This document discusses the use of digital signature technology to authenticate electronic dental records and provide them with the same legal validity as conventional paper records. It examines how digital signatures can be applied to each component of the electronic dental record, which may be produced by different parties. The technology guarantees authenticity by ensuring only the genuine signer could have created the signature attached to a document. While electronic records can potentially be manipulated, principles of good faith and burden of proof mean digitally signed records are assumed authentic unless proven otherwise, matching the legal standard for paper records. Widespread use of digital signatures may soon allow full implementation of this proposal to validate electronic dental records legally.

1. LITIGATION AND LEGISLATION
Digital signature of electronic dental records
Ivan Toshio Maruoa and Hiroshi Maruoa
Curitiba, Paran, Brazil
a
Introduction: The purpose of this article is to examine the feasibility of digital signature technology to guarantee
the legal validation of electronic dental records. Methods: The possible uses of digital signature technology, the
actual use of digital signature technology to authenticate electronic dental records, the authentication of each
part of the electronic dental record, the general legal principles involved, how to digitally sign electronic dental
record files, and the limitations of this method are discussed. Results and Conclusions: It is possible to obtain
electronic dental records that carry the same legal certainty as conventional, nonelectronic records. For this
purpose, each part of the electronic dental records should be digitally signed by the author of the document.
(Am J Orthod Dentofacial Orthop 2012;141:662-5)
O
rthodontics is a dental specialty that deals with Because of the difficulty in demonstrating that elec-
many technologic resources. Two-dimensional1 tronic records represent something that really exists, their
and 3-dimensional2,3 digital photographs, 3- legal validity (ie, their integrity and authenticity) can be
dimensional digital dental casts,4,5 digital radiographs,6 questioned in a judicial or an administrative lawsuit.
computed tomography,7 3-dimensional cephalometry,8 To guarantee the authenticity of digital medical images,
and magnetic resonance imaging9 permit accurate Smith13 proposed the use of “digital signature technology.”
diagnosis, planning, and treatment-result analysis. Subsequently, Kobayashi and Furuie14 presented an algo-
Furthermore, with scanners and digital cameras, we rithm to achieve viable integrity, authenticity, and verifica-
can digitize conventional, nonelectronic records and tion on digital imaging and communications in medicine
turn them into electronic records.10 (Digital Imaging and Communications in Medicine) medi-
Replacing conventional dental records with elec- cal images, also using digital signatures.
tronic records saves office space, facilitates access to pa- The United States,15 Brazil,16 and the European
tients’ medical and dental histories, integrates health Union17 regulate the use of digital signature technology,
care information, and helps to improve the quality of because electronic contracts are becoming common.
all health treatment. Simmons11 showed how electronic Surprisingly, although the system of digitally signing
health and dental records will be part of American health electronic health records was suggested in the United
professionals’ and patients’ routines within a few years. States,18 Brazil,14 Germany,19,20 Greece,21 and Taiwan,22
However, the transition from conventional to digital this subject is still largely unexplored for electronic den-
must be managed carefully. Any digital file, including an tal records. We searched the PubMed database using the
electronic dental record, can be forged, raising doubts terms electronic dental records and digital signature,
about its authenticity. Madhan and Gayathri12 demon- and found no articles.
strated that digital photographs and radiographs can The aim of this study was to examine the feasibility
be manipulated, simulating clinical results that do not of digital signature technology to guarantee the legal
exist in the real world and forging images of patients' re- validation of electronic dental records in a global
cords that seem to be real. Frequently, tampering is so perspective.
well conducted that only a specialist can detect it.12
a
POSSIBLE USES OF DIGITAL SIGNATURE
Private practice, Pontifical Catholic University of Paran, Curitiba, Paran,
a a
Brazil.
TECHNOLOGY
The authors report no commercial, proprietary, or financial interest in the prod- Digital signature means a mathematically generated
ucts or companies described in this article.
