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FDA Makes Statement on Medical Device Reporting Changes

Posted By Administration, Tuesday, June 25, 2019

device

By Patrick O’Brien, JD, legal coordinator for the American Med Spa Association

On June 21, the U.S. Food and Drug Administration (FDA) announced several changes meant to improve and streamline its reporting requirements for medical devices. This likely will be a welcome change for device manufacturers and hopefully reduce their compliance burden. In the press release, which you can click here to read, Jeffrey E. Shuren, MD, JD, the director of the FDA’s Center for Devices and Radiological Health, discusses three major changes to the agency’s strategy for tracking and monitoring medical device adverse events. Under current FDA rules, device manufacturers are required to submit a medical device report (MDR) within 30 days if the use of a medical device results in serious injury or death. In order to monitor trends, FDA has implemented several voluntary reporting processes for manufacturers to follow for device malfunctions that do not result in serious injury or death.

The agency announced the discontinuation of one such voluntary reporting process. The Alternative Summary Reporting (ASR) Program was implemented in 1997 and allowed manufacturers that were granted exemptions on particular devices to submit batched reporting for devices that had certain well-known risks. This program included exemptions for dental implants, implantable defibrillators and pacemaker electrodes, totaling 108 such devices in all. This program had been being phased out since 2017, first through the institution of a supplementary reporting process and now with the full discontinuation.

It will be replaced by a new program known as the Voluntary Malfunction Summary Reporting (VMSR) Program, which allows manufactures to report incidents quarterly. However, this is only for minor incidents—serious injury and death reports are still required within 30 days. One of the goals of this program is to make the reported data compatible with FDA’s information database, known as MAUDE; the ASR Program’s lack of compatibility with MAUDE was one of its shortcomings. FDA hopes to streamline MAUDE and make its data more user-friendly and accessible, all with the aim of monitoring and catching defective or problematic devices as quickly as possible.

In addition, FDA is instituting a new data monitoring system that can analyze data continuously and automatically using algorithms. The system is called the National Evaluation System for Health Technology (NEST), and it has been in development since 2012. It utilizes large sets of data tied to each device’s unique identification codes. FDA hopes that it will be able to better protect patients by identifying trends and issues earlier than a human would be able to.

FDA is making these changes in order to better protect the public and the users of these devices. The changes should also make it easier for device manufacturers to submit their required reports. And if all of these FDA acronyms make your head spin, you should consider attending one of AmSpa’s Medical Spa & Aesthetic Boot Camps. There, you’ll learn how to set your business apart from your competitors, including the latest in technology and the newest devices.

Tags:  AmSpa's Med Spa & Aesthetic Boot Camps  Med Spa Law  Med Spa Trends 

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This Name’s Taken: The Importance of Trademark Law in Your Practice

Posted By Administration, Monday, June 24, 2019

trademark law

By Alex R. Thiersch, JD, CEO of the American Med Spa Association (AmSpa)

A medical aesthetic practice’s brand is among its most valuable assets. When your patients think of your facility, your brand is the first thing that enters their minds. Therefore, it is vital that you take the utmost care in creating and protecting your brand, and obtaining trademark protection for it is an important part of this process. Whether you are already operating a practice or are planning to open one in the near future, this is important information to have. Here is a quick primer.

In on the Ground Floor

The American Medical Spa Association (AmSpa) recommends that before opening, dermatology practices, cosmetic surgical practices, and medical spas do a trademark search for the name that they plan on using. This isn’t necessarily important if you are a plastic surgeon who plans on using his or her name for the practice (for example, Dr. Meredith Anderson’s Plastic Surgery), but if your practice is a medical spa that is planning to use a name such as, say, Effervescence Medical Spa, you need to make sure that this name or a confusing similar name is not already in use.

“[Businesses] should engage an attorney experienced with trademark law to perform a searches to determine whether there may be any conflicts before they even hire a graphic designer to develop a logo or business name,” says Jim Stanford, partner at ByrdAdatto, a business and health care law firm based in Dallas. “I’ve run into problems so many times where a company has spent all sorts of money and resources developing its name and logo only to find out that there’s a conflicting use out there and they have to change everything. This typically occurs when they receive a cease and desist letter from the other party’s attorney or when they are seeking trademark registration.”

A properly conducted trademark search is a much more labor-intensive process than one might imagine.

“Typically, we hire an outside company such as Corsearch, and they’ll provide a comprehensive report that’s usually 200-300 pages long,” Stanford explains. “We review the various uses in the report that might be similar or conflicting with the proposed mark. If there aren’t any conflicts at all or registration appears feasible subject to potential challenges that are acceptable to the client, we’ll proceed with the application process. But if it looks like there might be a problem, we point that out to the client and discuss the risks, and sometimes we advise the client not to use their proposed trademark and search for another.”

The attorney may give the client the go-ahead to submit an application, but that doesn’t mean that the process is over. First, the attorney and the client must decide what elements of the branding they need to protect.

