Awesome Quote from History

I am frequently astounded that quotes from history...quotes that may have been made hundreds of years ago, are still true today (if not truer today). I was watching a history program on late night cable and there was a quote from Thomas Jefferson that rally caught my attention.  Mr. Jefferson stated: “My reading of history convinces me that most bad government results from too much government.” 

How did he know this type of thing? How could they be so acutely aware of the affect of anything on the future. I suppose that some things are fundmanetal and apparently, Mr Jerfferson stated this after reading history. Perhaps we all need to read a little more history.

Sooooo, I decided to read a few more quotes from Mr. Jefferson since has many quotes as they pertain to government and because I have had a fascination about him since graduate school at WIlliam and Mary.  He was a tall man yet his desk at William and Mary is tiny!!!! I always wanted to try and sit in it (it is roped off of course)!!!

Paddy Deighan J.D. Ph.D

http://www.medicalandspaconsulting.com

The Line Between Medical and Aesthetic Procedures: What Can an Esthetician do?

I am frequently asked to comment on the distinction between what is medical and what is aesthetic (non-medical)....the lines are blurry but in my opinion, they are being violated on a daily basis. The practice of medicine is relatively easy to define....it is the diagnosis OR treatment of a medical condition.  Good, bad or indifferent, acne, rosacea, eczema are medical conditions. Some things may not be as clear...for example, treating "razor bumps" MAY not be medical, but on the other hand, those "razor bumps" are follicultis barbae and then they would be medical. Frustrating...I know.

Additionally, the next level of analysis would be whether any medical device or product is being utilized in the treatment and of so, what federal classification is the device. Virtually all aesthetic lasers AND IPLs are Class II or Class IIb medical devices and they have to be owned and operated by licensed physicians (not RNs). Physicians may, in certain circumstances, delegate "operation" (but not ownership) to other individuals.

Many products are medical...Botox Cosmetic is a prescription drug...100% medical. The dermal fillers (Restylane for example) are all medical PRODUCTS (not a drug). They are still 100% medical but for a different reason.

In laser, you can look at two different types of scenarios...let's use laser hair removal and the treatment of leg veins.  Laser hair removal is NOT a medical procedure. However, if the patient is hirsute because of poly cystic ovary syndrome (PCOS), then it IS medical.  In this situation the treatment may not be medical but the device IS medical. Hence, laser hair removal IS medical.

Treatment of leg veins...this is both a medical treatment and a medical device. Two reasons not to perform this service.

With peels, it gets REALLY complex...one analysis would be to look at FDA guidelines. In 1996 the FDA concluded that "medical" is a product that penetrated the epi-dermal/dermal junction. They concluded that a 30% glycolic treatment achieves this. Prior to 1996, they mandated that a 40% glycolic solution achieved this. But what 30% glycolic? pure 30%, neutralized or buffered 30%?...remain unanswered. Soooo, if you utilize a 40% glycolic solution but you know that it is neutralized or buffered, then you are probably OK.

Jessner's peels and most TCA peels are mid-to high level strength peels and they are medical. Sal acid is non medical unless in high strengths....hydro quinones are non medical if they are under 2%...we could go on for hours...topical anesthetics can be medical or non medical too...depending upon the strength and formulation (this is actually a HUGE issue)

The problem is that regulation comes in the form of....state statutes, state and federal case law, federal mandate (FDA, FTC), state boards of medicine, cosmetology and nursing, Attorney General reports and cases...WHEW. There is no ONE place to look!

Recently, there was a discussion and an esthetician commented to me that she contacted her state board in NH. They said that as long as she was certified, it was OK for her to perform the procedure (I do not recall the specific procedure, but on its face, it was medical ...blade or syringe was utilized if I recall). That may have been true by NH board purposes, but federal law would disagree and Federal law trumps state law.

Paddy Deighan J.D. Ph.D

http://www.medicalandspaconsulting.com

Important HIPAA Lawsuit Update

Although HIPAA does not create a private cause of action, a recent Indiana Superior Court jury verdict indicates that HIPAA could still play an important role in private causes of action in state court based on negligence and professional liability as it relates to confidentiality. On July 26, a jury in Marion County, Indiana awarded $1.44 million to a Walgreens customer based on allegations that the customer’s pharmacist accessed, reviewed, and shared the customer’s prescription history with others who then used the information to intimidate and harass the customer. At the heart of the case was a tangled love triangle in which the pharmacist’s husband had previously been romantically involved with the customer, resulting in the birth of a child. When the pharmacist learned of the relationship, she allegedly accessed the customer’s prescription information and shared it with her husband, who then used the information to intimidate the customer when she began demanding child support payments.

