Consent for photography: legal issues

Published on 16/03/2015 by admin

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29 Consent for photography

legal issues

David J. Goldberg

Introduction

When dermal fillers are used for cosmetic purposes, appropriate informed consent is required both because of privacy-related issues (in the USA this is regulated by the Privacy Rule in the Health Insurance Portability and Accountability Act: HIPAA 1996) and because of medical liability issues. This chapter will first discuss the privacy-related issues behind the use of photography when dermal fillers are used for cosmetic purposes. This discussion will be followed an analysis of the medical liability issues associated with this. It should be noted that, although principles of US law will be applied, the overriding guidelines will apply to legal issues of ethical filler use throughout the world.

Photography

The use of patient photography, videotaping, digital imaging, and other visual recording during cosmetic filler treatment is common. Although cosmetic patient photographic documentation is fairly common, liability issues need to be considered and federal regulations observed.

Without proper precautions during such a healthcare encounter, patient photography may make an aesthetic physician liable for invasion of privacy. US courts have imposed liability primarily when the provider has exploited the patient for commercial benefit. However, courts have also imposed liability when the patient’s name or likeness was used for non-commercial purposes, finding that even taking a picture without the patient’s expressed consent was an invasion of privacy.

Physicians may also be subject to liability for publishing photographs or other images under the type of invasion of privacy known as ‘public disclosure of embarrassing private facts’. In one case, the court ruled that a physician had invaded a patient’s privacy by using ‘before’ and ‘after’ photographs of her face to demonstrate the effects of a facelift. The use of the photographs publicized the fact the patient had had a facelift, which she found embarrassing and distressing. Before allowing patient photography, it is important that a physician consider why it is being done and how the images will be used.

Regulation

The US standards for privacy of individually identifiable health information, also known as the final Privacy Rule from HIPAA 1996, address photographs and similar images both directly and indirectly.

Section 160.103 defines health information in a manner that implies inclusion of patient photography:

Health information means any information, whether oral or recorded in any form or medium, that:

(1) Is created or received by a health care provider, health plan, public health authority, employer, life insurer, school or university, or health care clearinghouse; and

(2) Relates to the past, present, or future physical or mental health or condition of an individual; the provision of health care to an individual; or the past, present, or future payment for the provision of healthcare to an individual.

According to Section 164.514(b)(2), Implementation Specifications: Requirements for Identification of Protected Health Information, photographic and comparable images are explicitly noted as an item to be removed during de-identification in order for records to avoid the protected health information status and fall outside the regulations:

A covered entity may determine that health information is not individually identifiable health information only if:

(2)(i) the following identifiers of the individual or of relatives, employers, or household members of the individual, are removed:

(Q) full face photographic images and any comparable images

The US Joint Commission on Accreditation of Healthcare Organizations and other similar organizations do advise that informed consent should be obtained from patients for purposes of patient photography. In the event that photographs are obtained prior to securing patient consent, they should be sequestered from use or release pending receipt of an appropriate consent.

The Joint Commission further advises that a confidentiality commitment be signed by anyone conducting filming or videotaping. This would be especially important to recognize when outsiders are involved because many organizations already require employees to sign annual confidentiality statements that should include patient photography within the commitment.

In offices where cosmetic fillers are given, patient photography is used routinely to document patient care. In such a setting, the practice of patient photography should be included in the US HIPAA-mandated notice of information practices, as well as in the consent for treatment signed by all patients. It is advised that a consent paragraph, such as the one below, be routinely used.

I understand that photographs, videotapes, digital, or other images may be recorded to document my care, and I consent to this. I understand that [physician’s name] will retain the ownership rights to these photographs, videotapes, digital, or other images, but that I will be allowed access to view them or obtain copies. I understand that these images will be stored in a secure manner that will protect my privacy and that they will be kept for the time period required by law or outlined in our [physician’s name] policy. Images that identify me will be released and / or used outside the office only upon written authorization from me or my legal representative.

It should be noted that such consent does not authorize the use of the images for other purposes, such as teaching or publicity. A separate consent for photography form should be used for such purposes.

In addition, HIPAA regulations require patient authorization for the release of protected health information, which includes patient photography, for purposes beyond treatment, payment, and healthcare operations.

Since photography is routinely undertaken when dermal fillers are injected, the above paragraph may be incorporated into the consent form for that procedure.

