The annual ConV2X is a leading international health tech symposium driving real world evidence, strategy, research, operations and trends to create a blueprint for a new digital health era. The 2021 symposium featured a scientific program of academic/research presentations in addition to business and industry talks. The research track focused on exploring and sharing developments in blockchain and emerging technologies in health and clinical medicine. Submissions were based on original research, conceptual frameworks, proposed applications, position papers, case studies, and real-world implementation. Selection was based on a peer-review process. Faculty, students, and industry researchers were encouraged to submit abstracts to present ideas before an informed and knowledgeable audience of industry leaders, policy makers, funders, and researchers.

This presentation was selected by the scientific review committee.

Submission Review Committee

• Dave Kochalko, CEO of ARTiFACTS
• Anjum Khurshid, UT Austin
• Carlos Caldas, UT Engineering
• Gil Alterovitz, Harvard Medical School
• Kayo Fujimoto, UT Health Houston
• Lei Zhang, University of Glasglow
• Sean Manion, CSciO of ConsenSys Health
• Vijayakuman Varadarajan, University of South Wales
• Vikram Dhillon, Wayne State University
• Yuichi Ikeda, Kyoto University

Regulating and monitoring a traditionally fragmented pharma supply chain has been a global challenge for decades. Without a trusted system and strong collaboration between stakeholders, threats such as counterfeits can easily intercept the supply chain and cause monumental disruptions. Today, the Covid-19 pandemic has accelerated the need for greater data transparency, better deployment of technology, and improved ways of connecting stakeholder information along the supply chain.

There is a need for improved ways of working to help build up supply chain resilience, and one way is by implementing better end-to-end traceability using blockchain technology such as Hyperledger Fabric. This paper will explore the business value that blockchain brings to the pharma supply chain with better end-to-end traceability, with the example of an industry-grade blockchain solution called eZTracker.

Through six key features, pharmaceutical manufacturers, patients, and Healthcare Practitioners (HCPs) can now participate in data-sharing, with extended use cases of integrating blockchain with warehouse platforms, a patient-facing mobile application, and an interactive dashboard for real-time verification and data transparency. Beyond anti-counterfeit verification, other potential use cases include effective product recall management, cold chain monitoring, e-product information and more.

The effectiveness of a traceability solution is heavily dependent on the amount of data collected and is affected by poor adoption and scalability. Existing limitations that need to be addressed include the lack of mandated serialisation in Asia and blockchain interoperability.

To maximise the value of blockchain, collaboration is key. Pharmaceutical manufacturers need to invest in new technologies such as blockchain, to help them break out of data silos, and operationalise data to build supply chain resilience.

There is increasing recognition that health-oriented datasets could be regarded as intangible assets: distinct assets with future economic benefits but without physical properties. While health-oriented datasets—particularly health records—are ascribed monetary value on the black market, there are few established methods for assessing value for legitimate research and business purposes. The emergence of blockchain has created new commerce opportunities for transferring assets without intermediaries. Therefore, blockchain is proposed as a medium by which research datasets could be transacted to provide future value. Blockchain methodologies also offer security, auditability, and transparency to authorized individuals for verifying transactions. The authors will share data valuation methodologies consistent with accounting principles and include discussions of black market valuation of health data. Further, this article describes blockchain-based methods of managing real-time payment/micropayment strategies.

A candid discussion that dives into the recesses of AI and ethics including topics such as what lessons can be used in healthcare from tech players implementing responsible AI and unbiased systems, how can responsible AI help build a clinical support system, examples from providers and payers and learnings from responsible AI which can be used in Obamacare and clinical trial implementation.   

Discussion topics will include:

• What is responsible AI? Is it the same as Ethical AI? 
• What lessons can be used in healthcare from tech players implementing responsible AI and unbiased systems?
• Why is responsible AI important for healthcare? Is there demographic bias in the treatment part of responsible AI?
• How can responsible AI help build a clinical support system? 
• What are some examples of responsible AI in the healthcare industry with respect to providers and payers? 
• What are learnings from responsible AI which can be used in Obamacare implementation?
• HHS introduced an interoperability rule between EMR/EHR systems in 2019. How does it help in the implementation of responsible AI?  
• How responsible AI is currently covered in new US government initiative such as AI.gov
• Responsible AI & data bias in clinical trials 

The annual ConV2X is a leading international health tech symposium driving real world evidence, strategy, research, operations and trends to create a blueprint for a new digital health era. The 2021 symposium featured a scientific program of academic/research presentations in addition to business and industry talks. The research track focused on exploring and sharing developments in blockchain and emerging technologies in health and clinical medicine. Submissions were based on original research, conceptual frameworks, proposed applications, position papers, case studies, and real-world implementation. Selection was based on a peer-review process. Faculty, students, and industry researchers were encouraged to submit abstracts to present ideas before an informed and knowledgeable audience of industry leaders, policy makers, funders, and researchers.

This presentation was selected by the scientific review committee.

Submission Review Committee

• Dave Kochalko, CEO of ARTiFACTS
• Anjum Khurshid, UT Austin
• Carlos Caldas, UT Engineering
• Gil Alterovitz, Harvard Medical School
• Kayo Fujimoto, UT Health Houston
• Lei Zhang, University of Glasglow
• Sean Manion, CSciO of ConsenSys Health
• Vijayakuman Varadarajan, University of South Wales
• Vikram Dhillon, Wayne State University
• Yuichi Ikeda, Kyoto University

The keynote highlights how rising healthcare costs, drivers of waste in the system, and an outdated infrastructure slow innovation and create a poor patient experience.  A modern infrastructure that connects the healthcare ecosystem is needed to deliver data liquidity with security. Modernizing the infrastructure of healthcare empowers innovation in blockchain, AI, DLT, and NLP.

