Literature Review – Blockchain Applications in Healthcare

Introduction

Blockchain, a form of distributed ledger technology, records transactions across a network of nodes so that each entry is time-stamped, cryptographically linked to the one before it, and difficult to alter after the fact. Since interest moved beyond cryptocurrency around 2016, health informatics researchers have proposed the technology as a remedy for several persistent problems in the sector: fragmented records, weak audit trails, counterfeit medicines, and limited patient control over personal information (Kuo et al., 2017). The proposition carries particular resonance in a health system such as Australia’s, where clinical data is dispersed across public hospitals, private practices, pathology providers, and the national My Health Record, and where interoperability remains a central objective of the Australian Digital Health Agency (ADHA, 2023).

This review synthesises the peer-reviewed and grey literature on blockchain applications in healthcare. It is organised around the application domains that recur across the sources, appraises the maturity of the underlying evidence, and considers the implications for Australian digital health specifically. The aim is not to advocate for the technology but to separate demonstrated capability from projection, and to identify where the evidence base remains thin. Scope is confined to health service delivery, records management, the medicine supply chain, and clinical research, excluding cryptocurrency and general enterprise uses.

Search strategy

Sources were identified through structured searches of PubMed, Scopus, and IEEE Xplore for the period 2016 to 2024, combining the terms “blockchain” or “distributed ledger” with “health”, “electronic health record”, “supply chain”, “consent”, and “clinical trial”. Peer-reviewed reviews and primary studies published in English were prioritised, supplemented by authoritative grey literature from Australian bodies, including CSIRO’s Data61 and the ADHA. After screening titles and abstracts for relevance, a focused set of frequently cited works was retained to represent each theme. The review is narrative rather than exhaustively systematic; the principal studies informing it are summarised in Table 1.

Table 1: Summary of key studies on blockchain applications in healthcare

Electronic Health Records and Interoperability

The most heavily represented application in the literature is the use of blockchain to coordinate access to electronic health records. Early proof-of-concept systems such as MedRec used a ledger to manage permissions and audit trails rather than to store clinical data itself, with the chain holding pointers to records that remain in providers’ existing databases (Azaria et al., 2016). This pattern, on-chain access logic paired with off-chain data storage, recurs across later designs because writing bulk clinical data to an immutable ledger is neither efficient nor compatible with privacy law (Kuo et al., 2017).

Subsequent work situates blockchain within, rather than against, existing interoperability standards. Zhang et al. (2018) built FHIRChain to exchange clinical data structured to the HL7 FHIR standard, arguing that a shared ledger can provide a tamper-evident index across organisations without forcing them onto a single database. Gordon and Catalini (2018) frame the same capability as a shift towards patient-driven interoperability, in which the individual, rather than the institution, mediates who may view their record. For the Australian setting, where My Health Record already provides a national summary layer but clinician trust and consistent use have been uneven, this literature suggests that blockchain is better understood as a possible access-control and consent-audit mechanism than as a replacement for the record itself.

Supply Chain and Pharmaceutical Provenance

The second consistent theme is provenance in the pharmaceutical supply chain. Counterfeit and substandard medicines are a substantial global problem, and Mackey and Nayyar (2017) review digital track-and-trace technologies, blockchain among them, as tools for verifying the chain of custody from manufacturer to dispensary. A ledger shared between manufacturers, wholesalers and pharmacies can record each transfer of a serialised product, so that a break or a falsified entry becomes detectable rather than invisible, producing a single, tamper-evident record that no participant can quietly rewrite.

The Australian relevance is qualified. Domestic supply is tightly regulated, and the Therapeutic Goods Administration already governs the sourcing and labelling of therapeutic goods, which limits the counterfeit risk that motivates much of the international work (TGA, 2021). The stronger local case lies in imported product lines, cold-chain assurance for biologics, and recall efficiency, where provenance data captured at each handover could shorten the time taken to isolate an affected batch. Even here, the literature is candid that a ledger only records what is entered into it: physical verification at the point of manufacture remains the weak link, and value accrues only when most participants in the chain adopt the same system (Mackey & Nayyar, 2017).

Consent and Data Sovereignty

A third cluster of studies addresses consent management and patient control over data. Smart contracts, self-executing rules stored on the ledger, are proposed as a means of encoding granular and revocable consent, so that a patient may authorise a particular researcher or clinician to access a defined dataset for a defined purpose, with every grant and withdrawal logged immutably (Kuo et al., 2017; Agbo et al., 2019). Advocates present this as a route to genuine data sovereignty, in which control shifts from the custodial institution to the individual.