Fillers used in investigational studies

Photographs taken as part of a research protocol should be approved by an institutional review board (IRB) or privacy board, as termed by HIPAA. Consent for such photography should be incorporated into the consent form the patient signs to participate in the research protocol. The HIPAA-directed privacy board (or IRB) should be directly involved in decisions related to practices regarding the collection and release of patient photography.

Medical education, teaching, or publicity

Written authorization should be obtained before photographing patients for medical education, staff teaching, or publicity purposes. The patient or his / her legal representative should sign and date the authorization form. Anyone other than the patient who has the legal authority to sign should indicate his / her relationship to the patient. The signature should be witnessed, and the witness’s signature should be included on the authorization form. The signed authorization form should be filed with the patient’s medical records. A new authorization form should be signed for each new series of photographs taken by individuals other than those named in prior authorizations. The authorization given for photography remains valid unless and until the patient or his / her legal representative withdraws or restricts the authorization.

Media photography during filler injections

When representatives from the news media ask to photograph a patient, permission may be given if: (1) the patient’s physician does not feel it would be detrimental to the patient, and (2) the patient or his / her legal representative signs a written authorization form agreeing to the photography. HIPAA supports the patient’s authority to grant authorization, provided no state laws to the contrary exist.

Telemedicine or internet

Consent should be obtained before any photographs or other images are used in telemedicine or on the internet. The images, along with the complete medical record, should be encrypted to protect the patient’s privacy. Of note, the technology used in some telemedicine or internet-based programs may not support the media originally used to record the patient data. In addition, videos, scans, or photographic images may have poor resolution resulting in misinterpretations. Quality monitoring should be performed periodically to verify the quality of images transmitted.

Policies

As a first step in developing filler photography consent policies, cosmetic physicians should take an inventory of the types and locations in which patient photography is being done. Each physician’s policies should outline the circumstances under which the office will allow patients to be photographed for any reason and the requirements for patient consent. Statements that address the sensitive nature of patient photography need to be in the facility’s policy. Staff training on the issues of photograph and image handling should be included in HIPAA-mandated privacy and security training of the work force, extended work force, and all business associates and chain of trust partners. Business associate agreements should obligate business associates, chain of trust partners, and any subcontractors to the same privacy standards regarding patient photography as those of the covered entity.

Maintenance of photographs and other images

Still photographs and scanned printouts taken for cosmetic documentation may be filed with the patient’s record for safekeeping. Videotapes, because of their size, may need to be filed separately in another secure area. The issue of patient privacy and confidentiality needs to be addressed when maintaining patient images. Sensitive images (i.e. photographs taken for cosmetic purposes) need to be available for patient care, but also need to be maintained in a manner that protects the patient from unauthorized viewing. Maintenance of medical record policies should address how and where patient images are kept. For example, patient photographs can be stored in sealed envelopes that are secured within the actual medical record, scan images should be affixed to pages of the medical record or concealed within an affixed envelope, and videotapes should be stored in a secure filing cabinet. If videotapes or other recordings are not filed with the patient’s record, a note should be made in the patient’s record indicating the availability and location of these recordings. All photographs, videotapes, and other images should be stored in a manner that ensures timely retrieval when requested. All recordings should be identified with the patient’s name, identification number, and the date on which the recording was made. The name of the photographer or recorder may also be included. Because photographs, videotapes, and other images used to document patient care may be considered part of the patient’s record, they should be kept for the same time period that state law requires medical records to be kept.

Disclosure

Unless otherwise required by local law jurisdictions, photographs, videotapes, scans, and other images should not be released to outside requestors without specific written authorization from the patient or his / her legal representative. The authorization should state that the patient agrees to have the photographs released to the requestor and the purpose for which they will be used. This may be incorporated into the facility’s standard authorization for release of information form.

If the patient wants the photographs for his / her own use, a copy may be provided unless otherwise prohibited by local law. The physician should keep the originals. If procedures involving several patients have been recorded on the same videotape, the footage specific to that patient should be dubbed onto a separate tape, so the patient is not given access to other patients’ information. Only the information pertaining to the persons who consented to the disclosure may be released. Editing or some other means of protecting the information and images of the non-consenting parties must be done to protect their confidentiality. Patients may be charged a reasonable fee to cover the cost of duplication.

