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Why Pharmacoepidemiology Must Embrace Patient Data Sovereignty and Decentralized Technologies: My Comments on the CIOMS XV Draft Report

Dr. Ajaz Hussain, Section Editor for Regulatory Science, Blockchain in Health Care Today, Independent Stakeholder, Pharmacoepidemiology and Digital Health Observer

The Council for International Organizations of Medical Sciences (CIOMS), established in 1949 by WHO and UNESCO, has shaped global standards in biomedical ethics, pharmacovigilance, and medical product safety for over seven decades. Its latest Working Group XV draft report, “Realising the Potential of Pharmacoepidemiology for Public Health Decision-Making” (Draft v3.0, 22 December 2025), continues this legacy with a clear, pragmatic, decision-oriented focus on real-world evidence (RWE).

As Section Editor for Regulatory Science at Blockchain in Health Care Today—a journal dedicated to trustworthy platform technologies, data sovereignty, privacy-preserving architectures, and governance in healthcare—I read the 91-page public consultation draft with keen interest. The document is excellent: it positions pharmacoepidemiology as an indispensable bridge science for RWE generation, benefit-risk assessment, crisis management, and equitable access to medicines. Chapters on paradoxes (Ch. 1), when not to conduct a study (Ch. 5), and the ten-stage public health crisis framework (Ch. 4) are particularly strong and timely.

Yet one critical opportunity is only hinted at—and that is why I submitted formal comments before the 13 March 2026 deadline.

The Single Mention of “Tokenization”—And What It Could Become

On page 16 (Chapter 1.4), the draft lists “advances in this field such as ‘big data’, tokenization, and, more recently, artificial intelligence…” (CIOMS XV Draft, 2025). That is the sole reference to any decentralized or Web3-related concept in the entire report.

This is a pivotal opening. We are now in the RWE Era paradigm shift from reliance on narrow randomized controlled trials to holistic evidence generation that embraces the complexity of routine healthcare (FDA, 2021; ICH, 2025). Tokenization, blockchain-enabled immutable consent trails, decentralized science (DeSci), patient-owned data marketplaces, self-sovereign identity (SSI), zero-knowledge proofs (ZKPs), and federated learning are practical tools already delivering results.

For example, federated learning enables secure cross-border pharmacoepidemiology studies without transferring sensitive patient data. In the MELLODDY consortium, ten major pharmaceutical companies collaboratively trained machine-learning models on their combined proprietary datasets while keeping all raw data local and private—dramatically improving model performance, representativeness, and privacy compliance (MELLODDY Consortium, 2024; Nature npj Digital Medicine, 2025). Similarly, SSI combined with ZKPs allows patients to issue revocable, granular consent through personal digital wallets, reducing consent fatigue and enabling larger, more diverse citizen-led cohorts for long-term safety studies.

Why I Commented the Way I Did: Putting Patients First

My seven specific comments aim to strengthen the final report in patients’ best interest:

Expand the tokenization reference into a dedicated subsection on Emerging Decentralized and Web3 Technologies. Patients deserve verifiable, patient-controlled consent mechanisms and the ability to join citizen-led cohorts without surrendering ownership.
Elevate patient involvement to true data sovereignty. Patient engagement means meaningful consultation and participation in research processes. True data sovereignty, however, means patients exercise actual ownership and control over how their real-world data is accessed, used, shared, or monetized. The report already calls for a “unified international framework” for patient engagement (Ch. 1.2.5). I urged explicit inclusion of SSI, granular/dynamic consent, and patient-owned repositories—building directly on CIOMS XI (CIOMS, 2022).
Add explicit human-rights safeguards. Pharmacoepidemiology operates at population scale, creating unique risks: re-identification in large aggregated datasets, algorithmic biases that disproportionately harm vulnerable groups, and unintended surveillance effects that can erode individual autonomy and privacy. A short new subsection or boxed text on “Safeguards for Individual Rights” (referencing the UN Right to Health and CIOMS ethical principles) would ensure collective benefit never overrides these fundamental rights.
Include a Risks & Safeguards Checklist (new Appendix 3) for decision-makers to monitor assumptions such as RWE representativeness or the notion that “population benefit always justifies individual trade-offs.”

5–7. Embed decentralized examples in equity sections, integrate ethical/rights considerations into the crisis framework, and update the Glossary & Appendices. These steps would make the guidance truly global and future-proof—especially for low- and middle-income countries.

These are not criticisms but natural evolutions of the report’s own excellent foundations. They protect patients, rebuild public trust in observational data, and unlock RWE’s full potential in an era of decentralized technologies.

A Call to the Global Community

The public consultation remains open until 13 March 2026. I strongly encourage researchers, regulators, patient advocates, blockchain developers, health-tech innovators, and digital-health colleagues to read the draft and submit comments.

How to participate:

Download the draft and official comment form: https://cioms.ch/working_groups/working-group-xv-pharmacoepidemiology-for-public-health/
Email completed forms to: info@cioms.ch

By participating, we contribute to a model of shared governance that truly empowers patients and strengthens the trustworthiness of pharmacoepidemiology worldwide.

Toward a New Era of Trusted, Patient-Centered Pharmacoepidemiology

If the final 2026 report incorporates stronger language on patient data sovereignty and decentralized technologies, it will not only realize pharmacoepidemiology’s potential—it will help build the trustworthy, equitable health-data ecosystem that patients and societies deserve.

I look forward to the final version and to continued research, discussion, and dialogue in the pages of Blockchain in Health Care Today.

References

CIOMS. (n.d.). About CIOMS. https://cioms.ch/about/
CIOMS XV Draft. (2025). Realizing the Potential of Pharmacoepidemiology for Public Health Decision-Making (Draft v3.0, 22 December 2025). https://cioms.ch/wp-content/uploads/2026/01/Public-Consultation_Realising-the-potential-of-pharmacoepidemiology-for-public-health.pdf
CIOMS. (2022). Patient involvement in the development, regulation and safe use of medicines. https://doi.org/10.56759/iiew8982
U.S. Food and Drug Administration. (2021, July 16). FDA approves new use of transplant drug based on real-world evidence. https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-new-use-transplant-drug-based-real-world-evidence
International Council for Harmonisation. (2025). ICH M14 guideline (Step 4, adopted 4 September 2025).
MELLODDY Consortium. (2024). MELLODDY: Cross-pharma federated learning at unprecedented scale. https://pubs.acs.org/doi/10.1021/acs.jcim.3c00799
Nature Digital Medicine. (2025). Crossing borders securely: synthetic data and federated networks. https://www.nature.com/articles/s41746-025-02126-8
Blockchain in Health Care Today. (n.d.). Mission and scope. https://blockchainhealthcaretoday.com/index.php/journal/mission

Posted 2.22.26

AI Ethics in Healthcare: A Structured Framework for Responsible Deployment

Muthu Ramachandran, PhD, Research Consultant at Forti5 Tech and at Self-Evolving Software (SES) Systems Group, London UK

Richard Marcotte, Tangent Bow Strategies, USA

Tomer Jordi Chaffer, McGill University, Faculty of Law, Canada

Artificial intelligence (AI) can greatly improve healthcare by helping doctors diagnose diseases faster and more accurately. However, it brings new challenges, including protecting patient privacy and ensuring the technology is fair and trustworthy. In this article, the authors explain how hospitals, technology companies, patients, and society must collaborate to ensure AI is used responsibly. It introduces a clear framework to help healthcare organizations check whether their AI systems are ethical and safe. In addition, it includes a free online tool and course to help healthcare teams learn to do this. Readers are encouraged to complete this short survey to share their views on AI ethics and help shape future healthcare policies.

