The Office of the National Coordinator might not always get what it wants when it comes to industry cooperation, but ONC officials have been pleasantly surprised by the positive response to its informational blockchain challenge.
The agency found its inbox flooded with 70 entries after offering a cash prize for academic papers that best capture the potential uses of blockchain technology for electronic health record management, data security, interoperability, and other critical big data tasks.
Respondents from a number of high-profile organizations, including MIT, the Mayo Clinic, Deloitte, IBM, and the National Quality Forum volunteered their expertise in this emerging field of information management, and the ONC chose fifteen entries to share in thousands of dollars of prize money.
“We are thrilled by the incredible amount of interest in this challenge,” said National Coordinator Vindell Washington, MD, MHCM. “While many know about blockchain technology’s uses for digital currency purposes, the challenge submissions show its exciting potential for new, innovative uses in health care.”
Blockchain, a methodology for conducting transactions that relies on a decentralized approach to authorization and edits, is finding its way from its origins in the virtual Bitcoin ecosystem to more traditional industries, such as mainstream finance, manufacturing, and healthcare.
The inherently sensitive nature of health data, along with the perennial challenges of interoperability, patient record matching, and health information exchange, have created opportunities for a blockchain approach, argue the winners of the challenge.
Their responses to the ONC’s request for information highlight a number of critical problems ripe for the solving, spanning many of the most difficult conundrums of the big data era.
How do these experts think that blockchain could change healthcare for the better, and how could the industry successfully adopt this innovative method of exchanging and securing big data?
Creating a trusted environment for decision-making
The growing focus on care coordination and EHR access across the care continuum has raised questions about how to ensure that multiple providers can view, edit, and share patient data while still maintaining an authoritative and up-to-date record of diagnoses, medications, and services rendered.
Blockchain’s ability to use time stamping to authenticate changes to a dataset, even if more than one user has permission to edit a document, is ideal for managing EHR data, says Beth Israel Deaconess CIO Dr. John Halamka and colleagues from the MIT Media Lab in one of the prize-winning papers.
“EHRs were never designed to manage multi-institutional, life time medical records,” the paper asserts. “Patients leave data scattered across various organizations as life events take them away from one provider's data silo and into another.”
Using a blockchain-based system called MedRec, patients can authorize new members of their private, secure EHR community, approve changes, and govern sharing between their disparate providers.
“Providers can add a new record associated with a particular patient, and patients can authorize sharing of records between providers,” Halamka and his team explain. “In both cases, the party receiving new information receives an automated notification and can verify the proposed record before accepting or rejecting the data. This keeps participants informed and engaged in the evolution of their records.”
“MedRec prioritizes usability by also offering a designated contract which aggregates references to all of a user's patient-provider relationships, thus providing a single point of reference to check for any updates to medical history.”
In addition to improving patient agency and control over data sharing, this methodology may help to remove one of the biggest barriers to clinical decision-making: the inability to trust the data available at the point of care.
“Trust is the foundation for the provision of healthcare services to patients,” says the entry from consulting firm Accenture, which focuses on the use of blockchain for health data interoperability. “The required trust might flow from a patient to a healthcare professional regarding whether they will receive the right care. Alternatively, it could flow the other way, from a healthcare provider to a patient, and involve the belief that the patient is honestly sharing his or her experiences and conditions.”
Blockchain is ideally suited to address a number of trust issues, such as patient identification, patient consent, provider-sided user authentication, and even the discovery and reduction of billing fraud and erroneous malpractice claims.
IBM points out that blockchain, otherwise known as the “chain of trust,” could eliminate the problem of unclear data ownership and improve the integrity of data by improving peer-to-peer accountability.
The traceable nature of blockchain transactions could reduce improper billing, prevent unauthorized staff members from accessing patient records outside of their purview, and even address issues such as counterfeit drugs and inappropriate prescribing.
Enabling patient-centered interoperability and health information exchange
The blockchain environment may also smooth over issues of patient consent for data sharing, one of the major obstacles of developing a health information exchange system. Current HIE efforts are founded on an opt-in or opt-out model, but they are typically required to add a number of caveats for the sharing of highly sensitive information, such as mental health diagnoses, HIV/AIDS status, and substance abuse treatments.
