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J Am Dent Assoc, Vol 131, No 6, 734-744.
© 2000 American Dental Association | ![]() |
COVER STORY |
| ABSTRACT |
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Conclusions. Numerous issues require resolution before telemedicine and teledentistry will truly realize their enormous potential to increase access to health care while decreasing health care costs. These issues include interstate licensure, jurisdiction and malpractice, as well as technological, security and ethical questions.
Practice Implications. Telemedicine and teledentistry are relatively new to the dental field. Many of the legal issues reviewed have yet to be resolved by the legislature or the courts. Furthermore, technology has not yet progressed to the point where the practitioner can be certain that no technological failure will occur during a teledental consultation. In spite of these problems, the potential of telemedicine and teledentistry is tremendous. Improvement in accessibility of health care and lowered health care costs are only two of the many advantages that will emerge as telemedicine and teledentistry become integrated with, and fundamentally change, the practice of medicine and dentistry.
The explosive growth of the Internet and its use bring with it the potential for electronic media to fundamentally alter the way dentistry and medicine are practiced. Information is now universally accessible to health care practitioners and to the general public. Global communication with colleagues is instantly available through a simple click of the mouse.
This universal accessibility to information has raised a number of legal concerns. This article is intended to make the potential teledentistry practitioner aware of some of the possible legal pitfalls inherent in use of the teledentistry medium. We review issues associated with the electronic transfer of information, specifically discussing dental licensure, malpractice, jurisdiction, privacy, security and informed consent. Technological and ethical issues are also addressed.
Telemedicine (and by inclusion teledentistry) has been defined in a number of ways.1,2 The state of California considers telemedicine to be "the practice of health care delivery, diagnosis, consultation, treatment and education using interactive audio, video, or data communications."1 The federal government, in its 1997 Telemedicine Report to Congress,3 defined it as "the use of electronic communication and information technologies to provide or support clinical care at a distance." In essence, it is the diagnosis and treatment of a patient using electronic and communication technologies.4 Currently, most of the law about this topic is focused on medical as opposed to dental issues. Dentistry can be viewed as falling under telemedicine laws by inclusion. Some states, however, are currently working to add specific language to include the practice of teledentistry in their interstate licensure requirements. For example, Alabama recently recommended amendment of its Dental Practice Act to include the Federation of State Medical Boards interstate licensure model.5,6
The importance of the World Wide Web and its effect on the dental profession will be profound. As a tool for easy access to information, it has no equal. However, its use as a vehicle for the propagation of inaccurate or poor information is also without peer. There are no "rules" on the Internetthere is no licensure and no verification. Anyone with or without credentials can hold themselves out to the public as having expert knowledge. There is no regulation and little accountability. Nowhere is the phrase "caveat emptor" more appropriate than on the Internet.
The problems with the Internet in general and telemedicine and teledentistry in particular are due primarily to a lack of well-defined standards.7 Currently, there is no method to ensure quality, safety, efficiency or effectiveness of information or its exchange. There are privacy and security issues as well as remuneration, fiscal and taxation issues associated with electronic commerce. Many of the legal issues, such as licensure, jurisdiction and malpractice, have not yet been definitively decided by legislative or judicial branches of government. In spite of this, many health care practitioners are embracing this new medium and charging headlong into the information age, without considering the potential impact or consequences of their actions.8
The potential of teledentistry is exciting. It has the ability to improve access to care, improve the delivery of health care and lower its costs.9 For example, teledentistry can be a much-needed resource for dental consulting, referral for specialized care, dental mentoring, dentist-laboratory communications and continuing education.10
Dental consulting is an area in which teledentistry can help a great number of patients, including those in rural areas, the incarcerated and the elderly. Rural areas can lack health care specialists. To gain access to specialized care, residents of rural areas frequently must travel significant distances. Teledentistry could enable rural patients to receive a specialty consultation without the expense in time and money of traveling to the site where the specialist is located.
