Post on 12-Apr-2017
BLOCKCHAIN IN HEALTHCARE SUPPLY CHAINS
Neil H. Wasserman, Timewave Analytics, LLC
Contact: nwasserman@tmwv.net
Nov 2016 The Impact of Blockchain on Pharma and Healthcare Service Delivery Processes
Blockchain, the technology underlying bitcoin and other virtual
currencies, is now a disruptive factor in IT services and
strategy for every major financial services organization, as
well as for companies, like IBM, Microsoft, and other IT service
organizations involved with information technology. Similarly
in healthcare, blockchain will have wide-ranging effects,
changing the character and cost structure for clinical trials,
enabling new modes of patient engagement, access to health
information, and personalization of drug design, drug
formulation, and treatment regimens.
This paper takes a high-level view of blockchain technology in
relation to its potential impact on the pharmaceutical industry
and healthcare more generally. We aim to identify why and
how those connected with the pharmaceutical industry need to
pay attention to critical issues associated with the impact of
blockchain on healthcare. This will enable the development of
strategies and initiatives appropriate to the rapidly changing
business environment for drug development and provision of
care for patients.
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Contents
WHY BLOCKCHAIN DESERVES YOUR ATTENTION.............................................................. 2
WHAT IS BLOCKCHAIN? ...................................................................................................... 2
Key Technical Features of Blockchain ................................................................................................... 3
Trusted Identity without a Central “Trusted” Administrator........................................................... 3
Distributed Ledger ................................................................................................................................ 3
Consensus Algorithms ............................................................................................................................ 3
Smart Contracts ..................................................................................................................................... 3
Blockchain-as-a-Service ....................................................................................................................... 4
Blockchain Business Capabilities ............................................................................................................ 4
Identity..................................................................................................................................................... 4
Anonymization ........................................................................................................................................ 4
Provenance ............................................................................................................................................. 5
Ownership ............................................................................................................................................... 5
Transaction Validation .......................................................................................................................... 5
Transferability, Access .......................................................................................................................... 6
Availability / Confidentiality .............................................................................................................. 6
CHALLENGES FOR DEVELOPMENT OF MEDICAL INTERVENTIONS ..................................... 6
Clinical Trials and Related Data Management .................................................................................. 6
Supply Chain ............................................................................................................................................. 6
Managing the Complexity of Patient Care ........................................................................................ 6
IMPACT OF BLOCKCHAIN ON PHARMA BUSINESS MODELS – KEY USE CASES ................ 7
Supply Chain Management .................................................................................................................... 7
Drug Development and Clinical Research ........................................................................................... 7
Integrity of Clinical Data ..................................................................................................................... 7
Expansion of Patient Cohorts .............................................................................................................. 7
Downstream Research on Patient Impact ............................................................................................. 8
Integrating Treatment Regimens with Adherence and Patient Capacity for Disease Management ............................................................................................................................................. 8
Assessment and Management of Patient workload ........................................................................ 8
Complexity of Chronic Disease Management ................................................................................. 8
Changing Models for Drug Design, Formulation and Delivery ....................................................... 9
Personalization of Drug Treatment Regimens and New forms of Patient Engagement .......... 9
New Business Models ......................................................................................................................... 10
Serving Populations with Limited Access Healthcare Services ................................................... 10
STRATEGIC ISSUES – WHAT NEEDS TO BE DONE NOW .................................................... 11
Intellectual Property Strategy ............................................................................................................ 11
Business Alliances for Pilot Implementation ...................................................................................... 11
Business Impact of Regulatory Change ............................................................................................. 12
CONCLUSION .................................................................................................................... 12
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Blockchain in Healthcare Supply Chains
WHY BLOCKCHAIN DESERVES YOUR ATTENTION For good reason blockchain technology is becoming a key factor in business strategy.
