ABSTRACT
For health care and information technology, this is an exciting time. Health care is experiencing
an innovative approach to disease prevention and treatment that combines an individual
patient's genetic composition, lifestyle, and environment, thanks to advancements in genetic
research and precision medicine. Simultaneously, technological advancements have resulted in
vast databases of health data, tools for tracking health data, and increased people's involvement
in their own health care. In the realm of health IT, combining these developments in health care
and information technology might result in dramatic change.
In this work, I will attempt to explain a blockchain-based access-control manager for health
data that would help to address the industry interoperability concerns identified in the ONC's
Shared Nationwide Interoperability Roadmap. Any infrastructure supporting Patient-Centered
Outcomes Research (PCOR) and the Precision Medicine Initiative must have interoperability
(PMI). A national health IT infrastructure built on blockchain has the ability to increase
precision medicine, advance medical research, and encourage patients to take more
responsibility for their health.
INTRODUCTION
Although blockchain has been around since the 2000s, it was only recently accepted into the
public in 2017. The Gartner Hype Cycle, a visual indication of how much attention emerging
technologies receive for their business-level potential, was nearing its apex that year. The
trading prices of popular digital currencies like Bitcoin and Ethereum (both of which are
blockchain-based) had also reached all-time highs by the end of 2017.
The immense potential of blockchain in healthcare is being explored, and Advanced Medical
Reviews (AMR) is ready to take advantage of it. AMR has always stressed the use of cuttingedge technologies in the medical review process, as seen by our proprietary portal's highly
adaptable data-gathering capabilities. Blockchain could be the next stage in the advancement
of quick, accurate, and well-informed reviews based on the most recent guidelines and peerreviewed medical research. It could, for example, provide for more regular and trustworthy
access to medical histories in nonclinical situations like physician-led case review.
Blockchain is, at its heart, a distributed system for recording and maintaining transaction data.
Blockchain is a distributed, immutable record of peer-to-peer transactions that is created from
connected transaction blocks and kept in a digital ledger. Blockchain uses well-established
cryptographic techniques to allow each network participant to communicate (e.g., store,
exchange, and view information) without the need for prior trust. There is no central authority
in a blockchain system; instead, transaction records are maintained and dispersed among all
network participants. Interactions with the blockchain are visible to all parties and need
network verification before information can be added, allowing for trustless collaboration
between network participants while also keeping an immutable audit trail of all transactions.
BLOCKCHAIN STRENGTHENS DATA INTEGRITY AND PATIENT DIGITAL
IDENTITIES
A blockchain that is interoperable can improve data integrity while also preserving patients'
digital identities. Hacking and IT mishaps resulted in 112 million health care record data
breaches in 2015.
A data breach is expected to affect one out of every three health-care recipients in 2016. The
intrinsic qualities of cryptography public/private key access, proof of work, and distributed
data on the blockchain give health care data a new level of trustworthiness. Each blockchain
network participant has a hidden private key and a public key that serves as an easily apparent
identifier. The pair is cryptographically linked, so the private key can only be used in one
direction for identification. As a result, in order to discover what information on the blockchain
is relevant to a participant's profile, one must have the private key. As a result, the blockchain
public/private key encryption scheme creates identity permission layers that allow patients to
share distinct identity attributes with specific health care organizations within the health care
ecosystem on an as-needed basis, reducing vulnerabilities resulting from the storage of PII on
all sides and allowing patients or providers to set data access time limits.
Furthermore, a single patient's private key may be hacked, limiting the potential for harm, as
the hacker would have to attack every single user separately to gain unique private keys to
access identifying information of value. Asynchronous encryption secures patient identities
travelling across or inside companies in an era of ubiquitous perimeter firewall breaches and
ransomware.
Furthermore, all health care organizations connected to the blockchain can keep their own
updated copy of the health care ledger – as a result, if a historical block is changed, it will
require the approval of 51 percent of network participants, as every copy of that blockchain
will need to be updated to reflect the change. Because modifications are promptly broadcast to
the network, and distributed ledgers provide protective copies against damaging hacks, this
feature increases security and can help decrease the risk of malicious action.
