INTRODUCTION: The amount of mandatory data that needs to be analyzed as part of a medical device postmarket surveillance (PMS) system has grown exponentially in recent times. This is a consequence of increasingly demanding and complex regulatory requirements from Health Authorities, aimed at a better understanding of the medical device safety evaluation. Proactive approaches to PMS processes are becoming more necessary as regulators increase the scrutiny of device safety. New technologies have been explored to address some of the challenges associated with this changing regulatory environment. AREAS COVERED: This paper focuses on the different technical aspects of blockchain and how this new technology has the potential to support the ongoing efforts to improve the PMS system for medical devices. EXPERT OPINION: To address these challenges, we suggest to generate a private PMS data permissioned blockchain with a proof-of-authority consensus mechanism, to which only a restricted number of designated and audited participants have authorization to validate transactions and add them to the PMS data blockchain ledger. Blockchain has the potential to support a more efficient approach, which could offer many advantages to the different stakeholders involved in the PMS process, such as supporting with new regulatory initiatives.
Khizar Abbas, Muhammad Afaq, Talha Ahmed Khan, Wang‐Cheol Song
From the last decade, pharmaceutical companies are facing difficulties in tracking their products during the supply chain process, allowing the counterfeiters to add their fake medicines into the market. Counterfeit drugs are analyzed as a very big challenge for the pharmaceutical industry worldwide. As indicated by the statistics, yearly business loss of around $200 billion is reported by US pharmaceutical companies due to these counterfeit drugs. These drugs may not help the patients to recover the disease but have many other dangerous side effects. According to the World Health Organization (WHO) survey report, in under-developed countries every 10th drug use by the consumers is counterfeit and has low quality. Hence, a system that can trace and track drug delivery at every phase is needed to solve the counterfeiting problem. The blockchain has the full potential to handle and track the supply chain process very efficiently. In this paper, we have proposed and implemented a novel blockchain and machine learning-based drug supply chain management and recommendation system (DSCMR). Our proposed system consists of two main modules: blockchain-based drug supply chain management and machine learning-based drug recommendation system for consumers. In the first module, the drug supply chain management system is deployed using Hyperledger fabrics which is capable of continuously monitor and track the drug delivery process in the smart pharmaceutical industry. On the other hand, the N-gram, LightGBM models are used in the machine learning module to recommend the top-rated or best medicines to the customers of the pharmaceutical industry. These models have trained on well known publicly available drug reviews dataset provided by the UCI: an open-source machine learning repository. Moreover, the machine learning module is integrated with this blockchain system with the help of the REST API. Finally, we also perform several tests to check the efficiency and usability of our proposed system.
Nuraslina Zainal Abidin, Firdaus Fanny Putera Perdana
Despite rooted from Islamic needs, Halal certification also attracts both Muslims and non-Muslims. In fact, the non-Muslim players are the ones dominating the industry. It is widely known that Halal food chain is quite vulnerable due to complications in maintaining Halal integrity, the necessity to prevent doubtful materials, lack of control of food norms, and the importance to retain high quality. The presence of Halal certification is a form of consumer protection and therefore, the integrity of Halal certification must be carefully monitored. There are some Halal violation cases and this can potentially affect the reputation of the Halal food products. Therefore, it is important to develop a system that integrates a verifiable, open, and safe shared database that is not run by a centralized operator. Blockchain technology is the one that offers such. The study presents a framework for blockchain technology for Halal product verification for manufactured food products. The results are desired to help the food industry players in maintaining a system that can improve the transparency and the integrity of their Halal food chain. The system also intends to ensure the affordability and accessibility of Halal certification for as many industry players as possible as blockchain technology is believed to remove the complications in the certification process and reduce paperwork related cost.