The customer filed suit against both the pharmacist and Walgreens in Indiana Superior Court, claiming that both parties had breached their statutory and common law duties of confidentiality and privacy. The complaint also included claims of negligence, invasion of privacy, and publication of private facts against the pharmacist and claims of negligent training, supervision, and retention against Walgreens for continuing to employ the pharmacist even after discovering the incident. The Court granted Walgreens’ Motion for Summary Judgment on the negligent training claim

At trial, Plaintiff argued that even though HIPAA did not create a private cause of action, it still defined the standard of care for a pharmacist’s duty of confidentiality and privacy to Plaintiff’s health information. Thus, according to Plaintiff, because the pharmacist’s actions violated HIPAA, the pharmacist had breached the standard of care and should therefore be held liable for the harm caused to Plaintiff. Additionally, because the pharmacist had acted within the scope of her employment, Plaintiff argued that Walgreens was also liable for the pharmacist’s actions. After a four day trial, the jury agreed on both points, awarding $1.44 million in damages to Plaintiff. Walgreens intends to appeal the verdict.

This is not the first case in which HIPAA has been the centerpiece of a private cause of action, but it does appear to be the first case resulting in a substantial jury verdict against a provider using HIPAA as the basis for the standard of care. Whether and to what extent HIPAA can be used to establish the standard of care in a professional liability, negligence, or other breach of professional duty case will be dependent on state tort law, and the outcome of this case on appeal is unpredictable. Nonetheless, as HIPAA continues to receive attention from trial lawyers seeking to establish the standard of care in negligence and professional liability cases involving the improper disclosure of health information, health care providers must be aware that, depending on the law of the state in which they are licensed, their potential liability for HIPAA violations could extend beyond Civil Monetary Penalties.

Paddy Deighan J.D. Ph.D

http://www.medicalandspaconsulting.com

Genetics Play a Role in Stretch Marks: Treatment Update

23andMe, a leading consumer oriented personal genetics company, has conducted the first genetic study of striae distensae (stretch marks). Researchers at the company identified four genetic markers significantly associated with the development of stretch marks that inform why some individuals are more susceptible to the skin condition.

Estimates of the prevalence of stretch marks range from 50-80 percent.  The exact causes of stretch marks are still widely unknown. Many factors, including excessive skin distension (during pregnancy, growth spurts, rapid weight gain), prolonged exposure to cortisol and genetics are thought to play a role.

Popular treatments, including topical creams and laser treatment often focus on stimulating collagen production to decrease the appearance of stretch marks. The strong association between (the breakdown) of elastin and stretch marks discovered through this research offers an opportunity to improve methods to prevent and treat stretch marks. However these treatments yield little visible results and patient satisfaction is exceedingly low with these modalities.  Cocoa butter?? Why bother!

There are effective treatments on the horizon and we will be discussing them in detail. 

"To date, no genetic variants were known to be associated with isolated stretch marks that affect the general public," said Joyce Tung, Ph.D., author and 23andMe Director of Research. "Through this first of its kind study, we've identified new genetic associations that can provide deeper insights into the root causes of stretch marks, and look forward to continuing research in this space. One intriguing area for further study is the potential effect of genes associated with obesity on the development of stretch marks, both independent of and via changes in Body Mass Index. Replicating this work in a more precisely phenotyped population would also be a logical next step."

23andMe conducted a genome-wide association analysis across 33,930 unrelated 23andMe customers of European descent; within the sample there were a total of 13,930 cases and 20,862 controls. Because loose skin is a symptom of syndromes caused by deletion or loss-of-function mutations in elastin, it is likely that variations in the elastic fiber component of the skin extracellular matrix contribute to the development of stretch marks. The expression of collagens, elastin and fibronectin is also decreased in striae, which could be linked to the reorganization and overall loss of elastic fibers in skin affected by stretch marks.

Paddy Deighan, J.D. Ph.D

http://www.medicalandspaconsulting.com

An Important Update on Facebook Privacy

I have never been a particular fan of Facebook. They do not respect privacy and they allow politics to interfere in the social networking sphere and there is no place for this in their reality.. They are allowed to do things with information that you are not allowed to do…adding to my disdain for them. True, they have SOME usefulness and hence, Facebook must be tolerated to some degree. You have all seen the Facebook ads that show us an image of one of our friends and notify us that this particular friend likes some particular brand or product.  However, were you aware that these images could not only be used to endorse products that you have already “liked,” but also those that have nothing whatsoever to do with you AND without your providing any permission other than simply using Facebook?

