CHAPTER 27 The Law and Dental Technology
Focus on Endodontics
Dentistry has always been at the forefront of technologic advances in health care. Until recently, those advances came at a steady and moderate rate that allowed the clinician to adapt using a traditional understanding of the laws affecting practice. However, the exponential growth of the Internet and the digitalization of health care systems have required clinicians to revisit their understanding of the laws of dental technology and the resulting changes in the standard of care.17
This chapter provides an overview of the nature of the technology and trends in dentistry, the issues that consequently arise, and the applicable laws.
Recent advances in dental technology have brought about rapid changes in every aspect of the delivery of dental care, including marketing, communications, record keeping, imaging, testing, diagnosis, treatment, education, and billing. Likewise, these advances have increased the capabilities of the dental clinician, and with their growing acceptance in the dental profession, the standard of care also has evolved.
Many homes and businesses in America have Internet access. Patients younger than 30 may have grown up using computers and cell phones as their primary sources of information and communication.10 Once just the name of another Internet web page, Google (www.google.com) has become a de facto verb that defines one of the most common methods of exploring an issue in dentistry, researching a proposed treatment, or even finding a dentist. Patients frequently investigate a dentist by googling; they find sites that rate dental offices, or they may go to a state’s licensing webpage.20 After selecting a dentist, the new patient is likely to use MapQuest (www.mapquest.com) for directions to the office if the dentist’s webpage does not already provide a link to a map page.
Dentists no longer need to wait for the mail carrier to deliver journals or find the time to attend a convention for an update on recent advances in dentistry. Many clinicians have Internet subscriptions to sites such the American Dental Association’s (ADA) (www.ada.org/prof/resources/pubs/adanews/index.asp) that regularly announce developments in dentistry by e-mail and provide links for further investigation. Accordingly, the legal standard of care, or the practices expected of a reasonable and prudent dentist, has become a standard that is defined on a national level rather than simply by the care provided in the local community wherein the dentist practices.
Conversion to digital dentistry soon will no longer be optional. It will become necessary because of the elevation of the standards of care, patient demands, and the requirements of the marketplace in general. At all major dental conventions, most trade exhibitors now market some form of digital dentistry. Also, clinicians increasingly are seeking patients by offering “high-tech” dentistry.
In the 21st century, dental technology affects every aspect of the delivery of dental care at an ever-increasing rate. At the same time, learning curves are flattening, and costs are dropping. State licensing boards and traditional dental societies are finding it difficult to keep up with the advances in dental technology. U.S. lawmakers and courts also are finding it difficult to keep pace; therefore they have taken laws designed for other technology industries and adapted them to meet medical and dental care issues.
In addition, the law has recognized the impact on privacy of the digital communications age and the ability to transfer electronic patient information instantly. The Health Insurance Portability and Accountability Act (HIPAA), passed in 1996, sets forth strict guidelines on confidentiality standards for patient data.2
Barriers to Adoption of Dental Technology
Traditional barriers to the adoption of technologic advances in dentistry have included investment limitations, slow approval by the U.S. Food and Drug Administration (FDA), office design issues, conversion costs, and resistance from clinicians who were very comfortable and reasonably productive with conventional dental systems. The old ways were simple, they worked, and they were cheap, but those barriers are falling. With greater community acceptance, the production of technologic devices has increased, lowering the cost of digital dentistry. Adaptation of technologies from other health care industries has increased the rate of regulatory approval for digital dentistry. A reasonable understanding of the laws of dental technology can help remove the last barrier: clinician resistance.
Traditional Avenues of Exposure
Traditional legal exposures for the dental practice included malpractice (negligence or substandard care), general liability (also known as premises liability), employment claims, and licensure issues. Typical claims against dental offices involve bad results or ineffective treatment arising from poor planning and execution. In many cases, they can be directly traced to poor record-keeping or to communication gaps between dentists and patients and/or between general dentists and specialists. These weaknesses often are readily spotted by lawyers. Particularly by those who specialize in dental malpractice cases.7
Digital dentistry, when used correctly, can reduce traditional legal exposures by increasing record-keeping capability, providing twice as much data at half the input time and eliminating legibility problems. E-mail and faxes provide instant, traceable forms of communication, record sharing, and data gathering; as a result, the clinician is better informed and better able to provide ideal treatment.
Although digital dentistry has the potential to reduce the risks associated with certain traditional areas of exposure, it has created some new avenues of potential exposure. Misuse of technology, inadequate maintenance of equipment, warranties, and confidentiality of records are emerging areas of potential liability exposure.