William Chien, Josenor de Jesus, Ben Taylor, Victor Dods · 7 authors
Purpose: As part of the FDA’s DSCSA Pilot Project Program, UCLA and its solution partner, LedgerDomain (collectively referred to as the team hereafter), focused on building a complete, working blockchain-based system, BRUINchain, which would meet all the key objectives of the Drug Supply Chain Security Act (DSCSA) for a dispenser operating solely on commercial off-the-shelf (COTS) technology. Methods: The BRUINchain system requirements include scanning the drug package for a correctly formatted 2D barcode, flagging expired product, verifying the product with the manufacturer, and quarantining suspect and illegitimate products at the last mile: pharmacist to patient, the most complex area of the drug supply chain. The authors demonstrate a successful implementation where product-tracing notifications are sent automatically to key stakeholders, resulting in enhanced timeliness and reduction in paperwork burden. At the core of this effort was a blockchain-based solution to track and trace changes in custody of drug. As an immutable, time-stamped, near-real-time (50-millisecond latency), auditable record of transactions, BRUINchain makes it possible for supply chain communities to arrive at a single version of the truth. BRUINchain was tested with real data on real caregivers administering life-saving medications to real patients at one of the busiest pharmacies in the United States. Results: In addition to communicating with the manufacturer directly for verification, BRUINchain also initiated suspect product notifications. During the study, a 100% success rate was observed across scanning, expiration detection, and counterfeit detection; and paperwork reduction from approximately 1 hour to less than a minute. The authors demonstrate a successful implementation where product-tracing notifications are sent automatically to key stakeholders, resulting in enhanced timeliness and reduction in paperwork burden. At the core of this effort was a blockchain-based solution to track and trace changes in custody of drug. As an immutable, time-stamped, near-real-time (50-millisecond latency), auditable record of transactions, BRUINchain makes it possible for supply chain communities to arrive at a single version of the truth. BRUINchain was tested with real data on real caregivers administering life-saving medications to real patients at one of the busiest pharmacies in the United States. Conclusions: By automatically interrogating the manufacturer’s relational database with our blockchain-based system, our results indicate a projected DSCSA compliance cost of 17 cents per unit, and potentially much more depending on regulatory interpretation and speed of verification. We project that this cost could be reduced with manufacturers’ adoption of a highly performant, fully automated end-to-end system based on digital ledger technology (DLT). In an examination of the interoperability of such a system, we elaborate on its capacity to enable verification in real time without a human in the loop, the key feature driving lower compliance cost. With 4.2 billion prescriptions being dispensed each year in the United States, DLT would not only reduce the projected per-unit cost to 13 cents per unit (saving $183 million in annual labor costs), but also serve as a major bulwark against bad or fraudulent transactions, reduce the need for safety stock, and enhance the detection and removal of potentially dangerous drugs from the drug supply chain to protect U.S. consumers.
BACKGROUND: Personal health record (PHR) security, correctness, and protection are essential for health and medical services. Blockchain architecture can provide efficient data retrieval and security requirements. Exchangeable PHRs and the self-management of patient health can offer many benefits to traditional medical services by allowing people to manage their own health records for disease prevention, prediction, and control while reducing resource burdens on the health care infrastructure and improving population health and quality of life. OBJECTIVE: This study aimed to build a blockchain-based architecture for an international health record exchange platform to ensure health record confidentiality, integrity, and availability for health management and used Health Level 7 Fast Healthcare Interoperability Resource international standards as the data format that could allow international, cross-institutional, and patient/doctor exchanges of PHRs. METHODS: The PHR architecture in this study comprised 2 main components. The first component was the PHR management platform, on which users could upload PHRs, view their record content, authorize PHR exchanges with doctors or other medical health care providers, and check their block information. When a PHR was uploaded, the hash value of the PHR would be calculated by the SHA-256 algorithm and the PHR would be encrypted by the Rivest-Shamir-Adleman encryption mechanism before being transferred to a secure database. The second component was the blockchain exchange architecture, which was based on Ethereum to create a private chain. Proof of authority, which delivers transactions through a consensus mechanism based on identity, was used for consensus. The hash value was calculated based on the previous hash value, block content, and timestamp by a hash function. RESULTS: The PHR blockchain architecture constructed in this study is an effective method for the management and utilization of PHRs. The platform has been deployed in Southeast Asian countries via the Asia eHealth Information Network (AeHIN) and has become the first PHR management platform for cross-region medical data exchange. CONCLUSIONS: Some systems have shown that blockchain technology has great potential for electronic health record applications. This study combined different types of data storage modes to effectively solve the problems of PHR data security, storage, and transmission and proposed a hybrid blockchain and data security approach to enable effective international PHR exchange. By partnering with the AeHIN and making use of the network's regional reach and expert pool, the platform could be deployed and promoted successfully. In the future, the PHR platform could be utilized for the purpose of precision and individual medicine in a cross-country manner because of the platform's provision of a secure and efficient PHR sharing and management architecture, making it a reasonable base for future data collection sources and the data analytics needed for precision medicine.