“The application part is somewhat administrative—we need to identify the goods and services that are associated with the mark so we can determine what classes they go into, prepare a description of the goods or services, and put the application together,” Stanford says. “If the client has a logo or design element to the mark in addition to the word mark itself, its often advisable to seek registration of both through separate applications to obtain broader protection.”

After the application is completed and submitted, the waiting game begins.

“Once the application is finalized, prosecution of the application, that is, seeking registration with the U.S. Patent and Trademark Office (USPTO) is a pretty lengthy process,” Stanford says. “We’re not going to hear back from the USPTO for at least four months. From there, if there are any issues or conflicts, we have to address them with the USPTO examining attorney, and there may be some back and forth. From my experience, the quickest a trademark may be registered with the USPTO is probably 9-10 months or so—it typically takes close to a year or longer to finally get it registered, if you don’t have any major issues.”

The total cost of the trademark process can vary greatly from case to case, but generally speaking, it is a somewhat notable financial commitment, especially since the medical spa or practice is just beginning its journey.

“The more classes you have, the more the initial cost is,” Stanford says. “The initial filing and search and clearance is typically $2,000-3,000, on average, but it’s much better to spend this money up front than to have to deal with potential conflicts or lawsuits in the future that will cost tremendous amount more to resolve.”

A Question of Complexity

Stanford recommends that those who seek trademark protection for their medical spa or medical practice’s name and logo make sure that it meets certain conditions before the filing process begins.

“The client [should do] their best to pick something that is not descriptive of what they’re doing, because that hurts the value of a mark,” he says. “The marketing world and clients in general prefer to select names and trademarks that either say or describe exactly what they’re offering and, from a trademark law perspective, this weakens the trademark or ability to get it registered as a trademark. [For example], ‘Star Medical Spa and Skin Care Center’—would be a challenge and likely would not get registered on the principal register as a trademark because it’s descriptive of the services that are associated with the mark and the only non-descriptive element is ‘Star’. The more the mark is arbitrary or at least only suggestive of the goods or services associated with the mark, the stronger the trademark will be, and the better chance of obtaining registration. Assuming there were no conflicting uses, ‘Effervescence’ as the sole trademark and only word in any logo or design mark would be a much better mark. When you put your sign on your wall or launch your website, you can always  use your trademark next to the words ‘medical spa’, for example, but they should not be part of the trademark itself.”

Investigating Infringement

Making sure that your practice’s brand isn’t already in use is important because the penalties for trademark or trade name infringement can be severe.

“If another party has a trademark registered with the USPTO and your mark is infringing, you have constructive notice, even if you didn’t actually know about the other mark, and you could potentially get hit with the other party’s actual damages, a reasonable royalty, and damages equal to your profits,” Stanford said. “Including possible treble damages if your infringement was determined to be willful--it could be a nightmare and it could cost you  your business.”

A trademark violation could lead to major financial problems for a medical aesthetic business. Even if you’ve registered a trademark with your state’s department of business services (which is usually associated with the secretary of state’s office), you may still be infringing on a national mark, which could lead to major problems.

Typically, however, the party owing the registered trademark will send a cease-and-desist letter and you should have the opportunity to negotiate a settlement. Although this certainly is preferable to court, the cost can still be substantial.

“The legal fees in just settling that situation could easily be $10,000-30,000, depending on how much it goes back and forth,” Stanford says. “In any potential dispute, the legal fees add up very quickly.”

The winners of these disputes tend to be the entity with the deeper pockets, even if they don’t have a legal position that ultimately would be successful in court—they simply want to cut out competition. If your medical practice is just starting out or establishing itself in the industry, chances are that won’t be you.

“I’ve had matters where I didn’t believe our client was infringing, but the party on the other side had more than enough money to pound our client into the dirt and we had to concede as our clientcouldn’t afford or at least justify the legal fees to fight it,” Stanford says.

A business can sink tens of thousands of dollars into marketing, product development, and branding, only to have to choose whether to redo all their branding because they’ve been hit with a trademark claim, or spend at least as much money on attorneys to fight an infringement claim, even though they have a fairly decent shot of winning in the end. The enormous expense associated with court cases such as these underscores the importance of making sure that your trademark protection is squared away as soon as possible.

“You spend $5,000 up front to try to make sure you do it right to avoid $50,000 to change your mark once you find out you have a conflict,” Stanford states.

Making Your Mark

One of the things ByrdAdatto always tells its clients at the beginning is that, if there is a specific name that you want to use, a trademark search should be done and, if advisable based on the situation, a trademark application should be filed. As the medical aesthetic industry grows, brands expand, and more and more large franchises emerge with a great deal of financial backing, it is simply not smart to operate without properly vetted trademark protection. Thanks to the Internet, it is easy to find a business that’s violating a company’s trademark, and you’d better believe that company’s lawyers are actively looking for just that opportunity. You might think you have the greatest name in the world, but if you can’t actually use it, it will do you far more harm than good.