Introduction: Rethinking AI Ethics in Healthcare

Artificial intelligence (AI) is poised to transform healthcare worldwide by improving diagnostic accuracy, personalizing treatments, reducing administrative burdens, and supporting early disease detection. In the United States, the recent AI Action Plan emphasized a “try-first” approach to integrating AI into healthcare, while acknowledging several barriers that have slowed adoption. These include scepticism or limited understanding of AI technologies, a complicated regulatory environment, and the absence of clear governance frameworks and risk management standards. While promoting AI adoption in healthcare is critical to addressing these concerns, we must not proceed without rethinking AI ethics in healthcare.

When rethinking AI ethics in healthcare, one must consider that the increasing use of AI promises to improve diagnostic accuracy, personalize treatments, reduce administrative burdens, and support early disease detection. However, alongside these benefits come significant ethical challenges related to bias, privacy, transparency, autonomy, and accountability. Crucially, achieving genuine transparency is uniquely challenging with advanced AI systems such as large language models (LLMs). Unlike traditional software, where decisions follow explicit, human-programmed rules, LLMs generate outputs based on complex statistical associations learned from vast datasets. As a result, it is often impossible to fully trace or interpret the reasoning behind a specific recommendation. As AI systems increasingly influence clinical decision-making, the potential for unintended harm becomes more acute—particularly when used with vulnerable populations or in high-stakes environments such as emergency medicine or mental healthcare¹.

To address these challenges, several frameworks have emerged over the past five years. These include the EU High-Level Expert Group on AI, which proposed seven ethical principles—such as human agency, technical robustness, and transparency—as foundations for trustworthy AI. Similarly, the Organization for Economic Cooperation and Development (OECD) Principles on AI advocates inclusive growth, fairness, and human-centric design. The National Institute of Standards and Technology (NIST) AI Risk Management Framework (RMF 1.0) provides a structured approach to managing AI risks across lifecycle stages.

In the healthcare context, additional layers of responsibility emerge, involving compliance with the Health Insurance Portability and Accountability Act (HIPAA), General Data Protection Regulation (GDPR), and International Organization for Standardization(ISO)such asISO27001 and ISO 27701, which govern information security and privacy. Despite their strengths, their frameworks often remain high-level or generic, making it difficult for healthcare organizations to operationalize them effectively within clinical workflow.

In this communication, the authors advance the proposition that traditional ethical frameworks, while valuable, must evolve into domain-specific, lifecycle-driven models—especially for healthcare. That is where the concept 'AI Ethics by Design' becomes critical in calling for proactive integration of ethical safeguards across all phases of the AI system lifecycle—from needs assessment, data curation, and algorithm selection to deployment, monitoring, and feedback. This approach ensures that ethical principles are not treated as external validations or post-hoc audits but as embedded requirements within the AI engineering process.

A practical extension of this approach is available through the online course AI Ethics by Design, which offers healthcare professionals and developers applied guidance on implementing ethical controls at each development phase. The course provides case studies, regulatory mappings, and hands-on templates that can be adapted to institutional governance and compliance practices. It bridges the gap between abstract principles and real-world execution—something urgently needed in the healthcare sector.

While ethical AI development is important across industries, healthcare demands a fundamentally different approach. Unlike finance or advertising, decisions made with AI in healthcare can have life-or-death consequences, directly impact human dignity, and affect long-term trust in medical systems. The deeply personal nature of health data, the diversity of clinical populations, and the complexity of medical risk all require tailored ethical scrutiny. Therefore, ethical principles cannot be applied uniformly; they must be context-sensitive, clinically aware, and institutionally grounded.

The authors propose a four-dimensional framework for assessing healthcare-specific AI ethics, aligned with international standards and tested through institutional assessment tools. It brings together clinical, regulatory, and social perspectives to support ethically sound, trustworthy AI systems across healthcare delivery environments.

Existing Studies on AI Ethics

Over the last decade, the discourse on AI ethics has evolved rapidly, reflecting growing public and regulatory concerns around fairness, transparency, and accountability in automated decision-making. Foundational scholarship by Floridi et al. (2018) and Mittelstadt et al. (2016) laid early conceptual groundwork by identifying ethical principles such as non-maleficence, justice, and explicability in AI contexts. These were further echoed by government-led initiatives such as the EU High-Level Expert Group on AI, which proposed seven key requirements for trustworthy AI—including human agency, robustness, and diversity.

Global policy bodies such as the OECD and UNESCO also contributed significantly by advocating value-based and rights-preserving frameworks for AI governance. On a technical front, NIST’s AI Risk Management Framework (AI RMF 1.0) offers a lifecycle-based methodology for evaluating risks from design to post-deployment. Similarly, ISO standards such as ISO/IEC 42001 and ISO/IEC 23894 provide emerging benchmarks for AI management systems and risk governance in institutional settings.

However, empirical studies reveal substantial gaps between principles and practice. For instance, research on clinical AI deployments indicates frequent difficulties in implementing ethical frameworks due to ambiguous accountability structures and data integration challenges (Vayena et al., 2018; Gerke et al., 2020). Studies by London (2019) and Duran & Jongsma (2021) emphasize that clinicians often lack interpretability tools and governance resources needed to safely rely on AI-generated outputs.

Several implementation challenges persist:

Bias and Disparities: Obermeyer et al. (2019) revealed racial bias in commercial algorithms used for risk stratification.

Transparency Gaps: Holstein et al. (2019) found that healthcare professionals face opaque AI systems with limited explainability.

Regulatory Uncertainty: Morley et al. (2020) and Fjeld et al. (2020) critique the over-reliance on principles without operationalization frameworks.

Despite the availability of principle-based guidelines, critics argue that real-world deployment requires context-specific, institutionalized ethical infrastructures (Char et al., 2020; Williams et al., 2022). This has led to the call for AI ethics to shift from abstract declarations to embedded lifecycle governance—a direction supported by entities like the World Health Organization (2021) and the British Medical Journal AI (BMJ AI, 2023).

To address these complex realities, recent literature emphasizes integrating ethics into system design and evaluation pipelines (Babic et al., 2021; McCradden et al., 2022), thereby aligning technological development with clinical and social accountability. Moreover, educational interventions such as the AI Ethics by Design course and implementation tools support practitioners in operationalizing ethical safeguards through real-world templates and audit frameworks.

