First used to track cryptocurrencies such as Bitcoin, blockchain is finding its way into tracking and quality control systems in healthcare, including clinical laboratories and big pharma
Four companies were selected by the US Food and Drug Administration (FDA) to participate in a pilot program that will utilize blockchain technology to create a real-time monitoring network for pharmaceutical products. The companies selected by the FDA include: IBM (NYSE:IBM), Merck (NYSE:MRK), Walmart (NYSE:WMT), and KPMG, an international accounting firm. Each company will bring its own distinct expertise to the venture.
This important project to utilize blockchain technologies in
the pharmaceutical distribution chain is another example of prominent
healthcare organizations looking to benefit from blockchain technology.
Clinical laboratories and health insurers also are collaborating on blockchain projects. A recent intelligence briefing from The Dark Report, the sister publication of Dark Daily, describes collaborations between multiple health insurers and Quest Diagnostics to improve their provider directories using blockchain. (See, “Four Insurers, Quest Developing Blockchain,” July 1, 2019.)
Improving Traceability and Security in Healthcare
Blockchain continues to intrigue federal officials, health network administrators, and health information technology (HIT) developers looking for ways to accurately and efficiently track inventory, improve information access and retrieval, and increase the accuracy of collected and stored patient data.
In the FDA’s February press release announcing the pilot program, Scott Gottlieb, MD, who resigned as the FDA’s Commissioner in April, stated, “We’re invested in exploring new ways to improve traceability, in some cases using the same technologies that can enhance drug supply chain security, like the use of blockchain.”
Congress created this latest program, which is part of the federal US Drug Supply Chain Security Act (DSCSA) enacted in 2013, to identify and track certain prescription medications as they are disseminated nationwide. However, once fully tested, similar blockchain systems could be employed in all aspects of healthcare, including clinical laboratories, where critical supplies, fragile specimens, timing, and quality control are all present.
The FDA hopes the electronic framework being tested during
the pilot will help protect consumers from counterfeit, stolen, contaminated, or
harmful drugs, as well as:
reduce the time needed to track and trace
product inventory;
enable timely retrieval of accurate distribution
information;
increase the accuracy of data shared among the
network members; and
help maintain the integrity of products in the
distribution chain, including ensuring products are stored at the correct
temperature.
In the FDA’s February announcement, Scott Gottlieb, MD (above), the FDA Commissioner at that time, said, “For the drug track-and-trace system, our goals are to fully secure electronic product tracing, which provides a step-by-step account of where a drug product has been located and who has handled it, [and] establish a more robust product verification to ensure that a drug product is legitimate and unaltered.” It’s not hard to imagine how such a tracking system would be equally beneficial in clinical laboratories and hospital pathology departments. (Photo copyright: FDA.)
Companies in the FDA’s Blockchain Pilot
IBM, a leading blockchain provider, will serve as the
technology partner on the project. The tech giant has implemented and provided
blockchain applications to clients for years. Its cloud-based platform provides
customers with end-to-end capabilities that enable them to develop, maintain,
and secure their networks.
“Blockchain could provide an important new approach to further improving trust in the biopharmaceutical supply chain,” said Mark Treshock, Global Blockchain Solutions Leader for Healthcare and Life Sciences at IBM, in a news release. “We believe this is an ideal use for the technology because it can not only provide an audit trail that tracks drugs within the supply chain; it can track who has shared data and with whom, without revealing the data itself. Blockchain has the potential to transform how pharmaceutical data is controlled, managed, shared and acted upon throughout the lifetime history of a drug.”
Merck, known as MSD outside of the US and Canada, is
a global pharmaceutical company that researches and develops medications and
vaccines for both human and animal diseases. Merck delivers health solutions to
customers in more than 140 countries across the globe.
“Our supply chain strategy, planning and logistics are built around the customers and patients we serve,” said Craig Kennedy, Senior Vice President, Global Supply Chain Management at Merck, in the IBM news release. “Reliable and verifiable supply helps improve confidence among all the stakeholders—especially patients—while also strengthening the foundation of our business.”
Kennedy added that transparency is one of Merck’s primary
goals in participating in this blockchain project. “If you evaluate today’s
pharmaceutical supply chain system in the US, it’s really a series of handoffs
that are opaque to each other and owned by an individual party,” he said,
adding, “There is no transparency that provides end-to-end capabilities. This
hampers the ability for tracking and tracing within the supply chain.”
Walmart, the world’s largest company by revenue, will
be distributing drugs through their pharmacies and care clinics for the
project. Walmart has successfully experimented using blockchain technology with
other products. It hopes this new collaboration will benefit their customers,
as well.
