Summary: In 2013, the Drug Supply Chain Security Act (DSCSA) was signed into law to address the growing threat of counterfeit drugs and to ensure prescription drugs remain safe and effective for patients. As part of this law, US pharmaceutical supply chain stakeholders are required to confirm the authorized status of trading partners for transactions and information disclosures, even when there is no prior business relationship. While larger Authorized Trading Partners (ATPs) have connectivity solutions in place, newer and smaller ATPs have not traditionally participated, including tens of thousands of dispensers. To unlock the full potential of the interoperable system mandated by the DSCSA, the authors tested eXtended ATP (XATP), a blockchain-backed framework for ATP authentication and enhanced verification in a real-world pharmacy with genuine drug packages. The objective of this research study was to prove that electronic authentication and enhanced verification can be achieved between ATPs using a mobile-based solution. Moreover, we tested accurate reading of drug and associated electronic med guides, flagging of expired and recalled drugs, and correct generation of documentation to support saleable returns. Methods: This study involved two dispensers and three participating manufacturers. Dispensers were onboarded to a mobile application and used supporting documentation to authenticate their identities, and then scanned 2D drug barcodes to submit drug verification requests to manufacturers (including 11 additional, randomly selected manufacturers). Genuine and synthetic drug package barcodes were used to test workflows against genuine and synthetic manufacturer serialization data records. Manufacturers authenticated the identity of requesting dispensers with verifiable credentials and responded to verification requests. Results: Enhanced drug verification was achieved, with 100% of requests successfully delivered to participating manufacturers and 88% of requests being delivered to other manufacturers (based on the pharmacist selection of random packages from the pharmacy). Drug verification matching against synthetic serialization data records resulted in 86% accuracy, with the 14% error rate attributed to human factors. All barcodes were successfully scanned and provided package-accurate data, and 97% of randomly selected packages successfully generated drug package inserts. All synthetic recalls and expired drugs were successfully flagged. Four of the manufacturers contacted were among the top 15 pharmaceutical manufacturers globally; all four responded. Conclusions: The XATP framework provides a secure, reliable, and seamless remote method to conduct enhanced verification as required by law. Interoperability between manufacturers and dispensers with no prior business relationship can be achieved on ‘day zero’ using mobile devices that enable digital authentication and rapid barcode scanning. As users retain control of their own private keys, the framework also mitigates the single-point-of-attack risks associated with centrally managed systems.

Current research on medical image processing relies heavily on the amount and quality of input data. Specifically, supervised machine learning methods require well-annotated datasets. A lack of annotation tools limits the potential to achieve high-volume processing and scaled systems with a proper reward mechanism. We developed MarkIt, a web-based tool, for collaborative annotation of medical imaging data with artificial intelligence and blockchain technologies. Our platform handles both Digital Imaging and Communications in Medicine (DICOM) and non-DICOM images, and allows users to annotate them for classification and object detection tasks in an efficient manner. MarkIt can accelerate the annotation process and keep track of user activities to calculate a fair reward. A proof-of-concept experiment was conducted with three fellowship-trained radiologists, each of whom annotated 1,000 chest X-ray studies for multi-label classification. We calculated the inter-rater agreement and estimated the value of the dataset to distribute the reward for annotators using a crypto currency. We hypothesize that MarkIt allows the typically arduous annotation task to become more efficient. In addition, MarkIt can serve as a platform to evaluate the value of data and trade the annotation results in a more scalable manner in the future. The platform is publicly available for testing on https://markit.mgh.harvard.edu.

The editorial is taken from commentary presented at the ConVerge2Xcelerate (#ConV2X) 2021 Symposium entitled "Blueprint for a New Digital Health Era." Tory Cenaj is the Owner and Publisher of Partners in Digital Health (PDH). The views expressed are solely her own and do not reflect those of the editorial board, reviewers, ambassadors, licensees or staff members affiliated with PDH.  

Objective: Distributed ledger technology can be used as a transparent, shareable ledger, that can record transactions between two parties efficiently and in a more secure, verifiable, and permanent way than the current electronic prescribing systems. We studied the use of a distributed ledger electronic prescribing programme, Prescription Abuse Greatly Reduced (PAGR) Prescriptions, to examine the effect of blockchain on provider prescribing efficiency at three family medicine clinics.

Design: The PAGR was installed side-by-side to the electronic health record at three family medicine practice clinics in middle Tennessee. A prospective, convenience sample of patients at all three clinics was used for analysis. Trained observers were used in each clinic to document the side-by-side use of current prescribing practice versus the use of the PAGR electronic prescribing system by the individual providers.

The primary outcome was total time to write the prescription. Secondary metrics included compliance with checking the state’s Physician Drug Monitoring Program (PDMP.) , accuracy of medicine reconciliation, use of patient’s eligibility on insurance, prescription benefits, and change in prescription caused by benefits analysis or drug-interactions. Provider satisfaction was measure on a 4-point Likert scale.

Data were analysed using two-tailed, paired Student T-tests with alpha set at 0.05. A sample size of 107 patients was calculated to have a power of 80% to detect a 50% change in the prescription writing time.