Marc Andreessen, the founder of Netscape, said that blockchain today is like the Internet was
in the 1990s. It will transform the way business is done. That is certainly the case for financial
services, with every major financial organization looking at blockchain as both a threat and
opportunity. Financial services invest a lot in IT, where small advantages in IT capability can
make a huge difference in terms of profitability and even viability. IBM, Microsoft, Deloitte
and virtually every major business service organization have blockchain innovation groups and
initiatives to address the impact of blockchain on their business and government customers.
But what of healthcare? Why should we pay attention?
The growing interest in applications of blockchain to healthcare is reflected in the growing
number of events on the subject. Most recently there was a conference sponsored by ONC and
NIST1, highlighting a number of initiatives based on blockchain technology to address urgent
healthcare issues. Some of these efforts will be discussed in this whitepaper.
WHAT IS BLOCKCHAIN?
The simplest answer is that blockchain is the technology underlying bitcoin and other virtual
currencies. In that technical model, it provides peer-to-peer verification of ownership, and
mechanisms for recording simple transactions that transfer ownership. The structure was
devised to solve the “double spending” problem without a central authority. One should not
be able to sell a bitcoin and then sell it again to a different party.
The principal features of blockchain are shown in the chart.
1 Office of the National Coordinator (ONC)and National Institute of Standards and Technology (NIST), Use of Blockchain in Healthcare and Research Workshop , Sept. 26-27, 2016. https://oncprojectracking.healthit.gov/wiki/display/TechLabI/Use+of+Blockchain+in+Healthcare+and+Research+Workshop
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In defining blockchain, it is common to offer simple answers such as blockchain is about
“provenance”. Blockchain is about a “distributed ledger.” But the answer to that question is
more complicated and dynamic.
Since the development of cryptocurrencies, many have recognized that the innovations involved
in the bitcoin model could have much wider impact. Some of the most creative scientists and
engineers have analyzed the original bitcoin technology, extracting features that have more
general applicability. The blockchain domain has now expanded to constitute features and
innovations that go far beyond the original bitcoin distributed application environment.
Key Technical Features of Blockchain
Trusted Identity without a Central “Trusted” Administrator
Identity of parties in the healthcare ecosystem is an essential requirement for many business
functions. Manufacturers must have trust in the supply chain. Patients must have trust in the
sources of information to which they have access. Several initiatives that build on the
blockchain infrastructure are addressing the need for peer to peer, distributed identity and
trust mechanisms.
See for example companies like Drummond Reed’s, RespectNetwork, and corresponding
standards initiatives are using blockchain to build a robust infrastructure for identity
management.2 :
Distributed Ledger
Blockchain is often described as a distributed ledger. It is more than that, but fundamental to
blockchain capabilities is the distributed record of transactions, or other content, which is
validated in a decentralized network. This data store is replicated, synchronized and
validated across a community of servers. The block contains a record of transactions and a
“hash” of the prior block in the chain, the hash being a code that can be used to validate the
content of prior blocks.
Consensus Algorithms
Associated with this distributed ledger are algorithms designed to validate and attain
consensus on which blockchains, that is what transaction records, are recognized as correct by
the community. There is the cost to building consensus, and one of the major areas of technical
focus is making that process more efficient, without sacrificing confidence in the validity of the
shared content.
Smart Contracts
One of the key developments subsequent to the original application of blockchain to
cryptocurrency is the attachment of rules for transactions executed in the blockchain
environment. This concept was promoted by Ethereum (www.ethereum.org), and continues to
be elaborated by other organizations and initiatives. These rules, embedded in contractual
2 Additional sources of information may be obtained at the repository of papers submitted to a workshop on
the subject, e.g., Web of Trust Design Workshop, https://github.com/WebOfTrustInfo/ID2020DesignWorkshop
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relationships, can be used to support many types of business transactions, access to data,
transfer of ownership — any operation dependent on who is participating and the state of the
participants’ environment.
