Little Health Law Blog

3 Considerations Before Offering SoftWave at Your Wellness Spa

September 12, 2024 | Little Health Law

Our healthcare and business law firm works with many providers and medical practices to ensure compliance with state and federal laws, rules, and regulations for given procedures, treatments, and prescriptions. As new treatments become popular, common questions circulate around who can and cannot order, prescribe, and/or administer such treatment. One device that is becoming popular is the SoftWave device. SoftWave uses ultrasound vibration to penetrate into muscles in an attempt to improve healing. This blog post outlines three considerations prior to introducing SoftWave or similar treatments to your medical and wellness practices’ offerings. If you need assistance understanding the full realm of considerations governing SoftWave or would like to discuss this blog post, you may contact our healthcare and business law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com. You may also learn more about our law firm by visiting www.littlehealthlaw.com.

The Food and Drug Administration Approved it for Prescription Use

The FDA has approved the SoftWave device, specifically OrthoGold 100, as a Class 1 medical device that does not need its own premarket approval because it is substantially similar to a device that’s already FDA approved (the Dermablate Effect). The FDA only approved it for prescription use (not over the counter use). K182682-connective-tissue.pdf (softwavetrt.com).

UPDATE: FTC Non-Compete Rule Blocked by Federal Judge

August 23, 2024 | Little Health Law

Our healthcare and business law firm guides many medical practices and physicians through employment matters. At this point, most people are aware that the Federal Trade Commission (“FTC”) published its final non-compete rule (“Non-Compete Rule”) on April 23, 2024. Our firm previously posted 3 Facts about the Non-Compete Rule, which provides information about the FTC Rule including that it limits non-competes both prospectively and retrospectively, applies to all workers with one limited exception, and that current non-compete disputes may still continue even if the Non-Compete Rule becomes effective. On August 20, 2024, a judge blocked the FTC from enforcing the Non-Compete Rule, and this post discusses that decision. If you need assistance with employment matters or would like to discuss this blog post, you may contact our healthcare and business law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com. You may also learn more about our law firm by visiting www.littlehealthlaw.com.

Legal Challenges

The Non-Compete Rule was set to become effective on September 4, 2024 despite many challenges. Those challenges were Ryan, LLC v. FTC in the U.S. District Court for the Northern District of Texas, ATS Tree Services, LLC v. FTC in the U.S. District Court for the Eastern District of Pennsylvania, and Properties of the Villages, Inc. v. FTC in the U.S. District Court for the Middle District of Florida.

Preliminary Court Orders

On July 3, 2024, the Judge in Ryan issued a Continue reading ›

3 Steps to Avoid Professional Boundary Violations

August 21, 2024 | Little Health Law

Our healthcare and business law firm works with many providers as they undergo investigations, discipline, and/or hearings before the provider’s licensing board. Over the years, our firm has been able to determine which situations licensing boards find particularly worrisome. Boundary violations are often one of those situations that boards are particularly concerned with. This blog post outlines three steps for avoiding boundary violations. If you need assistance with a licensing board matter or would like to discuss this blog post, you may contact our healthcare and business law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com. You may also learn more about our law firm by visiting www.littlehealthlaw.com.

Boundary violations discussed in this blog post include inappropriate relationships between provider and patient, which could involve romantic relationships or providing care to and writing prescriptions for immediate family members. Here three steps to avoid boundary violations.

First, know your licensing board’s rules!

These rules will explain boundaries that you, as a provider, must always maintain. For instance, Continue reading ›

The Corporate Transparency Act Reporting Rule

August 12, 2024 | Little Health Law

Our healthcare and business law firm works with medical practices to ensure compliance with state and federal laws, rules, and regulations. The Corporate Transparency Act (“CTA”) aims to combat illicit activity including tax fraud and money laundering. The reporting rule under the CTA requires certain entities to file beneficiary ownership information (“BOI”) reports. This blog post provides an overview of the reporting requirements. If you need assistance understanding how the reporting rule applies to your business or would like to discuss this blog post, you may contact our healthcare and business law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com. You may also learn more about our law firm by visiting www.littlehealthlaw.com.

The Report

The report must contain information about the entity and two categories of individuals: beneficial owners and company applicants. A beneficial owner is any individual who, directly or indirectly, exercises substantial control over a reporting company and anyone who owns or controls at least 25 percent of the ownership interests of a reporting company. Ownership includes equity, stock, voting rights, capital or profit interests, and convertible interests. As to company applicants, there are two categories. Continue reading ›

3 Key Facts About the FTC Non-Compete Rule

June 20, 2024 | Little Health Law

Our healthcare and business law firm guides many medical practices and physicians through employment matters. At this point, most people are aware that the Federal Trade Commission (“FTC”) published its final non-compete rule on April 23, 2024. As of the date of this blog post, the rule is expected to become effective on September 4, 2024. There are legal challenges against the rule, including Ryan, LLC v. FTC in the U.S. District Court for the Northern District of Texas and ATS Tree Services, LLC v. FTC in the U.S. District Court for the Eastern District of Pennsylvania. The judges in both cases anticipate making some decisions in each case within the next few weeks, which will provide more information about whether the rule will become effective on September 4, 2024. It is important, however, that businesses begin gathering necessary information for counsel to review, such as all employment agreements, independent contractor agreements, and employee handbooks, now so that business are able to comply with the FTC rule if it becomes effective on September 4, 2024. If you need assistance preparing for and complying with the FTC rule or would like to discuss this blog post, you may contact our healthcare and business law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@hamillittle.com. You may also learn more about our law firm by visiting www.hamillittle.com.