Tags:  Business and Financials  ByrdAdatto  Med Spa Law  Med Spa Trends 

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Join AmSpa at the Atlanta Medical Spa & Aesthetic Boot Camp

Posted By Administration, Friday, June 21, 2019

loews atlanta

By Alex R. Thiersch, JD, CEO of the American Med Spa Association (AmSpa)

Starting next Saturday, June 29, AmSpa will host its Atlanta Medical Spa & Aesthetic Boot Camp at the Loews Atlanta Hotel. We’re extremely excited for the opportunity to help medical aesthetic professionals develop their practices, and we can’t wait to visit Atlanta again. There’s still time to register for the event—just click here to sign up. Here is a quick overview of the program:

Saturday, June 29

The Boot Camp begins at 8 a.m. with a continental breakfast, followed at 8:30 a.m. with my opening keynote. From there, we will move into the main program:

  • 9 – 10:30 a.m.: The Plan, presented by Bryan Durocher (Durocher Enterprises)—What are the most effective ways to develop a business plan for your medical spa? Medical Spa Consultant Bryan Durocher discusses the ins and outs of the planning process and helps determine how long it realistically takes to open a practice.
  • 10:45 – 11:45 a.m.: The Lessons, presented by Louis Frisina—Every medical spa is different, but the successful ones share several common traits. In this session, Business Strategy Consultant Louis Frisina discusses the qualities that are typically found in practices that bring in a significant amount of revenue.
  • 12:45 – 1:30 p.m.: Medical Aesthetic Hot Topics Panel, featuring Tim Sawyer (Crystal Clear Digital Marketing), James David Brown (Environ Skincare), Helen Haynes (Bellus Medical) and a representative from Galderma—This panel, moderated by yours truly, will feature a spirited discussion of the current issues and events that concern medical spa owners and operators.
  • 1:30 – 3:30 p.m.: The Law, presented by Alex Thiersch (AmSpa) and Jay D. Reyero (ByrdAdatto)—In this presentation, we’ll discuss the long-standing and emerging legal issues that every medical spa owner needs to know about. As you can imagine, there is a lot to cover here, since new concerns seem to be arising daily lately.
  • 4:15 – 5 p.m.: The Treatments, presented by Terri Ross (Terri Ross Consulting)—Learn about the most profitable and popular treatments available to your practice, and find out how to best determine which treatments are right for you based on the state of your practice.
  • 5 – 6 p.m.: The Digital Marketing Ecosystem, presented by Tim Sawyer (Crystal Clear Digital Marketing)—Find out how to effectively spread the word about your medical aesthetic practice and how best to determine what’s working and what’s not. Your practice’s digital presence is more important than ever before, and curating it should be a top priority.

Saturday will wrap up with a cocktail reception from 6 – 7:30 p.m.

Sunday, June 30

Once again, the Boot Camp begins at 8 a.m. with a continental breakfast.

  • 8:30 – 9 a.m.: Anatomy of a $5-Million Med Spa, presented by Alex Thiersch (AmSpa)—Have you ever wondered what the difference is between your medical spa and one that’s mega-successful? It might be less significant than you think. This presentation will show what a $5-million med spa is doing right—and what you might be doing wrong.
  • 9 – 10 a.m.: The Financials, presented by Bryan Durocher (Durocher Enterprises)—At the end of the day, the money you’re bringing in is the most important measure of your practice’s success. This presentation will, among other things, demonstrate how to properly develop a budget and use metrics to determine your med spa’s strengths and weaknesses.
  • 10:30 – 11:30 a.m.: The Long-term Revenue, presented by Brandon and Jenny Robinson (Skin Body Soul MedSpa)—Simply being successful isn’t enough for a medical aesthetic practice; you have to know how to maintain and grow your success. In this session, Brandon and Jenny will show you how to build patient loyalty and move your business forward.
  • 11:30 a.m. – 12:15 p.m.: The Consultation, presented by Terri Ross (Terri Ross Consulting)—As the old saying goes, you never get a second chance to make a first impression. Learn how to put your best foot forward with effective patient consultations—and how to turn them into consistent business.
  • 1 – 2 p.m.: The Team, presented by Bryan Durocher (Durocher Enterprises)—A medical spa is only as good as its personnel, so it’s important to make sure that you hire a staff that can do everything you want it to—and more. In this session, you’ll learn about recruiting, hiring and retaining employees who can make your medical spa dreams come true.
  • 2 – 3 p.m.: The Marketing Plan and Social Media, presented by Brandon and Jenny Robinson (Skin Body Soul MedSpa)—This session will help you determine how to most effectively market your medical aesthetic practice using both traditional methods and cutting-edge techniques.

Also, you’ll have the chance to visit with a number of exceptional vendors during this event. Attend the Atlanta Medical Spa & Aesthetic Boot Camp to check out the latest and greatest from the following companies:

We hope you can join us in Atlanta next weekend. This Boot Camp is a tremendous opportunity to get your medical aesthetic business headed in the right direction and learn some tips and tricks that can take it to the next level. Click here to register!