The nature of health care, and particularly of dentistry, is such that maximization of production often is the primary business focus. Dentistry has always been creative in finding ways to provide treatment in less time and with less discomfort and fewer complications for the patient. However, that inventiveness may prompt clinicians to use technology for unapproved, or off-label, purposes and to take short cuts. In such cases, the guidelines issued by the manufacturer of a specific technology can be used as a statement of the standard of care. Examples include the Physician’s Desk Reference (www.pdr.net) for medications, the instruction booklet for endodontic electronic apex locators, template overlays for sizing dental implants, the user guides for virtual impressions, and the owner’s manual for electric high-speed handpieces.
In the event of a complication or bad result, the patient’s attorney may offer the manufacturer’s guidelines as evidence the jury should consider in deciding whether a problem suffered by a patient was the result of substandard care for which damages can be awarded. A particular manufacturer’s guide or standard that was not followed by a defendant dentist, projected in bold print on an 8 × 8-foot screen, tends to have a very powerful impact on a jury that is trying to decide whether a treatment complication was merely a bad result or evidence of substandard care.
In contrast, evidence of strict adherence to a manufacturer’s guidelines may be used by the attorney defending a dental malpractice suit. It may serve as powerful evidence that the complication or problem was not the result of substandard care but rather a risk of the procedure.
Inadequate Maintenance of Equipment
Manufacturers of dental technology can become targets of personal injury suits if a treatment complication or bad result can be traced to a failure or breakdown of the technology. For example, defective bearings in a high-speed handpiece may cause overheating, resulting in a burn on the patient’s lip, or an endodontic file can break in a canal during treatment. Therefore manufacturers of dental equipment have issued specific guidelines for the maintenance of dental devices. If those guidelines are not strictly followed, liability for an injury shifts from the manufacturer to the health care provider, even if the patient’s injury was caused by a manufacturing failure. The prudent clinician strictly follows the guidelines for maintaining equipment and, more important, documents adherence to those instructions. This policy should include regular and scheduled testing if such is required by the manufacturer. With regard to the example of the overheating handpiece, some manufacturers have issued revised guidelines calling for shorter and shorter recall cycles and for more frequent testing by the dentist. Failure to keep up to date on those changes could expose the user to liability for an equipment breakdown.
Breach of warranty presents a different type of legal exposure than breach of the standard of care. Failure to meet the standard of care is a form of dental negligence, which usually is determined by comparing the testimony of the defendant with the testimony of expert witnesses retained by both parties.
A warranty is a statement or promise of a specific result or, in dentistry, a promise of a specific outcome. In the event of a bad result or complication, the patient need not prove substandard or negligent care; the person need only show that he or she received something other than the promised result. Such representations must be avoided.
Dental high tech equipment, such as computer projections of potential treatment results, can create a warranty and the attendant exposure for less than the projected result. The prudent clinician therefore makes sure to have patients review and acknowledge disclaimers notifying the patient that such projections are merely estimates, that no specific result or outcome can be guaranteed, and that individual outcomes may vary. These disclaimers must be charted and also must become part of the informed consent process and the case documentation.
Some clinicians may think it acceptable to offer an expressly stated but limited warranty for dental treatment. In such cases, no evidence of substandard care is required; merely a failed or unsuccessful result, and the dentist who issued the warranty is required to pay for retreatment.15
The traditional standards of care have evolved to include reasonable standards of dental technology, which is subject to specific state and federal laws. A dentist may become liable for failure to suggest the option of a new form of dental therapy and for not allowing the patient to make an informed decision on options, regardless of whether insurance coverage is available for the ideal treatment or test.
The law has embraced a doctrine of informed refusal, which specifically requires discussion of the risks of refusing a recommended treatment or test. For example, the clinician would be required to discuss advanced endodontic treatment modalities, cone beam volumetric tomography (see also online Chapter 29), or dental implants, regardless of the patient’s insurance coverage. The prudent clinician documents such discussions with the patient. Such documentation should include a mention of the options discussed and states that the risks, benefits, and alternatives (RB&As) were discussed and the specific option was selected by the patient. If the patient chooses an inferior option (higher failure rate, more complications) because of financial limitations, the clinician should specifically document the informed refusal.