In addition to the above information about key dates and current legal challenges, below are three key facts about the FTC non-compete rule as it is currently written:

The rule limits non-competes both prospectively and retrospectively. Prospectively, the rule prevents employers from entering into non-competition clauses after the effective date. Retrospectively, it prevents employers after the effective date from enforcing non-competes that it previously entered into (and requires the employer to provide notice of the same).

What does the rule mean by stating that an employer may not “enforce” an existing non-compete? This is broadly construed to mean that the employer may not do things like initiate a lawsuit, send a demand letter, or even remind the worker of his or her non-compete obligations during an exit interview.

The Cosmetic/Aesthetic Procedures Position Statement by the Georgia Board of Nursing

June 14, 2024 | Little Health Law

Our healthcare and business law firm works with many medical spas to ensure compliance with state and federal laws, rules, and regulations. Recently in Georgia, the Georgia Board of Nursing published two long-awaited position statements; one on “Cosmetic/Aesthetic Procedures,” and the other on “IV Hydration.” This blog post discusses the Nursing Board’s position statement on Cosmetic/Aesthetic Procedures. Even if your practice is not in Georgia, it is helpful to consider the perspective of different states because state licensing boards will often consider other published positions when developing policies and positions. If you need assistance understanding how either position statement impacts your practice or would like to discuss this blog post, you may contact our healthcare and business law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@hamillittle.com. You may also learn more about our law firm by visiting www.hamillittle.com.

Prior to discussing the substance of Nursing Board’s position, here are some important points: Continue reading ›

The IV Hydration Position Statement by the Georgia Board of Nursing

June 14, 2024 | Little Health Law

Our healthcare and business law firm works with many medical spas to ensure compliance with state and federal laws, rules, and regulations. This week in Georgia, the Georgia Board of Nursing published two long-awaited position statements; one on “Cosmetic/Aesthetic Procedures,” and the other on “IV Hydration.” This blog post discusses the Nursing Board’s position statement on IV Hydration. Even if your practice is not in Georgia, it is helpful to consider the perspective of different states because state licensing boards will often consider other published positions when developing policies and positions. If you need assistance understanding how either position statement impacts your practice or would like to discuss this blog post, you may contact our healthcare and business law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@hamillittle.com. You may also learn more about our law firm by visiting www.hamillittle.com.

Prior to discussing the substance of Nursing Board’s position, here are some important points: Continue reading ›

Weight Loss Guidance For When Your State Has No Weight Loss Statute

May 23, 2024 | Little Health Law

Our healthcare and business law firm works with many providers and medical practices to ensure compliance with state and federal laws, rules, and regulations for given procedures, treatments, and prescriptions. A hot topic and sometimes controversial category of drug right now is weight loss drugs (also called weight management drugs). A provider should generally prescribe a drug or treatment pursuant to a patient-provider relationship when the drug is medically necessary and appropriate, but some states have laws and rules specifically governing prescribing weight loss drugs. If your state has rules or guidance on prescribing weight loss drugs, it’s important, of course, to follow that guidance. Unlike our firm’s look into Florida’s weight loss statute, blog post available here, this blog post examines what to consider when a state does not have specific weight loss rules by using Georgia as an example. If you need assistance understanding your state’s guidance on weight loss treatments or would like to discuss this blog post, you may contact our healthcare and business law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@hamillittle.com. You may also learn more about our law firm by visiting www.hamillittle.com.

If your state has no specific weight loss statute, such as the statute we previously examined in Florida, where do you turn? Below is an idea of where to start:

Are There Relevant Statutes or Rules?

Three Common Requirements for Physician Assistant (PA) Supervision

May 8, 2024 | Little Health Law

Our healthcare and business law firm works with many providers and medical practices to ensure compliance with state and federal laws, rules, and regulations. Mid-level providers, such as physician assistants (“PAs”) and nurse practitioners, are widely used, and they help expand the provision of medical care and services. States differ on the amount of oversight that is required for PAs to practice. This blog post outlines possible requirements that may be present in your state for PAs to practice under physician supervision, using Georgia as an example. If you need assistance understanding your state’s guidance on mid-level supervision and delegation requirements or would like to discuss this blog post, you may contact our healthcare and business law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com. You may also learn more about our law firm by visiting www.littlehealthlaw.com.

In Georgia, the rules governing PAs and their supervising physician include the following:

First, the Supervisory Relationship Must be Established:

Under Georgia Rule 360-5-.03, in order to supervise a PA, a supervising physician must submit an application to the Board that must be approved by the Board before delegating tasks. On the flip side, upon termination of the supervisory relationship, the PA and physician must give notice and date of termination. Continue reading ›

3 Considerations Before Offering Ozone Therapy at Your Med Spa

April 18, 2024 | Little Health Law

Our healthcare and business law firm works with many providers and medical practices to ensure compliance with state and federal laws, rules, and regulations for given procedures, treatments, and prescriptions. Providers have differing opinions on the use and efficacy of certain treatments. One such treatment is Ozone therapy. This blog post outlines considerations prior to introducing Ozone therapy to your medical and wellness practices’ offerings. If you need assistance understanding the full realm of considerations governing ozone therapy or would like to discuss this blog post, you may contact our healthcare and business law firm at (404) 685-1662 (Atlanta) or (706) 722-7886 (Augusta), or by email, info@littlehealthlaw.com. You may also learn more about our law firm by visiting www.littlehealthlaw.com.

Consider the Food and Drug Administration’s Regulations

21 C.F.R. 801.415 is a regulation of the Food and Drug Administration (“FDA”), which provides: “Ozone is a toxic gas with no known useful medical application in specific adjunctive, or preventative therapy.” Further on the regulation provides: “A number of devices currently on the market generate ozone by design or as a byproduct. Continue reading ›