“At least 1 in 10 medicines in low- and middle-income countries are substandard or falsified.” That line comes from the fact sheet on substandard and falsified medical products of the World Health Organization, dated 3 December 2024, and it is the strongest argument anyone selling blockchain in healthcare has. If every box of pills could be followed from the factory to the patient on a ledger nobody can rewrite, the reasoning goes, fake drugs would have nowhere to hide.
The second promise is about your medical file. Your records are split between a family doctor, a hospital, a lab and an insurer, and you rarely see all of them. A blockchain, its supporters say, could give patients one complete history and let them decide who reads it.
Both ideas have been tested for ten years now, by MIT researchers, the Estonian state, the US Food and Drug Administration and the largest American drug wholesalers. This lesson looks at what those tests actually built, what they found and what was left standing in October 2026. The short version: the serious designs never put medical data on a chain, and the systems that protect patients from fake drugs today in the US and Europe are mostly not blockchains at all.
Why hospitals and drug makers looked at ledgers
On paper, health looks made for a shared ledger. Data sits in many places that do not trust each other, and patients have little view of who opened their file. Medicines, for their part, change hands many times between a plant and a pharmacy shelf, with criminals trying to slip copies into the chain.
Our overview of blockchain use cases gives the one-paragraph version of health next to banking, logistics and land registries. Here we go further into the two cases health is known for. If you need the basics first, our guide to what a blockchain is explains blocks and nodes, and the difference between an open network such as Ethereum and the permissioned ledgers that hospitals and drug companies actually test is set out in public versus private blockchains.
The previous lesson of this path, on blockchain voting and why cryptographers resist it, met a problem that comes back here: a ledger can make a record hard to change, but it cannot make the information true when it is entered. That gap decides most of what follows.
Blockchain and medical records: the file stays in the hospital
No serious project puts an X-ray or a diagnosis on a blockchain. There are two plain reasons. A chain is copied to every node, so the data would be duplicated across machines run by other parties. And a chain is built so that nothing can be deleted, which is the opposite of what privacy law asks for health data.
What goes on the chain: permissions and fingerprints
The designs that hold up keep the record where it already lives, in the hospital or clinic database, and write only two kinds of small entries to the ledger. The first is a permission: patient A allows clinic B to read records of type C until a given date. The second is a fingerprint of the document, called a hash.
A hash is a short string computed from a file. Change one comma in the file and the hash changes completely, so anyone holding the file can check it against the hash on the chain and see whether it was altered. The hash does not let you rebuild the file. Our guide to what cryptography is shows how hash functions work, and why a blockchain is immutable explains why a record written into a block is so hard to change afterwards.
So the chain becomes an index and an audit log. It tells you that a document exists, where it is held, who may read it and who did read it. The document itself never leaves the hospital system.
MedRec, the MIT prototype of 2016
The best-known design came from the MIT Media Lab. The MedRec paper by Asaph Azaria, Ariel Ekblaw, Thiago Vieira and Andrew Lippman was presented at an IEEE conference on open and big data in 2016. It promised patients a complete, permanent log of their records across providers, through a modular design that plugs into the storage hospitals already use.
In MedRec, patients set access rules through smart contracts on an Ethereum network. A July 2018 technical brief for the IEEE Blockchain Initiative, written by Andrew Lippman and three MIT students about a newer version of the system, explains the mechanics: each provider runs a program that grants access to its own databases under the rules of those contracts, and the patient’s app fetches the data from there. The brief says the team tested it with databases supplied by Beth Israel Deaconess Medical Center, in Massachusetts. The 2016 paper had proposed an unusual reward: researchers and public health bodies would secure the network by proof-of-work mining and be paid with aggregated, anonymised data instead of coins.
The authors were clear about its stage: the paper presents a working prototype “prior to field tests”. In August 2016 the US Office of the National Coordinator for Health IT (ONC) named winners of a blockchain challenge from 70 submissions, according to ExecutiveBiz on 30 August 2016, and MIT and Beth Israel Deaconess were among them. We found no large hospital deployment of MedRec since. It remains a research prototype that shaped how others think about the problem.
Estonia: a national health record with a tamper-evident log
Estonia is the country most often cited. On 8 March 2016, e-Estonia reported that the local company Guardtime would protect patient data with its blockchain technology, working with the national e-Health Authority. The article quoted Mike Gault, Guardtime’s chief executive: “Every update to healthcare records and every access to healthcare records is registered in the blockchain.”