Tags:  AmSpa's Med Spa & Aesthetic Boot Camps  Business and Financials  ByrdAdatto  Med Spa Law  Med Spa Ownership  Med Spa Trends 

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Proposed Supervision Rule Change Creates Controversy at Texas Medical Board Stakeholders Meeting

Posted By Administration, Wednesday, June 12, 2019

physician supervision

By Patrick O’Brien, JD, legal coordinator for the American Med Spa Association

Last week, the Texas Medical Board held a meeting to solicit feedback from stakeholders on possible changes to medical board rules that are in development. Representatives from AmSpa attended this meeting and had conversations with stakeholders and interested parties. The meeting generated some lively discussion regarding the changes, one of which was for Rule 193.17. This rule provides protocols for physician delegation of “nonsurgical medical cosmetic procedures,” which encompass most of the treatments offered in medical spas.

It is important to understand that this meeting was to discuss rules “in development” that have not been formally proposed or begun the official process of adoption. These developmental rules may change before being officially proposed—if they are officially proposed at all.

The development committee offered two versions of proposed changes for Rule 193.17. The primary proposed change would require offices that provide nonsurgical medical procedures to post a notice in the treatment rooms and lobby that includes the name and license of the delegating physician, as well as information for making complaints to the Board of Medicine.  The specific details of this notice are contained in the current Medical Board Rule 178.

An alternative proposal was also discussed, and it would make three additional changes:

  • Physicians would no longer be able to delegate to unlicensed persons;
  • A physician or midlevel would need to provide onsite supervision whenever procedures are delegated; and
  • The rule would explicitly state that these nonsurgical cosmetic medical procedures constitute the practice of medicine, and facilities providing them would need to be owned by a Texas licensed physician.

The alternative proposed rules generated the most discussion from the stakeholders present. A number of different parties raised concerns and complaints over all three of the proposed amendments. In an email, the Texas Medical Board relayed that these alternative proposed rules would be held for further consideration and possible revision. It assured attendees that it would hold a future stakeholder meeting if these changes were considered again. At present, however, the board is not moving forward to the next stage of the revision process.

The Medical Board also informed attendees that the primary proposal regarding the notice requirements had not received any negative feedback; as such, this change will be presented to the full Medical Board for consideration. The board will consider this change at its June 14 meeting, and if they approve the change, a 30-day public comment period before formal adoption will begin.

Click here to view the present version of the changes that will be presented to the Board. AmSpa will continue to closely monitor these changes and will report any further developments.

Tags:  Med Spa Law  Med Spa Trends 

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Introducing QP

Posted By Administration, Tuesday, June 11, 2019

qp first issue

By Alex R. Thiersch, JD, CEO of the American Med Spa Association (AmSpa)

When we first started AmSpa in 2013, we knew that, ultimately, we would start a magazine. It was a natural evolution and was always in our plans; however, we always wanted it to be different. We didn’t want to simply put out another trade publication or industry magazine. Don’t get me wrong—there is a place for those publications in the world, and they bring great value to the industry.

But, as we looked at the landscape of aesthetics, there was nothing that truly spoke to medical spas. The medical spa industry is like nothing else in aesthetics. It’s its own unique industry, with its own characteristics and unique traits. These aren’t dermatology practices and they’re not surgery centers. They are definitely not traditional spas, either.

When we thought about how to capture the medical spa industry in print, we immediately discarded the traditional characterizations. We didn’t want doctors in lab coats or slick suits, and we didn’t want stock images of syringes or cookie-cutter offices, either. We also didn’t want extensive treatises on treatments or tactics. We wanted to capture the true essence of the industry—the spirit and underlying vibe that makes the industry go.

At its core, this industry is about people. Medical spas help people feel empowered. They help people recognize their true beauty. They inspire confidence, pride and hope. They make people look better, to be sure, but they also restore people from within. And they do this while making money and having fun. There is a sexiness and glamour to this industry that you won’t find anywhere else, and there is community and strength in the industry, as well.

It is our goal to capture this essence in a publication while ensuring that we stick to our core values of compliance and safety. After all, none of the allure and glamour is possible if we don’t provide impeccable patient care and adhere to strict medical standards. As I’ve often said in talks throughout the country, there is only one thing that can stop this industry from continuing its incredible growth trajectory—us. It’s us tolerating bad outcomes, receiving negative press and failing to follow the rules of the road. So long as we are compliant, professional and safe, the sky is the limit for this industry.

With that said, it is with great pleasure that I present the premier issue of AmSpa’s new quarterly publication, QP. It is an exploration—and a celebration—of the industry through the eyes of the people who have built it: you. In its pages you’ll find color, insight, advice and perspective that you may not have considered before. You’ll get to go inside the top medical spas in the country, read about the entrepreneurs who built the industry and share in their experiences.