Many dental risk management and professional liability companies now provide informed refusal forms for patient acknowledgment and documentation.9
Internet webpages have become a major business tool throughout the world and particularly in America (see also online Chapter 28). They are the new marketplace, post office, and meeting center—and a new potential for liability for the uninformed dentist. Therefore when planning a webpage, dentists should consider the legal issues as well as style and content.
Webpages are created by blending text with images and links (click-on pointers that can direct the viewer to another webpage), all of which are separate files that can be copied and downloaded to make another webpage. Such techniques are commonly used by webpage builders, but the material, text, and images are subject to copyright laws in the same fashion as text and pictures in a book. As such, the use of images and text taken from other webpages may subject the owner (dentist) of the recipient data to liability for copyright infringement. The prudent clinician makes sure that permission has been obtained and documented before using images taken from the Internet, unless the material is considered public domain and is so marked or labeled. This proviso also applies to links that use the logo of another company or person. Dentists cannot assume that buying a product or endorsing a company constitutes permission to put the company’s logo or trademark on the dentist’s webpage. Again, documentation by way of a confirming letter or e-mail should be obtained before such proprietary images or links are used on a webpage.18
Interactive webpages, created through the use of special programs and e-mail connectivity, present another potential legal issue: the remote and electronic practice of dentistry. Patients can submit questions, send digital photographs or scanned radiographs, and request an opinion through the website. However, responding to such an inquiry may be considered the practice of dentistry in the state where the patient resides, which may not be the same state where the dentist holds a license. The courts have seen several cases of prosecution of doctors for giving advice over the Internet to patients in states other than the state where the doctor is licensed. Also, charges have been brought against insurance company consultants for evaluating out-of-state claims for benefits.13
Although currently the subject of considerable discussion, nationwide licensure by credential would appear to be years away. Therefore the practice of dentistry is limited to the licensing of individual states (and nation) in which a dentist maintains a license. To avoid potential liability, a dentist with interactive webpages should use disclaimers specifically stating that the communication is to be considered only as data for informational purposes, not advice or diagnosis, and in all cases it is not a substitute for a consultation with a dentist in the community where the patient lives.
All dental health care providers have a basic understanding of the need to maintain the confidentiality of patient records and the information included in them. However, with the advent of paperless digital dental records and imaging, the potential for rapid and widespread distribution of a patient’s inadvertently disclosed confidential information has become a significant issue. The problem has increased with the growth of the Internet and the use of computer consultants with remote access. These matters have come to the attention of lawmakers and the courts. Laws have been passed to address such concerns.
Even if a dentist reasonably believes that he or she is not subject to HIPAA, almost all states have laws requiring that reasonable efforts be made to secure patient records and maintain their confidentiality. Coincidentally, many of those requirements mirror the regulations set forth by HIPAA.4 The following checklist for confidentiality compliance is useful for all clinicians, whether HIPAA qualified or not.
Although the laws of individual states may vary, certain basic requirements apply to computer records in health care settings.1
All computer systems should have an off-site backup data storage system. Daily or weekly backups of the computer files must be removed from the office and stored at another site; this prevents loss of the backup data in the office as a result of an event such as a flood or fire.
A valid digital record-keeping system must include programming that prevents alteration of the data after input. Any digital record-keeping system that allows postinput changes to the entries without maintaining evidence of the change may be challenged in court. The same rules apply to digital imaging such as radiographs and photographs.
The digital record must also note the identity of the person inputting the data, either by a login system or by a designation at the end of each recorded entry.8
The law requires offices with Internet access to use reasonable security methods such as computer firewalls and antivirus programs. In addition, computer consultants with access to digital files should provide written acknowledgment of their obligation to maintain confidentiality.
In the transition from paper to digital records, paper charts can be converted to digital records by scanning the documents into an Adobe portable document format (PDF) file,3 a graphic file that cannot be easily altered. It is important to remember that after a file has been converted into digital form, the paper records, radiographs, and photographs must be destroyed in a manner that maintains confidentiality (e.g., shredding). The law considers trash and paper given up for recycling to be similar to public property and readily accessible to anyone. Simply tossing old records into the trash is a violation of the laws that require maintenance of patient confidentiality.
The statute of limitations for bringing a lawsuit against a dentist for malpractice is 2 years in most states. However, various exceptions to that law exist, such as when the patient is a minor or is found to be legally incompetent. Because of these exceptions, most risk managers recommend that records, whether paper or digital, be maintained for at least 10 years after the patient’s last visit. After that, the records can be discarded, but this must be done in a manner that maintains patient confidentiality. Tip: As more health care facilities and offices go digital, be on the lookout for states to increase the time dental offices are required to keep records.