Two details matter. The health records themselves stay in a central database; SiliconANGLE reported on 3 March 2016 that the Estonian eHealth Foundation would integrate Guardtime’s KSI into its Oracle database engine, home to over a million healthcare records. And KSI, short for Keyless Signature Infrastructure, is not a blockchain in the Bitcoin sense. Its designers describe it in a 2013 paper by Ahto Buldas, Andres Kroonmaa and Risto Laanoja as a system that builds hash trees every second and publishes their root hashes. There is no mining, no coin and no open network of strangers. It is a hash-based way to prove that a log entry was not changed after the fact, which its vendor markets as a blockchain.
That is a useful tool, and it fits the pointer-and-fingerprint model exactly: the chain-like part guards the audit trail, not the medical data. What we could not confirm is whether the system still runs on the Estonian health records in 2026. The sources we found describe the 2016 announcement; none from 2024 to 2026 confirms its current use.
What GDPR says: a hash is still personal data
In Europe, the General Data Protection Regulation applies to every ledger, public or private. The European Data Protection Board, which groups the EU data protection authorities, adopted draft guidelines 02/2025 on blockchain on 8 April 2025. Their executive summary was blunt: “As a general rule, storing personal data on a blockchain should be avoided, if this conflicts with data protection principles.” After a public consultation, the Board adopted version 2.0 on 7 July 2026 and announced it the next day. The final text drops that summary sentence but keeps the substance: because erasing or correcting clear, encrypted or hashed data on a chain is “technically demanding and often difficult”, it is “not advisable” to record personal data in those forms on a blockchain, and it should be stored off chain instead.
The guidelines also close the obvious loophole. Putting only a hash on chain does not take you out of GDPR: both the draft and the final version say the hash itself will also be considered personal data, and that a plain unsalted or unkeyed hash is generally not enough protection on a public chain. The rights to erasure and rectification must be built in by design, which is hard once anything derived from a person sits on an append-only ledger. Where processing is likely to create a high risk for people, which health data usually does, a data protection impact assessment is mandatory, and the guidelines want the blockchain risks included in it.
France’s regulator, the CNIL, reached the same conclusion earlier, in a note of 20 September 2018: do not store personal data in clear on a chain, and first ask whether a blockchain is needed at all. For a health project, that question usually decides it.
HIPAA in the United States
In the US, health data held by doctors, hospitals and insurers falls under HIPAA, the 1996 law whose Privacy Rule governs how “protected health information” is used and disclosed. According to a CDC summary updated in September 2024, it covers health plans, healthcare clearinghouses and every provider that transmits health information electronically, plus the business associates that handle data for them.
HIPAA does not mention blockchains, and it does not need to. A clinic that writes patient-linked entries to a ledger shared with other companies still has to control who sees that information. The design answer is the same as in Europe: keep the record in the covered entity’s systems and put as little as possible, ideally nothing that identifies a patient, on the chain.
Can a blockchain stop fake medicines?
This is where the problem is undeniable. The question is whether a ledger is the tool that solves it.
The WHO figures and what they mean
The WHO fact sheet of 3 December 2024 gives three numbers that are quoted everywhere. At least 1 in 10 medicines in low- and middle-income countries is substandard or falsified. Countries spend an estimated $30.5 billion a year on such products. And the damage goes beyond money: the WHO lists treatment failure, death and a higher risk of antimicrobial resistance.
The two words do not mean the same thing. A substandard product is a real medicine that fails quality standards, often through poor manufacturing or storage. A falsified product deliberately misrepresents its identity, composition or source: that is the criminal fake. The 1-in-10 figure covers both, and a blockchain tracking boxes can only ever help with the second.