Teledentistry in consulting can present in two forms: real-time consulting and store-and-forward consulting.10 In real-time consulting, a video conferencing format is used and the patient, consulting dentist and referring practitioner are all present in real time. In store-and-forward consulting, the referring dentist collects applicable data and sends them to the consulting doctor via an electronic medium. The consultant reviews the material and returns an opinion via the same route. The patient is not present during the "consultation."
Either way, the potential for the patient to access specialized knowledge, care or both is increased via teledentistry. On the other hand, the potential for error could also be increased, as well as the potential for practitioners to incur additional liability. In either case, two or more practitioners are involved in the consultation. We do not recommend that teledental advice be given directly to a patient (for example, via electronic mail or a newsgroup). Just as it is ill-advised to make a diagnosis based only on a telephone conversation with a patient, it is equally inadvisable to make a diagnosis, treatment recommendation or both without an examination by a licensed practitioner.
What are some of the risks? Even simply sending an e-mail message to a colleague could be considered a teledentistry referral and may come under legal scrutiny. It is each practitioners responsibility to understand the implications of the use of information technologies and their associated legal ramifications for the dental practice. Each practitioner should seek the advice of a qualified attorney who is familiar with teledentistry and its implications.
There are a number of issues that arise with the use of telemedicine and teledentistry.1114 First, there are legal issues associated with the communication and transfer of information on the Internet. These include licensure, malpractice and jurisdiction. Additional items of concern are technological and ethical.
Because of the lack of boundaries associated with the Internet, electronic consultations frequently cross state and national borders. Indeed, this is one of the qualities that makes teledentistry consultations so beneficial. However, many states have decided that such referrals constitute the practice of medicine or dentistry in those states. Therefore, practitioners engaged in telemedicine/teledentistry must be licensed in each state in which they practice.1719
Currently, 20 states have restrictive licensure laws that require the health care practitioner to obtain a full license (with some exceptions) to participate in teledentistry across state lines (BoxTELEDENTISTRY HAS THE ABILITY TO IMPROVE ACCESS TO CARE, IMPROVE THE DELIVERY OF HEALTH CARE AND LOWER ITS COSTS.
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LICENSURE
TOP
ABSTRACT
LICENSURE
JURISDICTION
MALPRACTICE
TECHNOLOGICAL ISSUES
INFORMED CONSENT
ETHICAL ISSUES
RECOMMENDATIONS
SUMMARY
REFERENCES
Historically, the interstate exchange of information has received little attention. Practitioners were effectively free to communicate and exchange information with colleagues in other states. Physicians and dentists could use the telephone, fax or postal service to send and receive patient information, pathology specimens, and oral or written inquiries (consultations). Inherently, a level of confidentiality and specificity was assumed when using these methodsthe information was exchanged with only a single individual or office. Now that many providers have adopted a preference for electronic communication, this assumption has changed.15,16
, "State Telemedicine Licensure Status"). Another three states (Alabama, California and Oregon) provide that a limited license can be obtained for an expedited application process and a reduced licensing fee. This allows a practitioner who is licensed and in good standing in one state to avail himself or herself of reciprocity with any of these three states. A limited license entitles the practitioner to practice only telemedicine, as opposed to traditional hands-on health care in the licensing state. It should also be mentioned that acceptance of a limited license allows the teledentistry practitioner to be sued in the jurisdiction of the state in which the patient resides.19 An additional 27 states and the District of Columbia have not as yet established any law requiring licensure for the practice of teledentistry.19 A potential teledentistry practitioner should not, however, assume that he or she is free to practice teledentistry in those states or the district. The practice of dentistry without a license is illegal in all states and the district. If the matter is adjudicated, the practitioner could be found guilty of practicing without a license in those states in which he or she is practicing teledentistry. Extreme caution is recommended.1922
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This risk may extend to software and hardware manufacturers as well. Recently, a software manufacturer (Parsons Technology) was sued in Texas to ban the sale of its Quicken Family Lawyer software. The U.S. District Court ruled that the assistance provided to end-users of this program "goes too far" and results in an unauthorized practice of law in the state.24 The implications of such a legal precedent toward teledentistry are considerable.
| JURISDICTION |
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| MALPRACTICE |
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ANYONE SHARING INFORMATION OR PARTICIPATING IN A TELEDENTISTRY CONSULTATION MUST RECOGNIZE THAT HE OR SHE IS ACCEPTING INCREASED PROFESSIONAL LIABILITY.
