs

"Because healthcare is now focusing on keeping people well rather than reacting to illness, we are focusing on factors outside the traditional walls," Faulkner told Healthcare IT News.

"'E' has to go away now. It's all electronic," Faulkner said at the company's user group meeting in late September 2017. "We have to knock the walls down whether they're the walls of the hospital or the walls of the clinic." As she sees it, the 'E' should be replaced with a 'C,' for "comprehensive."

3. Epic to jump into medical billing, currently hiring for new unit

A want ad popped up on the Epic Systems website, looking for "bright, motivated individuals to join our new billing services team as we enter the world of medical billing.

"Our goal is to simplify the payment process by helping Epic organizations with the complexities of submitting claims and posting payments," the ad read. "Attention to detail is vital as you'll be posting payments and denials; reconciling payment files, claims, and statements; resolving posting errors; and calling payers to follow up on outstanding or unpaid claims."

4. Epic sued over millions in alleged anesthesia over-billing

In November, Epic was hit with a False Claims Act suit that alleged the company's billing system double bills the government for anesthesia services. According to the suit that was made public last November, an alleged glitch in the system resulted in hundreds of millions of dollars of overbilling. The company responded that the plaintiff's suit stemmed from "a fundamental misunderstanding of how claims software works."

5. Allscripts, Cerner, Epic signal more open EHRs ahead

Top executives at three electronic health record companies –  Allscripts, Cerner and Epic – revealed in March 2017 they were working to make their EHRs more open, embracing APIs as a means to enable third-parties to write software and apps that run on their platforms. Epic, for its part, was working on two new versions of its EHR and developing Kit to go with its Caboodle data warehouse (as in Kit and Caboodle). CEO Judy Faulkner said Kit "is making everything very open."

6. CVS-Aetna merger will make an even bigger giant out of Epic

While early reports in mid-December about the planned $77 billion merger between CVS, an Epic customer, and Aetna focused on massive market share in the pharmacy and insurance realms, there was also the implicit promise of a new era in analytics, interoperability and population health. Alan Hutchison, Epic's vice president of population health, said that by using Epic's Care Everywhere and Share Everywhere interoperability tools, CVS and Aetna could provide the community with information and insights to improve care.

7. Epic tops 2017 Best in KLAS awards, securing top spot for 7th straight year; see complete winners

At the end of January 2017, Epic Systems again landed the top spot for Overall Software Suite in the 2017 Best in KLAS: Software and Services report. The win marked the seventh consecutive year Epic took top honors in the report, draws from healthcare provider feedback. Epic also earned the top Overall Physician Practice Vendor and Best in KLAS awards in eight segments.

8. What happened when GE tried to buy Epic and Cerner and was shut down within 5 minutes

Former General Electric CEO Jeffrey Immelt revealed at the beginning of December that GE had once tried to acquire Epic and Cerner at different times. He said Faulkner told him, 'No, not interested." Immelt recalled the meeting lasting less than five minutes. (As for Cerner, the price was too high.)

9. How the Coast Guard's ugly, Epic EHR break-up played out

What began as a straightforward software contract with Epic resulted in the U.S. Coast Guard starting its entire EHR acquisition process over some seven years after it began. EHR implementations are notorious budget-busters often fraught with missed deadlines and other unforeseen complications, but for an organization to abandon the project altogether and embark on a new beginning is uncommon. Indeed, this occurrence includes some finger-pointing from both sides. So, what exactly went wrong?

10. Mayo Clinic kicks off massive Epic EHR go-live

Mayo Clinic hit a milestone this year with its $1.5 billion system-wide Epic implementation. The first 24 sites went live on July 8. The organizations said Epic will replace Mayo's existing three EHRs, which include rivals Cerner and GE Healthcare, as the hospital system's sole electronic health record platform.

Twitter: @Bernie_HITN
Email the writer: bernie.monegain@himssmedia.com

Hospitals participating in a Medicare Shared Savings Program have a leg-up on the value-based delivery structure needed to meet quality payments under MACRA. 

Hospitals can achieve savings and physicians in these accountable care organizations can earn bonuses for participating in MACRA’s merit-based incentive payment system.

“ACO-affiliated doctors do better on MIPS because they’re in an ACO,” said Tim Gronniger, Senior Vice President of Development and Strategy at Caravan Health in Kansas City, Missouri. 

[Also: Why more tech vendors are targeting ACOs with analytics, care management tools]

But there is more than one road to ACO Shared Savings results and a debate is brewing about whether it makes more sense to turn to technologies including EHRs and HIE software or start by focusing on physicians. 

Here are perspectives from Caravan, as well as Innovation Care Partners in Arizona and its ACO Scottsdale Health Partners, and Advocate Health Care in Illinois along with its ACO Advocate Solution Partners Accountable Care.

How Shared Savings work

The Medicare Shared Savings Program encourages ACOs to better coordinate patient care and reduce healthcare cost. 

The Centers for Medicare and Medicaid Services is giving ACOs more of a financial incentive to bear downside risk as an advanced alternative payment model. ACOs qualify to earn a lump-sum bonus payment equal to 5 percent of their Part B expenditures. 

To add to the some of the confusion over MACRA, this summer CMS gave mixed messages over how seriously it was moving forward with value-based initiatives when it raised the low volume threshold for MIPS, taking some doctors out of the program.

[Also: ACO wrangles data from 45 different EHRs for real-time analytics]

But most clinicians are participating in MIPS. Performance in 2017 affects payment in 2019. If physicians are not participating in MIPS, their compensation is frozen over the next few years, said Gronniger, who formerly worked as deputy chief of staff for CMS.