Liability reduction

Malpractice cases commonly use photographs that contain a potentially questionable medical incident. There are many pros and cons to having a video recording of a special procedure, but the facility must be aware of the liability risks involved. The following list offers a few ways to reduce the facility’s risks involved when video recording:

Create a policy that addresses the subject of videotaping filler injections. Use it consistently to avoid charges of ‘hiding’ images in cases that may have involved malpractice.

Document every video recording in the medical record. A videotape can be used to prove innocence as well as guilt and both parties are entitled to complete, unedited copies.

Do not offer souvenir copies of facility-made videotapes.

Although legal concerns can arise in the performance of any medical procedure, they are of increasing concern in the field of cosmetic medicine and the use of cosmetic fillers. Most of the legal issues that arise in this context are in the realm of negligence.

Standard of care in negligence actions

Any analysis of physician negligence must first begin with a legal description of the elements of negligence. There are four required elements for a cause of action in negligence. They are: duty, breach of duty, causation, and damages. The suing plaintiff must show the presence of all four elements to be successful in his / her claim.

The duty of a physician performing cosmetic filler injections is to perform that cutaneous laser procedure in accordance with the standard of care. Although the elements of a cause of action in negligence are derived from formal legal textbooks, the standard of care is not necessarily derived from some well-known textbook. It is also not articulated by any judge. The standard of care is defined, by some, as: ‘whatever an expert witness says it is, and what a jury will believe’. In a case against any physician performing procedures with cosmetic fillers, the specialist must have the knowledge and skill ordinarily possessed by a specialist in that field, and have used the care and skill ordinarily possessed by a specialist in that field in the same or similar locality under similar circumstances. A dermatologist, plastic surgeon, a physician extender, and for that matter an internist performing practicing filler injections will all be held to an equal standard. A failure to fulfill such a duty may lead to loss of a lawsuit by that individual. Appropriate documentation, including the use of photography, is part of that duty. If the jury accepts the suggestion that the provider mismanaged the case and that the negligence led to damage of the patient, then liability will ensue. Conversely, if the jury believes an expert who testifies for a defendant doctor, then the standard of care in that particular case has been met. Appropriately documented photography may be part of that duty. In this view, the standard of care is a pragmatic concept, decided case by case, and based on the testimony of an expert physician. The sued physician, or non-physician, is expected to perform the procedure in the manner of a reasonable physician. He / she need not be the best in their field, but rather need only perform the procedure in a manner that is considered by an objective standard as reasonable.

It is important to note that, where there are two or more recognized methods of using cosmetic fillers (fanning technique versus bolus injections), a physician does not fall below the standard of care by using any of the acceptable methods even if one method turns out to be less effective than another method. Finally, in many jurisdictions, an unfavorable result due to an ‘error of judgment’ by a physician is not, in and of itself, a violation of the standard of care if the physician acted appropriately prior to exercising his / her professional judgment.

Evidence of the standard of care in a specific malpractice case includes laws, regulations, and guidelines for practice, which represent a consensus among professionals on a topic involving diagnosis or treatment, and the medical literature including peer-reviewed articles and authoritative texts. In addition, obviously, the view of an expert is crucial. Although the standard of care may vary from jurisdiction to jurisdiction, it is typically defined as a national standard by the profession at large.

Most commonly for litigation purposes, expert witnesses articulate the standard of care. The basis of the expert witness, and therefore the origin of the standard of care, is grounded in the following:

The witness’s personal practice, and / or

The practice of others that he has observed in his experience, and / or

Medical literature in indexed peer-reviewed publications, and / or

Statutes and / or legislative rules, and / or

Courses where the subject is discussed and taught in a well-defined manner.

The standard of care is the way in which the majority of the physicians in a similar medical community would practice. It is the method by which other cosmetic physicians deal with their daily performance of cosmetic dermatology. If, in fact, the expert his / herself does not practice like the majority of other physicians, then the expert will have a difficult time explaining why the majority of the medical community does not practice according to his / her ways. Photography can very clearly document both clinical approach and technique.

It would seem then that, in the perfect world, the standard of care in every case would be a clearly definable level of care agreed on by all physicians and patients. Unfortunately, in the typical situation the standard of care is an ephemeral concept resulting from differences and inconsistencies among the medical profession, the legal system and the public.