In addition, a basic principle of tort law states that no cause of action for negligence exists unless the defendant (doctor) owes a legal duty to the plaintiff (patient). A doctor has a duty to exercise a reasonable degree of learning and skill, but only if a doctor-patient relationship exists.
If we examine these principles of malpractice with respect to a teledentistry consultation, the first issue requiring clarification is whether a doctor-patient relationship has been established.25 This is established, and legally begins, only with the consent of both the doctor and the patient. Traditionally, informal consultations, in which the practitioner discusses the patients dental history and current conditions with colleagues, do not establish a doctor-patient relationship as a result of those discussions.4 However, it has been argued that any practitioner offering an opinion over the Internet, either to a colleague or a layperson, via e-mail or formal consultation, has indeed established a doctor-patient relationship.2628
With respect to real-time videoconferencing consultations, technology now makes it possible for the patient, dentist and consultant to all be "present" at the same time, with the consultation being rendered both with the patients consent and on behalf of that patient. Under these circumstances, it is increasingly likely that the courts will determine that a doctor-patient relationship has been established via the electronic medium.4 Once this relationship is established, the consultant has a duty to act within the parameters of the standard of care.
If the establishment of a doctor-patient relationship is accepted, there are additional implications and questions: Has the patient given informed consent regarding the use of teledentistry? Is the specialist cognizant of the intent and establishment of a doctor-patient relationship with a patient whom he or she is likely never to examine in person? What will occur on termination of the teledentistry consultation? Might a patient claim abandonment upon completion of such a consultation?
Another issue is the establishment of standard of care. This is a controversial topic with respect to medicine and dentistry in general. A national standard of care for specialists has become the norm as opposed to a traditional locality-based standard of care.4 How this issue will be resolved with respect to teledentistry is unclear. What will be the standard of care for electronic referrals? Will a practitioner be held accountable to the standard of care for a traditional person-to-person patient contact, or will the standard of care for a teledentistry referral be different in some fashion? What will the implications be for a different standard of care for insurance reimbursement? For quality of patient care? If we do not accept a different standard of care, then how will participants ensure that the quality of a teledentistry-based opinion is equal to that of a traditional referral?
Establishment and acceptance of an altered standard of care, be it higher or lower than that for a traditional consultation, carry with them certain risks. Might providers be guilty of negligence for not availing themselves of the specialized care available via teledentistry? What if teledentistry results in improved care (a higher standard of care)? Failure to refer may constitute negligence. Telemedicine may affect the standard of care by elevating the standard to the point that not having telemedical capacity is in fact substandard.4 However, referral may expose the practitioner to additional liabilitya Catch-22.
COMMUNICATION AND UNDERSTANDING OF THE TECHNOLOGY AND ITS POTENTIAL PROBLEMS BECOME CENTRAL TO THE ISSUE OF WHETHER A PATIENT HAS RECEIVED SUFFICIENT INFORMATION TO GIVE INFORMED CONSENT.
The next concern is establishing the injuries a patient might suffer (or claim to suffer) stemming from a teledentistry referral. What is a providers liability for a missed diagnosis due to technological (rather than human) error? Might a dentist be guilty of negligent supervision of another provider? What if the specialist makes a recommendation that he or she knows the referring dentist may not follow (or may be incapable of following)is there a duty for the specialist to contact the patient?
