April 12, 2021 PAO-04-21-NI-01
It is clear why blockchain’s first widely used application was cryptocurrency, as a decentralized, anonymous, unregulated monetary system is appealing for a myriad of reasons. When you expand the paradigm, particularly as it pertains to the pharmaceutical industry and broader healthcare systems, it is almost a foregone conclusion that blockchain will eventually be integrated across all facets of healthcare — where efficiency, transparency, security, authenticity, and tracing all hold great value. Blockchain has promising implications in the management of healthcare data, clinical trials, and the continued battle against COVID-19 and future pandemics.
Health data — like consumer data — is typically stored in silos across disparate entities, and, while third parties can access, track, and trade that data, the people who create it and have the biggest stake are the ones who benefit the least. Our virtual selves do not belong to us, which creates problems for access, security, privacy, monetization, and advocacy.1 Our identities are ours, but the data that comes from them is owned by someone else — look no further than social media companies like Facebook and Twitter to better understand this concept.
Blockchain could put individuals in control of their health data by encrypting and storing it in a decentralized network. This would allow them to not only control who has access to the data, but also what they are allowed to do with it. Blockchain enables secure data sharing for critical public health purposes, such as contract tracing, without compromising privacy.1 As it relates to day-to-day individual health management in a more practical sense, people cannot use their own data to plan their healthcare, because treatment plans, pharmaceuticals and medical supplies, insurance, and health savings accounts — to name a few data sources — reside in different corporate data-silos. The disparate databases of healthcare providers, pharmacies, insurance companies, and local, state, and national agencies do not allow individuals to access their own data, but third parties like the American Medical Collection Agency (AMCA) can, and often do so without the patient’s expressed knowledge or consent.1
Individuals enjoy none of the rewards of this data usage yet bear most of the risk, for example, in the event of data mismanagement or security breaches in databases where information is stored. There is also no means for individuals to monetize their data — like in the case of Henrietta Lacks, whose cancer cells revolutionized the development of cancer treatment without her knowledge, generating billions of dollars for pharmaceutical companies without any compensation for Lacks’ family.2 It is estimated that an individual’s patient data is worth as much as $7,000 per year,3 and blockchain could potentially allow patients to monetize their own data rather than allowing various entities to profit from it without their expressed consent.
Looking beyond ownership and monetization of patient data, blockchain also presents the potential to increase healthcare efficiency and transparency. There are several benefits for healthcare providers who adopt and integrate blockchain. Leveraging blockchain technology could potentially lead to increased health data accuracy; a patient’s data is typically fragmented and siloed across multiple providers, but blockchain allows this data to be aggregated and integrated in an automated manner, so disparate healthcare providers can always have a complete picture of that patient’s complete medical history, allowing for them to be able to provide better care.
Blockchain also enables interoperability, which would allow providers to exchange information between systems made by different manufacturers. Most electronic health records (EHR) and electronic medical records (EMR) products are based on different clinical technologies, technical specifications, and functional capabilities,4 making it difficult to create and share data in a recognizable format across all platforms. In some cases, EHR systems built on the same platform are not even interoperable, because they are designed to meet the specific needs and preferences of a health institution.4 These limitations could be overcome by using a blockchain-based healthcare data management system, where all EHR/EMR data stored on the blockchain system follows a standardized data code, providing accessibility to any facility.
Additionally, medical records can be lost in cases of natural disasters, because centralized systems are tethered to the single point of failure.4 Blockchain can help to eliminate the risk of data theft or loss due to its immutability, which comes from sharing across a network of users located in various regions. Regional limitations could also be reduced if providers adopted a global sharing model, where EMRs can be part of a blockchain network that spans the globe, allowing for doctors to have access to a patient’s data regardless of where they live, resulting in access to personalized care all over the world.4
Furthermore, blockchain can prevent data leaks and cyberattacks that have wide-ranging consequences for patients and healthcare entities alike. Many healthcare organizations have fallen victim to preventable cybersecurity attacks, due in large part to the fact that many of them use manual systems based on a centralized infrastructure for handling digital medical records. These systems are often antiquated and lack modern security protocols, making them more vulnerable to cyberattacks. Data breaches can cost healthcare organizations up to $380 per affected record.5
The success of a clinical trial hinges on its reproducibility, which requires true and precise documentation. Every document prepared before a start of a study (e.g., informed consent, study protocol, study plans, regulatory documents) should be timestamped to prove that it existed in that exact form before the start of the trial.6 Each measurement in a trial should be digitally recorded in a way that prevents forgery or alteration that violates protocols, good clinical practice (GCP), or even laws.6 Clinical protocols should be cost-efficient, compliant with regulations, auditable, safe, fast, and transparent to all stakeholders in the network, and blockchain can provide all of the above, with an immutable audit trail that improves privacy and data security.7 Blockchain can increase clinical trial credibility while reducing costs, as the need for traditional audits, file reviews, lost document investigations, and litigation would decrease due to the existence of blockchain’s immutable data.7 Blockchain can help ensure the safety and privacy of trial participants while also reducing trial timelines, because it can aid researchers and clinicians in recording clinical data in real time as soon as it becomes available — improving accuracy, collaboration, and regulatory compliance.7
Another potential benefit of utilizing blockchain in clinical trials is in patient recruitment. There are a variety of competing concerns from trial sponsors, patients, and principal investigators, resulting in most clinical trials not meeting recruitment requirements on time.7 Conducting under-enrolled clinical trials affects the credibility of results, or causes premature trial termination.7 Clinical researchers can tackle recruitment issues by leveraging blockchain to match patients to studies — privately and securely — allowing for timely recruitment of the target number of enrolled patients.7
The early days of COVID-19 were marred by an absence of reliable and accurate information, which was exacerbated by a myriad of misinformation and conspiracy theories. Despite technological advances and innovation, and sophisticated information networks, there was still much confusion about the actual prevalence of COVID-19 — from the number of cases, hospitalizations, and deaths to effective preventative measures, efficacious treatments, and best strategies to control the pandemic globally.8 Due to the collective failure of global authorities to provide timely, accurate, and reliable information about the disease, the case numbers continued to climb and mistrust of government institutions and public health agencies proliferated.