However, these existing ethics frameworks and governance models tend to lack an adequate focus on stakeholders’ viewpoints, which is main focus of this article. As we transition from principles to practice, a structured, stakeholder-grounded model—such as one based on the stakeholder perspectives proposed here—offers a pragmatic bridge between high-level ethics and institutional AI deployment strategies.

Overall Methodology

To develop a framework for assessing stakeholder viewpoints, we performed a survey of the literature regarding primary stakeholders of AI in healthcare. The literature search utilized key terms including "AI Ethics," "Healthcare," and "AI Governance." We synthesized information based on relevance to the ethics of AI in healthcare, as well as alignment with key themes in leading AI governance frameworks outlined by the NIST, the EU, and ISO/IEC.

Leveraging a Stakeholder Assessment to Guide Responsible Innovation

Artificial intelligence is transforming healthcare by enhancing diagnosis, streamlining workflows, and personalizing treatments. However, these advancements carry significant ethical responsibilities, particularly in ensuring fairness, safety, explainability, and accountability across clinical and non-clinical domains. The application of AI must be evaluated not only for its technical efficiency but also for its alignment with human values, professional obligations, and regulatory compliance.

To address these concerns, we propose a comprehensive, lifecycle-based framework for evaluating AI ethics in healthcare. This framework aligns with the NIST AI Risk Management Framework, the EU’s 'White Paper on Artificial Intelligence,' and the ISO and International Electrotechnical Commission (IEC; ISO/IEC 42001 standard) for AI management systems. It consists of key thematic domains: Governance & Oversight, Security & Privacy, Data & Model Integrity, Fairness & Non-discrimination, Human Agency, Explainability, System Monitoring, and Societal Impact.

Enterprises attempting to assess AI-based healthcare solutions across these thematic domains face a substantially more complex task than certifying conventional software against traditional quality, safety, and legal compliance requirements. First, AI systems often operate as "black boxes," making it difficult to trace decision-making processes to ensure transparency and accountability — unlike deterministic code in traditional software. Second, AI models require continuous retraining with evolving data, necessitating ongoing validation to maintain accuracy, whereas conventional software typically relies on static, fixed algorithms. Third, healthcare AI must navigate fragmented regulatory landscapes—such as GDPR, HIPAA, and local medical standards—while balancing patient privacy, data security, and ethical use of sensitive health data. Fourth, the high stakes of patient outcomes demand rigorous real-world testing across diverse populations, unlike conventional software, which can often rely on controlled, synthetic datasets.

These challenges force enterprises to confront trade-offs between exhaustive testing, development costs, and deployment urgency, setting the stage for a critical discussion on prioritizing testing efforts. To enable enterprises to achieve ethical outcomes while balancing cost and schedule constraints, this paper proposes a multi-stakeholder framework for evaluating the ethical impact of AI in healthcare.

This framework emphasizes the interconnected responsibilities of four stakeholder categories: patients, healthcare providers, AI business organizations, and society at large. At its core lies societal impact, which is influenced by how well these entities uphold ethical principles. Patients are concerned with rights, informed choice, data ownership, and privacy. Healthcare providers are responsible for ensuring clinical safety, transparency, and effectiveness. The AI business organizations must implement responsible project practices and governance mechanisms. The continuous flow among these sectors reflects the dynamic, interdependent nature of ethical accountability, suggesting that responsible AI in healthcare can only be achieved through ongoing collaboration and oversight across all levels.

The authors have developed a survey tool, titled AI Ethics in Healthcare Survey, that enterprises can utilize to assess ethical challenges and gaps from each stakeholder perspective. The survey includes a dedicated section for each stakeholder viewpoint, enabling healthcare teams to identify ethical requirements and prioritize improvements. A link to the survey is provided at the conclusion of this article.

Applying the Lifecycle Framework to Ensure Ethical AI Solution Delivery

Once stakeholder perspectives have been assessed using the survey tool, AI solution design, development, and testing activities can proceed in line with the lifecycle-based framework described above for ensuring AI ethics in healthcare. Within the framework, each domain integrates measurable indicators to guide evaluation. For example, in the “Security & Privacy” domain, considerations include compliance with GDPR and HIPAA, implementation of differential privacy, and real-time threat modeling. Meanwhile, the “Fairness & Non-discrimination” component requires institutions to audit AI systems for dataset bias, proxy discrimination, and algorithmic disparity across protected groups⁵.

One often overlooked aspect is the lack of proper explainability and transparency in clinical decision support systems. Studies reveal that without robust explainability, healthcare professionals might either over-trust or completely disregard AI outputs, potentially leading to harmful consequences. Moreover, misuse or over-reliance on generative models without secure guardrails can result in misinformation, over-diagnosis, or patient harm⁷.

A pressing concern is the use of AI code assistants and automation tools in software design. Evidence suggests that these tools can produce insecure or misleading outputs when developers overly rely on them without proper oversight. In healthcare, such risks are amplified due to the safety-critical nature of applications.

To operationalize these principles, the authors developed a publicly available course, 'AI Ethics by Design,' which offers structured guidance on embedding ethical principles throughout the AI development lifecycle—from ideation and dataset curation to deployment and monitoring. This educational initiative complements the broader goal of fostering responsible innovation across healthcare systems.

Finally, healthcare institutions must fulfil their duty of care by embedding ethics assessments into procurement processes, engaging multi-stakeholder oversight panels, and preparing for audits through traceable model documentation. A structured ethics review process, such as the one embedded in this lifecycle framework, is no longer optional—it is foundational to the safe, just, and sustainable deployment of AI in healthcare.

Survey Participation

We invite all stakeholders—clinicians, developers, policymakers, business leaders, and patient advocates—to contribute to shaping the future of responsible AI in healthcare by completing our 'AI Ethics in Healthcare Survey.' Your input will help us better understand current practices, concerns, and priorities across the ecosystem.

Take the survey here: https://tinyurl.com/ai-ethics-healthcare

Your voice matters in building trustworthy, patient-centered, and ethically aligned AI systems.

Posted 8.29.25

Unlocking the Future of Healthcare: ConV2X 2025 Leads the Conversation on Blockchain, Platforms, and Technology for a Healthier Society

Tory Cenaj, Publisher, BHTY

As healthcare undergoes a seismic transformation, leaders from around the globe are gathering to discuss the most disruptive forces shaping the future: AI and blockchain technology.

ConV2X 2025, scheduled for September 25-26, in Cambridge, MA, is the premier event exploring how blockchain, decentralized technologies, and innovative platforms are redefining healthcare, life sciences, and the very foundations of patient care.

ConV2X (ConVerge2Xcelerate) is BHTY's annual symposium. The theme this year is Driving Platforms and Decentralized Tech in Healthcare and Life Sciences. This is an internationally recognized forum where trailblazers, technologists, policymakers, providers, and entrepreneurs come together to accelerate change.

With healthcare and life sciences facing growing pressures from cost containment to data
security to patient empowerment—ConV2X 2025 offers a critical platform to learn how AI and
decentralized technologies will improve outcomes, increase efficiencies, security, and expand
access for society at large.