The answer to all of these questions may be yes. While still not decided by the courts, many foresee the provider being responsible for not only the opinion rendered, but for the proper transmission of that information.4,29,30 Additionally, a consultant may be liable for the ultimate treatment undertaken by the referring dentist, especially if the consultant failed to independently inform the patient of his or her findings (termed "negligent supervision").
| TECHNOLOGICAL ISSUES |
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Failure of an accurate transmission, and its potential impact on clinical outcomes, should be communicated to the patient. Consider the electronic transmission of a clinical photograph, and the possible ways this image could be altered by the technologies necessary to transmit it to another person. How will the image become translated into an electronic image? If it is scanned, what resolution will be adequate? Is the potential loss of resolution clinically significant? Will the software use any type of image compression, either during scanning or transmission? As a consequence of this, will there be any potential loss of data (for example, by using a "lossy" compression algorithm)? Will the picture be encrypted to help ensure security and patient confidentiality? If so, will the image then be successfully decoded? Will the image suffer degradation during transmission itself, and will it be successfully received at the other end? Can it be guaranteed that the received image is identical to the image sent? While many would consider these issues to be beyond the practitioners control, health care professionals may find themselves sued for equipment failure or malfunction if that failure results either directly or indirectly in an injury to a patient.29,30
In addition, the equipment manufacturer, hardware and software distributors, and utility and equipment service companies could be joined in a claim for equipment failure or malfunction and could be held liable for technological problems associated with their products under one of the five theories of product liability, including strict liability.31 The theory of strict liability allows manufacturers to be held responsible without proof of negligence. There is currently little case law available discussing product liability as it relates to telemedicine. However, given the potential of an injury to the patient resulting from telemedicine use, suits joining a number of potential defendants are foreseeable.
Privacy. No matter what precautions are taken, any electronic transfer of information carries with it the risk of a persons intercepting that transmission and having access to the information it contains.3235 Patients should be willing to accept this risk as inherent to the nature of teledentistry.
PATIENTS SHOULD BE INFORMED THAT THE POTENTIAL EXISTS FOR THEIR DENTAL INFORMATION TO BE ACCESSED BY UNAUTHORIZED PEOPLE.
Patients should be informed that the potential exists for their medical or dental information to be accessed by unauthorized people, despite the best efforts of the physician or dentist treating the patient. Clearly, there are steps the practitioner can take to make it more difficult for a transmission to be intercepted. For example, data encryption,36 password protection and user access logs can help deter most people and protect patient confidentiality. Unfortunately, many practitioners do not use such safeguards, either because their professional responsibilities to ensure confidentiality are not clearly understood, or more likely because the use of such techniques has not become standardized and easy to use at this time. More complex technology-based solutions, such as fire walls and "server farms," are only beginning to become available to the independent health care practitioner.
As technologies become able to seamlessly integrate security protocols with the routine transfer of electronic data, security may be something that participants may accept as a de facto standard. However, at this time, security remains one of the critical barriers to widespread acceptance of teledentistry, and is currently the ultimate responsibility of the practitioner. Physicians and dentists engaged in telemedicine and teledentistry must make every effort to ensure the security of their systems, as well as any data they may transmit.
We should mention that the use of teledentistry between states may place a practitioner in a no-win legal situation. For example, in some states (such as Colorado and Minnesota) practitioners are required to report to the state the sexual partners of HIV-positive patients. In other states (such as California and, until recently, New York) such information is required to remain confidential. What happens when an electronic information exchange occurs between California and Colorado, and the patient is HIV-positive? Patients should be made aware that their medical information might be subject to the differing laws and differing jurisdictions depending on where and how the information is transmitted.
Finally, patients should be informed that their records will be stored electronically (most likely on a database), and that the possibility exists that non-medical personnel may obtain access to this information. While it is certainly true that unauthorized users could access paper records (and that disclosure of that fact is not the norm), electronic storage increases the number of potential unauthorized viewers; hence, disclosure of this possibility is advisable. Consider a computer technician given access to a system to install or update software, the company entrusted to safely make backups of data files, the clerical office worker digitizing imagesall could have access to confidential patient records.