Blockchain-as-a-Service
Few users of blockchain technology in the healthcare space will choose to develop their own
infrastructure. Standards for blockchain services, such as identity management, smart contracts,
and other features are in development. Service providers like IBM, Microsoft and numerous
smaller companies will offer a blockchain infrastructure to companies and individuals that want
to take advantage of the new capabilities for accessing data and managing transactions.
Companies entering the blockchain world will have to make decisions regarding their
participation in standardization initiatives and how they will access blockchain based business
services.
Blockchain Business Capabilities
What business strategists need to pay attention to, more than the technical infrastructure, is the
set of capabilities that affect current business processes and enable new ones. One pervasive
feature of the blockchain business environment is the ability to incorporate rules and constraints
on participant behaviors. More than just Smart Contracts, the rules pertain to virtually all
functions enabled by the blockchain environment.
Identity
Trust in a transaction environment begins with validating the identity of the participants. The
ability to provide a unique identifier to individuals in a distributed network will enable the
creation of new modes for data access across servers. Rules associated with identity can
enable consumer-controlled permissions, group associations, and non-repudiation for member
transactions. Validated identifiers can be attached to real and virtual objects for supply chain
validation and data assurance.
Anonymization
The ability to support anonymized identity and access to transactions is a core feature of the
original blockchain design as implemented in the bitcoin protocol. While anonymized
transactions may be controversial in some environments, the potential for anonymized,
validated identity has profound implications for what is possible in pharmaceutical
development and in delivery of healthcare services. As will be discussed in more detail below,
anonymization with permission rules expands potential patient participation and alters design
constraints for clinical trials and enables access to patient data that may reside at multiple
locations. This capability may in turn facilitate customization of service protocols, as well as
more detailed information on the efficacy of drugs in relation to individual patient
characteristics.
One important consideration is the need for analysis and regulation of deanonymization
capabilities. The aggregation of data may permit the identification of individuals who believe
they are gaining access to a service on an anonymous basis. Anonymization protocols must
therefore include safeguards to protect improper identification of individual participants, or at
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least warnings regarding deanonymization risks when individuals agree to participation on the
assumption of anonymity.
Provenance
Provenance, in relation to blockchain, is the ability to trace the origin and validity of an object
(product, data, person, action) over time. In a supply chain, for example, the origin of a
component in the manufacturing process may need to be validated and traced back to its
source. A transaction record or other piece of data may need to be verified and traced back
to its owner to validate the content and permissions associated with the use of the data. The
provenance of an object linked to a blockchain is validated by the hash and consensus
algorithms that assess the validity of the blockchain and its content. Confidence in the
provenance of the object associated with the blockchain is fundamental to the trust relationships
that the blockchain infrastructure supports.
Ownership
Ownership of a unit of cryptocurrency such as a bitcoin is a property of the original blockchain
use case embodied in the bitcoin infrastructure. “Ownership” is a construct of the community
that recognizes that particular relationship between an object and an individual or entity. The
power of the blockchain derives in part from the ability to support ownership contracts
recognized by a community. What is owned, or more specifically what is controlled, according
to established rules, may include tokens of value, payments, data, services, drugs, medical
devices, treatment regimens, or entities in a complex supply chain.
In the healthcare environment, ownership includes the ability to control permissions for the use
of information pertaining to the health of an individual, or data pertaining to the actions,
rights, and capabilities of a healthcare provider. This becomes particularly important as the
range of data pertaining to individual health expands to include IOT data, such as sensor-
produced data, GPS data, transaction data, or information on the behavior of the patient,
which may be relevant to a patient’s health, but which should remain under the patient’s
control.
Transaction Validation
A block in a blockchain holds batches of validated transactions. A key unique feature of the
blockchain infrastructure is the use of consensus algorithms to compare the validity of
alternative transaction records, and flag when a blockchain may have been corrupted. From
the business perspective, trust in the immutability of the record and in the identity of the
participants to the transaction is of enormous value. As the blockchain infrastructure has
evolved, conditions for executing transactions can be defined as Smart Contracts, without the
intermediation of third parties. Simple operations such as access to data can be conditional on
such contracts. More complex operations, such as payments or permissions for procedures can
also be supported with the implementation of rule-dependent transactions.