In our first issue, we present the top med spas in the country. Inside you’ll find exclusive photos and insight from some of the most successful medical spas owners in the world. What are their secrets? What drives them? And to what do they attribute their success? In future issues, we'll highlight influencers, innovators, technology, data, and, of course, regulation (it is AmSpa, after all). But through it all, we will focus on people.

And of course, we invite you to let us know what you think and what you want to see. This publication is for you, and it’s important to us that you’re proud of what you see. This has been a long time coming, and we hope to be around for many years to come.

AmSpa members should receive the premier issue of QP in late June.

(Please note that if you became an AmSpa Member prior to May 31, you'll receive the first issue in the mail. If you have become a Member since May 31, the second issue will be your first. If you want to receive QP—among many other benefits—become an AmSpa Member today.)

Tags:  AmSpa  Med Spa Trends  QP 

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How Core Doctors Can Overcome Generational Differences in Marketing, Advertising and Ethics, Part 2

Posted By Administration, Monday, June 10, 2019

vlog doctor

By Alex R. Thiersch, JD, CEO of the American Med Spa Association (AmSpa)

(Click here to read part 1)

Streaming video of procedures has helped many core doctors make names for themselves on social media and the internet, but this practice is understandably the source of a great deal of controversy. Recently, some prominent plastic surgery societies have begun to consider the ethical questions surrounding plastic surgeons broadcasting the procedures they perform on social media services, such as YouTube and Facebook. The doctors who stream these surgeries often say that they do this for its educational value, but these shows are also designed to raise the surgeon’s profile. If the event is properly publicized, several thousand people will tune in, and sometimes a staff member will even be in the operating room with the surgeon answering questions from the video’s chat function on a computer. This can lead to a great deal of income for the surgeon.

There is nothing illegal or even necessarily unethical about this but, on occasion, these videos make the surgeons and their staff members look unprofessional, especially depending on how they act during the procedure. While acting silly is almost expected from those engaging in social media today, it can be argued that medical professionals should hold themselves to a higher standard. If the purpose of the video truly is to educate rather than raise the surgeon’s profile, this sort of behavior should not be highlighted.

At the same time, it is undeniable that live streaming is an effective way for a surgeon to get his or her practice’s name on people’s lips. It also makes prospective patients comfortable with the surgeon, provides answers to questions that many patients have, and promotes plastic surgery as a whole. And if you ask the surgeons themselves, many who live-stream can point to a direct correlation between their marketing efforts and a sharp increase in revenue.

However, while it’s understandable that medical aesthetic doctors engage in marketing techniques such as these, those who make videos must make sure that they’re still representing medicine in a professional manner. This is still the practice of medicine, after all. They also need to make sure that they’re acting in a manner that is respectful to their patients, who often are unconscious on the operating table—it looks bad when doctors are dancing and joking while the patient is prone (yes, this has actually happened). It’s easy for a surgeon to lose sight of this when he or she is performing (because a live broadcast of a surgical procedure realistically is a performance), but it is something he or she should make a point to be mindful of. This is a competitive market in which many people are utilizing unorthodox sales techniques and, while medical aesthetic professionals have to ensure that a practice remains profitable, they are still dealing with medical patients.

Crossing Ts, Dotting Is

Although this should probably go without saying, it is critically important that any surgeon or medical spa planning on conducting a social media campaign receives written consent from featured patients that thoroughly cover all HIPAA and local patient privacy laws. The forms used for this must be very specifically drafted in order to address the legal minutiae of social media, so anyone planning to do this needs to be very careful to ensure that the patient understands exactly what is going to happen. This is not the sort of form that anyone can simply download off the internet—it will need to be vetted by an experienced health care attorney to guarantee that no legal entanglements result.

Again, it’s worth mentioning that when he or she signs such an agreement, the patient is consenting to having his or her likeness out there for the world to see for educational purposes, not to being a motionless prop while the surgeon or his staff members act foolish. It’s not hard to imagine a scenario in which a patient would be fine with participating in a social media campaign or educational live-stream, but then appalled when he or she sees the surgeon and staff members goofing around during the promotion. The end result may not be covered by the consent form the patient originally signed.

Direct Messages

So is it inherently bad for plastic surgeons to become social media celebrities? Isn’t that the goal of marketing and public relations? It probably doesn’t matter – the genie isn’t going back in the bottle and the industry is going to need to figure out how to deal with it. There are numerous questions that societies should be asking themselves, particularly given the number of non-core doctors entering the industry. Any physician can establish himself as an expert by virtue of social media and internet advertising, but it can be problematic when the physicians in question are young and perhaps doing work that they aren’t quite qualified to be doing. If patients are receiving misrepresentative information from these doctors—and if we’ve learned anything in this country in the past couple years—it’s that people tend to believe what they see on television and social media, and that can be extremely dangerous.

At this point, dealing with this issue seems to be about making the use of social media acceptable from an ethical standpoint. There really is no turning back—social media has become a key part of marketing for core doctors, no matter how badly some wish it weren’t true, and it isn’t going anywhere.