The regional picture comes from an older WHO count. In November 2017, the WHO said its global surveillance system had received about 1,500 reports of substandard or falsified products since 2013, as reported by Intellectual Property Watch at the time. Sub-Saharan Africa accounted for 42% of those reports, the Americas and Europe for 21% each, and antimalarials and antibiotics were the products most often reported. These are shares of reports, not of fakes: they reflect where checks are made and where reporting works. The WHO itself called the reports “just a small fraction of the total problem”.
| Figure | Value | Date | Source |
|---|---|---|---|
| Medicines substandard or falsified in low- and middle-income countries | at least 1 in 10 | fact sheet of 3 Dec 2024 | WHO |
| Yearly spending on substandard and falsified products | $30.5 billion | fact sheet of 3 Dec 2024 | WHO |
| Reports received by WHO surveillance, 2013 to 2017 | about 1,500 | 28 Nov 2017 | WHO, via IP-Watch |
| Share of those reports from sub-Saharan Africa | 42% | 28 Nov 2017 | WHO, via IP-Watch |
| Share from the Americas / from Europe | 21% / 21% | 28 Nov 2017 | WHO, via IP-Watch |
| FDA DSCSA pilot projects, blockchain or ledger in the title | 20 pilots, 5 so named | program concluded (page of 2024) | FDA |
| EU safety features compulsory on prescription packs | from 9 Feb 2019 | Delegated Regulation 2016/161 | European Commission |
| DSCSA stabilisation period | 27 Nov 2023 to 27 Nov 2024 | FDA statement of 30 Aug 2023 | FDA |
| DSCSA exemption for small dispensers | until 27 Nov 2027 | page current as of 26 Aug 2026 | FDA |
The WHO fact sheet itself lists blockchain among technological tools that can help, next to handheld spectrometers, mobile apps and track-and-trace systems. It is one option on a list, not the answer.
Europe already tracks every box, without a blockchain
The European Union chose a different route. Under the Falsified Medicines Directive (2011/62/EU), published on 1 July 2011, prescription medicines must carry two safety features on the outer pack: a unique identifier and an anti-tampering device. Delegated Regulation (EU) 2016/161 requires the identifier to be encoded in a 2D barcode of the Data Matrix type, and the verification system it sets up has applied since 9 February 2019.
In practice, each pack’s code is registered by the manufacturer and checked when the pharmacy scans the box before handing it over; a code that is unknown or already used raises an alert. That is a verification system built on central repositories with strict rules on who may write to them. No blockchain is involved.
The United States: the DSCSA and its long countdown
In the US, the Drug Supply Chain Security Act of 2013 set a ten-year path to electronic, package-level tracing of prescription drugs between manufacturers, wholesalers and pharmacies. The full requirements were due on 27 November 2023. In a statement of 30 August 2023, the FDA gave the industry a one-year stabilisation period until 27 November 2024, while warning that the extra year was no reason to delay compliance work.
Exemptions followed for different groups of trading partners. The latest, on a FDA page current as of 26 August 2026, frees small dispensers from certain requirements until 27 November 2027. A small dispenser here is one whose owning company has 25 or fewer full-time employees licensed as pharmacists or qualified as pharmacy technicians, counted as of 27 November 2026. So, as of October 2026, the American system is still being phased in, thirteen years after the law passed.
The law does not require any particular technology. Before choosing standards, the FDA ran a pilot project program with 20 projects. Five had blockchain or a ledger in their title: an IBM, KPMG, Merck and Walmart “DSCSA Blockchain Interoperability Pilot”, a UCLA Health project with LedgerDomain, a TraceLink project on distributed ledgers, an IDLogiq project with a transaction ledger, and the MediLedger DSCSA Pilot. The FDA says the program has concluded and that selection is not “an endorsement of a particular technology, system or other approach used in the pilots”.
MediLedger: a large blockchain pilot, and where it ended
MediLedger, built by the company Chronicled, ran one of the largest of these groups. When it published its pilot results, Ledger Insights reported on 17 February 2020 that its participants included all three major US wholesalers (AmerisourceBergen, McKesson and Cardinal Health), seven of the ten largest drug makers, Walgreens, Walmart, FedEx and the standards body GS1 US. The three wholesalers alone account for 94% of US drug sales, according to the same article. The goal was to trace a medicine from the point of dispensing back to the manufacturer.
The piece that found real users was more modest: a Product Verification System, launched in 2019, that helps trading partners and regulators meet the DSCSA rules on verifying product identifiers. On 14 June 2023, the National Association of Boards of Pharmacy (NABP) announced that it had bought that system from Chronicled to run it inside its own Pulse platform for DSCSA compliance. Chronicled said it would focus its blockchain-powered MediLedger Network on contracts and chargebacks, the billing side of the drug trade. Whether the verification service still relies on a blockchain under NABP in 2026 is not something we could establish.
