Neurofeedback, biofeedback, EEG, hypnosis, Reiki, energy healing … how do practitioners evaluate, and handle, malpractice liability risk? Do they have obligations of informed consent? What about the FDA? Let’s focus for now on neurofeedback.
Malpractice Liability – Neurofeedback
What kind of malpractice liability applies to neurofeedback or neurotherapy?
Most likely, few cases if any have emerged.
We know that malpractice (professional negligence) is generally defined as, delivering services below the standard of care, and thereby injuring the patient. The standard of care is usually testified to by an expert in the same field. So for example, we have a medical standard of care applicable to cardiology; a chiropractic standard of care; and so on.
There are probably questions as to what, in the first place, is the standard of care for neurofeedback—and who can or should testify about the standard of care; and how deviating from standard of care can cause injury.
Remember that the standard is set by the profession. So if a psychologist is under investigation, then a psychologist will probably testify as to the psychological standard of care for the treatment of the condition in question.
Must Practitioners Give Informed Consent About Risks & Benefits of Neurofeedback or Neurotherapy?
Informed consent is part and parcel of any healthcare practice. It is legally and ethically required.
Failure to provide adequate informed consent, can be a second theory of malpractice if the patient is injured.
The ISNR Standards state:
Neurofeedback practitioners keep accurate records of the services provided. Such records should include information documenting an informed consent process, disclosure of the practitioner’s policies and procedures (including procedures in case of emergencies), dates of service, fees charged and payments received, assessment information, types of services, and neurofeedback and ancillary treatment procedures that were used. Any side effects or adverse reactions, as well as regular notations of progress, should be chart noted. Appropriate protections are provided to ensure confidentiality of records and compliance with the Health Insurance Portability and Accountability Act (HIPPA), and confidential information is not released without appropriate written consent of the client or his or her legal representative. Practitioners are obligated to insure that information recorded and/or communicated electronically is appropriately protected and breaches in this information are reported to patients.
These standards clearly include informed consent.
Is it Malpractice Not To Inform Patients About Neurofeedback As a Therapeutic Option?
This is an interesting question.
In general, informed consent required discussion and disclosure of all reasonably feasible risks, benefits, and alternatives to a given course of treatment.
Few courts have held that failure to give informed consent of a complementary and alternative medicine (CAM) modality—or an emerging therapeutic approach—constitutes malpractice.
However, I have argued in my book, Complementary and Alternative Medicine: Legal Boundaries and Regulatory Perspectives, that failure to provide informed consent of a viable therapeutic approach—conventional or CAM, not matter what the label—should constitute malpractice; the flip side being that the clinician has a duty to bring up, for example, that neurofeedback may be a useful approach.
This is pushing the legal envelope to support a more holistic and inclusive healthcare system.
Is Neurofeedback, “Complementary & Alternative Medicine”? It is “Integrative?”
Some consider neurofeedback to be CAM or part of integrative medicine.
An American Psychological Association (APA) continuing education course says:
If you have used meditation, biofeedback, hypnosis or progressive muscle relaxation, you are part of the growing field of CAM, a group of diverse medical and health-care systems, practices and products that are not generally considered part of conventional medicine. While often grouped together, complementary and alternative medicine are actually two separate forms of treatment. Complementary medicine is used in addition to conventional forms of medicine. Alternative medicine is used instead of conventional medicine.
I spent an earlier part of my professional career, while on faculty at Harvard Medical School at the Division for Research and Education on Complementary and Integrative Medical Therapies, working within what I call the “war of epithets:” is it CAM or not? (Are you a friendly or a hostile or a neutral? Those were the times.)
It’s a new world. The APA course says: “Now, incorporating CAM into both daily life and health care is part of a larger movement that focuses on more integrative and holistic care. The psychology profession — with its strong history of integrating innovations — is among those embracing CAM.”
The course discusses: dietary supplements; meditation; chiropractic; aromatherapy; massage therapy; yoga; progressive muscle relaxation; spirituality, religion, and prayer; movement therapy; acupuncture; Reiki; biofeedback (including neurofeedback or EEG) (“an area of CAM that can be integrated into ongoing treatment with relative ease by appropriately trained psychologists using biofeedback equipment”); hypnosis; and music therapy.
The course states that Ethical Principles of Psychologists and Code of Conduct [APA Ethics Code] (APA, 2010) are relevant to the use of CAM. These principles include:
Ethical Standards 3.10, Informed Consent, and 10.01, Informed Consent to Therapy, require psychologists to share sufficient information with clients at the outset of the professional relationship so that clients can make informed decisions about their participation in the proposed treatment. Essential components of the informed-consent process include a review of reasonably available options and alternatives, along with a discussion of the potential risks and benefits of each. To fulfill this ethical obligation, each psychologist will want to discuss available treatment options, including various CAM modalities whose use for particular difficulties is supported by the scientific literature.
It makes sense that ethical standards such as informed consent apply whether a therapy is labeled conventional or CAM or integrative.
FDA Approval and Off-Label Medical Device Use
In general, FDA regulates biofeedback devices as Class 2 medical devices.
The relevant regulation provides:
PART 882 — NEUROLOGICAL DEVICES
Subpart F–Neurological Therapeutic Devices
21 CFR 882.5050. Biofeedback device.
(a)Identification. A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient’s physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.
(b)Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to 882.9.
Note that the above clearance does not approve treatment of conditions such as depression, anxiety, ADHD, and so on.
Advertising by a manufacturer or distribution for an unapproved use would be considered misbranding under relevant law.
However, physicians commonly use, and discuss with their patients, such “off-label” use of medical devices. This is considered the practice of medicine, which is regulated by states under the 10th Amendment power to promote and protect health, safety, and welfare, and generally the FDA is ‘hands-off’ when it comes to such clinical uses.
From a legal and ethical standpoint, off-label use represents a delicate balance between the regulatory objective of protecting patients from unsafe or ineffective drugs and medical devices on the one hand, and, on the other hand, the prerogative of physicians to use their professional judgment in treating patients.
Maxwell J. Mehlman, J.D., Director of the Law-Medicine Center, Case Western Reserve University School of Law.
See also Off-Label Use and Off-Label Drug Promotion and Marketing Yields Significant Penalties; and, Conflict of interest issue with doctor promoting off-label use.
If you have specific legal questions about neurofeedback legal issues, consult a healthcare and FDA lawyer.
Contact our healthcare law and FDA attorneys for legal advice relevant to your healthcare venture.
