Little Health Law Blog
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).
Our healthcare and business law firm often represents medical practices, including primary care practices, specialty practices, and med spas, in the initial set up phase of their practice. Whether a Management Services Organization (“MSO”) is necessary or advisable for your practice usually requires a detailed review of your business structure and state laws. If an MSO is advisable for your practice based on the Corporate Practice of Medicine (“CPOM”) doctrine in your state, this post provides 3 key provisions that should be within your Management Services Agreement (“MSA”). If you have medical practice set up or MSO questions 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, 
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Our healthcare and business law firm works with healthcare businesses to assist in compliance matters, including the Health Insurance Portability and Accountability Act (“HIPAA”) and the Health Information Technology for Economic and Clinical Health (HITECH) Act. The HITECH Act was designed to strengthen HIPAA in many ways. A question our healthcare business-owning clients often have is whether patients with insurance can choose to pay cash instead of billing to insurance. This post focuses on what the HITECH Act states on this subject. If you have a question about the HITECH Act 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, 
Our healthcare and business law firm consistently works with physicians who are dealing with complications resulting from adverse reporting to the National Practitioner Data Bank (“NPDB”) as well as entities in deciding what reports may be appropriate for certain situations. Whether you are on the side of the provider or reporting entity, it is important to understand the types of NPDB reports that are permitted. This post outlines the four types of reports. If you have a question about the NPDB 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, 
Our healthcare and business law firm works with numerous medical practices in compliance and regulatory matters. Many medical practices are unaware of the requirements of the Americans With Disabilities Act (“ADA”), and in particular the requirements to accommodate individuals with auditory disabilities (including individuals who are deaf or hard of hearing). The ADA does not just prevent disability discrimination by employers. Title III of the ADA applies to “public accommodations.” A public accommodation is a business that is open to the public or provides goods or services to the public and specifically includes a “professional office of a health care provider.” 28 CFR 36.104;