Despite the practitioners best efforts, there will always remain the possibility of human error. Consider recent events at a major university hospital, where patient information was inadvertently placed on a public, rather than a private, computer server. As a result, confidential patient information was universally available to anyone on the Internet. 37
Security. Preservation of the integrity of electronic data is in everyones best interestpatients, practitioners, insurance carriers, hardware and software vendors, and legislatures.38,39 All have a stake in the issues associated with electronic security. It should be stressed that no security protocol will be 100 percent effective, but a good faith effort to maintain system and data security will be important should a practitioner be challenged in a court of law. Indeed, federal legislation requires safeguards to ensure the integrity and confidentiality of electronically transmitted information.40
Patients should be informed of the security measures that a practitioner uses to ensure the safety of patient data. An explanation that there is the potential for a breach of that security should be included with this statement. Computer viruses, hacking, hardware and software failure, and disasters such as fire or theft may result in loss of patient information. Again, the consent form should mention that while efforts are made to ensure data protection, some loss of information might be inevitable should an extreme event occur.
PATIENTS SHOULD BE INFORMED OF THE SECURITY MEASURES THAT A PRACTITIONER USES TO ENSURE THE SAFETY OF PATIENT DATA.
Backup. No discussion of data security would be complete without a discussion of the importance of regular, secure data backup. This is the single most important way to maintain the integrity of electronic data, and is the most often neglected. For the private practitioner, this cannot be overlooked. This becomes a critical issue when patient records are involved, and exposes a practice owner to a negligence suit in the event of lost data, when a backup is unavailable. Should patient data be unrecoverable, it would be difficult for the practitioner to avoid being held liable for negligence.
| INFORMED CONSENT |
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For those practitioners who choose to venture toward this new frontier and its considerable additional legal exposure, a teledentistry consultation form is recommended, and is required in some states.2 While not a guarantee of protection, this form could offer some substantiation of a good faith effort at patient informed consent. It should become a standard part of our patient documentation. Such documentation includes a description of the teledentistry arrangement, a physical description of the hub and spoke sites, the reason a teledentistry consultation is being held and a description of the credentials of the consulting doctors.
In addition to including the general purpose of the consultation, the risks and benefits of a teledentistry consultation should be added. Statements should be included detailing the possibility of inaccurate diagnosis and treatment as a result of improper or faulty transmission. Furthermore, the possibility of breach of confidentiality and potential for information tampering should be addressed. The patient should be informed that the medical information will be computerized and stored on a database, and that the possibility exists for unauthorized access to that information. Finally, the patient should understand that he or she will have access to all information transmitted during a teledentistry interaction and that he or she may withhold or withdraw consent at any time without affecting the right to future care or treatment.
The telemedicine informed-consent form should be clearly explained to the patient. The patient should then sign a copy to be kept in the records of the referring doctor. The referring doctor should then provide a copy, via mail, fax or electronic transmission, to the consulting doctor before the consultation takes place.
| ETHICAL ISSUES |
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Public protection. Health care providers have an obligation to ensure that they, as individuals, as well as the profession as a whole, provide the best possible health care to patients.41 While the Internet offers the promise of an unprecedented improvement in patient care, it also can be easily abused. There are few standards available helping Internet users decipher the immense quantity of information available, nor is there a simple way to verify the credentials or veracity of the provider of that information.
WHILE THE INTERNET OFFERS THE PROMISE OF AN UNPRECEDENTED IMPROVEMENT IN PATIENT CARE, IT ALSO CAN BE EASILY ABUSED.
As an example, consider an Internet newsgroupa common medium where individual users can subscribe to a subject of interest (from among thousands) and, once subscribed, may access comments made by any other subscribers to the group, as well as post questions of their own. It is a shared system, where information is available and exchanged by all. Most of the time, this type of exchange works wellpeople can get answers to their questions on automobile mechanics, gardening, reviews of the latest movies or even health care.
Consider a newsgroup like "sci.med.dentistry". When an inquiry is posted (perhaps by a patient seeking treatment advice), anyone is free to responddentists, educators, other patients and manufacturers. Unfortunately, there is no way to verify the credentials of the person responding. Given the anonymous nature of the Internet, anyone may answer any question, whether he or she is qualified or not, whether he or she has a formal dental degree, or even if the person wishes to falsify credentials by impersonating a dentist. There is no simple way for a reader to substantiate any information about the person answering questions on a newsgroup.
