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S TA N D A R D S R E S E A R C HBlockchain in Health CareMarch 2021

BLOCKCHAIN IN HEALTH CAREAuthorPedro Elkind Velmovitsky, B.Sc., M.Sc., University of WaterlooPedro Augusto da Silva e Souza Miranda, B.Sc., M.Sc., University of WaterlooLaura Xavier Fadrique, B.Sc., M.Sc., PMP, University of WaterlooPlinio Pelegrini Morita, P.Eng., M.Sc., Ph.D., University of WaterlooProject Advisory PanelJim MacFie, Microsoft CanadaVictoria Hailey, The Victoria Hailey Group Corporation (VHG)Jennifer Teague, Ph.D., CSA GroupStephen Michell, B.Math., M.Sc., CSA GroupTania Donovska, B.Sc., M.Eng., PMP, CSA Group (Project Manager)AcknowledgementsThis work was supported in part by the MITACS Accelerate program.DisclaimerThis work has been produced by the University of Waterloo and is owned by the University of Waterloo and Canadian StandardsAssociation. It is designed to provide general information in regards to the subject matter covered. The views expressed in thispublication are those of the authors and interviewees. The University of Waterloo and Canadian Standards Association are notresponsible for any loss or damage which might occur as a result of your reliance or use of the content in this publication.csagroup.org2

BLOCKCHAIN IN HEALTH CARETable of ContentsAuthor2Advisory Panel2Acknowledgements2Executive Summary41 Introduction1.1 What Is Blockchain?672 Objective and Methodology83 Opportunities for the Use of Blockchain in Health Care3.1 Benefits of Blockchain3.2 Disadvantages of Blockchain3.3 Key Health Care Challenges and Use of Blockchain3.3.1 Electronic Health Records3.3.2 Supply Chain3.3.3 Health Insurance3.3.4 Genomics3.3.5 Consent Management3.3.6 Practical Exploration of Standards for Blockchain91010111112131415154 Developing a Consent Management Platform Using Blockchain4.1 Modeling the Consent Management Process4.2 Implementing the Consent Management Platform4.3 Complexities in the Development of a Blockchain Platform151718235 Standards in AAL and Blockchain5.1 Blockchain Standards5.2 Opportunities for Standards Development2425266 Conclusions29References30Appendix A – Digital Health Agencies/EHRs in Each Province/Territory41Appendix B – Additional Standards43csagroup.org3

BLOCKCHAIN IN HEALTH CAREExecutive SummaryHumans today are experiencing unprecedented longevity, with older adults wishing to age independently, actively,and at home. As a result, there must be a necessary shift in how governments and countries view health caresystems. These systems must be more proactive, promoting healthy lifestyles and behaviours, while having thenecessary infrastructure to provide support, minimize risks, and allow for successful aging in place.Globally, society is currently in an age of ubiquitous and smart technologies that can monitor our health effortlesslyand in real time, including mobile, wearable, and connected devices. Active Assisted Living (AAL) technologiesare used to promote independence and the quality of life of individuals, especially amongst vulnerable and elderlypopulations. When AAL is applied properly and respects security and privacy, it can facilitate an improved qualityof life for older adults that includes better health, increased longevity, and supported independence. Alongsidethe development of technologies like AAL, we are seeing advancements in new areas of Information andCommunication Technologies (ICT), such as Blockchain.Blockchain technologies have gained in popularity since the development of cryptocurrencies in 2008 and havesince been proposed as solutions to solve challenges in several fields. Blockchain can be seen as a tamperproof,decentralized virtual ledger that uses cryptography to ensure security and privacy. By design, Blockchain can providemore interoperability, availability, and robustness. Health care has long been plagued by inefficiencies and limitations,such as difficulties in the collection, sharing, and use of patient data to improve health outcomes – hence thepotential value of an immutable ledger in mitigating these issues. Solving these challenges may also allow for a bettermanagement of the demands of an increasingly aging population: as innovative and smart technologies collect, share,and analyze older adults’ data, they can help them live more independently and risk-free.Previously, CSA Group published reports on emerging sharing technologies with the Mowat Centre [1] and onthe AAL landscape in Canada with the Ubiquitous Health Technology Lab [2]. This current report builds on theseprevious reports by exploring how Blockchain is being used in industry to mitigate challenges in health care,exploring issues associated with this innovation, and focusing on how the technology can be used to improve AALtechnologies as well as current standards in the field and future opportunities.Insights and results have been obtained by conducting a literature review and consulting with stakeholdersthrough semi-structured interviews. The objective was to identify opportunities and challenges to the applicationof Blockchain for health care and, more in depth, in the field of AAL. These analyses also provided insights into thedevelopment of new standards for the development of solutions using Blockchain and AAL. The goal of this reportis to provide a better understanding of the Blockchain areas in which the development of standards can make adifference, specifically in the realm of connected devices and AAL.Throughout the literature review, the following challenges were identified and grouped into five areas:1. Electronic Health Records2. Supply Chain3. Health Insurance4. Genomics5. Consent Managementcsagroup.org4