Facebook recently settled a class action lawsuit regarding this practice. The settlement and resulting privacy-policy “clarifications” actually just make the practice legitimate. According to Facebook’s revised privacy policy, “you give us permission to use your name, profile picture, content, and information in connection with commercial, sponsored, or related content…served or enhanced by us…without any compensation to you.” WHAT????? This means Facebook can use your images basically anywhere, at any time, and for any reason.

The class-action lawsuit was brought by a man whose wife’s image was used in this manner to advertise a “hot singles” service, but despite the fact that Facebook ultimately settled, the judge who approved the settlement even said that “it is far from clear [that the plaintiffs] could ever have shown they were actually harmed in any meaningful way.” The only way to opt out of this term of use is to quit Facebook completely. Facebook has also received criticism lately for another relatively new feature that takes facial recognition to a new level in order to suggest tagging options for pictures. Not to mention that htis comes from a paragon of privacy protection, ABC News LOL Be forewarned!!!

Paddy Deighan J.D. Ph.D

http://medicalandspaconsulting.com

Non Medical Personnel Operating Lasers

It never ceases to amaze me how many medical products are marketed for use to the non-medical market. There are so many skin care products making outrageous claims and product manufacturers making claims about their devices and all the while, marketing them to people who cannot legally perform services with the device. This problem is more prevalent today than ever before and this is counter intuitive since there has never been more regulation in the health industry and the FDA has stepped up compliance. 

I have previously written about skin care products that claim to alter and repair DNA (this is really funny because it is so outrageous); other products that claim to treat rosacea (even though when you read the package insert it refers to treating “redness”) and devices that are marketed to the aesthetic market when they are being offered to treat medical conditions. Sometimes the problem is that the device is a medical device being offered to non-medical markets. Other times the problem is that the device is treating medical conditions or the use of the device is such that it constitutes the practice of medicine.

I was reading Day Spa magazine today and I ran across an advertisement that I have seen for MANY years. It was for the Lamprobe. Interestingly enough, I met the owner about ten years ago and asked how he is marketing the device to the non-medical market. He had an unsatisfactory answer. It is not my intention to malign any particular product, but this one typifies the problem.

The Lamprobe advertises that it treats skin tags, broken capillaries, cholesterol deposits, cherry angiomas, fibromas, spider nevi, clogged pores and milia. Very interesting. An esthetician can treat NONE of these proposed uses. How can this product be ethically marketed to the non-medical aesthetic market when the user cannot legally perform the treatments? Virtually all of these proposed uses are outside the scope of license of an esthetician and they are clearly and squarely within the parameters of medicine. 

Just because a product is marketed to you, does not mean that you are legally permitted to use the product or servoce. The laser companies would gladly sell a laser to my dog Stoli if he would pony up the money!!

Paddy Deighan JD PhD
http://www.medicalandspaconsulting.com

Connecticut Passes New Medical Spa Regulations

Connecticut is another in a series of states that has taken action in regard to the regulation of medical spas.  The new legislation in Connecticut seems fair and a well thought out effort to protect consumers in the state.

Many within the various related industries, such as aesthetics, believe that the regulation of medical spa procedures it’s a turf battle waged by physicians who are trying to protect their exclusive right to perform cosmetic medical procedures.  However, this law seems appropriate and my vast experience as a consultant to state medical boards and boards of cosmetology is that this type of regulation is borne out of a desire to legitimately protect citizens of a state.

Medical spas in Connecticut that offer cosmetic medical procedures must have an acting medical director who is a state-licensed physician. Bill SB-1067, which goes into effect on October 1, 2013, was passed by the state’s legislature on June 5, 2013. It states that any medical spa that offers procedures defined under the state’s sales tax laws as “cosmetic medical procedures” employ or contract with a medical director. An MD, PA, APRN or RN may perform the procedures. If a PA, APRN or RN is performing the treatment, he or she must be acting under a physician’s supervision and control. In addition, the facility must post notice of the name and specialty of the medical director, and he or she must perform an initial physical assessment of the patient before the procedure is performed. Violators are subject to fines of up to $500 per day while the violation continues.

In my opinion, there will be more new laws such as this one as state’s wrestle with this growing problem.  My only question in regard to this law is whether the nurses have to be employed by the physician. This is a growing issue.

If you wish to view a synopsis of this new law, log into http://www.cga.ct.gov/2013/BA/2013SB-01067-R01-BA.htm

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Paddy Deighan J.D. Ph.D

http://www.medicalandspaconsulting.com