Clinical recommendations, guidelines, and policies

At one polar extreme, the medical profession is dominant in determining the standard of care in the practice of medicine. In such a situation, recommendations, guidelines, and policies regarding varying treatment modalities for different clinical situations published by nationally recognized boards, societies, and commissions establish the appropriate standard of care. Even in some of these cases, however, factual disputes may arise because more than one such organization will publish conflicting standards concerning the same medical condition. Adding to the confusion, local societies may publish their own rules applicable to a particular claim of malpractice.

Thus, in most situations the standard of care is neither clearly definable nor consistently defined. It is a legal fiction to suggest that a generally accepted standard of care exists for any area of practice. At best there are parameters within which experts will testify. Unfortunately, owing to the increased acceptance of cosmetic dermatology, and unrealistic expectations by the public, physicians may sometimes run the risk of being held to an unrealistic and unattainable standard of care. But, in the end, it is the physician community that establishes that standard of care. For example, most would suggest that the safest technique for filler injections is to have all patients stop the use of aspirin prior to the injections. However, keeping a patient on such blood thinners may still be within the standard of care.

American physicians have in recent years put forth substantial efforts toward standard setting, specifying treatment approaches to various conditions. Clinical practice guidelines, position statements, and practice guidelines have been developed by specialty societies such as the American Academy of Dermatology, the American Society for Dermatologic Surgery, and the American Society for Aesthetics in Plastic Surgery. These guidelines as they pertain to cosmetic filler injections stipulate both who can and who cannot perform various treatments and in what setting non-physicians can use fillers. The Institute of Medicine has defined such clinical guidelines as ‘systemically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances’. Such guidelines represent standardized specifications for performing a procedure or managing a particular clinical problem.

Such clinical guidelines raise thorny legal issues. They have the potential to offer an authoritative and settled statement of what the standard of care should be for a given treatable condition. Although they do not represent law, a court would have several options when such guidelines are offered as evidence. Such a guideline might be evidence of the customary practice in the medical profession. A dermatologist, or physician extender working for that dermatologist, acting in accordance with the guidelines would be shielded from liability to the same extent as one who can establish that she / he followed professional customs. The guidelines could play the role of an authoritative expert witness or a well-accepted review article. Using guidelines as evidence of professional custom, however, is problematic if they are not necessarily consistent with prevailing medical practice. This is a common problem in the field of cosmetic dermatology, where many members have chosen not to follow their professional societal guidelines.

Clinical guidelines have already had an effect according to surveys of malpractice lawyers. A widely accepted clinical standard may be presumptive evidence of due care, but expert testimony will still be required to introduce the standard and establish its sources and its relevancy.

Professional societies also often attach disclaimers to their guidelines, thereby undercutting their use in litigation. The American Medical Association (AMA), for example, calls its guidelines ‘parameters’ instead of protocols intended to significantly impact on physician discretion. The AMA further suggests that all such guidelines contain disclaimers stating that they are not intended to displace physician discretion. Such guidelines, in this situation, could not be treated as conclusive.

Plaintiffs usually will use their own expert, as opposed to the physician’s expert, to define the standard of care. Although such a plaintiff’s expert may also refer to clinical practice guidelines, the physician’s negligence can be established in other manners as well. These methods include: (1) examination of the physician defendant’s expert witness, (2) an admission by the defendant that he / she was negligent, (3) testimony by the plaintiff, in a rare case where he / she is a medical expert qualified to evaluate the allegedly negligent physician’s conduct, and (4) common knowledge in situations where a layperson could understand the negligence without the assistance of an expert.

Committee records and reports

Rarely are cosmetic dermatology practices located within either hospitals or certified ambulatory care centers. In such situations, though, a plaintiff may seek hospital committee proceeding minutes about the allegedly negligent physician. The plaintiff may request production of a committee’s minutes or reports, set forth ‘interrogatories’ about the committee process and / or outcome, or seek to depose committee members about committee discussions. If the plaintiff is suing the cosmetic dermatologist, whose work was reviewed by the committee, the discovery process may seek to confirm the negligence of the professional or to uncover additional evidence substantiating the plaintiff’s claims. Such ‘discovery’ requests are often met with a claim that information that is generated within or by a hospital committee is not discoverable. Courts have ruled that the discovery protection granted to hospital quality review committee records prevents the opposing party from taking advantage of a hospital’s careful self-assessment. The suing plaintiff must utilize his or her own experts to evaluate the facts underlying the incident. It is felt, by the courts, that such immunity of committee proceedings protects certain communications and encourages the quality review process. External access to committee investigations, it is argued, stifles candor and inhibits constructive criticism felt to be necessary for a quality review process. Constructive, objective peer criticism might not occur in an atmosphere of apprehension that one doctor’s suggestion will be used as a denunciation of a colleague’s conduct in a malpractice suit.