The unique challenges associated with the COVID-19 pandemic have helped to cut red tape as it pertains to blockchain adoption. The virus has revealed many weaknesses in supply chains, as well as our collective inability to deploy resources where they are most needed in a timely manner. Additionally, capturing and sharing data needed to make rapid decisions in a fluid environment proved challenging. Blockchain solutions that have been in development for years have been repurposed and unleashed to address these challenges. One such solution came in the work of retired U.S. Airforce Colonel James Allen Regenor, who has been building a blockchain-powered platform for buying and selling traceable 3D printed parts since 2013.9 The platform allows for the scanning and tracking of parts through unique identifiers, and the blockchain ensures tamper-proof design and delivery.9 Regenor realized that his platform could help with the medical devices needed to battle COVID-19, so he founded a new company, Rapid Medical Parts, in March 2020.9 He rallied a global network of partners and, in just 12 days, the Pentagon awarded his company a contract for converting the abundant supply of sleep apnea machines into ventilators, utilizing blockchain for the printing of parts, serialization, and shipping.9
From equipment manufacturing and reconfiguration to clinical trials, supply chain management, and the dissemination of timely and accurate information, future pandemic response teams can potentially leverage blockchain to help control the spread much more efficiently. Blockchain can also be utilized for contact-tracing initiatives, as its secure and private design could put people at ease in sharing their data, while helping to protect others.
Blockchain has potential use cases across all aspects of the healthcare and pharmaceutical industries, and it should continue to be developed and harnessed to create better health outcomes around the world. Blockchain can assist in nearly every facet of efforts to continue to advance medical breakthroughs, and can help improve global collaboration, drug development, data security, supply chain logistics, and more.
Tapscott, Don; Tapscott, Alex. “What Blockchain Could Mean for Your Health Data.” Harvard Business Review. 12 Jun. 2020. Web.
Witze, Alexandra. “Wealthy Funder Pays Reparations For Use Of HeLa Cells.” Springer Nature. 29 Oct. 2020. Web.
Dimitrov, Dimiter. “Blockchain Applications for Healthcare Data Management.” US National Institutes of Health. 31 Jan. 2019. Web.
Yaqoob, Ibrar; Salah, Khaled; Jayaraman, Raja; Al-Hammadi, Yousof. “Blockchain for Healthcare Data Management: Opportunities, Challenges, and Future Recommendations.” Springer Nature.
“Blockchain for Healthcare Data Security.” Identity Management Institute. 2021. Web.
Andrianov, Artem; Kaganov, Boris. “Blockchain in Clinical Trials—The Ultimate Data Notary.” Applied Clinical Trials. July. 2018. Web.
Marbouh, Dounia; Abbasi, Tayaba; et al. “Blockchain for COVID-10: Review, Opportunities, and a Trusted Tracking System.” US National Institutes of Health. 12 Oct. 2020. Web.
Khurshid, Anjum. “Applying Blockchain Technology to Address the Crisis of Trust During the COVID-19 Pandemic.” US National Institutes of Health. 8 Sep. 2020. Web.
van Hoek, Remko; Lacity, Mary. “How the Pandemic is Pushing Blockchain Forward.” Harvard Business Review. 27 Apr. 2020. Web.
Kshitij (TJ) has been a part of Nice Insight since 2014. TJ’s role involves research design and operations, developing and maintaining syndicated studies, business intelligence data analysis, content development and article writing on the latest developments in the biopharmaceutical industry. Prior to market research, TJ spent time in academia research working on a broad range of subject matter, including pharmacoeconomics, drug delivery and genetics. TJ holds a masters of biotechnology degree from the University of Pennsylvania.