Background: Pharmaceutical corruption is a serious challenge in global health. Digital technologies that can detect and prevent fraud and corruption are particularly important to address barriers to access to medicines, such as medicines availability and affordability, stockouts, shortages, diversion, and infiltration of substandard and falsified medicines.Objectives: To better understand how digital technologies are used to combat corruption, increase transparency, and detect fraud in pharmaceutical procurement systems to improve population health outcomes.Methods: We conducted a multidisciplinary review of the health/medicine, engineering, and computer science literature. Our search queries included keywords associated with medicines procurement and digital technology in combination with terms associated with transparency and anti-corruption initiatives. Our definition of ‘digital technology’ focused on Internet-based communications, including online portals and management systems, supply chain tools, and electronic databases.Results: We extracted 37 articles for in-depth review based on our inclusion criteria focused on the utilization of digital technology to improve medicines procurement. The vast majority of articles focused on electronic data transfer and/or e-procurement systems with fewer articles discussing emerging technologies such as machine learning and blockchain distributed ledger solutions. In the context of e-procurement, slow adoption, justifying cost-savings, and need for technical standards setting were identified as key challenges for current and future utilization.Conclusions: Though there is a significant promise for digital technologies, particularly e-procurement, overall adoption of solutions that can enhance transparency, accountability and concomitantly combat corruption, is still underdeveloped. Future efforts should focus on tying cost-saving measurements with anti-corruption indicators, prioritizing centralization of e-procurement systems, establishing regulatory harmonization with standards setting, and incorporating additional anti-corruption technologies into procurement processes for improving access to medicines and to reach the overall goal of Universal Health Coverage.
Medication quality and safety are crucial to the health of the public. Responding to the urgent need for medication information provenance and anti-counterfeiting, this study proposes a blockchain based method for medication information storage, inquiry, and anti-counterfeiting along a medication supply chain. Leveraging the features of decentralization, tamper-proof, traceability, and participative node maintenance of blockchain technology, the proposed method can assure the transparency and openness of medication supply chains. An access control policy model based on smart contract is designed to prevent medication information from being altered or disclosed at nodes of the blockchain. In addition, a point-accumulation upgrade/downgrade mechanism is introduced to improve the consensus mechanism. The proposed solution eliminates the needs for centralized institutions and third-party organizations, and provides a full record of the medication circulation process. Our simulation results show that efficiency and security are enhanced by the improved consensus algorithm and access control mechanism. As a result, our method can render high level of security and privacy protection that is critical to the integrity of a medication information management system.
Jan Heinrich Beinke, Christian Fitte, Frank Teuteberg
BACKGROUND: Data security issues still constitute the main reason for the sluggish dissemination of electronic health records (EHRs). Given that blockchain technology offers the possibility to verify transactions through a decentralized network, it may serve as a solution to secure health-related data. Therefore, we have identified stakeholder-specific requirements and propose a blockchain-based architecture for EHRs, while referring to the already existing scientific discussions on the potential of blockchain for use in EHRs. OBJECTIVE: This study aimed to introduce blockchain technology for EHRs, based on identifying stakeholders and systematically eliciting their requirements, and to discuss the key benefits (KBs) and key challenges (KCs) of blockchain technology in the context of EHRs. METHODS: The blockchain-based architecture was developed in the framework of the design science research paradigm. The requirements were identified using a structured literature review and interviews with nine health care experts. Subsequently, the proposed architecture was evaluated using 4 workshops with 15 participants. RESULTS: We identified three major EHR stakeholder groups and 34 respective requirements. On this basis, we developed a five-layer architecture. The subsequent evaluation of the artifact was followed by the discussion of 12 KBs and 12 KCs of a blockchain-based architecture for EHRs. To address the KCs, we derived five recommendations for action for science and practice. CONCLUSIONS: Our findings indicate that blockchain technology offers considerable potential to advance EHRs. Improvements to currently available EHR solutions are expected, for instance, in the areas of data security, traceability, and automation by smart contracts. Future research could examine the patient's acceptance of blockchain-based EHRs and cost-benefit analyses.
Olivia Choudhury, Noor Fairoza, Issa Sylla, Amar K. Das
The cost of conducting multi-site clinical trials has significantly increased over time, with site monitoring, data management, and amendments being key drivers. Clinical trial data management approaches typically rely on a central database, and require manual efforts to encode and maintain data capture and reporting requirements. To reduce the administrative burden, time, and effort of ensuring data integrity and privacy in multi-site trials, we propose a novel data management framework based on permissioned blockchain technology. We demonstrate how our framework, which uses smart contracts and private channels, enables confidential data communication, protocol enforcement, and and an automated audit trail. We compare this framework with the traditional data management approach and evaluate its effectiveness in satisfying the major requirements of multi-site clinical trials. We show that our framework ensures enforcement of IRB-related regulatory requirements across multiple sites and stakeholders.