“With successful blockchain pilots in pork, mangoes, and leafy greens that provide enhanced traceability, we are looking forward to the same success and transparency in the biopharmaceutical supply chain,” said Karim Bennis, Vice President of Strategic Planning of Health and Wellness at Walmart, in the IBM news release. “We believe we have to go further than offering great products that help our customers live better at everyday low prices. Our customers also need to know they can trust us to help ensure products are safe. This pilot, and US Drug Supply Chain Security Act requirements, will help us do just that.”
KPMG, a multi-national professional services network
based in the Netherlands, will be providing knowledge regarding compliance
issues to the venture.
“Blockchain’s innate ability within a private, permissioned
network to provide an ‘immutable record’ makes it a logical tool to deploy to
help address DSCSA compliance requirements,” said Arun Ghosh, US Blockchain
Leader at KPMG, in the IBM news release. “The ability to leverage existing
cloud infrastructure is making enterprise blockchain increasingly affordable
and adaptable, helping drug manufacturers, distributors, and dispensers meet
their patient safety and supply chain integrity goals.”
The FDA’s blockchain project is scheduled to be completed in
the fourth quarter of 2019, with the end results being published in a DSCSA
report. The participating organizations will evaluate the need for and plan any
future steps at that time.
Blockchain is a new and relatively untested technology
within the healthcare industry. However, projects like those supported by the
FDA may bring this technology to the forefront for healthcare organizations,
including clinical laboratories and pathology groups. Once proven, blockchain
technology could have significant benefits for patient data accuracy and
security.
Despite the widespread adoption of electronic health record (EHR) systems and billions in government incentives, lack of interoperability still blocks potential benefits of digital health records, causing frustration among physicians, medical labs, and patients
Clinical laboratories and anatomic pathology groups understand the complexity of today’s electronic health record (EHR) systems. The ability to easily and securely transmit pathology test results and other diagnostic information among multiple providers was the entire point of shifting the nation’s healthcare industry from paper-based to digital health records. However, despite recent advances, true interoperability between disparate health networks remains elusive.
One major reason for the current situation is that multi-hospital health systems and health networks still use EHR systems from different vendors. This fact is well-known to the nation’s medical laboratories because they must spend money and resources to maintain electronic lab test ordering and resulting interfaces with all of these different EHRs.
Healthcare IT News highlighted the scale of this problem in recent coverage. Citing data from the Healthcare Information and Management Systems Society (HIMSS) Logic database, they note that—when taking into account affiliated providers—the typical health network engages with as many as 18 different electronic medical record (EMR) vendors. Similarly, hospitals may be engaging with as many as 16 different EMR vendors.
The graphics above illustrates why interoperability is the most important hurdle facing healthcare today. Although the shift to digital is well underway, medical laboratories, physicians, and patients still struggle to communicate data between providers and access it in a universal or centralized manner. (Images copyright: Healthcare IT News.)
The lack of interoperability forces healthcare and diagnostics facilities to develop workarounds for locating, transmitting, receiving, and analyzing data. This simply compounds the problem.
Pressure from Technology Giants Fuels Push for Interoperability
According to HITECH Answers, the Centers for Medicare and Medicaid Services (CMS) has paid out more than $38-billion in EHR Incentive Program payments since April 2018.
Experts, however, point out that government incentives are only one part of the pressure vendors are seeing to improve interoperability.
“There needs to be a regulatory push here to play referee and determine what standards will be necessary,” Blain Newton, Executive Vice President, HIMSS Analytics, told Healthcare IT News. “But the [EHR] vendors are going to have to do it because of consumer demand, as things like Apple Health Records gain traction.”
Another solution, according to TechTarget, involves developing application programming interfaces (APIs) that allow tech companies and EHR vendors to achieve better interoperability by linking information in a structured manner, facilitating secure data transmission, and powering the next generation of apps that will bring interoperability ever closer to a reality.
TechTarget reported on how University of Utah Hospital’s five hospital/12 community clinic health network, and Intermountain Healthcare, also in Utah, successfully used APIs to develop customized interfaces and apps to improve accessibility and interoperability with their Epic and Cerner EHR systems.
Diagnostic Opportunities for Clinical Laboratories
As consumers gain increased access to their data and healthcare providers harness the current generation of third-party tools to streamline EHR use, vendors will continue to feel pressure to make interoperability a native feature of their EHR systems and reduce the need to rely on HIT teams for customization.