Biography

Stuart Hanson is a lifelong strategist a innovator I healthcare and fintech. From the beginning of his career, Stuart identified unique ways to leverage technology to improve processes and transform consumer experiences. As CEO of Avaneer Health, he leads the team building an inclusive network that solve the problem of interoperability by ensuring all stakeholders have equal ad easy access to patient data when it is needed most. Prior to joining Avaneer, Stuart served as head of healthcare payments and served as a senior healthcare executive at JP Morgan Chase. He led and negotiated the filrm’s largest acquisition in healthcare when acquiring InstaMed in 2019. Previously, Stuart served as general manager of consumer payment solutions at Change Healthcare. Stuart has also served in leadership roles for healthcare solutions at Citi and Fifth Third Bank. He chaired the HIMSS Revenue Cycle Improvement Task Force, focused on creating a vision for the next generation of revenue cycle management tolls and processes to drive administrative cost containment, interoperability and a better consumer experience.

During the COVID-19 pandemic, we witnessed how sharing of biological and biomedical data have facilitated the researchers, medical practitioners and policymakers to tackle the pandemic at a global scale. Despite the growing use of EHR by medical practitioners and wearable digital gadgets by individuals, 80% of the health and medical data remain unused, adding little value to the researchers and medical practitioners. Legislative constraints related to health data sharing, centralised siloed design of traditional data management systems and most importantly, lack of incentivisation models are thought to be the underpinning bottlenecks for sharing health data. With the advent of the General Data Protection Regulation (GDPR) of the EU and the development of technologies like blockchain and distributed ledger technologies (DLT), it is now possible to create a new paradigm of data sharing by changing the incentivisation model from current authoritative or altruistic form to a shared economic model where financial incentivisation will be the main driver for data sharing. This can be achieved by setting up a digital health data marketplace (DHDM). Here we reviewed papers that proposed technical models or implemented frameworks that use blockchain-like technologies for health data. We seek to understand and compare different technical challenges associated with implementing and optimising the DHDM operation outlined in these papers. We also examined the legal limitations in the context of European Union and other countries such as the USA to accommodate any compliance requirement for such a marketplace. Last but not least, we reviewed papers that investigated the short, medium and long terms socioeconomic impact of such a marketplace on a wide range of stakeholders.

Pharmaceutical supply chains are complex structures including various actors, and blockchains are seen as a promising solution to increase effectiveness and overcome some of the main challenges in these supply chains, especially the lack of trust. However, the European Union has set strict rules in the domain of pharmaceutical supply chains in order to protect patient safety and public health, and using blockchains brings further legal requirements to comply. Among these requirements, personal data protection is of utmost importance because it has been argued, for years, that blockchains and the EU data protection regime are in conflict by their natures. However, it is also claimed that when rightly designed and combined with other technological solutions, blockchains can offer great opportunities to enhance data protection. Nevertheless, blockchains’ potential in pharmaceutical supply chains has not yet been realized as most use cases are in the Proof of Concept or pilot stages.

This paper will examine the debates around blockchains and data protection with the objective of drawing constructive conclusions on whether blockchains solutions can be designed in data protection-enhancing ways and whether this can help realize blockchains’ potential in pharmaceutical supply chains, particularly by creating trust.  For this purpose,  this paper takes the example of an ongoing EU-funded innovative research project called PharmaLedger as a case study to concretize its theoretical examinations. This project is chosen since it gathers together a wide variety of stakeholders representing different interests and aims to create a digital trust ecosystem in healthcare, by providing a widely trusted platform that supports the design and adoption of blockchain-enabled healthcare solutions while accelerating the delivery of innovation that benefits the entire ecosystem from manufacturers to patients.

The award was announced during the ConV2X 2021 conference, themed “Blueprint for a New Digital Health Era,” broadcast November 9-11, 2021. The winning article is titled: "The Last Mile: DSCSA Solution Through Blockchain Technology: Drug Tracking, Tracing, and Verification at the Last Mile of the Pharmaceutical Supply Chain with BRUINchain," by lead author William Chien (PharmD, MBA) and fellow authors from UCLA Health and LedgerDomain. The article is located at https://doi.org/10.30953/bhty.v3.134.

The groundbreaking article was part of the FDA’s Pilot Project Program for the Drug Supply Chain Security Act (DSCSA), and centered on a healthcare center pharmacy operating solely on commercial off-the-shelf (COTS) technology. It presented the highest number of BHTY 2020 reader engagements, with the most downloads and views.

The study demonstrated a 100% success rate across scanning, expiration detection, and counterfeit detection; and paperwork reduction from approximately 1 hour to less than a minute. Projecting out to 4.2 billion prescriptions being dispensed each year in the United States, the study found that distributed ledger technologies (such as blockchain) would not only save $183 million in annual labor costs, but also avert 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.

Swarm learning opens new opportunities for collaboration and innovation in clinical research where all members of the swarm have equal rights. Only algorithms and parameters are shared – with no central authority. Swarm creates many new opportunities in clinical research to develop new therapeutics, epidemiology, genetics research and more. This session will unlock swarm principals, challenges and opportunities in clinical R&D driving wider adoption of its application(s) in the health domain.

Key learnings will include:

• Understanding the differences between federated machine vs swarm learning
• The technical, policy and application barriers when it relates to transferring significant amounts of data
• The steps and frameworks needed to drive wider understanding and adoption of the technology in clinical R&D
• The pharma perspective: where does Swarm AI offer new solutions yet to be introduced to the drug development process