Author analyzes the possibilities of using blockchain technology in pharmaceutical sphere with the purpose of detection of counterfeit and poor-quality medicinal products and discusses the legal acts concerning the use of this technology. Author examines the grounds for the legal provision of blockchain technology in pharmaceutical sector in order to protect the rights of patients. The necessity of legal regulation of the use of blockchain technology by private parties is substantiated taking into account the private legal nature of this system. The mechanism of application of this technology in pharmaceutical activity is revealed.
Patrick G. Sylim, Fang Liu, Alvin Marcelo, Paul Fontelo
BACKGROUND: Drug counterfeiting is a global problem with significant risks to consumers and the general public. In the Philippines, 30% of inspected drug stores in 2003 were found with substandard/spurious/falsely-labeled/falsified/counterfeit drugs. The economic burden on the population drug expenditures and on governments is high. The Philippine Food and Drug Administration (FDA) encourages the public to check the certificates of product registration and report any instances of counterfeiting. The National Police of Philippines responds to such reports through a special task force. However, no literature on its impact on the distribution of such drugs were found. Blockchain technology is a cryptographic ledger that is allegedly immutable through repeated sequential hashing and fault-tolerant through a consensus algorithm. This project will develop and test a pharmacosurveillance blockchain system that will support information sharing along the official drug distribution network. OBJECTIVE: This study aims to develop a pharmacosurveillance blockchain system and test its functions in a simulated network. METHODS: We are developing a Distributed Application (DApp) that will run on smart contracts, employing Swarm as the Distributed File System (DFS). Two instances will be developed: one for Ethereum and another for Hyperledger Fabric. The proof-of-work (PoW) consensus algorithm of Ethereum will be modified into a delegated proof-of-stake (DPoS) or practical Byzantine fault tolerance (PBFT) consensus algorithm as it is scalable and fits the drug supply chain environment. The system will adopt the GS1 pedigree standard and will satisfy the data points in the data standardization guidelines from the US FDA. Simulations will use the following 5 nodes: for FDA, manufacturer, wholesaler, retailer, and the consumer portal. RESULTS: Development is underway. The design of the system will place FDA in a supervisory data verification role, with each pedigree type-specific data source serving a primary data verification role. The supply chain process will be initiated by the manufacturer, with recursive verification for every transaction. It will allow consumers to scan a code printed on the receipt of their purchases to review the drug distribution history. CONCLUSIONS: Development and testing will be conducted in a simulated network, and thus, results may differ from actual practice. The project being proposed is disruptive; once tested, the team intends to engage the Philippine FDA to discuss implementation plans and formulate policies to facilitate adoption and sustainability. REGISTERED REPORT IDENTIFIER: RR1-10.2196/10163.
Liam Bell, William J. Buchanan, Jonathan Cameron, Owen Lo
There are several areas of healthcare and well-being that could be enhanced using blockchain technologies. These include device tracking, clinical trials, pharmaceutical tracing, and health insurance. Within device tracking, hospitals can trace their asset within a blockchain infrastructure, including through the complete lifecycle of a device. The information gathered can then be used to improve patient safety and provide after-market analysis to improve efficiency savings. This paper outlines recent work within the areas of pharmaceutical traceability, data sharing, clinical trials, and device tracking. Keywords: Asset Tracking, Blockchain, Drug tracking, Ethereum, Healthcare, Internet of Things, IoT
Blockchain is at the center of attention recently and it is expected to have a huge impact on healthcare industry including dentistry as well. Blockchain is a fundamental technology behind Bitcoin and itis all about decentralization, security, reliability, and transparency. These characteristics of the technology empower it to disrupt the current healthcare industry in innumerable practices such as supply chain management in pharmaceuticals to prevent the counterfeited medicine, clinical trials to guarantee transparency, healthcare information exchanges or personal health record systems to ensure data integrity and interoperability, etc. It will surely revolutionize the way the current healthcare system works; from provider-oriented to patient-centered. Hence, it is time to seriously consider how we could be a part of this blockchain revolution in dentistry.