The bottom line is that the medical aesthetic industry needs to be careful—it shouldn’t get too brazen with its marketing, because medical societies have much louder voices in halls of government than the medical spa industry does. A group of Northwestern Medicine authors recently proposed a code of ethics for videos, for example, and I think this is a good idea. After all, if these campaigns truly are for educational purposes, they don’t need the theatrics. But at the same time, the ability of medical spas to market themselves aggressively is one thing that sets them apart and allows them to succeed in a very crowded marketplace. And the personalities of practitioners come through in social media campaigns, and often the providers become much more relatable than their surgeon counterparts. There is a delicate balance that must be struck and, if the industry is going to survive, it is imperative that we make this balancing act a priority.

To stay updated on this issue and learn about many others, become an AmSpa Member and schedule a complimentary initial consult with our partners at ByrdAdatto.

Tags:  AmSpa's Med Spa & Aesthetic Boot Camps  Med Spa Law  Med Spa Trends 

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How Core Doctors Can Overcome Generational Differences in Marketing, Advertising and Ethics, Part 1

Posted By Administration, Friday, June 7, 2019

doctor vlogger

By Alex R. Thiersch, JD, CEO of the American Med Spa Association (AmSpa)

Core doctors—plastic surgeons, facial plastic surgeons, oculoplastic surgeons, and dermatologists—are, as their moniker suggests, the center of the medical aesthetic industry. As physicians, they are allowed to own and operate medical spas, and their fields of expertise coincide with many of the procedures sought by those who frequent these businesses. Historically, core doctors have made a lot of money by operating medical spas along with their more traditional practices.

However, in recent years, younger core doctors, nurse injectors and medical spa owners have courted controversy by stepping outside the role of humble healer that physicians traditionally take on, and into another role—celebrity provider. These doctors do not hesitate to market themselves and their businesses in ways that some older physicians find gauche and undignified, and they have created a great deal of controversy in the medical community by doing so. This generation gap must be addressed, but the issues at the heart of the matter must first be understood by both sides.

Social Studies

Younger core doctors primarily market themselves with social media sites such as Twitter, Instagram, and Facebook. The use of social media is a very different form of promotion than what many core doctors are used to, and it can be difficult for more traditional doctors to wrap their heads around what it is and what it does.

Because medical aesthetics has become so lucrative, it has arguably moved away from more traditional medicine. While traditional rules and traditional ethos apply, aesthetic medicine is governed in many ways by a completely different dynamic—aesthetic treatments are all voluntary, they are all cash-based, and there is a great deal of competition. Doctors are taught the Hippocratic Oath and other ethical ideals that have governed the profession for millennia. But when people choose to undergo surgery for purely cosmetic purposes, medical providers are no longer healing a patient per se, but rather providing the patient with a service that is advertised and sold on the open market. So, how do you take medical ethics that are designed to help cure disease and apply them to a competitive industry where patients shop for—and doctors sell—treatments that address patients’ desire to change the way they look?

The medical aesthetics industry also intersects with technology and marketing in ways that traditional medicine does not, which has contributed to this discord. It’s not entirely generational—there certainly are younger doctors who believe that the actions of some core doctors are a bit over the top, and there are older doctors who have bought into social media—but there clearly is a generational line between some of the older plastic surgeons who were trained in a time where marketing their practice, and themselves, was not as important as it is now. For many, the medicine and science behind plastic surgery has been subverted by the need for views, shares and likes. These surgeons feel that many in plastic surgery are missing the point of what it means to be a surgeon, and that the need for celebrity has overtaken the need to practice medicine.

But in today’s world, particularly among younger surgeons who have been using social media for years, the idea of not marketing yourself is unthinkable. In their world, one must adapt or die, and failure to compete in the marketplace through use of social media, video and marketing is the easiest way to make your practice extinct. Although there have always been surgeons who are at least somewhat famous, with social media and reality television becoming ubiquitous in recent years, this has been taken to a whole new level. With social media especially, celebrity has become democratized, and physicians can become famous through sheer hustle. There are young surgeons who have become far more famous than their older counterparts purely by utilizing the social media tools at their disposal, and this has, to some extent, disrupted the established order and ruffled some feathers. So the question must be asked: Is this merely the competitive marketplace shaking itself out or has aesthetic surgery crossed the line into something more problematic that needs to be reined in? It depends on who you ask.

(Check back on Monday morning for part 2)...

To learn more about the legalities that govern medical aesthetics, sign up for an AmSpa Boot Camp. You will learn how to operate your medical spa compliantly and profitably.

Tags:  AmSpa's Med Spa & Aesthetic Boot Camps  Med Spa Law  Med Spa Trends 

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How to Stay Compliant When Using Social Media Influencers

Posted By Administration, Wednesday, June 5, 2019

influencer

By Alex R. Thiersch, JD, CEO of the American Med Spa Association (AmSpa)

As is the case in most industries, the use of social media influencers to promote medical aesthetics is extremely common. However, because medical spas offer medical treatments, the regulations that govern influencer marketing in this space are more stringent than with many large brands you might see represented on Instagram, YouTube or other social channels.