BLOCKCHAIN IN HEALTH CAREThe interviews were used to confirm the results from our literature review, as well as obtain more information onBlockchain technologies. For example, Blockchain can provide several features to address health care issues,including immutability, decentralization, and security. However, Blockchain technology also has disadvantagesthat need to be balanced in its implementation, such as scalability issues, redundancy, and complex governancestructures.From the aforementioned challenges, consent management was singled out as one of the most pressing andpromising applications of Blockchain in health care. All challenges and issues highlighted throughout the reportdepend, on some extent, on data sharing between different entities in a trusting and secure manner. To furtherour understanding of the application of Blockchain in health care, the main findings from the literature review andinterviews were used to guide the development of a Blockchain-based consent management platform for AAL data.This platform can potentially increase transparency in the consent management process, enabling more efficientdata-sharing.The interviews conducted by our research team, in combination with the experience in the development of aBlockchain platform, have provided critical insights on current gaps in the availability of standards, guidelines, andbest practices for supporting the use of blockchain in the AAL domain. There are currently few standards focusingon AAL technology, Blockchain, and the integration of both. Most stakeholders who are developing Blockchainsolutions or who are involved with remote patient sensing are using existing health care and health informaticsstandards; Blockchain standards are currently in development or have been very recently published. In this report,we provide an overview of relevant Blockchain standards under development, in addition to discussing severalopportunities for standards development such as knowledge translation, cybersecurity, governance, and privacyby design.csagroup.org5

BLOCKCHAIN IN HEALTH CARE"While technology has long been exploredas a means to help the elderly with dailyactivities, the research and health carecommunities are just recently able tocapitalize on the benefits of technologies at ascale that allows successful aging in place."1 IntroductionThe world’s age distribution is shifting towards an olderpopulation. By 2050, for example, Latin America, theCaribbean, and most of Asia, will have a median ageof 40 years old, compared to a median age of around30 today [3]–[5]. In Canada, nearly one in sevenpeople were aged over 65 years old in 2012, and thisnumber is expected to increase to one in four by 2030[6]. According to the American Association of RetiredPersons, 71% of people between the ages of 50 and 64and 87% of people aged over 65 want to live at homewhile they age [7].Successful aging in place requires older adults to beas independent, secure, and as healthy as possible.However, old age is associated with deterioratinghealth conditions and increases in chronic disease. Forinstance, it is estimated that 90% of Canadians over65 years of age have at least one chronic condition [6].Hence, aging in place can pose risks for the elderly.As seniors are a rapidly growing percentage of theCanadian population, “living longer and healthier livesthan previous generations” [6], there is an expectationfrom this demographic group for active aging inplace [8]. Going further, they expect to remain in thecommunity and at home in a safe, comfortable, andindependent manner as they age.We live in a world of global exponential innovation.Referred to as a Fourth Industrial Revolution, emergingtechnologies such as the Internet of Things (IoT) andArtificial Intelligence (AI) [9] are increasingly prevalentcsagroup.orgin people’s daily lives (e.g., smartphones, homeassistants, and smart appliances create a connectedsystem of smart devices). While technology has longbeen explored as a means to help the elderly with dailyactivities, the research and health care communitiesare just recently able to capitalize on the benefits oftechnologies at a scale that allows successful aging inplace [2].The field of Active Assisted Living (AAL) involves theuse of Information and Communication Technologies(ICT) to “improve quality of life, bring independence,and enable healthier lifestyles for those who needassistance at any stage of life”, particularly vulnerableand aging individuals [2]. Currently, consumer-gradedevices are being used as AAL technologies due totheir mass availability and ease of implementation.This presents two issues of concern: interoperabilityand privacy.Devices used for AAL purposes are often producedby different manufacturers without comprehensiveprotocols for interoperability with devices from othervendors [2], presenting challenges for data integration.Different smartwatches may require the use of distincttechnologies and proprietary platforms. As an example,an Apple Watch will require an iPhone integration (andthis integration is limited to the types of data acceptedby HealthKit [2]). Researchers wanting to collect datafrom Apple Watches along with other smartwatcheswill need to make use of several different technologiesand applications. In addition, regarding privacy, the6