Reprint requests to: Ivan Toshio Maruo, Rua Pasteur, 95, Bairro Batel, CEP mark using asymmetric key cryptography techniques that
80250-080, Curitiba, Paran, Brazil; e-mail, ivan_maruo@yahoo.com.br.
a is unique to both the signatory and the information
Submitted, revised and accepted, February 2012. signed.15 For its implementation, a digital certificate
0889-5406/$36.00
Copyright Ó 2012 by the American Association of Orthodontists. (an electronic document that binds a person's identity
doi:10.1016/j.ajodo.2012.02.012 to his or her digital signature), a digital signature
662

2. Litigation and legislation 663
infrastructure (software, hardware, personnel resources, condition, opinion, or diagnosis.29 So, if each part of
and the required procedures to effectively use digital cer- the electronic dental record is digitally signed by its au-
tificates and digital signatures), and certification au- thor, all of the electronic dental records are considered to
thorities (issuers of digital certificates) are needed.15 be authentic.
LEGAL PROCESS AND THE ACTUAL USE OF GENERAL LEGAL PRINCIPLES
DIGITAL SIGNATURE TECHNOLOGY TO The efficiency of the digital signature technology to
AUTHENTICATE ELECTRONIC DENTAL RECORDS legally validate electronic dental records can be ques-
In Brazil, for example, the Brazilian Public Keys tioned, because manipulated digital files can be digitally
Infrastructure (ICP-Brasil) was created by a Provisional signed after forgery.
Executive Order in 2001.16 In 2006, the ICP-Brasil To elucidate this matter, it is important to under-
permitted the computerization of judicial processes, ac- stand that certain values comprise a common founda-
cording to law number 11419/2006,23 in which only tion among western legal systems, and these values are
digital documents are used. In 2007, the Brazilian expressed by the general principles of law.30 Two of
Federal Board of Medicine approved the technical stan- these principles must be analyzed in the case of digital
dards of medical records digitizing and permitted the signatures of electronic dental records: the good-faith
elimination of conventional records if ICP-Brasil digital principle and the burden-of-proof principle.
certificates to digitally sign the files were used.24
Documents are admissible in court as long as they are GOOD-FAITH PRINCIPLE
relevant. A relevant document is one that tends to make The good-faith principle means that the parties in
a material fact more or less likely than it would have been a transaction must deal honestly and fairly with each
without the document.25 If a dentist or a physician is other, represent their motives and purposes truthfully,
a defendant in a liability lawsuit, the patient’s health re- and refrain from taking unfair advantage that might re-
cords are relevant documents. sult from a literal and unintended interpretation of the
In law, the relevant documents are referred to as ev- agreement between them.31
idence. In the United States, federal courts adhere to the So, respecting the good-faith principle, it is assumed
Federal Rules of Evidence, which determine what type of that health care professionals and patients are honest,
evidence is admissible and in what situations.26 State and there is no reason for digitally signing health records
courts have adopted their own rules, but most mirror that do not correspond to reality.
the federal laws.26 According to these rules, to be admis- Actually, it is the same reasoning that is applied to
sible as a piece of evidence in court, a document must be conventional nonelectronic records. Because of the
authentic.27 good-faith principle, when complementary examina-
The problem with electronically stored information, tions are made by a radiology laboratory, the health
such as an electronic dental record, is the ease with care professional considers them to be authentic without
which it can be tampered with or even fabricated asking for proof.
completely. In some court cases, electronic data were It means that the digital signature technology does
not allowed to be admitted into evidence because they not guarantee absolute authenticity of electronic health
could not be adequately authenticated, even without and dental records. In fact, digital signature technology
clear-cut proof that the items were not authentic.28 guarantees to the electronic records the same legal
Digitally signing important electronic documents is validity as the conventional nonelectronic ones.
one recommended security measure to establish their
authenticity.28 BURDEN OF PROOF PRINCIPLE
When the authenticity of electronic dental records
AUTHENTICATION OF EACH PART OF THE and conventional nonelectronic dental records is ques-
ELECTRONIC DENTAL RECORD tioned, the burden-of-proof principle is used. It means
Dental records include documents that are produced that enough evidence must be introduced before the
by the treating dentist (eg, the treatment progress form), jury or other tribunal.32
the radiographic laboratory (eg, the computed tomogra- Each country might treat differently the issue of the
phy files), and the patient (eg, the signed informed con- burden of proof, but the general rule is that the person
sent form). who affirms something must prove it.32 When some-
The purposes of authentication are to show author- thing is alleged and not proved, the court considers
ship and to assign responsibility for an act, event, that what was claimed is untrue.