Why Blockchain and Tech Matters Now
Blockchain and decentralized platforms are poised to revolutionize healthcare’s most pressing challenges. From securing patient data against cyber threats, to streamlining supply chain management, to enabling patients to own and control their health records, blockchain promises to build a more transparent, efficient, and equitable healthcare ecosystem.

At ConV2X 2025, experts will dive deep into how these technologies are already being deployed — and what’s coming next. With real-world use cases, case studies, and lively panel debates, attendees will leave armed with insights they can apply immediately to their organizations and innovation roadmaps.

Top Speakers, Transformative Ideas, and Real World Applications
ConV2X consistently features some of the brightest minds in global healthcare and tech. Past
speakers have included CEOs, CTOs, researchers, policymakers, clinicians, and pioneers from
startups to Fortune 500 companies. The 2025 lineup promises even more groundbreaking
dialogue, featuring:

- Leading blockchain and decentralized application (dApp) innovators
- Health system executives driving tech transformation
- Regulatory experts providing clarity on compliance and standards
- Entrepreneurs building the next generation of digital health tools
- Academics showcasing cutting-edge research into blockchain, AI, and emerging
technologies

Sessions will cover topics like patient data ownership, decentralized clinical trials, AI integration in decentralized health networks, Web3 business models for healthcare, and ethical implications of decentralized medicine.

Join the Ecosystem
ConV2X 2025 is more than an event; it's a catalyst for change. Participants will find networking opportunities with decision-makers and potential collaborators, forge new partnerships, and gain early access to ideas and strategies that will shape the future of healthcare.

Whether you are a healthcare provider, technologist, policy leader, investor, or startup founder, ConV2X is the place to be if you want to stay ahead of the curve and be part of a global movement committed to harnessing technology for a healthier world.

About Us
ConV2X is organized by Partners in Digital Health (PDH), publisher of the highly respected
Blockchain in Healthcare Today Platform Approached Journal (BHTY). With a longstanding reputation for bringing visionary ideas to the forefront. PDH ensures ConV2X delivers unmatched content, credibility, and networking opportunities year after year.

Save the Date and Register Now
ConV2X 2025
September 25-26, 2025
The Foundry, 101 Rogers Street
Cambridge, MA, USA

Visit https://conv2xsymposium.com to secure your spot and be part of the conversation that will shape the next era of healthcare. Seats are limited.

posted June 19, 2025

Blockchain-based Blood Transfusion Networks

Prasad Kothari, Head of Data Science and AI, Hansa Cequity, India

Years ago, I wrote about the Apollo Hospital blood donation social network and how technologies like blockchain could revolutionize blood supply and distribution in my book. Now, this vision is gaining traction, with pilot programs and initiatives demonstrating the immense potential of these innovations.

Every day, in hospitals around the world including India, countless individuals face critical health challenges, and for an estimated one in ten, a blood transfusion is a vital bridge to recovery. These aren't just statistics; they are stories of resilience, hope, and the unwavering human spirit. It's a stark reminder of our shared responsibility to ensure a safe, efficient, and readily available blood supply for all who need it.

Imagine the impact we can make by transforming the current landscape. The need is undeniable, with nearly 16 million blood components transfused annually in the U.S. alone. Each unit represents a life potentially saved, a family kept whole, and a community strengthened.

Blockchain: A Catalyst for Change

Blockchain technology offers a groundbreaking approach to address some of the most pressing challenges in blood transfusion services.

Consider the possibilities:

Enhanced Efficiency: Streamlining the complex logistics of blood collection, testing, and distribution, ensuring that blood reaches those who need it faster and more reliably.
Unwavering Quality: Guaranteeing the quality and safety of blood products through transparent, tamper-proof tracking at every stage of the supply chain.
Empowered Donors: Creating a secure and user-friendly platform that incentivizes blood donation and fosters a sense of community among donors.
Improved Access: Connecting blood banks and hospitals in a seamless network, optimizing inventory management, and minimizing waste.
Pioneering Initiatives: A Glimpse into the Future

The Collective Mission

The journey towards a blockchain-enabled blood supply chain has already begun, with organizations like EY and Canadian Blood Services (CBS) launching pilot programs in 2020 to enhance operational efficiency. These initiatives demonstrate the tangible benefits of blockchain in improving supply chain transparency and traceability.

Furthermore, the launch of BloodChain by the Indian Government last year (Blockchain.gov.in) marks a significant milestone in leveraging blockchain for blood management.

The Bloodchainn covers the network of

Donors
Colleection Centers
Tsting Centers
Bloodbanks
Hospitals
Dept of Health and family welfare, DCD, Citizens

These are not just technological advancements; they are opportunities to create a more equitable, efficient, and life-saving blood transfusion system. Let's embrace these innovations and collaborate to:

Expand Blockchain Implementation: Advocate for the widespread adoption of blockchain technology in blood transfusion services, driving greater efficiency and transparency with advocacy towards data sharing & patient centricity through scaled-up operations.
Foster Collaboration: Encourage partnerships between hospitals, blood banks, technology providers, and government agencies to accelerate the development and deployment of blockchain solutions.

References

Status of hospital-based blood transfusion services in low-income and middle-income countries: a cross-sectional international survey; Linda S Barnes et. al.; https://pmc.ncbi.nlm.nih.gov/articles/PMC8852762/

U.S. Blood Donation Statistics and Public Messaging Guide; https://americasblood.org/wp-content/uploads/2024/01/U.S.-Blood-Donation-Statistics-and-Public-Messaging-Guide-Jan.-2024.pdf
Hospital red blood cell and platelet supply and utilization from March to December of the first year of the COVID‐19 pandemic: The BEST collaborative study; https://pmc.ncbi.nlm.nih.gov/articles/PMC9349645/
National Blood Collection and Utilization Survey; https://americasblood.org/abc-newsletter/blood-donation-transfusion-data-2021-nbcus/
WHO Global Database; https://www.who.int/news-room/fact-sheets/detail/blood-safety-and-availability
Healthcare Social Media Management and Analytics: For hospitals, Insurance companies, Pharmaceuticals, Public health professionals, and Patients; https://www.goodreads.com/book/show/25449696-healthcare-social-media-management-and-analytics

posted April 24, 2025

Is Academia Hindering True Innovation Acceleration?

Tory Cenaj, Founder and Publisher, Blockchain in Healthcare Today, contact t.cenaj@partnersindigitalhealth.com. The views expressed are solely her own and do not reflect those of the editorial board, reviewers or staff members.

Partners in Digital Health (PDH) announced a no APC fee aimed specifically at negative, unconventional, null, neutral, and failed research, on the heels of the White House Office of Science and Technology Policy (OSTP) Federally Funded Research Guidance announcement, in Sept 2022.

To date, no such research has been submitted.

Last week I spoke with a Rear Admiral, Chief Nurse, from the US Public Health Service, and others in government and NGO service. All agree how important sharing negative data is.