When a plaintiff seeks discovery of a facility or hospital incident report, rather than a committee proceeding, policy considerations are somewhat different. Incident reports kept in the medical records, and possibly filed by a staff member, are often more directly related to a single claim for malpractice than would be general committee investigations. Courts are usually less willing to protect such incident reports.

Innovative / experimental approaches

Because the field of cosmetic dermatology has evolved rapidly over the past decade, physicians are quick to try new innovations and experimental concepts. Such innovations partially explain the excitement of this growing field. New filler injection approaches may fall into a regulatory gap not covered by the strict regulations for the filler itself. Licensing through the US Food and Drug Administration (FDA) carefully regulates such fillers. A variety of dermal fillers are used in an off-label, non-FDA cleared manner. Such ‘experimentation’ is, in fact, an almost necessary reason for the explosive growth of cosmetic dermatology. Most human experimentation is governed by regulations of the Department of Health and Human Services. The regulations require that an institution sponsoring research must establish an IRB. Such an organization will evaluate research proposals before any experimentation begins to determine whether human subjects might be ‘at risk’ and, if so, how to protect them.

It is not usually difficult to determine whether a new cosmetic dermatologic procedure is being used experimentally. It is, however, very difficult to determine whether an actual given procedure is experimental. Cosmetic dermatologists often view themselves as artists (not experimenters) in addition to scientists, custom tailoring a treatment for a particular condition. Such approaches can lead to a bad result with variable outcomes in the courts. A dermatologist trying a filler for penile enhancement might also be seen as an innovator. Such a physician would be no more liable for straying from his duty than the physician who might use a standard procedure, with the same complication, for the same procedure.

In fact, most clinical innovation falls between standard practice and experimental research. Much of this innovation is unregulated by the government. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research has suggested that any ‘radically new’ procedure should be made the object of formal research at an early stage in order to determine whether such a procedure is safe and effective. It could be argued that some of the cosmetic dermatology procedures that have evolved using previously FDA-cleared devices or drugs might be considered radical; most clearly are not.

Establishing negligence

It is clear then that, in order for the plaintiff to win his / her negligence cause of action against the cosmetic physician filler injector, the patient must establish that the physician had a duty of reasonable care in treating him / her and had in fact breached that duty. However, that breach must also lead to some form of damage. A mere inconvenience to the plaintiff, even in the setting of a physician’s breach, will usually not lead to physician liability in a case of action for negligence. Appropriate photography will go a long way in establishing whether or not the standard of care has been followed.

The physician extender

These issues become magnified when being performed by a physician extender. The issue as to who can perform those procedures is governed by state law – not by any specialty society. Such laws vary from state to state and will always outweigh a more liberal society guideline. Where the non-physician is legally performing cosmetic dermal filler injections, and where that physician extender is performing within the scope of her duty, both the extender and the physician will be found liable for physician extender-caused negligence.

Conclusion

In the end a variety of legal and ethical issues can arise when a physician is using a dermal filer. Most commonly these relate to issues of medical malpractice. It is often difficult to predict in any given malpractice cause of action what the ultimate outcome will be. However, a clear understanding of the aforementioned principles will markedly decrease the chance of a physician losing any negligence cause of action brought against him. Appropriately taken photography, with proper consent, can go a long way to protecting the cosmetic filler injector.

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Consent for photography: legal issues

Introduction

Photography

Regulation

Fillers used in investigational studies

Medical education, teaching, or publicity

Media photography during filler injections

Telemedicine or internet

Policies

Maintenance of photographs and other images

Disclosure

Liability reduction

Standard of care in negligence actions

Clinical recommendations, guidelines, and policies

Committee records and reports

Innovative / experimental approaches

Establishing negligence

The physician extender

Conclusion

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Consent for photography: legal issues

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