BLOCKCHAIN IN HEALTH CAREubiquitous nature of AAL technologies (which are nowextremely common and pervasive in people’s lives)increases the complexity of data collection points,making it harder to know exactly what data are beingcollected and for what purpose. This is particularlyconcerning for older adults, who traditionally haveless advanced technological literacy compared withyounger populations [10].such as Bitcoin. Blockchain is a distributed virtualledger that uses cryptography and consensusmechanisms to ensure that all ledger participantsview a single immutable log of information. In otherwords, it can be seen as a tamper-proof data structurethat is ideal to safely track and store events andassets, increasing trust among parties while enablinginteroperability of different components.AAL technologies need to be adopted at scale incommunities to allow safe and active aging in place.With a large and mature ecosystem of connected AALdevices, manufacturers and regulators could improveupon interoperability and data privacy issues. Thecurrent ecosystem is fragmented and composed ofseveral devices that do not connect with each other orhave their own data collection and privacy-preservingmethods, making integration more difficult. The AALprogramme in Europe, for instance, supports andfunds projects focusing on the development of AALtechnology to solve challenges in aging [11], [12].As another example, Japan, with the oldest agingpopulation in the world, is focusing on the creation ofassistive robotic technologies to assist this population[12]. Canada lags when compared to other countriesin the adoption of large-scale AAL platforms, althoughthe country is a part of the AAL Programme and thereare several networks of researchers exploring healthaging, such as Age-Well [2], [13]. Even countries andregions that are more advanced in terms of large-scaleadoption of AAL technologies still face challengesrelated to privacy, interoperability, and data sharing.Given the fragmentation and immaturity of thisgrowing sector, new solutions are needed to addresspersistent issues around data governance and privacyarising from data collection, use, and disclosure. Onetechnology that could help increase interoperabilitywhile maintaining privacy and enabling the rise ofan AAL ecosystem such as the one described isBlockchain.Currently, the technology’s potential to increasetransparency and trust in several fields (e.g.,environment, energy) is being recognized, includingin health care [9], [12]. Given the novel applicationsof Blockchain in health care and in AAL, mitigatingissues such as data sharing, interoperability, security,and privacy, the goal of this project is to explore thepotential of Blockchain in the development of AALtechnologies. This report focuses on how Blockchaincan mitigate or solve current challenges in healthcare, how the health care industry is perceiving andimplementing Blockchain solutions, and if this workrelates to AAL and the needs of older populations. Thereport has a secondary goal of exploring opportunitiesand challenges for standards implementation tosupport the use of Blockchain in the health careindustry and in the field of AAL.Blockchain is considered to be a “foundationalemerging technology of the Fourth IndustrialRevolution” [9] and has gained popularity since itscreation due to the development of “cryptocurrencies”,1.1 What Is Blockchain?Blockchain is a digital distributed ledger that usescryptography techniques to record transactions.It is composed of a peer-to-peer (P2P) network ofcomputers called nodes, each possessing the samecopy of the ledger. This ensures that all participantsaccessing the network view one version of the truth[12], [14].The transaction recorded in the network can beanything, from a financial currency exchange to thetransfer of a land title. While different Blockchainsusually handle one type of information1, the underlyingconcept of Blockchain technologies works the sameway: a transaction is time-stamped and then “sealed”inside a block, which is then linked to the chain ofexisting blocks through a consensus mechanism[12], [14].1 For example, a transaction in the Bitcoin Blockchain is composed of an amount of Bitcoin, the person sending the Bitcoin, and the person receiving it.csagroup.org7