The obstacle is academia and its promotion reward system.

To reiterate our message: "Progress in science is not only made based on positive data, but also on negative results. Guidance to the scientific community should include and emphasize the importance of negative data across both public and open access scientific publications.”

Scientists have become accustomed to celebrating only success and have forgotten that most technological advances stem from failure. When negative results aren’t published, other scientists can’t learn from them and end up repeating failed experiments, leading to a waste of public funds and a delay in genuine progress.

Researchers are particularly challenged to disclose negative results that are not consistent with previously published positive data. In addition, positive findings are more likely to generate citations and funding for additional research, but negative data saves institutions funding wasteful projects and puts ecosystems on the right track for faster solutions and outcomes that benefit the entire ecosystem. This is critically important in new research fields and markets that are evolving - fostering real world applications and scaled implementations.

Partners In Digital Health is pleased to facilitate these critical efforts to accelerate research success, augment true innovation, and create a trusted repository where research, public, and private communities can find unconventional answers to streamline meaningful solutions. The publisher will waive the APC for negative and null research, for accepted peer reviewed manuscript submissions.

Topic areas will include but are not limited to the following:
> What and why the research did not work, eg., rigor in study design, lack of funding, issue with patient recruitment, support from superiors or colleagues, bias, etc
> Analysis of impact
> Consequences of negative research
> Lessons on mitigating negative results and why
> Benefits of sharing research
> Good research practices, best practices
> Key personal learnings
> Addressing issues of reproducibility
> Ethical violations

Papers on related and complementary topics will be considered.

Submission Requirements
> Papers should be original submissions not previously published or under active consideration by other journal
> Papers will be 3,000 maximum word count
> Submissions must include a section for an analysis and recommendations for future researchers, and journal readers

Upload on th BHTY Submission Portal at https://blockchainhealthcaretoday.com/index.php/journal/about/submissions

Posted: 10.3.2023

It’s Time for an Integrity Throwdown: Conflicts of Interests in Scientific Communications

Some people begin their day with a market or news update, meditation, exercise routine or something funny. I begin my day with a dose of Retraction Watch. Recently, a couple of articles caught my eye.

As the publisher of two new emerging market journals, I’m particularly sensitive to the ethics and integrity exhibited in the marketplace. New publishers are typically met with a great deal of skepticism. Ivory tower eyebrows are raised and so is the word “predatory” when a new journal is launched – unless, of course, you are a member of the “legacy brigade.”

During the height of unscrupulous fraud in the crypto currency market, I decided to validate and build credibility for blockchain technology’s potential by launching the first international open access peer reviewed journal in blockchain for healthcare (BHTY), and proceeded to roll the boulder up the hill.

I was careful to distance the journal with a niche editorial mission and ethical practices to set us not only apart from the heard, but anticipated how much more relevant ethics would become.

I believe it is time for an integrity throwdown.

When we launched BHTY, we did not accept editorial board members or peer reviewers that were from the commercial side albeit some of the most brilliant minds were employed there - and we needed them because it was such a groundbreaking field. Why? Because we didn’t want potential “commercial interests” besmirching the integrity or perception of the clarity, purpose and ethics of the journal’s editorial rasion d’etre or reputations listed on the masthead.

It pained me to asked three board members to step down when they transitioned to the commercial side. We published mission pillars and partnership expectations, which are still in effect (see http://www.partnersindigitalhealth.com/method.html). In year two of publication, we opened the board to those on the commercial side because many were accelerating the market with hands on experience versus theoretical, so we bit the proverbial bullet. Ultimately, two board members rejoined while the third took another path.

From the outset, we required publishing conflict of interest/financial disclosures. This is for transparency and trust purposes. I wanted to be as transparent with the audience as possible to conclude BHTY was and is a credible journal. COIs are published here. All journal editorial, review and staff members submit disclosures that are published on the journal site on the COI tab. To my knowledge, no other journal in the market does so.

Our portfolio motto is “building trust through truth.” We were recently recognized as new members of COPE. I don’t doubt COI disclosures were a factor in the decision.

Fast forward and back to Retraction Watch. One morning, I was opening emails to find an article titled "Obesity journal editor’s extensive company ties raise concerns about conflicts of interest in publishing.” This time, my eyebrow is raised. The link led me to an article published by Ed Silverman, a reporter from Pharmalot (note: this is a paywall publication, but I couldn’t resist. The first 30 days are free – remember to end your subscription before the trial is over!).

Long story short, the associate editor-in-chief (AEIC) of the Obesity journal in the article was outed because:

The AEIC co-authored a paper in which a manufacturer’s product was mentioned which also included her published financial disclosure (this meets guidelines)
The AEIC embellished the article with added benefits of the therapy (I assume all were on label)
The company paid a firm to provide writing assistance for the AEIC’s article (huge no-no, even in 2013/14)
The AEIC co-authored an editorial praising the company’s pricing model
The AEIC did not disclose the financial relationship in the editorial (again, big no-no)

I’m familiar with the adage “repeat advertising works,” but not by and under the guise of a medical journal associate editor-in chief (AEIC) – or anyone on the board or staff of one.

That same week, another article appeared in Pharmalot by the same author with the title "Conflicts of interest are common among editors and authors of psychopharmacology textbooks.’

With my eyebrow raised (again), what I found disconcerting was that it reported:

“… few professional medical journals report conflicts of interest held by their editorial staffs. To wit, 129 of 130 high-impact medical journals required authors to disclose conflicts, but only 16 of those same journals reported potential conflicts held by individual editors. Meanwhile, in half of 26 journal categories examined…not one journal provided public disclosure of conflicts held by individual editors.”

I contacted the author because there is one publisher that DOES require disclosures from researcher/author, journal board and staff. The bar is set high for new journals like BHTY, and I often wonder if legacy complacency would pass ethics requirements if publishers had to submit their journal(s) today.

After a year of false claims, hysteria and politicizing research, we need to get back to basics and infuse trust in a market that must place patient safety and product efficacy before shareholder and venture capital interests.

Shall we challenge the industry to an integrity throwdown?

Posted: 11.24, 2021

Three Recent Events to Make Us Consider Blockchain for Healthcare Data Management

Hao Sen Andrew Fang^,SingHealth Polyclinics, SingHealth, Singapore; SingHealth Duke-NUS, Singapore^,andrew.fang.h.s@singhealth.com.sg

As an observer of current affairs with a keen interest in blockchain, it has already been a very eventful start to the year. For one, the Bitcoin price made new all-time highs, surpassing US$40,000 and triggering significant media buzz. Yet amid all the hype of Bitcoin and cryptocurrency prices, I found three major news events to be particularly relevant and instructive for the blockchain healthcare community, especially with regard to data management. In this blog, I wish to share my brief thoughts on these recent events.

Dispute over U.S. presidential election votes

As results from the recent U.S. presidential election were announced, there were already numerous legal challenges to the results citing voter fraud. The Wall Street Journal also reported an appeal made to Georgia’s top election official to re-calculate the state’s results.¹ Dispute over electoral results is not unprecedented, and it reveals the possibility of data manipulation while more importantly underscoring the need for better transparency in data provenance.

