As with integrative care practices, med spas can present unique legal issues and raise malpractice concerns. Their establishment creates an unsafe working environment with illegal business models such as corporate practice of medicine violations, fee splitting arrangements and “renting” physicians’ licenses by businesses to provide cosmetic treatments.
Florida law limits physicians to acting as medical directors for medispas when present on site; otherwise, PA or NP medical directors working under protocols written and reviewed by physicians must assume this role.
Legality
American medical spas are experiencing unprecedented growth thanks to technological innovation and consumer demand. State governments are struggling to keep up with this industry’s meteoric expansion; as a result, many Med Spas operate within an unclear legal environment where services like hairstyling and manicures exist alongside diagnostic tests and surgeries offered at traditional clinics.
To operate treatments at a Med Spa that use FDA medical devices, a professional license from either a board-certified physician, an advanced registered nurse practitioner (ARNP), or physician assistant is necessary. Cosmetologists, facial specialists and massage therapists do not qualify to provide these services, which require knowledge about how these devices work as well as safe usage practices.
Med Spas are legally limited by the definition of “medical device” as set forth by Section 201(h) of the Federal Food, Drug, and Cosmetic Act; this term includes any instrument, machine, contrivance implant or in vitro reagent designed to treat, cure mitigate prevent or diagnose disease in human beings. Even common household devices like tongue depressors or thermometers could fall within this scope if approved by FDA.
This expansive definition makes it difficult to ascertain which services are permitted under state law. For instance, certain states prohibit Botox sales without medical license from certain healthcare providers performing treatment; similarly there may be states allowing only specific healthcare providers to administer laser therapies.
To avoid legal complications, med spa owners must remain knowledgeable of state laws in their state. Consulting a med spa attorney may help.
Medical spas offering procedures such as CoolSculpting that is regulated by the Center for Devices and Radiological Health (CDRH) must abide by its home-use device regulations; this requires creating a written protocol as well as training both patient and care provider on how best to perform this procedure.
Risks
Med spas have proliferated rapidly across the United States, offering traditional cosmetic services as well as newer medical devices for aesthetic use. Most medspa owners do not fall under either licensed physician ownership or mid-level practitioner (MLP) status; over one third are owned by estheticians, general entrepreneurs or business managers instead.
Amid the growth of medspas has come an increase in reported issues related to these businesses, most often laser and light treatments used at these businesses. According to one 2003 study by the American Society for Dermatologic Surgery, laser and light treatments caused most incidents; scarring, skin irritation, nerve damage, permanent disfigurement were reported by many participants; traditional cosmetic procedures have sometimes caused even greater harm; for instance a woman lost her leg following Botox injection at a spa.
Medical spas and companies supplying them with devices must stay apprised of legal developments impacting these businesses and operate them legally compliantly. An experienced attorney could assist in navigating through the maze of regulations governing this field of business.
The Food and Drug Administration regulates medical devices based on class. Class I devices such as bandages or handheld surgical instruments pose minimal risk, while essential class III devices requiring stringent clinical trials fall under class III regulations. Medspa owners may be eligible to acquire some class I or II devices from the 510(k) process of the FDA; for classes III or IV devices an Investigational Device Exemption might be necessary before they can go onto the market.
As is common with small businesses, med spas have limited profit margins that make compliance costs difficult to cover; those operating outside compliance may incur fines or civil penalties as a result, as well as suffering reputational harm that is difficult to repair. By hiring an attorney experienced in dealing with compliance matters for these establishments or providing medical devices to medspa clinics can mitigate these risks and continue providing cutting-edge treatments while meeting legal obligations.
Safety
The FDA is an extremely tightly regulated agency that sets standards for what products can be considered safe to use, from cosmetic and medical procedures to spa services. Their regulations cover various industries – cosmetic and med spa operations in particular must take various safety measures in order to minimize injuries resulting from cosmetic procedure errors.
As its name implies, a medical spa (med spa) is a type of beauty salon offering both traditional cosmetic services as well as newer medical devices for aesthetic use. They tend to be small privately-held businesses run by one owner; typically neither a physician nor mid-level practitioner such as an APNRNRNRNRARPAP are among these professionals – more likely estheticians or general entrepreneurs!
Before their devices can be sold in the US, medical device manufacturers must submit them for review and approval by the FDA. Devices are classified according to their level of risk posed, with Class I devices such as bandages or handheld surgical tools having lower risks while Class III devices such as pacemakers and deep brain stimulators pose greater dangers.
Defective devices can often result in serious injuries or even deaths, prompting reports to be submitted to the Food and Drug Administration and further investigations to be undertaken. If necessary, actions will also be taken against manufacturers who did not inform consumers about potential issues with their product.
Before providing treatments that use FDA-approved devices to a client, physicians must conduct a Good Faith Exam – similar to how doctors must complete a prescription drug exam before prescribing drugs – before providing treatments involving such devices. Furthermore, doctors cannot use off-label usage without prior permission of FDA.
Medical spa owners and suppliers should stay abreast of legal developments to operate their businesses legally compliantly, such as laws regarding corporate practice of medicine, physician responsibility allocation and state telehealth regulations. Legal representation experienced with medspa operations can provide invaluable insight on this topic and help both parties operate within compliance of applicable laws.
Compliance
State laws and regulations vary greatly when it comes to medical spa operations, with Florida offering relatively friendly regulations regarding their creation, ownership and operation. Although Florida may provide favorable legislation for creating, owning and operating medical spas it’s still vital that one stay informed regarding state rulings and regulations to avoid breaking them.
Many procedures such as laser hair removal or injectable dermal fillers fall under the realm of medical practice and must be performed by licensed healthcare providers. Therefore, med spas must always have properly trained and licensed staff on-site at all times, as well as conducting initial exams known as Good Faith Exams before treating clients – this allows the med spa to build an appropriate physician-patient relationship and determine if their client is an ideal candidate for the procedure they’re interested in undergoing.
These exams may be conducted by a licensed healthcare professional, physician assistant, or nurse practitioner and typically focus on areas receiving treatment as well as discussing past medical history and current medications being taken by the client.
Before providing nonsurgical cosmetic treatments to clients, a Good Faith Exam should be performed. This allows a medical spa to legally provide these types of services while assuring patients are in good health prior to proceeding with treatments. In order for this procedure to remain legal and ensure patient safety, medical spas must keep a detailed record of each Good Faith Exam conducted and refer back to this record when performing treatments as it will help medical professionals evaluate if certain methods are safe for a given client.
The FDA has created detailed regulations for medical device manufacturers and initial distributors. To comply with them, manufacturers and initial distributors must register with them, designate a US agent, notify of any significant modifications to their product or clinical trial, report adverse events to them as required and report any serious or life-threatening side effects from a device they sell.