MSSP is working to save money for about 30 percent of the ACOs in the program. 

In 2016, the latest year for program results, 134 out of 432 ACOs in the Medicare Shared Savings Program earned savings of more than a collective $700 million. Another 294 broke even, neither losing nor earning savings.

Persistence pays off

To do well, stay in the program, experts say, for the likelihood of getting shared savings increases with experience. A high benchmark is also a good predictor of achieved savings. 

Also, both physician-led and smaller ACOs tend to have higher savings than hospital-led or integrated ACOs, according to a  Health Affairs blog.

While some experts said doing well requires going all-in on integration, including having a connected electronic health record, a Scottsdale, Arizona ACO is an example of a large, but physician-focused organization that showed great results without a linked EHR.

Innovation Care Partners in Arizona and its ACO, Scottsdale Health Partners, in 2016 had one of the highest savings rate in the country, achieving more than 9 percent, according to COO Faron Thompson.

[Also: Aledade gets boost for ACO business with $23 million in new funding]

The first year of MSSP, in which systems were paid just for reporting, the ACO had a score of 60 percent. The second year it was 92 percent, and in the third year, 97 percent.

More physicians in the health system of about 500 practices are independent rather than employed, Thompson said.

The system is not vertically integrated. And he said, they are proudly not on the same EHR.

What the ACO is, however, is very physician-centric.

To make the lives of physicians easier, the organization built web-based software that has a dashboard and progress charts to replace Excel spreadsheets that weren’t always being completed.

“We basically took all of the quality metrics and built it into this front-end, UI (user interface) experience,” Thompson said. “It caters to them and their time constraints.”

Physicians earn points and gain-sharing distribution for participating in the company’s performance objectives.

The provider also has a complex care coordination program that includes medics who are military veterans. The 35-40 care coordinators and about 3,000 patients enrolled in the program form a long-term trusting relationship, Thompson said.

The care coordinators work with patients while they’re still in the waiting area of an emergency room, often redirecting them to their PCP for a same-day appointment. 

In Arizona, the average readmission rate is 17 percent, Thompson said. Innovation Care Partners has readmission rates of 5 and 6 percent.

The ACO has also made a big investment in health information exchange technology. About 60,000 messages per month are sent to patients.

The ACO is considering becoming an advanced APM.

“It gives an automatic bump on reimbursement,” Thompson said. “We’re proving we can do this without vertical integration.” 

The integrated approach

Caravan Health in Kansas City, Missouri, has a reason to believe in integration. The organization saved more than $26 million in 2016 across its 23 ACOs and more than 14,000 clinicians in 47 states.

The average ACO saved nearly $1.1 million. 

Every clinician billing under the Caravan Health ACO is projected to have MIPS performance scores above 90 percent in 2017, Gronniger said.

Caravan received a perfect 100 percent quality reporting score in its first year of program participation, and an average year two quality score of 96 percent.

“We help mostly health systems to create clinically-integrated networks,” Gronniger said.

The mistake some systems make is focusing on the shared savings rather than the bigger picture, he said. 

“They have to figure out how to make this entire model sustainable for them in generating non fee-for-service revenues,” he said.

When they started running an ACO, health system costs went up by 6 percent in the first year. 

They hired care managers and set up quarterly care meetings and hired a population health nurse.

The population health nurse set up annual wellness visits.

Annual wellness visits are a missed opportunity for most health systems, Gronniger said. Less than 10 percent take advantage of them, while at Caravan, more than 50 percent of patients are coming in for such preventative care as flu and pneumonia vaccinations. 

“That drives up quality score improvements and patient results,” Gronniger said. “Annual wellness visits creates opportunities for health systems to create a sustainable business model.”

The wellness visits create enough revenue to pay for the position of a population health nurse.

Along with the technology and integrated model, Caravan believes that getting physicians involved is key.

Medicare’s new chronic care management codes have helped, in paying physicians for work they’ve been doing without previously earning reimbursements, such as checkups over the phone. 

The changes have required significant workflow alterations, Gronniger said.

“It really requires a comprehensive system-wide change effort. It’s easy to be middle of the pack,” Gronniger said. 

ACOs and pop health turning cost curve down

Advocate Health Care in Illinois is also an integrated health system with an ACO, Advocate Solution Partners Accountable Care.

Advocate was ranked second in savings of 432 ACOs participating in the Medicare Shared Savings Program in 2016. It has the experience, having spent four years in the program.

“Our quality scores have improved every year,” said chief medical officer Lee Sacks, MD.

Advocate Health Care, the largest participating ACO in the program, saved $60.6 million in 2016 by applying key population health strategies and launching initiatives to better manage chronic conditions, Sacks said. 

The total cost of care for Advocate’s Medicare population was less in 2016 than it was in 2013. 

“We’re not just bending the cost curve, we’ve turned it downward,” Sacks said. “It reflects the fact that we’re a clinically-integrated network. We’re not just focused on Medicare. We have an infrastructure that’s been in place for 20 years.”

Clinical integration requires the ability to get data and having a critical mass of the business in population health, he said.

“We decreased our inpatient discharges and also had a multi-year focus on better managing post-acute care,” Sacks said. “It has reduced the average length of stay by about seven days. At $500 a day.”

The system pays for a team of advanced practice clinicians to make the rounds each day to address patient concerns. It reduces readmissions and moves their treatment plan forward, he said.

“For ACOs, it’s a journey,” Sacks said. “You need to understand the data and where the excess Medicare spend is. It gets hard to say we’re going to improve everything.”

Twitter: @SusanJMorse
Email the writer: susan.morse@himssmedia.com