BLOCKCHAIN IN HEALTH CAREFor example, the Bitcoin Blockchain uses a consensusmechanism called Proof-of-Work (PoW), in whichthe participating nodes in the network try to guess arandom number, called a nonce, that is the answer toa mathematical problem. The first node to correctlyguess the nonce can use it as a digital key to attachthe block with a transaction to the Blockchain in aprocess called mining; the nodes that try to guessthe nonce are called miners, and the winning nodereceives a reward for maintaining the network throughthe consensus mechanism (in the case of Bitcoin, thewinning node is rewarded with an amount of Bitcoins)[12], [14]. Every transaction in the network is validatedthis way.Blocks are linked through a method called hashing,which converts data into an almost arbitrary string ofcharacters. Hashing methods are extremely sensitiveto input. For example, if a small piece of informationin the inputted data is changed, the generated hashwill be completely different. This makes it impossibleto reconstruct the original information from a hash. Inthe case of the Bitcoin Blockchain, the nonce is hashedtogether with the transaction and the hash of theprevious block, generating a new hash. If an attackertries to tamper with a previously linked block (e.g.,trying to remove a block and include a new one withmodified information), the hash will be altered and theBlockchain will be broken. This allows Blockchain to bea tamper-proof and immutable ledger [12], [14].According to the access structure of Blockchaintechnologies, they are usually divided into the followingtypes [15]: Public Blockchain: All nodes in the network canread/write information (Bitcoin and Ethereum areexamples of public Blockchains). It is a public ledger.In public Blockchain, information cannot be deleted.Permission (Consortium/Federated) Blockchain:The nodes consist of a consortium of participantswho operate the network and define rules andpermissions, including the ability to change or deleteinformation. For example, a Blockchain consisting ofhealth care stakeholders can allow patients to jointhe network and edit their information, while onlyhealth care providers can append new information.csagroup.org Private Blockchain: A single owner controls theBlockchain and defines rules and permissions.Blockchain technologies can also be leveraged to allowthe implementation of smart contracts. A traditionalcontract sets terms of agreements between parties toincrease trust between them. The contract can be usedto ensure compliance in case a party does not followthrough with the agreed-upon terms. Smart contractsfurther increase trust through the introduction ofautomation by codifying the terms of contracts intosoftware [12], [14]. For example, a smart contract maybe implemented to receive input from crop sensorsand, in the event of crop damage, the contract wouldactivate an insurance claim [16]. With the help ofBlockchain’s permanent and distributed ledger,smart contracts can be a powerful tool to increasetransparency and trust between parties and removethe need for human intervention and inefficiencies inthe process.2 Objective and MethodologyThe objective of this report is to explore the use ofBlockchain for improving on some of the challengescurrently faced in the health care sector, with a focuson the field of AAL, and to investigate opportunitiesfor standards adoption in these areas. Therefore, inaddition to exploring this field, we want to highlightany existing gaps in standards that can facilitatethe adoption of Blockchain for AAL. To this end, wefollowed three exploratory methods: a literature review,interviews with knowledgeable stakeholders, and apractical implementation of a Blockchain proof-ofconcept.A literature review was conducted on the current useof Blockchain solutions in health care to develop anunderstanding of what these technologies entail, and toidentify existing challenges in health care.For this report, the following research questions weretaken into consideration:1. W hat are the current challenges faced by thehealth care industry today that could be addressedby Blockchain technology?8