In the healthcare environment, trusted identity and rule-based transactions (Smart Cntracts) can
be applied to all actions that affect the health status of the patient. These may include
behaviors carried out by the patient, such as those associated with adherence to prescribed
regimens, communications between the provider and the patient, and changes in the patient’s
data produced by diagnostic and sensor devices. The validated transaction record can then
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be reliably used to manage the condition of the patient, as well as to support research on the
impact of alternative treatment regimens. Controlled access to patient data can then be used
to assess outcomes in relation to detailed data on the characteristics of individual patients and
patient populations.
Transferability, Access
With ownership goes the ability to transfer objects from one owner to another. The blockchain
infrastructure provides the ability to control such transfers, and control access to any object
referenced on the blockchain. This capability can include access to data, as well as access to
physical objects such as pharmaceuticals, and medical devices.
Availability / Confidentiality
Because of the ability to manage permissions for access to multiple data sources, one of the
use cases to be implemented early on is likely to be interoperability for data access. With
appropriate controls supported by the blockchain infrastructure, a more open data
environment can be supported within HIPAA rules and other requirements for privacy of patient
data.
If such data is to be provided to entities other than the patient, even with permission,
deanonymization may be an issue. The rules-based capability for managing permissions will
have to be structured to address this concern. But blockchain promises to offer a common
protocol for permissions and integrated access to multiple electronic data sources, a challenge
that has impeded integrated patient care and decision-making.
CHALLENGES FOR DEVELOPMENT OF MEDICAL INTERVENTIONS Blockchain technology promises to address a number of challenges that prevent efficient
development of new treatment regimens. Some of these obstacles to innovation and patient
care include:
Clinical Trials and Related Data Management
High cost
Small size of patient cohorts
Delays in commercialization (time-to-market)
Supply Chain
Safety and quality control and manufacturing
Safety in delivery to the consumer
Recall management
Managing the Complexity of Patient Care
Adherence and patient engagement
Managing patients with multiple chronic conditions
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IMPACT OF BLOCKCHAIN ON PHARMA BUSINESS MODELS – KEY USE CASES
Supply Chain Management
Pharmaceutical companies and other healthcare providers depend upon a global supply chain
of products and services.
Assurance in the provenance of active ingredients. – For pharmaceuticals, patient
safety and company liability depend on the reliability of active ingredients used
during the manufacturing process.
Traceability and validation or products. – Counterfeit drugs pose a threat to both
consumer safety and the profitability of pharmaceutical suppliers. Assurance that
product content meets specifications, and has not been compromised, is a core value
for pharmaceutical producers.
Improved data on the movement of pharmaceuticals globally, and data on inventory
would be of great value to multiple stakeholders, pharmaceutical companies,
pharmacies, and healthcare providers.
Managing recalls, when necessary, is very expensive and difficult to execute reliably.
The ability of blockchain technology to maintain immutable records of provenance addresses
many of these issues. Given the current expense of addressing these problems, there is likely
to be swift payback for blockchain initiatives.
Drug Development and Clinical Research
Integrity of Clinical Data
Validation and traceability of data generated during the course of clinical trials is a key
requirement for navigating the phased process for evaluating proposed medical interventions.
The ONC Challenge submission from Merck3 highlights the use of blockchain for verifying the
integrity of data obtained in connection with clinical trials. The authors highlight the
opportunity to obtain such data without violating the privacy of trial participants.
Expansion of Patient Cohorts
The combination of interoperability, data and transaction validation, and anonymization offers
a basis for expanding the size and diversity of patient cohorts in clinical trials.