Kevin A. Clauson, Elizabeth A. Breeden, Cameron Davidson, Tim K. Mackey
Background: Effective supply chain management is a challenge in every sector, but in healthcare there is added complexity and risk as a compromised supply chain in healthcare can directly impact patient safety and health outcomes. One potential solution for improving security, integrity, data provenance, and functionality of the health supply chain is blockchain technology. Objectives: Provide an overview of the opportunities and challenges associated with blockchain adoption and deployment for the health supply chain, with a focus on the pharmaceutical supply, medical device and supplies, Internet of Healthy Things (IoHT), and public health sectors. Methods: A narrative review was conducted of the academic literature, grey literature, and industry publications, in addition to identifying and characterizing select stakeholders engaged in exploring blockchain solutions for the health supply chain. Results: Critical challenges in protecting the integrity of the health supply chain appear well suited for adoption of blockchain technology. Use cases are emerging, including using blockchain to combat counterfeit medicines, securing medical devices, optimizing functionality of IoHT, and improving the public health supply chain. Despite these clear opportunities, most blockchain initiatives remain in proof-of-concept or pilot phase. Conclusion: Blockchain technology has the unrealized promise to help improve the health supply chain, but further study, evaluation and alignment with policy mechanisms is needed. Keywords: Blockchain, Distributed Ledger, Pharmacy, Pharmaceutical, Supply chain
Patrick G. Sylim, Fang Liu, Alvin Marcelo, Paul Fontelo
BACKGROUND Drug counterfeiting is a global problem with significant risks to consumers and the general public. In the Philippines, 30% of inspected drug stores in 2003 were found with substandard/spurious/falsely-labeled/falsified/counterfeit drugs. The economic burden on the population drug expenditures and on governments is high. The Philippine Food and Drug Administration (FDA) encourages the public to check the certificates of product registration and report any instances of counterfeiting. The National Police of Philippines responds to such reports through a special task force. However, no literature on its impact on the distribution of such drugs were found. Blockchain technology is a cryptographic ledger that is allegedly immutable through repeated sequential hashing and fault-tolerant through a consensus algorithm. This project will develop and test a pharmacosurveillance blockchain system that will support information sharing along the official drug distribution network. OBJECTIVE This study aims to develop a pharmacosurveillance blockchain system and test its functions in a simulated network. METHODS We are developing a Distributed Application (DApp) that will run on smart contracts, employing Swarm as the Distributed File System (DFS). Two instances will be developed: one for Ethereum and another for Hyperledger Fabric. The proof-of-work (PoW) consensus algorithm of Ethereum will be modified into a delegated proof-of-stake (DPoS) or practical Byzantine fault tolerance (PBFT) consensus algorithm as it is scalable and fits the drug supply chain environment. The system will adopt the GS1 pedigree standard and will satisfy the data points in the data standardization guidelines from the US FDA. Simulations will use the following 5 nodes: for FDA, manufacturer, wholesaler, retailer, and the consumer portal. RESULTS Development is underway. The design of the system will place FDA in a supervisory data verification role, with each pedigree type–specific data source serving a primary data verification role. The supply chain process will be initiated by the manufacturer, with recursive verification for every transaction. It will allow consumers to scan a code printed on the receipt of their purchases to review the drug distribution history. CONCLUSIONS Development and testing will be conducted in a simulated network, and thus, results may differ from actual practice. The project being proposed is disruptive; once tested, the team intends to engage the Philippine FDA to discuss implementation plans and formulate policies to facilitate adoption and sustainability. REGISTERED REPORT IDENTIFIER RR1-10.2196/10163
Halal supply chains are vulnerable due to their credence quality attributes, importance of maintaining halal integrity throughout the supply chain, need to avoid doubt, lack of control of food norms, and sensitivity of the Muslim consumer towards halal. These vulnerabilities make halal supply chains complex to design, manage, and optimise. Transparency of halal supply chains is needed in order to ensure trust and authenticity of a halal brand. The principle of a shared database that is safe, open and verifiable without a central operator is an attractive proposition to embed trust and authenticity for halal food, cosmetics, home care, and pharmaceuticals.
In this thesis, I explore how blockchain technology can improve pharmaceutical supply chain operations and discuss how the technology should be implemented. Furthermore, I study how the life science company Bayer's pharmaceutical division can utilize blockchain technology in its supply chain operations. I begin by defining the concepts of blockchain technology, smart contracts and pharmaceutical supply chain. Then I discuss the benefits and implementation in different sections: participating entities and information flow, contracts and payments, logistics, transparency and product security and blockchain infrastructure and governance. Both Bayer and the industry as a whole can benefit from blockchain technology. Blockchain enables for example efficient, safe and private transactions, product transparency and security and open information sharing without exposing trade secrets. For the first time a platform for all stakeholders can be developed that enables transacting information and value simultaneously.