BLOCKCHAIN IN HEALTH CARE2. F or each of these challenges, which Blockchainsolutions are being developed by the health careindustry?3. Which of these solutions can also apply to AAL?4. How can standards contribute to AAL/Blockchain?Grey literature (comprised of the web pages ofcompanies and solutions reviewed in this project) wasreviewed in addition to academic literature (e.g., IEEEand PubMed) and news outlets (e.g., CoinDesk [17],Cointelegraph [18], and Medium [19]). The keywordswere a combination of “blockchain”, “distributedledger”, ”health”, “industry”, and “health care”. Wheneverpossible, technical reports were reviewed in additionto news articles. Health care companies identifiedthrough this review were grouped into common themesto explore how innovators claimed to use Blockchainand what health care challenge was addressed.The literature review was followed by telephoneinterviews with key stakeholders in the fields ofBlockchain and AAL. The purpose of the interviewswas to build on the results of our literature reviewas well as to confirm, with active participants in thefield, that Blockchain was indeed being currentlyused as stated in the field. Details on the limitationsof the technology are not often raised in publisheddocuments, so these interviews were also used toexplore any disadvantages of Blockchain technologies.All interviews followed a semi-structured interviewguide, which provided the flexibility of adaptingquestions to each participant’s context. Sinceany future standards for supporting Blockchaintechnologies are implemented to benefit innovators,we focused on interviewing stakeholders thathad experience with this technology. A subset ofthe interviewees also had experience in applyingBlockchain for health care contexts. For this reason,end users of the Blockchain tools were not included inour interviews.During the literature review, we identified key conceptsand themes related to Blockchain and health care. Thiswas followed by a thematic analysis of the interviewcsagroup.orgtranscripts by summarizing and prioritizing whichareas in the health care industry benefit from the useof Blockchain, as well as any mention of standards (orlack thereof). During the thematic analyses, conceptsrelated to the health care challenges identified duringthe literature review stage were specifically consideredwith a focus on how these benefits can translate intothe field of AAL. The results are presented accordingto these themes, with the literature review andstakeholder input being presented together undereach theme.The main findings were used to guide the developmentof a proof-of-concept in order to better understandthe use of Blockchain in health care. The goal of thisprototype was to explore the utility of Blockchain in aspecific use case, highlighting benefits or limitationsof the approach, as well as identifying future researchneeds and opportunities for the development ofstandards.3 Opportunities for the Use ofBlockchain in Health CareThe main findings of this research are presentedbelow. Section 3.1 and 3.2 review the benefitsand disadvantages of Blockchain accordingto the interviews and Section 3.3 presents thechallenges found in the literature review, followedby an exploration of how health care innovators areusing these technologies to address some of thesechallenges. In this section, we explicitly mentionthe interviews if a specific topic was highlighted bystakeholders. Section 4 describes how these resultsled to the development of a Blockchain platformfor consent management, and Section 5 describesexisting Blockchain standards, as well as current gapsand opportunities for standards development withBlockchain, health care, and AAL. Eleven stakeholdersparticipated in the interviews. Eight stakeholdersworked in industry and were involved with security,privacy, and Blockchain; and three stakeholders camefrom academia.9

BLOCKCHAIN IN HEALTH CARE"The stakeholders interviewed for the projectcited auditability, proof of transactions,and immutability as major advantages ofBlockchain technologies."3.1 Benefits of BlockchainThe stakeholders interviewed for the project citedauditability, proof of transactions, and immutabilityas major advantages of Blockchain technologies.Due to their decentralized structure and consensusmechanism, these technologies can also increase trustin distributed spaces, as all partners involved will haveclear, transparent, and trusted records.Several attributes can be included in the Blockchain,such as titles and legal documents [12], [14]. In thehealth care domain, one stakeholder pointed out thatattributes such as test results, instructions for medicaldevices, compliance with standards, among others, arepossible artifacts to be appended on the Blockchain.Blockchain technologies are flexible enough toaccount for different regulations. For instance, it ispossible to set up nodes in different regions to complywith geographical regulations such as data not leavinga territory.providing an unchanging log of events, Blockchaincould be an excellent tool for solving this problemthrough consent management for data collection.3.2 Disadvantages of BlockchainStakeholders were quick to raise current limitationswith the technology. Four stakeholders mentionedthat, currently, there is a lack of understanding ofwhat Blockchain is (further confounded in that manypeople think only in terms of cryptocurrencies andfinancial applications). This leads to the overuse/overhype of the technology, with Blockchain beingapplied to situations in which it might not be thebest solution. One stakeholder mentioned that thisimmaturity is not different from other new technologies,and innovation requires a trial-and-error period. Onedifficulty generated out of immaturity is the lack ofrobust models of how a Blockchain should work (e.g.,rules, governance structure, access control) in differentapplications.Blockchain can also be easily integrated with othertechnologies such as Artificial Intelligence (AI).Some examples are explored in the next sections.If integration with different tools is needed, developersmust take that into account when developing theirinfrastructure.Two stakeholders mentioned a fear of litigation with theadoption of innovative technologies. This is particularlytrue in the health care domain, in which the qualityof life of patients must be maintained, as well as theirsecurity and privacy; implementing new technologiesthat disrupt the current workflow can be a deterrent toadoption.One common theme throughout the literature reviewand stakeholder interviews is that privacy is a majorconcern for AAL and data collection in general. ByScalability was also identified as an issue by threestakeholders. Most current Blockchain implementationscannot handle large volumes of data, and it is generallycsagroup.org10