In the healthcare context, it is also not hard to imagine a central authority altering health data for its own benefit—such as to report glowing health statistics. In fact, corruption in health systems is real and there are anti-corruption efforts being undertaken by the global health community to address them.² Even in scenarios where there is no malicious intent, the current lack of transparency in which most health data are collected, analyzed, and reported has raised questions and doubts. We had already witnessed this first-hand in the early days of the COVID-19 pandemic when erratic numbers coming out of Wuhan evoked public doubt and distrust.³ These scenarios only highlight the importance of data immutability and, more broadly, data transparency in the modern age.

Whatsapp announces changes in privacy policy

The issue of data privacy recently came under the spotlight, triggered by the privacy policy changes of messaging app Whatsapp.⁴ Although Whatsapp has since clarified that its new terms will not allow it to access users’ messages, its announcement had users flocking to rival messaging apps perceived as having better privacy features. This unexpectedly strong collective response indicates a deep societal expectation for data privacy. A global survey conducted by Ipsos provides a more quantitative sense of consumers’ worries, showing roughly one-third of the respondents saying they knew little or nothing about how much their personal information is used by companies or governments, and with only a minority (39%) of them trusting their national government.⁵

Currently, health data privacy is protected by law such as the Healthcare Insurance Portability and Accountability Act (HIPAA), General Data Protection Regulation (GDPR) and Personal Data Protection Act (PDPA) depending on jurisdiction. While it is reassuring to know there are such laws in place, the Whatsapp move demonstrates how the protections still fall short. It is not hard to imagine a commercially driven healthcare organization selling patient data (even if it is de-identified) for profit, without explicit knowledge of its patients. To address this, there are growing calls to rethink the current approach of data privacy protection to that of data ownership, including lawmakers.⁶ In this proposed model, healthcare organizations may license the use of patient data and patients earn a dividend from the use of their data. Such a model could eliminate concerns of data privacy as any use of the data would need patients’ explicit consent. In addition, such a model would also offer a more equitable relationship for patients and healthcare organizations with regard to the value generated from the data.

Robinhood abruptly halts services

Amid a Reddit driven rally of certain company stocks including GameStop and AMC, consumer investment platform Robinhood abruptly suspended trading of those stocks.⁷ This unilateral decision enraged retail investors who later went on to file a class action suit against the platform. This exposed the weakness of centralization, where users are at the mercy of a single monopoly platform.

In healthcare, one major area of centralization is in data management. Especially for healthcare organizations that store and access their data on the cloud, it is very likely that they would utilize one among a handful of services such as Amazon Web Services and Microsoft Azure. What happens if these services suddenly decide to block its services? Subscribing to an additional provider is possible, but it would be prohibitively costly for most. This highlights the need for a system that is not under the control of a single party or small consortium. We need a decentralized data management system which cannot be turned off on a whim.

While these events may seem disparate and unrelated to healthcare—one from politics, one from legal and another from finance—I believe they hold key lessons for the healthcare industry which could easily face similar challenges as presented above. These events demonstrate certain shortcomings and potential weaknesses of existing data services and information systems, which can also be applicable to healthcare. These shortcomings call for systems built on data transparency, ownership and decentralization—properties that are inherent to blockchain technology. Given these recent events and the lessons they bring, blockchain should be strongly considered as a solution to enable a paradigm shift in data management, especially for the healthcare industry.

Acknowledgements: The author would like to thank his family and work organization, SingHealth Polyclinics, for their support.

REFERENCES

Posted 2.13.2021

Should Emerging Technology be a Part of Medical School Curriculum?

Cole Holan,¹ Cody Cowley,¹ Jeremiah Alexander¹

¹Dell Medical School at the University of Texas, Austin, Texas

When we applied to medical schools there were specific aspects of a program that we wanted. We needed a school that embraced change and encouraged students to seek opportunities outside of the curriculum that allows innovation in medicine to occur.

Modern medical education consists of 1.5 to 2 years of pre-clinical education in a classroom and 2 to 2.5 years of clinical rotations. Currently, only three schools have moved to 1-year pre-clinical, which opens up an extra year of time during medical school. One article suggested that to prepare students for the rapidly changing healthcare environment, undergraduate medical education programs should have the freedom to implement curricula allowing students to individualize their study plan based on their career path and competencies.¹

In the traditional model of medical education, we must determine if we are training doctors to conform to a broken model or to become the solution through innovation and creativity? If the goal is to teach medical students to change the current platform, it is wise to expose students to opportunities to innovate and rethink aspects of healthcare. Medical students need the ability to contribute and work within teams that are innovating. Faculty at our institution have been tremendously helpful in introducing us to some of these innovative technologies.

During our first year in medical school, we had the opportunity to aid in the construction and testing of patient-centric blockchain identity and consent management system with a multidisciplinary team. This experience increased greatly our understanding of the healthcare system.

We think all medical students should be exposed, and, if possible, have the opportunity to work on projects that involve emerging technology —like blockchain. This would benefit student’s learning two-fold: they would get early exposure to technologies they will likely encounter in a clinical setting and they would get to help develop these technologies, allowing a smoother transition into their clinical years and decreasing the learning curve of the health record system or other instruments commonly used in medical practice. The potential of blockchain in healthcare is promising and will likely play a part in the future healthcare landscape.²

We have seen how to view one particular problem while realizing the type of team it takes to brainstorm a multitude of ideas addressing that problem. Working on this project gave us perspective on how emerging technology can shape healthcare, while getting the experience of working within an interdisciplinary team. As new health information systems are built to phase out the current electronic health record system and usher in new ones, it is vital that the teams working on these projects are composed of different backgrounds, so that intricacies of the system are not overlooked. Physicians work on teams to deliver the best outcomes to patients. It should be no different in development of technology to care for patients.

Early exposure to technologies that are likely to be implemented or already recently being implemented in healthcare settings will be paramount to the future physician. Going forward, we should expect medical students to be engaged in what our future looks like. We must learn how to build strong teams that include our counterparts from varying fields, and we must learn how it feels to work on a project with the potential to change the way medicine is practiced. If we don’t see how we can change the system we are in, we won’t.

References

Green M, Wayne DB, Neilson EG. Medical Education 2020—Charting a Path Forward. JAMA. 2019;322(10):934-935.
Khurshid A, Gadnis A. Using blockchain to create transaction identity for persons experiencing homelessness in America: policy proposal. JMIR Res Protoc. 2019;8(3):e10654.

Posted 1.24.2021

**BHTY "Best of" Open Access Articles**

Now in its 3^rd year of publication, join BHTY’s international community of researchers and pioneers accelerating data-driven integration, interoperability and utilization across the healthcare industry around the globe.