Results: The primary outcome of total prescription writing time was 171 ± 41 sec for current prescribing practice versus 63 ± 15 sec for the PAGR system (p = 0.0006). All providers were extremely satisfied with the use of the PAGR programme.

Conclusion: Use of the PAGR electronic prescription programme significantly saved a mean of 1 min 48 sec per written prescription at the three Family Medicine Clinics. The PAGR also provided accurate medicine reconciliation and complete PDMP checks for controlled substance prescriptions. The patient real-time benefits check and drug-drug and allergy-drug reviews resulted in the provider changing the prescription 28% of the time, enhancing safety and out-of-pocket patient expenses. Future enhancements include expanding the insurance benefits analysis and developing provider notifications when patients are non-compliant with filling their prescriptions.

Adopting and implementing the Clinical Decision Support System (CDSS) technology is a critical element in an effort to improve national quality initiatives and evidence-based practice at the point of care. CDSS is envisioned to be a potential solution to many current challenges in the healthcare sphere, which includes information overload, practice improvement, eliminating treatment errors, and reducing medical consultation costs. However, the CDSS did not manage to achieve these goals to the desired levels and provide context-appropriate alerts, although integrated with the electronic health records (EHRs) (1). Clinical decision support alerts can save lives, but frequent ones can cause increased cognitive burden to clinicians, worsen alert fatigue, and increase the duplication of tests. This ultimately increases health care costs without refining patient outcomes. Studies show that 49–96% of clinical alerts are ignored, raising questions about the effectiveness of CDSS (1). Blockchain, a decentralized, distributed digital ledger that contains a plethora of continuously updated, time-stamped, and highly encrypted virtual record, can be a key to addressing these challenges (2). The blockchain technology if integrated with the CDSS can serve as a potential solution to eliminating current drawbacks with CDSS (3). This article addresses the most significant and chronic problems facing the successful implementation of CDSS and how leveraging the Hyperledger Fabric can alleviate the clinical alert fatigue and reduce physician’s burnout using patient-specific information. The proposed architecture framework for this study is designed to equip the CDSS with overall patient information at the point of care. This then empowers the physicians with the blockchain-integrated CDSS, which holds the potential to reduce clinician’s cognitive burden, medical errors, and costs and ultimately enhance patient outcomes. The research study broadly discusses how the blockchain technology can be a potential solution, reasons for selecting the Hyperledger Fabric, and elaborates on how the Hyperledger Fabric can be leveraged to enhance the efficacy of CDSS.

Objective: To develop a research and development program to study factors that will support research, education and innovation using blockchain technology for health in an effective and sustainable manner. We proposed to conduct qualitative research to generate insights for developing a market strategy to build a research lab for the promotion of blockchain technologies in health in academic environments. The team aimed to identify the key barriers and opportunities for developing a sustainable research lab that generates research, education, and application of blockchain in healthcare at an academic medical institution and test those strategies in a real-world scenario. Methods: The research team identified potential customers and stakeholders through interviews and snowball sampling. The team conducted semi-structured interviews with 4 faculty researchers, 10 industry leaders, and 6 students from a variety of disciplines and organizations. The findings of these research activities informed our understanding of the needs of stratified customers and helped identify key assets and activities the lab will have to offer to meet those needs. Results: The research insights from data analysis were used to build the business model for establishing a blockchain in health impact lab. This systematic study of areas where blockchain technology can impact health will guide the future development of research agenda for the researchers on campus. Conclusion: Based on our learnings, we hope to design a Blockchain in Health Impact Lab to serve as a platform for students and faculty to come together with industry partners and explore current challenges of blockchain in healthcare. The academic medical center’s partnership with other healthcare providers will help create real-world opportunities to demonstrate and implement new technologies.

Editor’s note: This article is one of an ongoing series covering topics published in conjunction with the Health Information Management and Systems Society (HIMSS) describing the development of blockchain technology and its applicability to healthcare.  As described by the World Economic Forum (WEF),1 the fourth industrial revolution is here and is changing business models across every industry vertical. This revolution includes digital technology, big data, artificial intelligence, distributed ledger technology (DLT, or blockchain), and analytics, and represents new ways in which technology is being integrated into societies. This changing interaction with technology will impact business models. Traditional business models are historically based on a centralized framework for delivery of goods and services to the consumer. The new business model is based on the decentralization of the creation and delivery of goods and services. At the core of the new model, organizations must demonstrate value-creation and value-delivery, while ensuring their solutions are secure, scalable, and interoperable to remain competitive. A decentralized business model built on a blockchain framework can provide the decentralization and security needed for this industry shift. 

During our 2019 ConVerge2Xcelerate (ConV2X) conference in Boston, we focused on the theme "Proving Market Value with Pragmatic Innovation in Healthcare" (see https://conv2x-2019.eventcreate.com/). This year, along with BHTY editorial board members, conference speakers were invited to join with Tory Cenaj, Publisher of BHTY, to contribute their expertise and share insights for the near-term landscape of blockchain in healthcare.  

In 2020, Blockchain in Healthcare Today (BHTY) begins its third year of publication. We thank our global community of passionate leaders and early adopters for their support and diligence in making technology innovation in healthcare attainable for both the healthcare consumers who are the key stakeholders in patient-centered care and the broader healthcare system.