The Australian privacy framework both motivates and complicates this vision. The Privacy Act 1988 and the Australian Privacy Principles require that personal information be handled transparently and that individuals be able to seek correction of their records (OAIC, 2022). A transparent, patient-controlled consent log aligns with these principles, yet the immutability that gives the ledger its integrity sits awkwardly with the right to have information corrected or erased. The literature has not resolved this tension, and most designs sidestep it by keeping identifiable data off-chain and recording only consent events and hashed references on the ledger. Data sovereignty in the Australian context also carries a collective dimension, since Indigenous data governance frameworks assert community, not merely individual, authority over health information, a consideration largely absent from the international engineering literature.

Clinical Trials and Credentialing

Blockchain has also been proposed for the integrity of clinical research and for the verification of professional credentials. Benchoufi and Ravaud (2017) argue that time-stamping trial protocols and participant consent on a ledger can protect against retrospective alteration, selective outcome reporting and consent disputes, thereby strengthening reproducibility. Because the record of what was agreed, and when, cannot be revised after the fact, the approach targets well-documented weaknesses in the trial evidence base rather than a purely technical inconvenience.

A related, smaller strand concerns credentialing. A shared ledger of verified qualifications and registration status could allow hospitals to confirm a practitioner’s credentials quickly across jurisdictions, reducing reliance on manual checks and forged documents (Agbo et al., 2019). In Australia, where the Australian Health Practitioner Regulation Agency already maintains a national register of registered health practitioners, the incremental benefit of a ledger is modest for domestic verification but potentially greater for cross-border recognition, and here too the literature describes a plausible mechanism more often than a deployed and evaluated system.

Barriers to Adoption: Scalability, Governance and Privacy Law

Across every application domain, the reviewed studies converge on a common set of barriers. The first is scalability. Public, permissionless ledgers process transactions slowly and consume considerable energy, which is unsuited to high-volume clinical settings; most healthcare proposals therefore adopt permissioned ledgers, trading some decentralisation for throughput (Kuo et al., 2017; Zhang et al., 2018). The second is governance. A shared ledger requires agreement on who operates the nodes, who may write to the chain, and how the rules are changed, questions that are organisational and political rather than technical. The CSIRO Data61 analysis of systems using blockchain and smart contracts stresses that these governance and design decisions, rather than the cryptography, determine whether such systems are trustworthy and fit for purpose (Staples et al., 2017).

The third barrier is legal. The immutability that underpins the ledger’s integrity conflicts with data-protection rights to correction and erasure, and the status of a distributed, multi-party record under existing privacy law is not settled (OAIC, 2022). Interoperability with legacy hospital systems, the cost of migration, and the absence of agreed standards compound these obstacles. None of these barriers is presented in the literature as insurmountable, but together they explain why enthusiasm has outpaced deployment.

Maturity of the Evidence

Two systematic reviews provide the clearest read on how far the field has actually progressed. Holbl et al. (2018) screened the published record and found that the overwhelming majority of contributions were conceptual papers, prototypes or proofs of concept, with very few evaluated in real clinical environments. Agbo et al. (2019) reached a similar conclusion, reporting broad interest across records, supply chain and trials but limited scalability testing and almost no measurement of clinical or economic outcomes. As Table 1 shows, the studies that define the field are dominated by design papers and reviews rather than controlled evaluations or sustained implementations. The evidence base, in short, is wide but shallow: many domains have a demonstrated mechanism, few have a demonstrated result.

Synthesis and Gaps

Read together, the literature supports three broad conclusions. First, the credible applications are those in which the ledger performs a narrow, well-defined role, indexing records, logging consent, or recording custody, while sensitive data and clinical work remain outside the chain. Second, the barriers that matter most are organisational and legal rather than cryptographic: governance, standards and the fit with privacy law. Third, the balance between promise and proof still tilts heavily towards promise. Figure 1 maps the four application domains identified in this review and the cross-cutting barriers common to them.