That arc is typical. A ledger helped competing firms agree on shared data without handing it to one of them. Then the useful service was bought by a trade body, which is a central operator, and the story of a decentralised supply chain became a story about a well-run database.
The limits of blockchain in healthcare
Beyond the two cases, the same weaknesses come back in every project. Some are technical; most are about people and law.
A chain cannot see a pill
This is the decisive one. A ledger records what someone types or scans into it. If a counterfeiter copies a genuine barcode onto a fake box, or a corrupt distributor scans real codes onto bad stock, the chain faithfully records a lie. Engineers call this the oracle problem: getting reliable facts from the physical world onto a chain needs a trusted source, and that source is where the fraud happens. The same limit appears in our lesson on blockchain in supply chains.
Barcode systems share that weakness, which is why both Europe and the US pair them with tamper-evident packaging, licensed trading partners and inspections. A pharmacist who checks the seal is doing something no ledger can.
Privacy and the right to be forgotten
The second limit is legal. As the EDPB guidelines say, even hashes and wallet-style identifiers can be personal data, and the right to erasure must work by design. A permanent shared log of who accessed which patient file is itself sensitive: it can reveal that someone visited an oncologist or a psychiatrist. Projects have to encrypt, salt or keep such entries off chain, which reduces what the chain adds.
Few systems got past the pilot
The research literature agrees. A systematic review by Shaikh, Memon, Ebrahimi and Wiil, published in the journal Healthcare in May 2025, states in its abstract that adoption of blockchain in health information systems “remains limited to conceptual or proofs-of-concept”, often using simulated datasets rather than real-world data. The authors went looking for implementations with validated results and kept 82 studies.
Behind that sit practical costs: connecting a ledger to decades-old hospital systems, deciding who runs the nodes and who pays for them, and agreeing on governance when a hospital, a lab and an insurer disagree. When one trusted operator exists, such as a national health agency or a pharmacy association, a regular database with good logs usually does the job for less.
Regulators set duties, not technologies
Finally, neither the EU directive nor the DSCSA requires a blockchain. They require results: a verifiable identifier on each pack, data shared with trading partners, alerts when something is wrong. Companies were free to build that with a ledger. Most chose databases and standard messaging, and the FDA was explicit that its pilots endorsed no technology.
What this means for patients in the US and Europe
For a patient, blockchain in healthcare is mostly invisible so far. If you live in the US, the protection against fake prescription drugs in your pharmacy comes from the DSCSA, which the FDA oversees, and from licensed wholesalers and pharmacies, not from a blockchain you can check. Records held by your doctor, hospital or insurer are covered by HIPAA however they are stored; a consumer app that is neither a covered entity nor working for one falls outside it. Any app that asks you to put health records “on the blockchain” in exchange for a token deserves the same suspicion as any other crypto offer.
In Europe, the box in your hand carries a 2D code checked at the counter since 2019, and your data falls under GDPR, and the EDPB advises keeping personal data off chains. The next large change is the European Health Data Space regulation, in force since 26 March 2025: from March 2029, patient summaries and ePrescriptions are due to be exchangeable across the EU, and from March 2031 medical images, lab results and hospital discharge reports. It is a legal duty to make records travel between existing systems.
Outside these two systems, the WHO figures above show where the risk is highest, and national medicine regulators decide which verification tools are used. A blockchain can be one of them; nowhere in the sources we checked is it the main one.
What holds up in October 2026
- Medical records do not go on a blockchain. Serious designs keep them in hospital systems and log permissions or hashes, and European regulators treat even those hashes as personal data (EDPB guidelines, final version of July 2026).
- MedRec (MIT, 2016) remained a prototype, and Estonia’s 2016 health-records deal used a hash-based log its vendor calls a blockchain; its use in 2026 is not confirmed.
- Fake and substandard medicines are a real problem: at least 1 in 10 medicines in low- and middle-income countries, according to the WHO in December 2024.
- The EU (since 9 February 2019) and the US (DSCSA, phased in with exemptions to 27 November 2027) fight fakes with barcodes and databases, not blockchains.
- MediLedger ran one of the largest blockchain pilots; its verification service has been run by the NABP since its purchase in June 2023.
The next lesson of this path looks at land registries and real estate, the other field where governments have tested ledgers to protect official records.