BLOCKCHAIN SUPPORTS FRICTIONLESS CONNECTIVITY, SUPPORTED BY
SMART
CONTRACTS
AND
CONSISTENT
AUTHORIZATION
TO
ACCESS
ELECTRONIC HEALTH INFORMATION
Smart contracts can be developed in an interoperable blockchain to serve as a gateway for
storing standardized data that is immediately accessible to all businesses with permission to
the blockchain. To feed the smart contract, you'll need to create an application program
interface (API) oriented architecture. All participating organizations connected to the
blockchain will have access to the APIs, which will allow for seamless integration with each
organization's existing systems. When the API is used, it will send the contents of the patient
interaction to a blockchain-based smart contract.
Querying data from the blockchain is also possible via a series of API calls that each connected
organization can use. Organizations can query specific blocks on the chain or submit defined
query parameters by using these APIs (e.g. patients with ages over 25). The APIs can be used
to feed a common portal that any connected health care institutions can access and utilize for
direct system integration. Organizations can continue to focus on their internal systems thanks
to the API-oriented framework, which only requires the redirection of specific data fields.
PCOR AND PRECISION MEDICINE INSIGHTS ARE MADE POSSIBLE BY
BLOCKCHAIN
The blockchain transaction layer could provide instant access to a large amount of
standardized, non-personally identifiable data. As the number of parties in the vast cohort
needed to advance precision medicine grows, blockchain acts as an integrating component
without taking on storage or data standardization responsibilities for the many stakeholders.
This data can be shared with academic institutes and existing government initiatives, and
because blockchain runs on top of or within cloud platforms, it can be integrated into the
Precision Medicine Initiative's ongoing operations (PMI).
One of the keys to unlocking the value of the data inherent in a historically-sized cohort is
interoperability, and both the volume of data and the advantages of exploiting it in a timely
manner have the potential to be exponential. To further examine the junction of demographics,
genetic markers, and a variety of other data, Big Data analytics and cognitive
computing/machine learning may be applied to this blockchain data set.
PCOR can use the standardized data set to help design its Data Access Framework program,
as well as perform clinical research, patient safety event reporting, and adverse event detection,
as well as public health reporting. PCOR researchers and partnering organizations can also
access a single source of truth of information that maintains the integrity of each patient's health
care information thanks to the blockchain's privacy and security qualities.
CHALLENGES AND CONSIDERATIONS IN IMPLEMENTATION
Blockchain technology has tremendous applications in health care, but it is not yet fully mature
or a panacea that can be used instantly. Before a health care blockchain can be embraced by
companies across the country, a number of technical, organizational, and behavioral economics
difficulties must be overcome.
Tradeoffs between transaction volumes and available processing capacity are imposed by
scalability limits. According to the Blockchain Framework, companies can deploy
permissionless or permissioned blockchain solutions. Permissionless blockchains are
appealing because they open up the network to more people, allow for open-permissionless
innovation, and tap into more processing power.
Existing permissionless blockchains, such as Ethereum or Bitcoin, are constrained by
transaction volume. The Bitcoin blockchain now processes about seven transactions per
second, despite the fact that it has over ten million users and 200,000 daily transactions. Many
in the sector are advocating for technology to advance so that processing times can be reduced.
Permissioned blockchains, on the other hand, can speed up transaction processing times, but
they may run into computational resource constraints due to lower network involvement. HHS
could theoretically provide the processing capacity required to process all blockchain
transactions on a single, permissioned network for a chosen group of users; but, this would
make HHS the relative owner of the blockchain, reducing the utility of a truly decentralized
system. A countrywide blockchain with a significant number of health-care players would
improve the system's interoperability while simultaneously increasing its security.