BLOCKCHAIN IN HEALTH CAREaccepted that the technology should not be used asa database. This means that typical implementationsshould not be used, for example, to store health recordinformation or other data types. Rather, the strengthof the technology lies in storing a log of events withreference to information off-chain in an immutable way.It is important also that any external data referencedshould also be made immutable to maintain thebenefits of Blockchain. One way to achieve this is byhashing each document and storing the hash in ablock; in this manner, users would be able to check ifthe data were tampered with in any way.Ultimately, a lack of standards for these technologies,and specifically for health care, was a limitation notedby all participants.The immutability of Blockchain technologies canalso be a disadvantage, as information included inpublic Blockchains cannot be deleted. Permissionedor private Blockchains, however, have their own setsof rules regarding appending, updating, and deletinginformation, as previously mentioned. In addition, itis important to note that time-stamping, validation,and securing records/assets on the Blockchain doesnot necessarily guarantee data quality, as this comesfrom the source of data input (e.g., human error, sensormalfunction).3.3 Key Health Care Challenges andUse of BlockchainSince current Blockchain implementations oftenconsume large amounts of energy, one stakeholderpointed out that these technologies might beunsustainable as their benefits do not compensatefor the damage done to the environment. The miningprocess and the large number of nodes, typical ofcryptocurrency systems, are a large part of the energyuse, and other implementations that do not dependon these may consume less energy. Given the novelaspect of the technologies, there is also uncertaintyabout its usability, especially related to different regionsand legislations (e.g., regulation of Electronic HealthRecords, democratic economies versus authoritarianregimes, geopolitical problems). Therefore, whileone of the potential benefits includes flexibility inthe technology to deal with distinct regulations, itsimplementation may be hampered by external factors,as described above.Two stakeholders pointed out that most Blockchainsolutions in health care are in early, prototyping stages,while another stakeholder mentioned one example ofa solution already deployed with large hospital chains.csagroup.orgIndeed, in our literature review, we found that, with afew exceptions, most solutions seem to be at initialprototyping stage. While their functionalities arealready planned and being implemented or tested,there is a lack of wide usage and large-scale adoptionof finalized solutions. In addition, these are commercialsolutions, which may require a fee or subscription touse them once they are completed.The literature review, along with the targetedinterviews, revealed five key themes around whichBlockchain has been explored in health care. Thefive key challenges reviewed in this report includeElectronic Health Records, supply chain (subdividedinto drug and food supply chains), health insurance,genomics, and consent management.The challenges presented in this report represent asample of issues and are not meant to be exhaustive.For example, there are issues that cross multiplesectors, such as identity management. When needed,these additional challenges will be presented.3.3.1 Electronic Health RecordsThe use of Electronic Health Records (EHRs), whichcontain digital health-related data from patients, hashelped to increase the quality and delivery of care [20].One of the biggest challenges facing the health careindustry today is

3 Opportunities for the Use of Blockchain in Health Care 9 3.1 Benefits of Blockchain 10 3.2 Disadvantages of Blockchain 10 3.3 Key Health Care Challenges and Use of Blockchain 11. 3.3.1 Electronic Health Records. 11 3.3.2 Supply Chain 12 3.3.3 Health Insurance 13 3.3.4 Genomics 14 3.3.5 Consent Management 15

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