American Journal of Orthodontics and Dentofacial Orthopedics May 2012 Vol 141 Issue 5

3. 664 Litigation and legislation
Fig. Checking the signer's personal data, digital signature validation, and time of the file signature with
a digital signer software. The file was signed by an author, and his personal data were covered.
For example, in the Brazilian legal system, when To sign digital files, a person must purchase a private
there is doubt concerning the authenticity of docu- key (which is saved in either smart cards or tokens)
ments, the court will apply the burden-of-proof princi- bound to a public key.18 The public key is issued by a cer-
ple, laid down in article 333 of the Civil Process Code33: tification authority (a trusted third party) and is available
the burden of proof rests (1) with the plaintiff, in for verification but cannot be used to sign new docu-
relation to the constitutive fact of his or her right; and ments.18
(2) with the defendant, in relation to the existence of When a digital signer software, such as BRy Signer
the impeditive, amending, or extinctive fact of the (BRy Tecnologia S. A., Florianpolis, Brazil), is used,
o
plaintiff’s right. the file is encrypted with both the private key and
Because digital signature technology is usually the public key. The software can both sign digital files
regulated by government laws, there is no reason to and check the digital signature of previously signed
deviate from this rule.15-17 It means that the person files.
who questions the authenticity of an electronic or The Figure illustrates how the digital signer soft-
a nonelectronic document must prove that it has been ware checks the digital signature of a digital file. The
forged. signer's personal data, the digital signature validation,
Because of the good-faith principle, although the and the time of the file signature are shown by this
authenticity of electronic and nonelectronic documents software.
can be questioned in a lawsuit, the person who digitally
signs a file guarantees that it is not forged. In addition, LIMITATIONS OF THIS METHOD
because of the burden-of-proof principle, signed docu- The limitation for the immediate implementation
ments are assumed to be authentic until proven other- of this proposal for the legal validation of electronic
wise. dental records is the necessity of the dentist’s,
the radiology laboratory’s, and the patient’s digital
DIGITALLY SIGNING ELECTRONIC DENTAL certifications.
RECORDS FILES However, this limitation is momentary, because dig-
A digital signature is a method for ensuring the in- ital signature technology is improving and being used in
tegrity of a message or document, authenticating the many countries.15-17
identity of the signer, and establishing nonrepudiation Soon, every citizen will have a digital signature.
of the signature. This is possible because only the au- From now on, this proposal for the legal validation
thenticated signer could have created the digital signa- of electronic dental records will be available to all
ture that is attached to the document.18 professionals.
May 2012 Vol 141 Issue 5 American Journal of Orthodontics and Dentofacial Orthopedics

4. Litigation and legislation 665
CONCLUSIONS 18. Zuckerman AE. Restructuring the electronic medical record to in-
corporate full digital signature capability. Proc AMIA Symp 2001;
It is possible to obtain electronic dental records that 791-5.
carry the same legal certainty as conventional nonelec- 19. Pharow P, Blobel B. Security infrastructure services for electronic
tronic records. For this purpose, each part of the elec- archives and electronic health records. Stud Health Technol Inform
tronic dental record should be digitally signed by its 2004;103:434-40.
20. Pharow P, Blobel B. Electronic signatures for long-lasting
author.
storage purposes in electronic archives. Int J Med Inform 2005;
74:279-87.
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American Journal of Orthodontics and Dentofacial Orthopedics May 2012 Vol 141 Issue 5