The power of social media influencers is undeniable. If an influencer goes to a medical spa for a treatment, he or she may film the entire visit and broadcast it throughout the world on his or her social media channels. If the influencer has a significant following, this can have a major impact on a medical spa’s business.

However, most of these visits are not spontaneous situations. More often than not, medical spas compensate influencers with cash and/or free treatments to get them to portray their practices in a positive light. If your medical spa is engaging in this sort of advertising, you need to understand the legal issues surrounding these matters, although in most cases, precedent has yet to be established, as these transactions are occurring in a new medium.

Written Agreements

If a medical spa uses an influencer to promote the practice, it must have a written agreement with the influencer in place. This agreement should dictate what the influencer’s responsibilities are—how many times he or she is going to post about the practice and what he or she is going to post. The medical spa should have as much editorial control over the posts as possible, since the influencer’s primary goal is to promote his or her brand—not yours—and the medical spa is responsible for keeping the influencer on message. The deal must meet the medical spa’s expectations to ensure that it’s getting its money’s worth. Even if you’re compensating the influencer with a treatment, you need to make this as clear as possible, and a written agreement will help both sides understand the nature of the deal. This also helps you to assign a value to the services you are providing.

Advertising Rules

As a medical provider, when you compensate someone to promote your brand, you are subject to medical advertising rules and regulations, which are much stricter and have much more dire consequences for violations than common advertising rules. Primarily, this means you cannot say anything that can be construed as misleading, untrue, aggrandizing or exaggerated—everything that’s said about your medical spa must be provably true. You can’t simply say that you’re the best injector in the world, for example, because you can’t prove that. That advertisement is asking for trouble.

When influencers are being paid—or given free treatments—to represent your medical spa, they are legally acting as a paid advertiser. As such, you’re responsible for everything they say, so if they say something hyperbolic, you are responsible for that message, and the situation can get very sticky if a medical board finds out about it. You will need to make sure that the influencer understands that the medical spa is subject to these restrictions and that he or she must be sensitive about precisely what is said in these videos or blog posts. With a written agreement, you can disclaim some of these factors, which allows you to exert some control over the message.

Disclosure Guidelines

Influencers also have their own set of guidelines to worry about. In 2017, the Federal Trade Commission (FTC) issued warnings to more than 90 social media influencers who failed to disclosure when they were being compensated in exchange for coverage, and reiterated its guidelines for compliance. These include:

  • Keep your disclosures unambiguous;
  • Make your disclosures highly visible; and
  • Avoid hard-to-read, buried disclosures in strings of hashtags that are skipped by readers.

Influencer marketing can be a very powerful promotional tool, but it must be wielded with some care in order for your medical aesthetics practice to remain compliant. As I mentioned earlier, the legal aspect of its use in a medical setting is still developing, so if you’re unsure about how to proceed, be sure to consult with an experienced health care attorney.

For more information about utilizing social media to build your practice and about the laws governing medical aesthetics, sign up for an AmSpa Medical Spa & Aesthetic Boot Camp.

Tags:  AmSpa's Med Spa & Aesthetic Boot Camps  Business and Financials  Med Spa Law  Med Spa Trends 

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Lips Stay on the List

Posted By Administration, Monday, June 3, 2019

lips

By Alex R. Thiersch, JD, CEO of the American Med Spa Association (AmSpa)

Lips have always played a major role in the medical aesthetic industry, although lip treatments have not always been embraced by those who provide them. In recent years, some surgeons have shied away from operating practices where high volumes of fillers and toxins are administered, because they didn’t believe the margins for these treatments were high enough. Industry observers speculated that eyebrows would be the new lips, and that the recent rise of treatments such as vaginal rejuvenation and CoolSculpting might change the business permanently. However, a large percentage of medical spa revenue still comes from lip treatments, and this is expected to continue to be the case for years to come.

Through marketing and the use of mid-level practitioners (rather than physicians) to administer these procedures, practices are beginning to focus on providing specialized treatments on lips with fillers and Botox, and they’re making a lot of money doing it. Although devices such as lasers and CoolSculpting will definitely continue to play significant roles in medical spas, many practices are going to go back to focusing on fillers and other injections. Quite simply, they are inexpensive, effective, low-risk treatments that get people through the door.

As silly as this may sound, the “selfie” phenomenon has a lot to do with this. People, particularly millennials, are constantly taking photos of themselves, and their lips are front and center in all these shots. When young people see the Kardashians, for example, in countless selfies with “duck lips” and pouty faces on social media, it makes them want to do the same, and they want to ensure that their lips look good in these images.