The prudent clinician recognizes that as the quality of digital radiographs improves and the cost decreases, digital imaging will become a standard of care. There are several reasons for this. Digital radiographs expose the patient to less radiation, are not subject to the same processing problems as conventional films (underdeveloping, poor fixation), can be downloaded to the chart and instantly sent to other dental offices, and ultimately will be required for online insurance submissions. In the not-too-distant future, clinicians may see the end of the darkroom and the passage of laws that ban or severely restrict the use of the chemicals required to process radiographs, because of toxicity concerns.
These same issues will apply to digital photography versus conventional photography, because of the digital mode’s easier storage, transmission, and submission to insurance companies. As digital photography becomes more popular with the public, patients will expect that photographs taken by the dentist will be readily and easily transmitted to other health care providers or the patient.
Perhaps the single most dramatic change in the standard of care has come with the advent of cone-beam three-dimensional (3D) imaging, described in Chapter 29.12 This imaging system provides the clinician with virtually complete anatomy of a tooth and surrounding structures—information that can be used in planning, evaluating, and performing endodontics.12,21 The data obtained can display conditions such as root curvature, sinus anatomy, and instrument location to the point that treatment is more predictable and reliable and complications more avoidable.16 The prudent clinician must consider giving patients the option of 3D cone-beam imaging if such data would enable better treatment planning, reduce risks and complications, and foster greater success. If a patient declines the use of such imaging, the clinician—after educating the patient about the risks, benefits and alternatives—should obtain and document informed refusal.
Materials, postage, and labor constitute a significant part of the costs incurred by insurance companies for processing dental insurance claims. In the not-too-distant future, insurance carriers will forbid or add a surcharge for claims submitted as paper documentation, using plastic radiographs, and paper photographs. Other industries already require digital submissions. Airlines now add a surcharge for paper tickets, and banks charge a fee for maintaining and returning canceled paper checks. Some courts, such as the Federal District Court of Northern California, strictly prohibit the submission of paper documents (all filings must be submitted over the Internet as Adobe PDFs). Insurance companies will easily find judicial favor when they start to require digital submission of claims for dental treatment and begin charging a fee to process paper submissions.5
As dental practices begin to use online computer services such as e-mail and Internet access, as well as digital record storage, the office should establish and enforce staff management policies regarding the use of those technologic aids.
E-mails and Internet surfing are two common sources of computer viruses, spam, and spyware. Computer viruses can damage or destroy data. They typically and unknowingly are sent by a friend who is sharing a joke or photograph that has been passed around by other computer users. While surfing the Internet, users can unknowingly download computer spyware programs; these programs secretly take up residence on a computer system and then silently begin transmitting information about the user’s computer over the Internet to outside individuals and companies. The use of e-mail and the Internet also can result in a person’s e-mail address being sent or sold to spam companies and businesses that mass produce millions of unwanted e-mail marketing messages per day.
In most states, the law holds that employee use of e-mail, in the absence of a specific policy to the contrary, is considered private, similar to the use of a telephone, and employers may not access such communications without an employee’s permission, just as tapping a phone call is illegal. For these reasons, offices providing employee access to e-mail and the Internet should have written policies that specify the restrictions and violation warning (Box 27-1).
BOX 27-1 Sample Written Policy for Employees With E-Mail and/or Internet Access
Violation of these policies may subject an employee to termination of employment.
Some clinicians have considered documenting their patient consultations by recording them with video or audio devices. Recent developments in digital recording make it possible to record and store huge amounts of video and audio data on relatively compact systems. DVDs can record and store up to 6 hours of video/audio on a single disk, which currently costs less than $2. Devices with hard drives can record and store more than 80 hours of video and audio data.
The laws of most states prohibit the recording of conversations conducted over the phone or in person when anyone in the conversation could have a reasonable expectation of privacy. Hidden microphones or cameras are illegal recordings and subject the user to both criminal and civil penalties. However, the law allows recording of a conversation and/or the patient’s image if the patient gives expressed consent to the recording.
If the clinician decides to record a consultation (video, audio, or both), the patient’s permission should be obtained before recording begins. After this permission has been obtained, the patient’s consent to being recorded should be stated, including the time and date, at the beginning of the recording and again at the end of the recording. The fact that the consultation was recorded should be noted in the patient’s chart.