“EHRs were never designed to manage multi-institutional, life time medical records."
Patients might choose to deny HIE consent entirely if they feel this data is at risk, which may prevent optimal care across the healthcare system. But blockchain would allow for more tailored consent provisions, Accenture says, and ensure that requests for information withholding are properly recorded and available.
“By capturing patient consent statements in an immutable blockchain, healthcare professionals and others involved in the care cycle are able to trust those statements and act upon them accordingly,” the authors wrote.
“In addition, patients are able to add consent statements at any point in their care journey – confident that the blockchain will hold them securely. Healthcare professionals can act upon those directives, and the systems that they use can interpret them as access control decisions – with the assurance that the system is adhering to patient wishes.”
Deloitte Consulting also believes that blockchain could revolutionize the current health information exchange environment.
Instead of relying on a designated intermediary for information exchange, such as a state-designated HIE or a private network established between local hospitals, the decentralized nature of the blockchain would allow any approved participants to join an exchange community, without the need to build data exchange “pipes” between certain organizations.
Source: Deloitte Consulting, LLP
Using blockchain, providers could create a system of “smart contracts” that leverage a “consistent, rule-based method for accessing patient data that can be permissioned to selected health organizations.”
Blockchain could also facilitate HIE and interoperability by leveraging a system of “on-chain” and “off-chain” data storage, Deloitte added.
On-chain data is directly stored on the blockchain, while off-chain data, like large imaging study files, can be accessed by secured links. On-chain resources are immediately viewable by anyone with permission to access the blockchain, while links to off-chain data stored in more traditional databases can be managed by consents according to patient or provider wishes.
Source: Deloitte Consulting, LLP
The paper suggests that the industry develop a standardized dataset for on-chain storage, which may include basic information similar to that currently shared through the Continuity of Care Document (CCD). Patient demographics, problems and allergy lists, medication lists, and recent service history could form the basis for this standard packet of information.
Supporting the growth of accountable care and quality metrics
In addition to sharing individual patient data, the blockchain may be useful for the population health management and quality reporting tasks that underpin accountable care.
Ramkrishna Prakash, CEO of TrustedCare, Inc., suggests that smart contracts could make it easier for providers and payers to share the quality data required to fuel value-based reimbursements.
“The ability to seamlessly track and manage smart contracts in which the benefits can be redeemed with significant ease provides the necessary ‘carrot’ for providers and patients to actively engage in a symbiotic collaboration,” he wrote.
“In contrast, if one or more participants tend to misbehave, appropriate penalties, via liabilities, can also be levied with similar ease. This ‘carrot/stick’ approach, we believe, would provide the necessary push that is needed to shift the healthcare industry from a sickness-management mindset to a wellness-lifestyle mindset.”
The National Quality Forum believes that blockchain would also make it easier to develop patient-reported outcome measures (PROMs), which include indicators of patient experiences, lifestyle issues, pain levels, and chronic disease management capabilities.
PROMs are not always a priority for healthcare providers, a recent survey reported, and less than one-fifth of hospitals routinely integrate this type of patient-provided data into their care routines and decision-making processes.
"This ‘carrot/stick’ approach would provide the necessary push to shift the healthcare industry from a sickness-management mindset to a wellness-lifestyle mindset.”
But accountable care and the long-term financial responsibility for patient wellness are starting to stress the use of this data as the healthcare system focuses on the external factors that may impact patient adherence to treatments or the outcomes of certain treatments.
“The success of a well-developed PROM that adequately and accurately reflect that patient’s perspective relies on the use of an instrument that is psychometrically tested and validated and can capture the burden of disease or treatment,” explains Jason Goldwater, MA, MPA, on behalf of the NQF.
“This means the instrument must be reliable, in that the PROM yields the same metric for evaluation each time it is administered, providing that the construct being measured has not changed.”
Developing a meaningful PROM can take two or three years, Goldwater says, due to the complicated process of collecting balanced and verified data from a large enough sample of patient participants.
The Internet of Things is helping to streamline this process by putting patient-generated health data tools directly into the hands of consumers. Big data from wearables, fitness trackers, and other generators of quantifiable lifestyle information can be used to better understand daily behaviors or develop baseline data for understanding certain health concerns without requiring patients to take any extraordinary action, such as signing up for a study or focus group.
