AAPB Board recommendations for personal use of “biofeedback” hardware, software, and mobile sensors

AAPB differentiates devices used for biofeedback as:

Bound Systems: Systems that are designed to be used by individuals with limited expertise in biofeedback and applied psychophysiology (e.g., reading and interpreting physiological data, designing evidence-based treatment plans, modifying device for optimal application). Most systems have limited feedback modalities and limited forms of feedback to the patient/client. Often, comparative data bases are pre-selected, normative values are assumed, and algorithms generating data for the patient/client are proprietary. Responsibility for efficiency relies largely on the producer of the equipment. End-user should take caution interpreting the data. Technicians and Health-care providers using such devices should follow BCIA code of ethics, as well as all national and state laws related to their professional license.

Unbound Systems: Advanced systems that are designed to be used by individuals with expertise in biofeedback and applied psychophysiology (e.g., reading and interpreting physiological data, designing evidence-based treatment plans, modifying device for optimal application). Knowledge of states of body and brain functioning is required. Not recommended for use by individuals without advanced training in biofeedback and psychophysiology—certification by BCIA is and national/regional/state licensing board strongly recommended. Technicians should provide care only under supervision. Systems require elevated level of administrative and interpretive skill and broad clinical knowledge. Programs, protocols, and treatment parameters are discrete and determined by individual patient/client need.  Progression measures are often stochastic (compared and contrasted to individualized pretests as well as clinical and normative data bases).

Mobile applications or unregulated systems:Bound and often unregulated devices sold and used indiscriminately. Often without supporting empirical data. Usually proprietary. Mechanisms of action frequently undetermined.

Advisory Note:
Biofeedback equipment is classified by the Food and Drug Administration (FDA) as a Class II Medical Device. Medical devices have varying levels of risks and benefits and the degree of regulation is based on the level of control that the FDA considers being necessary to assure the safety and effectiveness of the device. There are three levels of classification. Class I devices have the lowest level of regulation because they present a minimal level of risk for harm. General controls such as registration, following the Good Manufacturing Practices, and labeling are considered sufficient for ensuring safety and effectiveness. Class II devices are those for which special controls are considered necessary by the FDA for assuring safety and effectiveness and where there are existing methods for providing such assurances. Special controls can include guidance documents, special labeling requirements, mandatory performance standards, and post market surveillance (www.fda.gov/cdrh/dsma/dsmaclas.html). Class III devices require the most stringent regulation because insufficient information exists for assuring safety and effectiveness and these devices are generally those that support or sustain human life.

Consumers should be advised that certain mobile applications or low to moderately technical devices may hold themselves out to the public as “biofeedback”, when in fact they are not regulated as such. They may have poor ability to accurately detect a bodily signal. They may not have research to support the algorithms of data analysis. They may not have an evidence base that their use can modify individual functioning in any positive way (or that is does not produce harm). Please be careful when using such devices and ask a licensed health care provider regarding application of such devices for personal use.

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