Digital systems are available for patient education. The fact that a patient viewed educational material about a proposed treatment option or a diagnosis, whether the material is in the form of a booklet or an audio or video program, should be recorded in the patient’s chart. The prudent clinician documents what, where, and when the patient was provided educational material, as well as the fact that the dentist and patient had an opportunity to discuss the material.
Even the education of dental students has gone digital; at some schools, all textbooks are provided to students through laptops rather than on paper.11
Dental technology is growing at an accelerated rate, and the digitalization of all aspects of dental care is on the near horizon. The process began with electronic records, moved to digital imaging, and is progressing to digital treatments, such as endodontic electronic apex locators, automatic periodontal probes, virtual impressions, computer-fabricated restorations, and in-office testing (“laboratory-on-a-chip” systems) to evaluate a patient’s blood sugar, perform microbial assays, and monitor a patient’s stress level. Patients have come to expect complete treatment in one session, such as single-visit root canal therapy (indicated in most cases), preparation and placement of crowns, and same-day surgical placement and restoration of implants.6 One of the present challenges for clinicians considering endodontics is the growing school of thought that removing the tooth and replacing it with an implant may be the better long-term treatment in cases where saving a tooth with endodontics would also involve a post, build-up, pins, crown lengthening, and a crown. In such cases, the prudent clinician should advise the patient of both options, regardless of financial issues, and allow the patient to decide. If the patient chooses the lesser of two options (say, because of insurance coverage), informed refusal should be obtained and documented.19
In the near future, after a patient chooses a dental clinician, the individual will have his or her computer’s scheduling program contact the dental office’s computer over the Internet to schedule an appointment. At the same time, the patient will authorize a HIPAA-qualified release of digital records and imaging from other health care providers, and the information will be downloaded to the dentist’s database patient health history profile, which will place appropriate tags for the staff and dentist to review before the first consultation. The dentist’s office will have no darkroom, no record storage area (paper or models or imaging), no laboratory, and in some cases, no waiting room because no paperwork would need to be filled out, and patients who might be at the mall next door could be paged on their cell phones just before an appointment. Sound futuristic? It’s already here; some dental service companies are completely digital and provide standard-of-care dentistry in a two- or three-operatory recreational vehicle (RV).14
Dental technology is raising the bar for the standard of care. Very soon, some aspects of conventional methods of record keeping, image gathering, and patient treatment will become substandard. The prudent clinician considers and, when appropriate, adapts to new dental technologies but only with an appreciation of the legal issues involved.
1. law.onecle.com/california/health/123149.html Accessed July 24, 2009
2. www.ada.org/prof/resources/topics/hipaa/index.asp Accessed July 24, 2009
3. www.adobe.com/products/acrobat/readstep2.html Accessed July 24, 2009
4. www.cms.hhs.gov/SecurityStandard/Downloads/securityfinalrule.pdf Accessed July 24, 2009
5. www.deltadentalins.com/dentists/guidance/claim-completion.html Accessed July 24, 2009
6. www.dental.washington.edu/conted/courses/CE0441.htm Accessed July 24, 2009
7. www.dentallawyers.com/law/homepage.html Accessed July 24, 2009
8. www.dentalrecord.com/news_detail.php?id=5 Accessed July 24, 2009
9. www.dentists-advantage.com/rskmgt/forms/index.jsp Accessed July 24, 2009
10. www.itfacts.biz/index.php?id=P2396 Accessed July 24, 2009
11. www.jdentaled.org/cgi/content/full/70/5/480 Accessed July 24, 2009
12. www.jendodon.com/article/S0099-2399(07)00564-X/abstract Accessed July 24, 2009
13. www.medbd.ca.gov/licensee/telemedicine.html Accessed July 24, 2009
14. www.onsite-dental.com Accessed July 24, 2009
15. www.prestonwooddental.com/smile_guarantee/smile_guarantee.htm Accessed July 24, 2009
16. www.scielo.br/pdf/bdj/v19n2/v19n2a05.pdf Accessed July 24, 2009
17. www.tmhlaw.com/medical-malpractice.php Accessed July 24, 2009
18. www.tradename.com/utilities/netatty.html Accessed July 24, 2009
19. www.utoronto.ca/dentistry/newsresources/evidence_based/ongtermsuccess.pdf Accessed July 24, 2009
20. www2.dca.ca.gov/pls/wllpub/wllquery$.startup Accessed July 24, 2009
21. www.interscience.wiley.com/journal/118494140/abstract Accessed July 24, 2009