For pathology groups, medical laboratories, and other diagnosticians who interact with EHR systems daily, the impact of interoperability is clear. With the help of tech companies, and a shift in focus from government incentives programs, improved interoperability might soon offer innovative new uses for PHI in diagnosing and treating disease, while further improving the efficiency of clinical laboratories that face tightening budgets, reduced reimbursements, and greater competition.
While approaches differ between the three companies, heavy investment in EMR/EHR and other HIT solutions could signal significant changes ahead for a market currently dominated by only a few major developers
If healthcare big data is truly a disruptive force in healthcare’s transformation, then a big battle looms for control of that data. Some experts say that the companies now dominating the electronic health record (EHR) market will soon face tough competition from the world’s biggest tech companies.
How this will impact medical laboratories and pathology practices remains to be seen. Labs are sure to be influenced by coming events, since clinical laboratory test data represents the largest proportion of an individual patient’s permanent medical record. It’s important to note, though, that while most EHR/HIT developers have been motivated by federal incentives, Google (NASDAQ:GOOG), Apple (NASDAQ:AAPL), and Microsoft (NASDAQ:MSFT) are motivated by consumer demand, which increasingly dictates the direction of health technology development.
Thus, they may be better positioned to compete moving forward, as patients, physicians, and hospitals turn to precision medicine and value-based care for improved outcomes and increased revenues.
“The EMR efforts have moved hospitals from paper to digital records,” Bruce Carlson (above), Publisher of Kalorama Information, told HIT Infrastructure. “The next step is for tech giants to glean the data and improve upon that infrastructure. We’ll be talking about EHR in different ways in the next ten years.” (Photo copyright: Twitter.)
EMR/EHR Market Poised for Disruption
According EHR Intelligence, as of 2017, 97% of all US non-federal acute care hospitals and 84% of US hospitals had adopted an EHR system. Of these hospitals, more than half (50.5%) use products from just two developers—Cerner or Epic. That’s according to Health Data Management’s coverage of the KLAS report “US Hospital EMR Market Share 2017.”
However, recent interest in HIT and EHR systems by major Silicon Valley tech companies could lead to potential disruptions in the current state of the market. According to The New York Times, in the first 11 months of 2017, 10 of the largest US technology companies were involved in healthcare equity deals worth $2.7-billion. This marks a drastic increase over the 2012 figure of $277-million.
Though each company is approaching the market differently, Google, Microsoft, and Apple are all working on projects that could influence how both consumers and healthcare professionals interact with and utilize medical record data.
Of the three, Apple is the most consumer-centric with their Apple Health personal health record (PHR) integration into Apple iOS for iPhones and iPads. Microsoft, however, is working on developing analytics tools and storage solutions aimed at healthcare providers in general. And Google, through its parent company Alphabet, is focusing on data processing and storage.
Amazon also is working on its own HIT project which it calls 1492. While details are scant, HIT Infrastructure reports that the project is focused on interoperability among disparate EHR systems to improve sharing of protected health information (PHI) between providers, patients, and other healthcare providers, such as clinical labs and pathology groups. HIT Infrastructure also reported on rumors of Amazon branching into telemedicine using their Amazon Echo and Alexa platforms.
Security Concerns and Opportunities for Clinical Laboratories
According to Computerworld’s coverage of IDC research, by 2020, 25% of patients are expected to be taking part in ‘bring your own data” healthcare scenarios. Tech-savvy medical laboratories could find opportunities to interact directly with patients and encourage follow-through on test orders or follow-up on routine testing.
However, shifting protected health information to devices carried by consumers is not without risks.
“How do I know the data won’t make its way to some cloud somewhere to be shared, sold, etc.” Jack Gold, Principal Analyst with J. Gold Associates, told Computerworld. “And if I rely on an app to tell me what to do—say, take my meds—and it somehow gets hacked, can it make me sick, or worse?”
Nevertheless, with tech giants already developing products for the consumer market and healthcare provider industry, it’s a given consumers will soon gain greater access to their own healthcare information. Whether patients will ultimately embrace it, how they will use it, and how developers will interact with the data, is still undefined. But it’s coming and clinical laboratories should be prepared.
Could biometrics increase security and safety of clinical laboratory patient identification and specimen tracking processes as well?
Positive patient identification is a common problem for all healthcare providers, including medical laboratories. That is why there is strong interest in developing technologies that use biometric data to identify patients. The challenge has been to find a biometric solution that has acceptable accuracy and can make the positive identification in a speedy fashion, particularly when the patient presents for service or to provide a clinical laboratory specimen.
