products. Companies producing these devices are eager to market and deliver their products and services directly to defined demographic consumer groups for certain low-risk health conditions. The marketing campaigns and business models they use for national expansion, including how licensed practitioners are involved, depend upon the application of state professional practice laws.Professional practice laws govern who can collect patient data, administer tests, make diagnoses, determine treatment plans and issue prescriptions, among other things. These laws vary by state and are based on product-by-product and professional license-by-license categories. The laws may dictate the relationship between the device and licensed practitioners and ultimately determine a company’s organizational structure. Further, professional practice laws may define the content of advertising for the medical devices and the health conditions they address. Typically, violations of these professional practice laws are classified as misdemeanors.
Many of these laws were enacted decades ago when legislators never contemplated telehealth and the advanced technology of today’s medical devices. Often, state professional licensing boards will apply the laws to these innovative devices – even if the laws may not specifically address them; for example, they may allege that the device company is illegally engaged in the practice of medicine. Where a board determines that the device services can be delivered only by licensed practitioners or takes actions that effectively exclude the device company from the market, the board’s motivations need to be scrutinized. Although a professional licensing board (comprised of the practitioners the board regulates) can protect the public’s health and safety, a board cannot engage in anticompetitive conduct aimed at protecting their own financial interests as licensed practitioners. See North Carolina Board of Dental Examiners v. Federal Trade Commission, 135 S. Ct. 1101 (2015).
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