INCREASE IN SIZE
Blockchain in combination with sensors and IOT support can allow for more detailed
documentation of patient actions and observational data for clinical trials. The lower cost for
3 Nishan Kulatilaka, ONC Blockchain Challenge – Blockchain Clinical Trials.
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monitoring patient compliance and the ability to manage permissions for participation have the
potential to expand the feasible size of the patient cohort involved in clinical trials.
INCREASE IN PRECISION
The increase in the size of the patient cohort connected with the clinical trial will permit
experimental designs in which multiple groups of patients can be analyzed in relation to
narrowly-defined variables that may be associated with the efficacy of treatment regimens.
The capabilities of anonymization and validation may make it possible to collect more detailed
data on individual patients. This in turn may give insight into how drug formulations and
treatment regimens can be adapted to individual patient characteristics and capabilities.
Downstream Research on Patient Impact
The blockchain infrastructure, permitting validated access to patient data, will also support
research on the impact of treatment regimens for a large fraction of the customer population.
Downstream research on patient adherence and the impact of interventions on patient well-
being will provide an enhanced basis for ongoing improvement of interventions and
customization of interventions to varying patient characteristics.
Integrating Treatment Regimens with Adherence and Patient
Capacity for Disease Management
Assessment and Management of Patient Workload
The efficacy of a particular intervention may depend upon the capacity of the patient to
manage the treatment workload.4 As described in the work of Dr. Vincent Montori at Mayo
Clinic, proposed treatment regimens should be matched to the capacity of the patient to
manage the workload associated with the new demands placed upon the patient. Blockchain
technology will permit collection of detailed data on the patient and patient’s environment and
support the development of a treatment plan consistent with the resources and capability of
the patient to meet the burdens of adherence.
Complexity of Chronic Disease Management
One of the positive trends in the healthcare industry has been a renewed focus on chronic
disease. The industry is still, however, largely structured in terms of siloes defined by
professional expertise associated with narrowly defined domains of specialization. It is
becoming increasingly recognized that these silos interfere with the ability to have a more
integrated view of the patient’s condition. Blockchain technology provides a promising means
to access data across multiple silos and to support new methods for managing the complexity
involved in the care of patients with multiple chronic conditions.
4 See for example, Boehmer, KR, et. al., “Patient capacity and constraints in the experience of
chronic disease: a qualitative systematic review and thematic synthesis.”
https://www.ncbi.nlm.nih.gov/pubmed/27585439
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DRUG INTERACTIONS
One opportunity to apply blockchain to an urgent medical need is the assessment of
medication interactions in patients requiring multiple medications and treatment regimens. An
initiative called “MedChain” is described in one of the ONC Challenge papers5. In MedChain,
a blockchain infrastructure is used to compile validated medication lists and to apply analytical
capabilities to flag the possibility of Adverse Drug Events. Of course, these incidents may be
due to other factors than drug interactions. The point is that access to a more complete set of
patient information, including reliable drug lists, enabled by a blockchain infrastructure, will
reduce the risks associated with drug interventions.
ACCESS DATA TO MANAGE MULTIPLE CHRONIC CONDITIONS
The MedChain model addresses the specific case of drug interactions. The more general
requirement is to access the more complete set of data required to manage multiple chronic
conditions. The same capabilities (identity management, anonymization, transaction validation,
and interoperability) that apply to drug interactions can be applied to the more general case
of accessing data relevant to the management of multiple chronic conditions. As noted earlier,
this information can include larger data sets than may be traditionally stored in EHR systems.
The larger universe of relevant data would include behavioral and environmental information
relevant to the patient’s condition and support network. The anonymization capabilities may
be particularly important for acquiring data related to these social and behavioral factors.
Changing Models for Drug Design, Formulation and Delivery
Personalization of Drug Treatment Regimens and New forms of Patient
Engagement
Blockchain will enable controlled access to medical and behavioral information associated with
the patient. See for example the model and pilot, “MedRec,” a collaboration between MIT’s
media Lab and Beth Israel Hospital6. This pilot implementation of blockchain technology
establishes interoperable access to the medical records of patients. The blockchain
infrastructure will enable all nodes in the patient-care supply chain to access patient data (with
appropriate permissions) and deliver information to customize treatment regimens and flag
high-risk conditions.