One Canadian company believes it has a biometrics-based solution almost ready to bring to market. AceAge, Inc., a Canadian healthcare technology company, recently added facial recognition software to their Karie at-home medication dispensing appliance, according to Biometric Update. The Ver-ID facial recognition authentication application they chose was developed by Ontario-based Applied Recognition, Inc.
Karie (above right) is designed to help patients accurately schedule, monitor, and take their medications. The companion facial recognition software—one of several security features—will enable homebound individuals who use mobile devices or the Internet to electronically sign-in and notify caregivers that medication was taken as ordered, an AceAge news release noted. “Now, our end users can dispense their prescriptions at a glance and without worry that, for example, a child might inadvertently get access. This will help bring security to medication in people’s homes,” Spencer Waugh, AceAge’s CEO (above), stated in the news release. (Image copyright: AceAge.)
The new Karie automated solution, is expected to launch later this year. Developers anticipate that the facial recognition feature also could be of value to researchers in late-stage clinical trials, where documentation of medication adherence is critical.
How Does Facial Recognition Software Work?
According to Applied Recognition, Ver-ID uses an algorithm that is more than 99% accurate in detecting and recognizing faces. Here’s how it works:
A patient registers his or her face using the camera on a mobile device or camera-enabled computer;
The patented Ver-ID algorithm matches 75 points and creates a “facial print” or “signature,” capturing unique features;
Then, as the person uses their mobile device or computer, the facial signature is authenticated against the registered signature to control access to the app or device.
AceAge’s Karie device would authenticate the patient’s facial image against a stored facial signature in the same manner.
Fingerprint Readers Give People Identity, Care Access in Africa
Danny Thakkar, co-founder of Bayometric of San Jose, Calif., a global provider of fingerprint scanners and biometric software, says biometrics improves patient identification and is faster and more reliable than manual identification of patient records in a master patient index.
“The process of patient enrollment and admission becomes fast and hassle-free as a simple biometric scan is all it takes to identify and admit a patient,” Thakkar noted in a blog post.
In fact, biometrics technology has made it possible for residents of developing countries, without driver licenses or credit cards, to secure identity and access to healthcare services, according CNN.
COHESU, a Kenyan community health charity, is reportedly working with Simprints, a nonprofit technology company in the UK that makes fingerprint scanners for mobile platforms and charities worldwide, to implement biometrics for patient identification.
After having their fingerprints registered by the Simprints biometric scanner, Kenyan patients receive a unique identifier that can be matched to their healthcare records. Caregivers use mobile apps to access their patients’ health records and review or update them, CNN reported.
“Biometrics as a technology has completely changed our way of thinking. Without it, they would probably stay at home and accept their fate,” Nicholas Mwaura, a systems and database administrator with COHESU told CNN.
Hospitals Have Outdated Patient ID Methods, Says HealthsystemCIO Survey
Meanwhile, 42% of hospital CIOs acknowledged in an Imprivata/HealthsystemCIO.com survey that patient matching is a top priority at their organizations, according to a news release. Another 24% of CIOs surveyed said patient matching is not a priority, but it should be.
“Many hospitals still rely on methods that do not guarantee accurate patient identification, such as a person’s date of birth or a health insurance card. By implementing a registration solution—such as biometric identification technology—that accurately identifies patients and matches them with their correct EMPI (enterprise master patient index) and EHR (electronic health record) records, hospitals can reduce the very real risks highlighted in this survey,” Sean Kelly, MD, Imprivata’s Chief Medical Officer, told EHR Intelligence.
Clinical laboratory leaders already use processes and software to identify patients and match them with records and specimens. In the near future, biometric facial recognition might provide additional patient identification, safety, and medical laboratory security.
Insurers might use blockchain technology to enable instantaneous verification and interoperability of healthcare records, which could impact clinical laboratory payment systems
Medical laboratories and anatomic pathology groups are keenly aware that connected, secure, interoperable health records are critical to smooth, efficient workflows. However, the current often dysfunctional state of health information technology (HIT) in America’s healthcare system often disrupts the security and functionality of information exchange between hospital and ancillary practice patient record systems.
One solution to this could be blockchain technology. With its big data and abundant touchpoints (typically: insurer, laboratory, physician, hospital, and home care), the healthcare industry could be ripe for blockchain information exchanges. Blockchain might enable secure and trusted linkage of payer, provider, and patient data. But what exactly is blockchain technology and how might it impact your laboratory?
Blockchains Could Transform Healthcare
Blockchain refers to a decentralized and distributed ledger that enables the interface of computer servers for the purpose of making, tracking, and storing linked transactions.