STANDARDIZATION AND SCOPE OF DATA
Organizations should examine what information is stored on or off the blockchain when
assessing permissionless and permissioned blockchains. The most urgent worry for health care
data stored on the blockchain is the amount of data kept on the blockchain. A free-form upload
of data to the blockchain, such as doctor notes, may result in needlessly huge transaction sizes,
negatively impacting the blockchain's performance. However, given a limited collection of
data, like as demographic information, medical history, and codes for services rendered, the
blockchain can still be used effectively. Organizations should agree on a framework for
regulating what data, size, and format can be supplied to standardize data stored on the
blockchain and manage performance. Technical APIs can concatenate and de-concatenate
information saved and broadcasted to reduce data size in specific instances. Finally, members
can privatize the blockchain, allowing only registered and legal companies to access it.
Adoption and Participation Incentives
For blockchain to succeed, two levels of incentives are required. A network of networked
computers (nodes) must be present on a technological level to provide the computational power
required to build blocks after a transaction is submitted. Individuals are enticed to give their
processing power to a permissionless blockchain by monetary incentives in the form of
cryptocurrency. Financial incentives or access to blockchain data in permissioned blockchains
could stimulate involvement.
EXCHANGE FOR THE PURPOSE OF TRANSACTION PROCESSING
In addition to technical incentives, additional support may be required to incentivize enterprises
to adopt blockchain and participate in a shared network. While some companies are already
experimenting with blockchain to authenticate and manage medical records and claims
internally, the technology will become more powerful as the number of users on the shared
network grows. Programs like the CMS's Meaningful Use program11, which incentivizes
doctors to migrate to electronic medical records, could boost adoption and make a statewide
blockchain health exchange possible.
OPERATING COSTS OF BLOCKCHAIN TECHNOLOGY
While blockchain technology allows for speedier, near-real-time transactions, the cost of
running such a system is unknown at this moment. Traditional information systems and data
exchanges need a large amount of time and money to set up and manage, requiring staff to
regularly troubleshoot difficulties, update field parameters, undertake backup and recovery
measures, and extract information for reporting reasons. The open-source technology, features,
and distributed nature of blockchain can assist in lowering the cost of these processes. The
parameters of a blockchain and its smart contracts become absolute once they are configured,
eliminating the need for frequent upgrades and troubleshooting. Recovery contingencies are
unneeded because blockchain records are immutable and stored across all participating users.
Furthermore, the transparent information structure of blockchain could eliminate several data
exchange integration points and time-consuming reporting tasks. A blockchain, on the other
hand, uses a lot of computational power to process transactions. The cost of computing power
is determined by the volume and quantity of transactions sent through the network, as well as
the type of transactions that take place on the chain (e.g. data storage vs. value exchange).
Beyond the Bitcoin blockchain, there are few fully operational blockchains, making it difficult
to estimate the expenses of running a blockchain at scale within a private company or among
a group of partners.
Targeted trials and shared blockchain rules are needed to iteratively test the technology with a
view to scale in order to determine the possible costs of a fully scaled blockchain, customized
to satisfy HHS and partner demands.
REGULATIONS TO THINK ABOUT
Health-care policymakers should consider working closely with industry to better understand
and support ecosystem growth while staying within the confines of the current regulatory
framework and new administration policy goals. The implications of the blockchain's
distributed storage nature, who owns data (and when does ownership change? ), and how access
is allowed via the blockchain are all things to consider.
HHS creates national guidelines to protect the privacy of medical records through the HIPAA
Privacy Rule. The Rule establishes the requirements for protecting the privacy of personal
health information, as well as limits and conditions on the uses and disclosures that may be
made without patient consent. Because of these factors, a blockchain solution could help to
comply with the HIPAA Privacy Rule by segregating and encrypting identity, PII, and PHI into
separate entities that can be accessed via the blockchain using KSI hierarchies. Patients can
share distinct identifying features with the health care ecosystem on an as-needed basis, as
discussed in the interoperability section.