Several gaps are consistent across the sources. Real-world deployments are rare, so claims about performance rest largely on prototypes tested under favourable conditions. Economic evaluation is almost absent, leaving the cost of building and running these systems uncompared with simpler alternatives such as standard databases with strong audit logging. Governance is under-theorised relative to its practical importance, and Australian-specific empirical work is scarce, with most studies drawn from North American, European and East Asian settings. The result is a body of literature rich in architecture and thin in evidence of benefit.

Implications for Australian Digital Health

For Australian digital health, the literature counsels targeted interest rather than wholesale adoption. The national reform agenda already prioritises interoperability through the ADHA’s connected-care strategy and the progressive adoption of FHIR-based data exchange (ADHA, 2023); blockchain is best considered as one possible mechanism within that agenda, not a substitute for it. The applications most defensible on current evidence are narrow: provenance and recall assurance for higher-risk imported medicines alongside existing TGA controls, and tamper-evident consent and access logging that could complement My Health Record without replacing it.

Two conditions should temper any pilot. First, the tension between ledger immutability and the correction and erasure rights protected by the Privacy Act 1988 must be resolved in design, by keeping identifiable data off-chain, before deployment rather than after (OAIC, 2022). Second, the CSIRO Data61 emphasis on governance implies that any Australian implementation would need a clear operator model and accountability structure agreed among participating jurisdictions and providers (Staples et al., 2017). Given the shallow evidence base, the prudent course is small, well-evaluated pilots with explicit comparison against conventional database approaches, so that adoption follows demonstrated benefit rather than expectation.

Conclusion

The literature on blockchain in healthcare describes a technology of genuine but bounded promise. Its most credible applications, coordinating record access, assuring supply-chain provenance, logging consent, and protecting trial integrity, share a common shape: the ledger performs a narrow integrity or access function while sensitive data and clinical judgement remain outside it. Against this promise stands a candid record of immaturity. The field is dominated by prototypes and reviews, real deployments and economic evaluations are rare, and the decisive obstacles are matters of governance, standards and privacy law rather than cryptography. For Australia, whose digital health priorities centre on interoperability and on the trusted stewardship of data under the Privacy Act 1988, the sensible posture is neither dismissal nor enthusiasm but disciplined experimentation: targeted pilots, rigorous comparison with simpler alternatives, and adoption reserved for the applications that can show, rather than assert, a benefit.

References

Agbo, C. C., Mahmoud, Q. H., & Eklund, J. M. (2019). Blockchain technology in healthcare: A systematic review. Healthcare, 7(2), 56.

Australian Digital Health Agency. (2023). National Digital Health Strategy 2023-2028. Australian Digital Health Agency.

Azaria, A., Ekblaw, A., Vieira, T., & Lippman, A. (2016). MedRec: Using blockchain for medical data access and permission management. In Proceedings of the 2nd International Conference on Open and Big Data (pp. 25-30). IEEE.

Benchoufi, M., & Ravaud, P. (2017). Blockchain technology for improving clinical research quality. Trials, 18(1), 335.

Gordon, W. J., & Catalini, C. (2018). Blockchain technology for healthcare: Facilitating the transition to patient-driven interoperability. Computational and Structural Biotechnology Journal, 16, 224-230.

Holbl, M., Kompara, M., Kamisalic, A., & Nemec Zlatolas, L. (2018). A systematic review of the use of blockchain in healthcare. Symmetry, 10(10), 470.

Kuo, T.-T., Kim, H.-E., & Ohno-Machado, L. (2017). Blockchain distributed ledger technologies for biomedical and health care applications. Journal of the American Medical Informatics Association, 24(6), 1211-1220.

Mackey, T. K., & Nayyar, G. (2017). A review of existing and emerging digital technologies to combat the global trade in fake medicines. Expert Opinion on Drug Safety, 16(5), 587-602.

Office of the Australian Information Commissioner. (2022). Australian Privacy Principles guidelines. OAIC.

Staples, M., Chen, S., Falamaki, S., Ponomarev, A., Rimba, P., Tran, A. B., Weber, I., Xu, X., & Zhu, J. (2017). Risks and opportunities for systems using blockchain and smart contracts. Data61 (CSIRO).

Therapeutic Goods Administration. (2021). Counterfeit and unapproved therapeutic goods in the supply chain. Therapeutic Goods Administration.

Zhang, P., White, J., Schmidt, D. C., Lenz, G., & Rosenbloom, S. T. (2018). FHIRChain: Applying blockchain to securely and scalably share clinical data. Computational and Structural Biotechnology Journal, 16, 267-278.