“At its core, blockchain is a distributed system recording and storing transaction records. More specifically, blockchain is a shared, immutable record of peer-to-peer transactions built from linked transaction blocks and stored in a digital ledger,” explained risk-management group Deloitte in a report, which goes on to state:
“Blockchain technology has the potential to transform healthcare, placing the patient at the center of the healthcare ecosystem and increasing the security, privacy, and interoperability of health data. This technology could provide a new model for health information exchanges (HIE) by making electronic medical records more efficient, disintermediated, and secure.
“Blockchain relies on established cryptographic techniques to allow each participant in a network to interact (e.g., store, exchange, and view information), without pre-existing trust between the parties.
“In a blockchain system, there is no central authority; instead, transaction records are stored and distributed across all network participants. Interactions with the blockchain become known to all participants and require verification by the network before information is added, enabling trustless collaboration between network participants while recording an immutable audit trail of all interactions.”
Key principles of blockchain (above) demonstrate the decentralization of the healthcare data. In some ways, this resembles electronic health record (EHR) systems that feature federated databases, rather than centralized databases. (Image copyright: Deloitte.)
Instant Verifications and Authorizations at Point-of-Care
In a Healthcare Finance News (HFN) article, insurers acknowledged blockchain’s potential for information verification and authorizations in real-time, fast payments, and access to patient databases that could fulfill population health goals.
“Everybody that is part of a transaction has access to the network. There’s no need for an intermediary. Blockchain allows for verification instantly,” noted Chris Kay, JD, Senior Vice President and Chief Innovation Officer at Humana, in the HFN article.
At clinical laboratories, blockchain could enable nearly instantaneous verification of a patient’s health insurance at time of service. Blockchain also could enable doctors to review a patient’s medical laboratory test results in real-time, even when multiple labs are involved in a person’s care.
“Everyone has to have a node on the blockchain and have a server linked to the blockchain. The servers are the ones talking to one another,” explained Kay. “What’s really transformative about this is it takes the friction out of the system. If I see a doctor, the doctor knows what insurance I have because it’s on the network. All this is verified through underlying security software.”
Healthcare Obstacles to Overcome
Breaking down data silos and loosening proprietary holds on information can help healthcare providers prepare for blockchain. However, in our highly regulated industry, blockchain is at least five years away, according to blockchain experts in a Healthcare IT News (HIT News) article.
“We’re hearing that blockchain is going to revolutionize the way we interact with and store data. But it’s not going to happen tomorrow. Let’s find smaller problems we can solve as a starting point—projects that don’t have the regulatory hurdles—and then take baby steps that don’t require breaking down all the walls,” advised Joe Guagliardo, JD, Intellectual Property/Technology Attorney and Chair of the Blockchain Technology Group at Pepper Hamilton, a Philadelphia-based law firm, in the HIT News article.
Healthcoin: Rewarding Patients for Improved Biomarkers
One company has already started to work with blockchain in healthcare. Healthcoin is a blockchain-based platform aimed at prevention of diabetes, heart disease, and obesity. The idea is for employers, insurers, and others to use Healthcoin (now in pre-launch) to reward people based on biomarker improvements shown in medical laboratory tests.
Healthcoin’s Chief Executive Officer Diego Espinosa and Chief Operating Officer Nick Gogerty, founded the company in 2016 after Espinosa, who had been diagnosed with diabetes, made diet changes to reverse it, according to an article in Bitcoin Magazine.
“When I saw my blood labs, the idea for Healthcoin was born—shifting the focus of prevention to ‘moving the needle’ on biomarkers, as opposed to just measuring steps,” Espinosa told Bitcoin Magazine.
Blockchain Provides Security
What does blockchain provide that isn’t available through other existing technologies? According to Deloitte, it’s security and trust.
“Today’s health records are typically stored within a single provider system. With blockchain, providers could either select which information to upload to a shared blockchain when a patient event occurs, or continuously upload to the blockchain,” Deloitte notes. “Blockchain’s security and ability to establish trust between entities are the reasons why it can help solve the interoperability problem better than today’s existing technologies.”
Should Clinical Laboratories Prepare for Blockchain?
It’s important to note that insurers are contemplating blockchain and making relevant plans and strategies. Dark Daily believes the potential exists for blockchain technology to both disrupt existing business relationships, including those requiring access to patient test data, and to create new opportunities to leverage patient test data in real-time that could generate new revenue sources for labs. Thus, to ensure smooth payments, medical laboratory managers and pathology group stakeholders should explore blockchain’s value to their practices.