Worse still is the situation in which the respondent is indeed a credentialed practitioner, but the response is inappropriate. If posed a question by someone at a cocktail party, most practitioners would carefully temper a response and remain cautious and careful, especially without the opportunity to personally examine the individual. However, in an online setting, this may change. As an example, consider the following responses to a patients inquiry about dental care posted to a dental news-group by people identifying themselves as dentists:
While one can argue whether these replies were appropriate, it becomes apparent that the responses do create an impression of our profession. While many dental practitioners might be thinking the above thoughts, few would be willing to say them in public, or put them in print, but, at least for the above responders, they were willing to send them over the Internet. It is important to remain cognizant of the impact the words of a professional carry, their ethical implications and the impressions they leave about the profession, be they written in ink or digitally encoded.
Fraud. Of great concern with electronic information in general is the issue of fraud. Great efforts have been undertaken to ensure the integrity of data for users of the Internet. Electronic commerce is constantly struggling to provide a balance between ease of use and security. Such issues also invade the realm of teledentistry.
Fraudulent alteration of medical records has been a longstanding problem. Unfortunately, with the advent of electronic data storage, the potential exists for an undetectable alteration of an electronic record. Consequently, most states do not consider an electronic record to be an acceptable form of medical information storage. All electronic records should be supported with a written copy of patient information, in addition to any electronic archives. In addition, the original record should be identified and maintained as such. The Health Insurance Portability and Accountability Act of 1996, commonly known as HIPAA, specifically addresses many of the standards surrounding electronic exchange.40
Alteration of records becomes more significant when discussing electronic data storage. Consider the issues associated with digital imaging. Here, since the original record is stored electronically as a digital image (a dental radiograph, for example), there is no way to maintain an original record that is truly unalterable. While a printed copy of the radiograph can be made, this negates some of the advantages of digital imaging (for example, less storage space required).
This issue can become critical for insurance claims processing. Most insurance companies require submission of a radiograph before approving many services (for example, fixed partial dentures). In addition, the movement toward electronic claims submission as a whole has been encouraged, with the likelihood of electronic imaging becoming the preferred method of radiograph submission in the near future.
The figure
is a digital image obtained with a currently available digital dental radiograph system.42 This image clearly shows an open margin on the distal surface of the maxillary second molar. By digitally editing this image, using currently available software,43 this margin can be corrected in approximately 15 minutes. The implications for insurance carriers are extreme. The ethical implications of such fraud to the profession are even more grave. Such alterations could be used to falsify completion of procedures without ever having treated the patient. Indeed, a person familiar with this technology could alter digital dental radiographs at will. While many are willing to forge ahead to the digital age, we as a profession must do so with caution, and always with the best interests of our patients in mind.
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| RECOMMENDATIONS |
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Before attempting to practice teledentistry, the potential provider should clarify and document the parties responsible for installation, maintenance, access, security and privacy efforts associated with the equipment used. Transmission verification procedures should be developed and documented at both the local and remote sites. Documented contingency plans should be developed, including a description of the backup protocols used. Furthermore, clinical guidelines should be established and documented that are at least equal to the accepted standards of care in the dental community.
Both the local and consulting doctors should separately and thoroughly document the patients medical and dental histories, examination results, diagnoses, differential diagnoses, treatments, consultations and recommendations. It would also be wise for all practitioners involved to carry insurance specifically designed to provide coverage in the event of a teledentistry failure, including malfunction of any equipment or software.
Finally, patients should sign a teledentistry consultation consent form specifically detailing the issues associated with their care. Each provider must remain aware of all of the issues applicable to the use of teledentistry.45 It makes sense for each practitioner to clearly define what the relationship is between the patient in question and the consultant. A signed written informed-consent form could help clarify other secondary issues, such as abandonment,4648 establishment of the standard of care,49,50 jurisdiction and negligence.51
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Practitioners choosing to include teledentistry as part of their practices should educate themselves as to the legal, technological and ethical issues that are a part of this new practice medium. Practitioners are encouraged to remain aware of the legal requirements in their states of practice and to remain vigilant regarding the legislative changes in this rapidly developing field. Furthermore, we advise dentists to retain the services of an attorney who is familiar with this relatively new and frequently changing aspect of the law.
| FOOTNOTES |
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