The ways lips are treated has become more refined in recent years. Some medical spas offer combination lip treatments that include fillers combined with botulinum toxin. In these treatments, the botulinum toxin is applied above lip in order to free the muscle so that the lip is drawn up in such a way as to make the lip appear fuller. The botulinum toxin also can be applied to the sides of the mouth in order to achieve the same effect.

Additionally, mid-level practitioners—typically registered nurses and nurse practitioners—have become exceptionally good at administering filler and botulinum toxin injections. This is because they perform a lot of injections—physicians typically delegate these procedures to nurses because the physicians tend to have more lucrative procedures to attend to. As a result, nurses have become experts at creating lips. As nurses have begun to gain more agency in the medical aesthetic industry through changes to nurse practice acts, their expertise in this area may create new opportunities in the near future.

Lip treatments aren’t necessarily the most sensational or lucrative treatment that a medical spa can provide, but they are a foundation of the industry. If your medical spa does not offer fillers, it’s definitely worth exploring what they can offer for your patients. After all, selfies aren’t going anywhere, and as long as people pucker their lips trying to look like a celebrity, there will be money to be made from lip treatments.

For more medical spa legal and business tips sign up for AmSpa’s email newsletter to receive business strategies, news and medical spa law directly in your inbox.

Tags:  Med Spa Trends 

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How to Find Legal Answers for Your Medical Spa

Posted By Administration, Wednesday, May 29, 2019

lawyer and statue

By Alex R. Thiersch, JD, CEO of the American Med Spa Association (AmSpa)

At AmSpa and ByrdAdatto, we are asked every day about the legalities of the medical aesthetic industry. We constantly hear from professionals wondering, for example, if an aesthetician can perform a particular procedure, or whether a licensed vocational nurse can inject a certain product, among many others. The number and types of questions we receive speak to the complexities of the industry.

Providing information such as this to medical aesthetic professionals is the reason why AmSpa was started in the first place, but people often question our conclusions or wonder why, if the law is what we say it is, no one is following it. As it turns out, finding legal answers in the medical aesthetic industry is not easy, and the answers themselves are not simple, and there are numerous reasons why.

Some conversations about the legalities of the industry repeatedly occur. For example, I will explain the requirement that a physician, physician assistant or nurse practitioner perform a face-to-face examination of a patient before a laser treatment or filler injection, and the person with whom I’m speaking will say that can’t be true—nobody does that. If that is what’s required, they say, you could shut down every medical spa in the state for violating this law. But it is true, it is the law, and yes, a regulatory agency probably could shut down most medical spas in a given state if it had the manpower to investigate them all.

The medical aesthetic industry is unique in many ways. First of all, its procedures are all elective, so medical spas must market to people who choose to undergo their procedures rather than require it. Also, medical spas do not deal with insurance—the industry is entirely cash-based. Because of these factors, medical spas have to market themselves to a degree that traditional medical outlets do not.

As a result of this need for effective marketing, non-physicians play key roles in the health of these businesses. For example, a registered nurse who is a skilled injector can be the person patients come to see, as opposed to the physician. This is a much different dynamic than can be found anywhere else in the world of medicine.

Additionally, medical aesthetic practices typically have to deal with multiple practice groups, including medical boards, nursing boards and boards of cosmetology. And because the medical aesthetics industry is so young, many of these agencies are dealing with questions that are being raised for the first time. Essentially, the industry is governed by laws that are not designed to govern it and people who are more concerned with other issues.

For example, nursing boards probably won’t have too much to say about CoolSculpting, since much of their time is spent dealing with pressing matters such as opioids. They have so much to deal with that they can’t reasonably be expected to understand the nuances of the medical aesthetics industry.

When AmSpa researches the laws that apply to medical aesthetics practices in a particular state, we start by finding what we can in the state’s legislation, but most of the time, these laws’ use in relation to medical aesthetic situations is tangential; they’re typically written to deal with other areas of medicine and nursing. Therefore, regulatory interpretation of these laws with regard to medical aesthetics is vital. If a board has not published an opinion on a matter, that does not necessarily mean it does not actually have an opinion—it means that it has not yet presided over an incident that has caused it to issue an opinion. When you’re dealing with multiple boards with multiple opinions, the situation is further complicated.

All this makes AmSpa’s job very challenging. Usually, we have to take what we know about the laws and the boards and try to determine what a ruling would be. When we say, “This is what we believe the rule is in this particular state,” it’s unlikely that it is taken directly from legislation, because there’s a good chance that specific legislation doesn’t exist. We can, however, combine precedents with our legal knowledge to give you the most complete possible interpretation of the situation.

Our attorneys have been researching these regulations for years. They have appeared before nursing and medical boards to argue cases, and they have spoken with officials about these issues. This is how we learn about these issues. It’s very difficult work, but we’re confident that our attorneys provide our members the best possible information.

For more information about med spa laws, become an AmSpa Member to schedule a complimentary initial consult with our partners at ByrdAdatto.

Tags:  ByrdAdatto  Med Spa Law  Med Spa Trends 

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