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Electronic signature and digital signature

In short

An electronic signature is any electronic data a person associates with a document with the intent to sign it; a digital signature is a cryptographic technique, based on certificates, that makes it possible to verify who signed and that the document has not changed. Each country decides which type of signature has which legal effect. In health care it matters for prescriptions, certificates, reports and documents exchanged between systems.

Type
Concept
Steward
No single steward: general concept or generic technology
Reviewed
October 25, 2026

Explanation

What it is

  • Electronic signature: a broad legal term. The eIDAS Regulation defines it as data in electronic form which is attached to or logically associated with other data in electronic form and which is used by the signatory to sign.
  • Digital signature: in this glossary, a technical term. It uses public-key cryptography and certificates to provide authentication, message integrity and non-repudiation, the three features HHS cited when adopting a digital signature standard in 2026.
JurisdictionLawLevels
European UnioneIDAS (Regulation (EU) No 910/2014, amended by Regulation (EU) 2024/1183)Simple, advanced and qualified; a qualified signature has the equivalent legal effect of a handwritten signature (Art. 25(2))
BrazilLaw 14,063/2020Simple, advanced and qualified; the qualified level uses an ICP-Brasil digital certificate
United StatesESIGN Act (15 U.S.C. 7001)A signature may not be denied legal effect solely because it is electronic, in interstate or foreign commerce transactions
CanadaPIPEDA, Part 2"Secure electronic signature" prescribed by regulation for documents under federal laws

Uses in health care

  • Brazil: electronic prescriptions for controlled medicines and electronic medical certificates are only valid with a qualified signature (Art. 13 of Law 14,063); other documents by health professionals require an advanced or qualified signature (Art. 14). Those minimums do not apply to internal hospital acts.
  • United States, controlled substance prescriptions: the DEA requires the application to authenticate the practitioner with two of three factors (something they know, something they are, something they have) in order to sign (21 CFR 1311.115).
  • United States, HIPAA: the 2026 final rule on claims attachments requires that, if a provider signs those attachments electronically, it follows the HL7 CDA R2 Digital Signatures and Delegation of Rights guide. Compliance is required by 26 May 2028.

Common misconceptions

  • Using "electronic signature" and "digital signature" as synonyms. The first is a broad legal category; the second, a cryptographic technique.
  • Believing a scanned image of a signature provides technical assurance. In the 2026 attachments rule, HHS noted that such forms generally do not provide robust support for identity verification, authentication or assertion of signer intent.
  • Assuming one level fits everything. Brazil requires a qualified signature for certain prescriptions but accepts an advanced one for other health documents.
  • Confusing authentication with signing. Logging in identifies the user; a signature links a person to a specific document.

Usage examples

  1. In the European Union, a qualified electronic signature has the equivalent legal effect of a handwritten signature (eIDAS, Art. 25(2)).

  2. In Brazil, an electronic prescription for a controlled medicine is only valid with the professional's qualified electronic signature (Law 14,063, Art. 13).

  3. In the United States, signing an electronic prescription for a controlled substance requires two-factor authentication under DEA rules (21 CFR 1311.115).

  4. The 2026 HIPAA rule on claims attachments adopted the HL7 CDA R2 Digital Signatures and Delegation of Rights guide for electronic signatures on those attachments.

  5. In Canada, PIPEDA Part 2 defines the "secure electronic signature" for documents governed by federal laws.

  6. In the United States, the 2000 ESIGN Act prevents a signature from being denied legal effect solely because it is electronic, in interstate or foreign commerce transactions.

Relation to other terms

Relies on0

This term does not rely on other glossary terms.

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No glossary term depends on this one.

Sources

  1. EUR-Lex — Regulation (EU) No 910/2014 (eIDAS), consolidated text of 18.10.2024eur-lex.europa.eu
  2. Planalto — Lei nº 14.063, de 23 de setembro de 2020 (assinaturas eletrônicas)planalto.gov.br
  3. 15 U.S.C. 7001 — Electronic Signatures in Global and National Commerce Act (govinfo)govinfo.gov
  4. eCFR — 21 CFR Part 1311, Requirements for Electronic Orders and Prescriptionsecfr.gov
  5. Federal Register — Administrative Simplification; Adoption of Standards for Health Care Claims Attachments Transactions and Electronic Signatures (91 FR 14350, 24 March 2026)federalregister.gov
  6. Justice Laws Website — Personal Information Protection and Electronic Documents Act, Part 2 (Canada)laws-lois.justice.gc.ca
Health interoperability glossary