The MedRec pilot is an initial step in the application of blockchain technology to new forms of
patient and provider engagement. Imagine the possibility of creating flexibly defined private
social groups, to which patients with common conditions can belong, while maintaining complete
privacy. Incentives can be attached via blockchain to motivate patient behaviors. Access to
data from IOT sources can provide immediate feedback on medical adherence and adoption
5 MedChain: Secure, Decentralized, Interoperable Medication Reconciliation Using the
Blockchain
6 A Case Study for Blockchain in Healthcare: “MedRec” prototype for electronic health
records and medical research data
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of key patient behaviors. Blockchain enables a supply chain for patient care and engagement
involving the multiple stakeholders in the patient’s well-being.
New Business Models
Core blockchain capabilities for verifying identity, validating transactions, providing
permission-based interoperable data access and anonymization will encourage the
implementation of new business models, development of treatments, and improvements in
managing the supply chain of products and services from source to customer.
Blockchain will affect operations and the competitive environment for all stakeholders —
pharmaceutical companies, pharmacies, medical professionals, insurers, in-home caregivers,
and patients.
Pharmaceutical companies - Building on a blockchain infrastructure, the
pharmaceutical company can offer a range of medical products and treatment
regimens, customized to the patient’s genomic and medical data, as well as on
information related to the patient’s behavioral characteristics and support environment.
Pharmacies – With data on patient requirements, the pharmacy can oversee drug
prescriptions and guidance on how the drug is to be used, personalized to the
requirements of the patient. The pharmacy and/or healthcare provider can then
follow-up on adherence and efficacy with data provided by the sensors, mobile phone
application, and other sources of data in the care environment.
Healthcare professionals – With blockchain-managed permissions, physicians and
other healthcare providers can access information relevant to the patient’s condition
and care requirements. Integrated access to real-time data from the patient with other
electronic records will enable new mechanisms for alerting healthcare providers to
patient risk, and improve decision-making relevant to the changing needs of patients.
Serving Populations with Limited Access to Healthcare Services
Healthcare is a global business with wide variances in characteristics of local populations. One
of the most important opportunities from the standpoint of global population health is the use
of blockchain to provide access to health information and services for underserved populations.
LOWERING THE COST OF ACCESS
In many countries with poor roads and infrastructure, cell phones may be a principal means of
obtaining critical information. Blockchain technology can be a mechanism to connect sparsely
distributed health care services to populations in which the principal means of access to outside
information is the cell phone. In conjunction with other techniques, blockchain technology can
provide a low-cost way to help patients access health information, support patient engagement
in healthful behaviors, and provide for the distribution of pharmaceuticals, and other health
products. With this model, limited health resources can be leveraged to greater effect.
ADDRESSING SOCIAL IMPEDIMENTS FOR HIV AND OTHER COMMUNICABLE DISEASE
In many regions, health challenges are made greater due to social stigma and fears associated
with disease conditions. Blockchain can deliver the capability to support private
communications and, if necessary, anonymized access to health information and services. This
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may help alleviate the social challenge of managing instances of communicable disease in
these socially sensitive environments. The blockchain infrastructure can then be used to track
interventions and help manage the distribution of pharmaceuticals, with particular value in
cases where distribution networks are vulnerable to disruption.
STRATEGIC ISSUES – WHAT NEEDS TO BE DONE NOW
What should be on the priority list? How does blockchain matter now for healthcare
executives?
It is widely assumed, for many reasons, that healthcare lags other industries in terms of IT
innovation. Wide use of electronic records is a recent phenomenon in healthcare, decades
behind similar transformations in manufacturing and financial services.
Nevertheless, as we have outlined, blockchain technology has the potential to address current
challenges, such as the management of chronic disease, the rising cost of clinical trials, supply
chain management, and interoperable access to healthcare information.