At the same time, the type of high-level demographic data saved on the blockchain needs to be
carefully considered; a combination of this demographic data and location data, in theory,
might allow for the triangulation of a specific individual. A rural locale, for example, may have
a higher chance of identifying someone with a rare health condition than a densely populated
urban center. A permissioned blockchain could help alleviate some of these concerns.
Nonetheless, the questions will need to be carefully explored as blockchain projects progress.
DEFINING THE FUTURE OF BLOCKCHAIN
Blockchain technology offers one-of-a-kind possibilities for reducing complexity, enabling
trustless cooperation, and generating safe and immutable data. HHS is correct to keep an eye
on this quickly changing field in order to spot trends and identify areas where government
assistance may be required for technology to reach its full potential in health care. HHS should
consider mapping and convening the blockchain ecosystem, building a blockchain framework
to coordinate early-adopters, and sponsoring a consortium for dialogue and discovery to help
define the future of blockchain.
CONVENE AND MAP THE ECOSYSTEM
Blockchain technology is continuously changing, with new advancements appearing on a
weekly basis. As technology evolves and new applications become viable, the Office of the
National Coordinator can play an important role in bringing together stakeholders from health
care providers, plans, startups, and academia to discuss progress, share lessons learned, and
identify open questions. To that end, HHS may create a sensing system to track promising new
firms and provide a forum to connect them with more established institutions to conduct tests.
TO EXPERIMENT, FORM A CONSORTIUM
The Department of Health and Human Services has an opportunity to help a health-care
consortia evaluate blockchain technology. As blockchain becomes more widely used in health
care, the financial services industry may be able to benefit from its experience. R3 CEV is a
group of financial services sector veterans, technologists, and representatives from more than
40 financial institutions. In early blockchain trials, a similar consortium might support the
exchange of digitized medical records. HHS could play a key role in identifying and bringing
together key actors for experimentation.
EXPERIMENTS MUST BE PLANNED AND CARRIED OUT.
Experiments with blockchain technology could aid HHS in determining what the technology
is capable of. The experiment design should focus on addressing problem sets that span many
work streams and involve transactions.
EXPERIMENTS MUST BE PLANNED AND CARRIED OUT.
Experiments with blockchain technology could aid HHS in determining what the technology
is capable of. From creation to archival storage, the experiment design should focus on
addressing holistic work stream problem sets with transactions spanning several parties. Prior
to nationwide adoption, developers and policymakers can resolve friction points and find areas
of advantage by starting the trial early and following it through complete transaction cycles.
TAKE INTO ACCOUNT THE INVESTMENT
Industry interest in blockchain technology is increasing, with the main consortium R3 recently
requesting $200 million in funding to fund blockchain enterprise trials. If the predicted yearly
savings of $20 billion are realized, the level of investment will be quite low. Government and
industry could save billions of dollars due to potential efficiency, cost savings, and better
security. Existing capabilities or technologies could be utilized for near-term benefits in a
resource constrained setting, while targeted experiments can indicate where blockchain
technology could bring transformational, long-term value.
ESTABLISH BLOCKCHAIN IN HEALTH CARE SUGGESTED GUIDELINES
Similar to the Internet, the potential of blockchain grows as the number of users in the network
grows; yet, in order for all participants to benefit from the network, a standard strategy is
required. The National Coordinator's Office may set rules for data standardization and storage
on the blockchain. ONC could, for example, determine which data should be saved on or off
the blockchain, as well as the format in which it should be stored.
While blockchain technology is still in its infancy, it offers a wide range of possibilities. A
blockchain-enabled, trusted interchange of health data can provide longitudinal perspectives of
patients' health, generate new insights about population health, and aid the transition to valuebased treatment. HHS may get insights for better safety, effectiveness, quality, and security of
foods, medications, vaccines, and medical devices with greater transparency, trust, and access
to data. Blockchain's promise has far-reaching ramifications for all players in the health-care
ecosystem. Using this technology to connect disparate systems and produce insights and better
measure the value of care has the potential to be transformative. A state-wide blockchain
network could increase efficiencies and enable improved patient outcomes in the long run.