Series 6 · Signatures by sector · 6.2

Health: signing where lives are at stake.

Informed consent, medical records and prescriptions.

October 20266 min read

In few places does a signature carry as much weight as in health care. An informed consent authorizes an intervention on one's own body. A prescription authorizes a medication to be dispensed. A medical record captures decisions that may be reviewed decades later. And all of this happens in an environment of emergencies, shifts, many professionals and specially protected data.

Three documents, three logics

DocumentWho signsWhat needs to be proven
Informed consentThe patient or their representative, and the professional who provides the information.What was explained, in which version, how much time there was to decide, and who did the explaining.
PrescriptionThe licensed professional.Their identity, their current license, and that the prescription was neither altered nor reused.
Medical recordEach professional who records an act.Authorship of each entry, its time, and that nothing was deleted or changed without a trace.

Informed consent

A consent signed on a tablet, with no record of what was shown, proves less than it seems. What law and ethics protect is not the signature but the informed decision. That is why the evidence must include the exact version of the document, the risks explained, the time that elapsed between the information and the signature, and the identity of the person who provided the information. When the patient cannot sign, the representative and their relationship to the patient must be documented.

In health care, the signature does not protect the document. It protects a decision about one's own body.

The medical record

The medical record is a living document to which many professionals add entries over the years. Its integrity depends on each entry being signed by its author at the moment it is written, and on corrections being added as new entries, without deleting earlier ones. It is the same principle as the electronic case file: an ordered history that can be retold.

What sets the sector apart

  • Urgency. The signature cannot hold up care. Procedures are needed for signing afterward, with a record of why.
  • Many hands. Shifts, residents and teams. Each person signs their own work, with clear roles.
  • Licensing. It is not enough to know who is signing: you need to know whether they are licensed for that act.
  • Sensitive data. Health data receive heightened protection under almost every personal data protection law. The evidence must preserve the proof without exposing more than necessary.
  • Long retention periods. Medical records are kept for many years, which requires long term signatures.
An everyday case

A patient signs the consent for a scheduled surgery. The system records the version of the document, the time at which the physician explained the risks, and the time of the signature, two days later. If the patient later asks what they were told, the answer is complete and verifiable.

Key points

Three logics coexist in health care: informed consent, which protects a decision; the prescription, which requires a license; and the medical record, which accumulates authorship over time. All three call for precise evidence, respect for sensitive data, and signatures that last as long as the document.

Sources

  1. Regulation (EU) 2016/679, General Data Protection Regulation, Articles 4 and 7
  2. ETSI EN 319 142, PDF Advanced Electronic Signatures (PAdES)
  3. ISO 15489 1:2016, Records management

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