If the transformative impact of blockchain is not going to be felt within the next year or more,
what needs to be done now? The conservative answer is to take actions that manage risk, that
is, take actions that put the company in a position to take advantage of appropriate
opportunities when they arise, and defend against possible competitive threats. These steps
would address such issues as intellectual property, business alliances, preparing for regulatory
change, and developing internal company resources that can allow the company to move
quickly when necessary, and to assess the changing strategic landscape.
Intellectual Proper ty Strategy
Marc Andreessen’s comparison of blockchain now to the Internet in the 1990s may also apply
to intellectual property development. In the 1990s there was a rush to claim territory in the
Internet domain. Many of those claims for patent protection were overly broad. Since the
Bilski v. Kappos decision (2010), it has become much more difficult to gain USPTO patent
approval for broad business applications of technology. Nevertheless, there is a similar land
rush for intellectual property in the blockchain space.7 Dell Products and has, for example,
filed a patent on distributed ledger applications.8
Patents are being applied for blockchain applications in healthcare, which may affect the
ability of companies to compete in business areas in which they have an interest. It would
therefore be wise to monitor developments in this area, and perhaps explore the development
of appropriate patents, if only as a defensive measure.
Business Alliances for Pilot Implementation
The competitive landscape for companies developing technology and services related to
blockchain infrastructure is evolving rapidly. Companies aiming to take advantage of
7 See Bailey Reutzel, The Looming War for Blockchain Patents, http://www.coindesk.com/looming-war-blockchain-patents 8 US Patent Application Publication 2016/0261690. “Computing device configuration and management using a secure distributed transaction ledger,” Sept. 8, 2016
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blockchain at some future point in time need to identify the technical components and business
partnerships that will enable them to implement desired changes in business processes and
customer relationships. For example, lowering the cost of clinical trials, and implementing new
experimental designs for testing safety and efficacy will require experience with pilot
implementations. These will in turn depend upon appropriate business partnerships that can
supply the needed capabilities for blockchain implementation.
Business Impact of Regulatory Change
In the United States, the FDA already has initiatives to explore new models for pharmaceutical
development and regulation. As discussed previously, blockchain technology has the potential
to change the manner in which drugs are tested and monitored. This will drive regulatory
change. It will be important for pharmaceutical companies to establish positions with respect to
regulatory policy development, and to be aware of the likely directions for such initiatives.
For example, companies may want to participate in the FDA’s Clinical Trials Transformation
Initiative, and other efforts to improve processes associated with clinical trials. Other initiatives
such as the NIH sponsored Million Person Precision Medicine Study may benefit from the
efficiencies enabled by blockchain technology. These initiatives will foster change in the
regulatory environment for clinical trials and in the evaluation of proposed interventions.
CONCLUSION Healthcare services form a complex network of supply chains. Blockchain technology is ideally
suited to manage provenance in a supply chain. This would apply to the typical supply chains
involved in manufacturing and distribution. It would also apply to other entities and associated
transactions, whether those entities represent materials for a manufacturing process, services,
payments, data, or the various stakeholders’ connection to that network. Given the expense
and risks associated with supply chain management, the payback for blockchain
implementations is likely to be substantial.
Blockchain technology will have a profound impact on the way that healthcare is delivered to
patients, especially for patients with multiple chronic conditions. Pharmaceutical companies,
insurers, healthcare providers, and other stakeholders in the healthcare industry are well
advised to anticipate the impact of blockchain on their business models.
The best way to learn about the potential business impact of blockchain is probably through
careful exploration of pilot implementations. Without incurring much risk, a pilot allows for the
exploration of scenarios involving blockchain applications for a particular business environment.
There has been and will continue to be a burst of creativity powering the evolution of
blockchain technology. A similar creative effort on the business side may produce new ways of
looking at healthcare opportunities to the great benefit of companies and their customers.