Indexed in ScienceOpen, Index Copernicus, Unpaywall, NEBIS, Google Scholar and PKP meta data harvester and member of the International Association of Scientific, Technical and Medical Publishers and DOAJ – and read by nearly 200,000 viewers around the world – we celebrate the “Best of” articles to date and invite you to become a prestigious author and member of the BHTY global community of change innovators too!

To celebrate our continued support for the multidisciplinary ecosystem, we’re sharing articles from past editions to inspire, educate and communicate the breakthrough research and innovation the technology presents for healthcare.

1. The Last Mile: DSCSA Solution Through Blockchain Technology: Drug Tracking, Tracing, and Verification at the Last Mile of the Pharmaceutical Supply Chain - William Chien, PharmD, et al

DOI: https://doi.org/10.30953/bhty.v3.134

2. Leveraging Blockchain Technology to Enhance Supply Chain Management in Healthcare: An Exploration of Challenges and Opportunities in the Health Supply Chain - Kevin Clauson, PharmD et al

DOI: https://doi.org/10.30953/bhty.v1.20

3. DMMS: A decentralized Blockchain Ledger for the Management of Medication Histories - Patrick Li et al

DOI: https://doi.org/10.30953/bhty.v2.38

4. Blockchain as a Foundation for Sharing Healthcare Data - Marek A Cyran

DOI: https://doi.org/10.30953/bhty.v1.13

5. Applications of Blockchain within Healthcare - liam Bell et al

DOI: https://doi.org/10.30953/bhty.v1.8

6. Pragmatic, Interdisciplinary Perspectives on Blockchain and Distributed Ledger Technology: Paving the Future for Healthcare - Ron Ribitzky et al

DOI: https://doi.org/10.30953/bhty.v1.24

7. Enforcing Human Subject Regulations Using Blockchain and Smart Contracts - Olivia Choudhury, PhD et al

DOI: https://doi.org/10.30953/bhty.v1.10

Submit your manuscript here or click https://blockchainhealthcaretoday.com/index.php/journal/about/submissions

Questions? Reach out to info@partnersindigitalhealth.com

We look forward to your manuscript or technical brief submission.

BHTY Team

Posted 1.20.2021

Transforming Health Care in the Wake of a Global Pandemic

Tory Cenaj, Publisher, Telehealth and Medicine Today

Some of the world’s top leaders and influencers in healthcare delivery transformation and health technologies, including blockchain in health tech and telehealth, converged at the 4th Annual ConVerge2Xcelerate (#CONV2X) 2020 Symposium held virtually from November 10th-12th, to exchange perspectives and solutions to shortfalls in global patient care exposed by COVID-19. The theme of this year’s symposium BHTY hosted was “US-World Health Transformation.”

Impact of COVID-19 on health care

The global COVID-19 pandemic showed how vulnerable healthcare delivery is to patients around the world. Healthcare systems in every country have been challenged – not only in treating patients with coronavirus, but in trying to maintain optimal care for non-COVID patients at the same time.

As a result, new advances in digital health technologies, including telehealth, blockchain, AI and others, are successfully transforming patient treatment models on an international scale. What this event proved is that healthcare transformation, via technology and new global models for greater access and more efficient and effective delivery of healthcare services to patients, is much closer to reality than ever before.

Many of the sessions over the two-day event focused on two main topics: healthcare interoperability, digital health, adoption, scale and equity.

Healthcare interoperability

On Day 1 of the event, this topic was highlighted by speakers from the UK, India, North America and the European Union. Interoperability is the ability of different healthcare systems and processes to communicate and share secure information with other healthcare systems and processes, either within or across organizational borders, in order to advance the effective delivery of healthcare. The consensus was that patients will enable interoperability through trust – a pivotal facet of adoption and scale.

Technology players will have to continue to grow in partnership with healthcare systems, which will be required for both the systems and for consumers.

Digital health

According to Keynote speaker, Dr. Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization, “Digital health is a new reality that will bridge disparity and access to those with lower income and the underserved.” Other Keynotes from Teladoc Health and Mayo Clinic Digital Platform emphasized transforming health care with digital health and virtual care delivery systems, which would make care affordable and equitable, decrease disparities among income levels and geographies, and create global standards and regulations for citizens and health systems around the world.

But digital health is a broad term, one that encompasses several technologies, including telehealth, virtual care, and digital tools and services, requiring standards and integrations that make health care delivery broader, easier and more flexible.

A Keynote session titled, “Virtual Health: The Next Frontier for Healthcare,” with Alex Harris, Partner, McKinsey & Company and moderated by Lyle Berkowitz, MD, FACP, FHIMSS, CEO of Back9 Healthcare Consulting discussed he radical digitization of health care with supply and demand factored in. Healthcare has lagged behind other industries in terms of digitization. But on the consumer (patient) side, mindset and behavior changes have moved the needle on telemedicine visits, and it is projected that 60% of those over age 65 will avail themselves of this technology in the near future.

Physicians question the effectiveness of telehealth visits and financial compensation, and they wonder about adoption and when it will stabilize. Telehealth visits were high in April, but decreased, perhaps due to restrictions in movement as things shut down.

The challenges to adoption that still exist include funding and parity for certain services and long-term reimbursement. Fee-for-service vs. value-based is still unclear. So while providers are still wondering about financial implications, consumers are starting to feel more comfortable.

It is clear that this past year has presented both many challenges to healthcare delivery and opportunities for innovations. The manner in which health care is delivered is occurring at a time when traditional physical interaction between patient and provider has basically been a “cease and desist order” for the safety of both parties.

To learn more and get access to the agenda and program, visit https://conv2x-2020-ondemand.eventcreate.com/

For a top line introduction and select presentations visit BHTY at https://blockchainhealthcaretoday.com/index.php/journal/ConV2X2020

Posted 11.20.2020

Emotional Wellness in the Times of Covid-19

Shanmugavel Sankaran, Founder, NixWhistle

There is no doubt that the COVID-19 has made a huge impact in all our lives now. It has become a part of history which the future generations will be studying about from the internet and maybe textbooks. From following our daily routine of getting up in the morning and heading to work/ education center and coming back in the evening, we are now stuck between the four walls of our house after getting used to the lifelong time of leading our monotonous lives. Although most of us are lucky to stay home and be with our families, there are so many people who were unfortunate to be left back in different cities once the lockdown was declared. There are many highly respectable providers of service and safety who are constantly working out there, battling with the virus and trying their best to not let it reach the citizens of the nation. But sadly, they are unable to go home to their families as they too will have to take precautions.

With so much going on in everyone’s lives now, the pandemic has begun to affect the mental peace of us human beings. We are all used to always staying out, being with people, socializing, and now, we are privileged to go out of the house only when we have to purchase essential items. Although staying indoors at such a time is highly important, it took a lot of people some time to get adjusted to the new yet temporary lifestyle. It was quite expected that some of us will be dealing with akathisia in this overwhelming situation the entire world is facing. It is not easy to just be sitting in one place and sticking to your laptop or phone when you are so used to moving about and exploring.

