Immutability Is Not Trust: Recourse, Reversibility, and the Patient at the End of the Chain

Immutability is not trust

Authors

  • Nuno Galante Valério, MsC in Pharmaceutical Science Head of Innovation, R&D Quality, Merck Healthcare KGaA, Darmstadt, Germany https://orcid.org/0009-0009-3361-642X

Keywords:

Accountability, immutability, patient safety, recourse, reversibility

Abstract

Blockchain promises records that can never be changed, and in healthcare this is often sold as a way to make data trustworthy. This piece argues that an unchangeable record solves only one part of the problem. It proves nobody altered the record after it was written. It does not prove the record was correct, say who is responsible for it, or let a patient challenge a decision that turns out to be wrong. Using data-integrity rules already standard in regulated medicine, the author argues that correcting mistakes and seeking a remedy are essential to the trust that blockchain in healthcare is meant to deliver.

  • An unchangeable record proves only that data was not altered later, not that it was right to begin with.
  • Trustworthy medical systems must let errors be corrected while keeping a permanent, attributed trail of each correction.
  • Europe's right to erasure and the EU AI Act both assume records can change, and decisions can be contested.
  • A permanent record of a wrong decision, that nobody can appeal, protects the record, but it does not protect the patient.

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References

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2. Medicines and Healthcare Products Regulatory Agency. “GXP” data

integrity guidance and definitions. London: MHRA; 2018.

3. European Parliament and Council of the European Union. Regulation

(EU) 2016/679 (General Data Protection Regulation), Article 17

(Right to erasure). Off J Eur Union. 2016;L119:1–88.

4. European Parliament and Council of the European Union.

Regulation (EU) 2024/1689 (Artificial Intelligence Act), Article 14.

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good clinical practice. Geneva: ICH; 2025.

Published

2026-08-31

How to Cite

Galante Lourenco Goncalves Valério, N. F. (2026). Immutability Is Not Trust: Recourse, Reversibility, and the Patient at the End of the Chain: Immutability is not trust. Blockchain in Healthcare Today, 9(2). Retrieved from https://www.blockchainhealthcaretoday.com/index.php/journal/article/view/518

Issue

Section

Opinions/Perspectives/Point of View