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  • 1. LITIGATION AND LEGISLATIONDigital signature of electronic dental recordsIvan Toshio Maruoa and Hiroshi MaruoaCuritiba, 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 bedimensional 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 medicineturn 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 Europeantients’ 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 signinghealth and dental records will be part of American health electronic health records was suggested in the Unitedprofessionals’ 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 theelectronic 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 feasibilitybe manipulated, simulating clinical results that do not of digital signature technology to guarantee the legalexist in the real world and forging images of patients re- validation of electronic dental records in a globalcords that seem to be real. Frequently, tampering is so perspective.well conducted that only a specialist can detect it.12a POSSIBLE USES OF DIGITAL SIGNATURE Private practice, Pontifical Catholic University of Paran, Curitiba, Paran, a aBrazil. TECHNOLOGYThe authors report no commercial, proprietary, or financial interest in the prod- Digital signature means a mathematically generateducts or companies described in this article.Reprint requests to: Ivan Toshio Maruo, Rua Pasteur, 95, Bairro Batel, CEP mark using asymmetric key cryptography techniques that80250-080, Curitiba, Paran, Brazil; e-mail, a is unique to both the signatory and the informationSubmitted, revised and accepted, February 2012. signed.15 For its implementation, a digital certificate0889-5406/$36.00Copyright Ó 2012 by the American Association of Orthodontists. (an electronic document that binds a persons identitydoi:10.1016/j.ajodo.2012.02.012 to his or her digital signature), a digital signature662
  • 2. Litigation and legislation 663infrastructure (software, hardware, personnel resources, condition, opinion, or diagnosis.29 So, if each part ofand 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 tothorities (issuers of digital certificates) are needed.15 be authentic.LEGAL PROCESS AND THE ACTUAL USE OF GENERAL LEGAL PRINCIPLESDIGITAL SIGNATURE TECHNOLOGY TO The efficiency of the digital signature technology toAUTHENTICATE 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 digitallyInfrastructure (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 aredigital documents are used. In 2007, the Brazilian expressed by the general principles of law.30 Two ofFederal Board of Medicine approved the technical stan- these principles must be analyzed in the case of digitaldards of medical records digitizing and permitted the signatures of electronic dental records: the good-faithelimination 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 PRINCIPLErelevant. A relevant document is one that tends to make The good-faith principle means that the parties ina material fact more or less likely than it would have been a transaction must deal honestly and fairly with eachwithout 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.31idence. In the United States, federal courts adhere to the So, respecting the good-faith principle, it is assumedFederal 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 recordscourts 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 tosible as a piece of evidence in court, a document must be conventional nonelectronic records. Because of theauthentic.27 good-faith principle, when complementary examina- The problem with electronically stored information, tions are made by a radiology laboratory, the healthsuch as an electronic dental record, is the ease with care professional considers them to be authentic withoutwhich 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 doesnot allowed to be admitted into evidence because they not guarantee absolute authenticity of electronic healthcould not be adequately authenticated, even without and dental records. In fact, digital signature technologyclear-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 recommended security measure to establish theirauthenticity.28 BURDEN OF PROOF PRINCIPLE When the authenticity of electronic dental recordsAUTHENTICATION 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 theby the treating dentist (eg, the treatment progress form), jury or other tribunal.32the radiographic laboratory (eg, the computed tomogra- Each country might treat differently the issue of thephy files), and the patient (eg, the signed informed con- burden of proof, but the general rule is that the personsent 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 considersship 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 signers 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 privatethere 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 availablethe 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 Signerthe impeditive, amending, or extinctive fact of the (BRy Tecnologia S. A., Florianpolis, Brazil), is used, oplaintiff’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 filesregulated by government laws, there is no reason to and check the digital signature of previously signeddeviate 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. Theforged. signers personal data, the digital signature validation, Because of the good-faith principle, although the and the time of the file signature are shown by thisauthenticity of electronic and nonelectronic documents software.can be questioned in a lawsuit, the person who digitallysigns a file guarantees that it is not forged. In addition, LIMITATIONS OF THIS METHODbecause of the burden-of-proof principle, signed docu- The limitation for the immediate implementationments are assumed to be authentic until proven other- of this proposal for the legal validation of electronicwise. dental records is the necessity of the dentist’s, the radiology laboratory’s, and the patient’s digitalDIGITALLY 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 integrity of a message or document, authenticating the many countries.15-17identity 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 validationthenticated signer could have created the digital signa- of electronic dental records will be available to allture 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 665CONCLUSIONS 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 electronictronic records. For this purpose, each part of the elec- archives and electronic health records. Stud Health Technol Informtronic dental record should be digitally signed by its 2004;103:434-40. 20. Pharow P, Blobel B. Electronic signatures for long-lastingauthor. storage purposes in electronic archives. Int J Med Inform 2005; 74:279-87.REFERENCES 21. Lekkas D, Gritzalis D. Long-term verifiability of the electronic 1. Machado AW. Whats new in digital photography? Dent Press J healthcare records authenticity. Int J Med Inform 2007;16: Orthod 2010;15:20-3. 442-8. 2. Hajeer MY, Millett DT, Ayoub AF, Siebert JP. 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