When it comes to children, they spend most of their time outdoors with their friends running around and playing for hours together. After they come back from school, they look forward to going and playing with their friends the most. But with the pandemic, it is most important for them to stay inside the houses without coming in contact with anyone from outside in order to avoid the spread of the virus. But what happens when a child is forced to stay at home for more than 2 days? They get highly restless and impatient if they are not engaged with something. This restlessness can lead to yelling and shouting because their brain would have heated up. This results in broken peace in the house and because they are young and going out to play is all they can think about, it can be difficult to make them understand the reason behind not letting them go out of the house. In the process of calming down their kids, even parents start losing their patience leading to a lot of disruption in the house.

It's extra overwhelming the ones living by themselves. So many thoughts, so many things to work on, so many thoughts in their minds, it’s just chaotic for them. Living alone might be looked at as having all the freedom where one can do anything as they wish, but the truth is, along with all that comes a lot of responsibilities. Taking care of their house, earning and paying rent, making meals for themselves, etc. They wake up and they don't have anyone around to look at, while having a meal, they’ll be by themselves with no one to speak to. Now this would have been an entirely different scenario when they were living their normal lives of going to work, being with their colleagues, going out with them and then coming back home for the night. But constantly having to be at home from the time they wake till the time they go back to sleep without having any sort of human interaction for more than a month can add a lot of anxiety and overthinking to their lives.

With the economy going down the drain, entrepreneurs are dealing with a lot of stress at this point in their lives. With no inflow of money in their accounts, they are finding multiple ways to reduce their expenditure and to live as minimalistic as possible. Individuals who had plans of beginning their entrepreneurial lives this year will have to postpone their plans to the next year as they would be seeing very little to no success at all if they started their company during a period where everything is shattering.

Blockchain based solutions like WellnessSpeak is all about hearing people out ensuring complete trust and assurance about their emotional turbulence. Such platforms has been made to help individuals having a bad time in this pandemic, speak their thoughts out while in return seeking some support online hoping to make these better for them. All the stakeholders like Tele Health providers and Emotional Wellness clinics are able to come onboard as additional stakeholders onto the platform.

There are so many more problems than the ones listed above which people are going through right now, but because the world is so busy fixing itself, the blockchain powered wellness platforms can be our virtual friend, counsellor or even a guide so that you won't feel like you are alone in this.

Posted: May 2020

Blockchain and Drug Supply Assurance in the Coronavirus Era

Ben Taylor, Founder and CEO, LedgerDomain

Over the past two years, our team at LedgerDomain has been working on bringing the drug supply chain out of the digital dark ages and into a secure real-time mode with blockchain. With the rise of COVID-19, need for real-time drug supply chain assurance has never been more pressing. While healthcare leaders and front-line workers rally together and fight this disease, we believe that a blockchain-based solution capable of tracking therapeutics, test kits, vaccines, and ventilators is necessary to accelerate their efforts to protect the public.

As part of a peer-reviewed study commissioned by the US FDA and published in Blockchain in Healthcare Today, LedgerDomain and UCLA Health joined forces to deploy and test BRUINchain, a last-mile blockchain-driven solution used by real caregivers to help deliver lifesaving medications. The study is among the first of its kind to reveal exactly how blockchain could save pharmacies billions of dollars in labor and safety stock costs alone. In this post I’d like to reflect on the key takeaways from the study and how we can map them onto the new health landscape.

Background on BRUINchain is available here.

Current State of Pharmaceutical Supply Chain

In today’s pharmaceutical supply chain, each transacting party typically manages its own database systems. These private databases allow each party to minimize external security threats while maximizing internal data consistency. However, this also means that there’s no shared global system of record representing the single source of truth describing the flow of items through the pharmaceutical supply chain. This leaves the supply chain as a whole more vulnerable to common attack vectors such as man-in-the-middle or spoofing.

Why Blockchain for Pharmaceutical Supply Chain?

In three years, under the Drug Supply Chain Security Act (DSCSA), the US pharmaceutical supply chain will be brought together by an electronic, interoperable system to identify and trace prescription drugs as they're distributed throughout the country. One of the core requirements of the DSCSA is that prescription medications must have a unique product identifier, which takes the form of a 2D barcode.

We realized that these federally mandated barcodes could be the foundational information building block for a common data model. Combined with blockchain, this could enable a system of record that would lessen the need to trade data integrity and privacy for global visibility and interpretability. In this way, blockchain can be a source of universal truth for hundreds of pharmaceutical and biotech enterprises and their vendors to work collaboratively and communicate with hundreds of wholesalers and tens of thousands of dispensers.

The BRUINchain Pilot Application

The keystone of our study was BRUINchain, a blockchain-based mobile solution and notification system designed to track and trace changes in custody of drug within a dispenser organization using FDA-stipulated barcodes. By combining blockchain with commercial off-the-shelf technology, BRUINchain makes it possible to track and verify drugs in a busy hospital or neighborhood pharmacy.

From the receiving bay to patient administration, caregivers scanned unique 2D drug barcodes using the BRUINchain mobile app. During their journey, drugs passed a series of checks until they were administered to the patient. New barcodes were routed to a trading partner for verification, and the drug was held back from being administered. At any time, the prescriber could view the progress of the drug through the pharmacy into the clinic.

BRUINchain Learnings and Outcomes

The BRUINchain pilot provided us with important insights into what a larger implementation of a DSCSA verification system would look like. It also validated the use of commercial off-the-shelf technology in a pharmacy that relies heavily on legacy systems. Barcode scanning was nearly 100% effective with commercial off-the-shelf technology. Drugs could be tracked at a highly granular level. The system was able to track expiration dates, verify barcodes, and make it easier for pharmacists to inspect and report problems.

During the study, we found that the rollout costs for DSCSA compliance could be massively reduced by a real-time blockchain system – a $183 million annual savings to dispensers in the United States, as well as a major bulwark against bad or fraudulent transactions. Real-time verification would also minimize the amount of safety stock that dispensers need to retain in the event of potential quarantine events, freeing up $20 billion in inventory.

Blockchain and COVID-19

So what does this mean in the coronavirus era? The unique identifiers mandated by DSCSA were essential to our pilot, but many types of medical supplies lack unique identifiers. We’ve heard again and again from industry stakeholders that the value provided by a blockchain leveraging these unique identifiers exceeds the implementation cost of unique 2D barcodes by an order of magnitude.

With that in mind, blockchain can play a role in three key areas. The first leverages existing unique identifiers on products for real-time track-and-trace solutions like BRUINchain. The second leverages unique identifiers for people, such as Social Security numbers, to provide patients, doctors, and health authorities with real-time updates. The third involves using blockchain in the absence of unique identifiers to power secure and private notifications related to issues at the lot or product level, such as recalls or expiry date extensions.

From the need for improved public hygiene to more robust track-and-trace systems, we will emerge from COVID-19 with some hard-earned lessons. As we rethink healthcare and global supply chain security in the United States and around the world, we have the opportunity to create new tools and systems to empower healthcare providers and patient. Not just against COVID-19, but in all areas of healthcare.

Posted: May 2020