“The significant amount of data being generated through these devices, such as electronic medical records (EMRs), quantified self-tracking devices, smartphone applications and personal health records (PHRs) provide an opportunity to gather insight into a patient’s health status that was previously only available through the administration of a psychometrically validated instrument,” Goldwater says.
Blockchain may contribute to this methodology by providing the secure, easily authenticated backdrop for exchanging and manipulating this data while bypassing the issues of data interoperability that have stymied so many big data analytics efforts in the past.
“A blockchain can collect information from web-based and mobile applications, as well as sensor technologies and integrate through representational state transfer (REST) application programming interfaces (API),” the NQF explains.
RESTful APIs form the underlying architecture of the Internet, and are gaining traction in healthcare through the FHIR standard. These APIs use the familiar HTTP standard to exchange data, just like a regular webpage.
“Through this standard and platform-independent network, information can be collected through multiple devices,” Goldwater says. “As information is collected and given a digital signature that represents a single patient, information from the EMR can be transported through the FHIR APIs to the blockchain and matched with that same digital signature.”
“The blockchain then becomes the backbone for digital health, incorporating data from patient-based technologies and the EMR to provide a robust and comprehensive pool from which authorized users, such as providers and patients, has access.”
This data could be used in a variety of ways, from tailoring an individualized care plan and aiding medical research to tracking medication adherence, improving population health management programs, or contributing to the creation of data-driven PROMs.
What are the challenges of developing the blockchain for healthcare?
Blockchain is still a very new concept for the healthcare ecosystem, numerous obstacles stand in the way of its speedy deployment. Stakeholders are not quite sure how to scale blockchain technology, and many of the winning papers are quick to point out that the new architecture is not a cure-all for what ails the industry.
“Like every technology, blockchain has limitations and is not suited for application to all scenarios,” IBM says. “It is not well suited for high performance (millisecond) transactions involving just one participant with no business network involved, or for replicated database replacement. It is not useful as a transaction-processing replacement and is unsuitable for low-value, high-volume transactions.”
“There are also challenges with throughput capacity and storage limits related to permissions, as well as integration challenges when corporate legacy systems and systems of record are involved.”
Deloitte notes that blockchain may only be an attractive solution if multiple parties who cannot rely on third parties as the “arbiters of truth” are accessing a shared repository and they need to trust that every transaction is valid.
“Like every technology, blockchain has limitations and is not suited for application to all scenarios.”
If these transactions require enhanced security to maintain the integrity of the system, and the transactions are designed to transfer value or verify changes to datasets, then the blockchain may be appropriate.
“Implementation also requires selection of a blockchain protocol – the underlying blockchain technology and framework that guides the structure of the blockchain and development of applications,” Deloitte continued.
“Platforms such as Ethereum provide the ability to create decentralized applications built on top of blockchain architecture; it is a leading blockchain protocol for both permissioned and permissionless blockchain development.
MedRec, the project initiated by Beth Israel Deaconess, uses Ethereum to create and manage its smart contracts and cryptography requirements.
Hyperledger is another option, Deloitte says. This alternative is an open source infrastructure created by the Linux Foundation, which aims to develop a blockchain platform that could be used in the corporate setting.
“The choice of blockchain protocol is important, because it will influence the range of possible applications and the number of users participating on the network,” the paper added.
The costs of developing and operating a blockchain-powered healthcare network are currently unknown, several of the submissions acknowledged.
While the open-source nature of blockchain, along with its inherent standardization, may be significantly less expensive than previous investments in the fragmented and proprietary health IT options currently available, there are few successful examples of blockchain-based projects just yet.
There is also no regulation that addresses the unique properties of blockchain data exchange, and there isn’t likely to be much movement on that front in the near future. After all, the ONC admittedly knew very little about even the basic principles of blockchain before initiating the informational contest, and the industry is still struggling to understand its fundamental big data needs under the traditional method of data generation and exchange.
Blockchain may be an intriguing promise for enabling the trusted, seamlessly interoperable big data environment of the future, but healthcare providers and technology developers will need to think long and hard about how to apply this promising approach to real-life situations, and will no doubt find more questions than answers as they do so.