The Difference Between Non-Solicitation and Abandonment Of Patients
Physicians who leave a practice need to balance any non-solicitation issues in their employment contracts with the need to inform patients that the patient may need a new doctor.
HIPAA and Access. Legal Summary and Recent Investigations
The HHS Office of Civil Rights has guidance on how and when covered entities should respond to a right of access request for the personal health information of a patient.
Compliance Issues in the Emerging Field of Medical Tourism
American physicians are working to benefit from medical tourism by targeting patients to come to America and by setting up practices in foreign countries.
Legal Compliance Issues for American Medical Tourism Health Practices
Physicians who wish to work in the medical tourism sector need to be careful to separate their medical tasks from their business and marketing tasks and to avoid fee-splitting issues
FDA Warning Letters – COVID-19 Testing Kits
FDA is sending warning letters to companies that claim the company can diagnose COVID-19. FDA has granted an Emergency Use Authorization) for at least one at-home testing kit.
Legal Risk Issues in Regenerative Medicine and Anti-Aging Medicine
As the population ages, health providers and health companies are developing and expanding their regenerative medicine and anti-aging practices. As with all healthcare services and products, [...]
The FDA Provides New Guidance on the “Minimal Manipulation and Homologous Use” of Cell and Tissue Products.
The FDA new guidelines on minimal manipulation include questions and answers. Meeting the minimal manipulation test can save companies a fortune in IND studies and clinical trial tests.
FDA Issues Warning Letter to Company that Sells CBD Products Online and Through Social Media
FDA sends warning letter to a company because its website and social media accounts made claims about CBD products that suggest they are drugs or dietary supplements and were misbranded.
New HHS 21st Century Cures Act IT Rule – Part 2
These are two more of the non-fulfillment exceptions to the ONC rule. Another three fulfillment exceptions follow. The exceptions try to balance the ability of the developers and practitioners to [...]
New HHS 21st Century Cures Act IT Rule – Part 1
The Office of the National Coordinator for Health Information Technology (ONC), which is part of the Department of Health and Human Services, approved a final rule which implements certain [...]
New Proposed Rules from the CMS and the OIG-HHS on Stark Law and from the Anti-Kickback Statute
The CMS and HHA are proposing new rules, such as the Patients over Paperwork Initiative, where the focus of Stark and AKS will be on value-based arrangements
September 2020 FDA Warning Letters
FDA and FTC warning letters continue to find violations of the FD&C Act when companies boast their products can cure or treat diseases such as COVID-19.
Judge Confirms FDA Regulation of Stem Cell Industry
A federal judge confirmed that the FDA has the right to regulate for-profit stem-cell therapy treatments. Autologous treatments may require FDA approval as drugs.
Regulatory Compliance for Cosmetics, Nutrition, and Cannabis Companies – Part 1
Regulatory compliance of cosmetics, diet, and CBD products including FDA misbranding and adulteration, FTC compliance, labeling requirements, and other legal issues.
DOJ Penalizes Doctors, Hospitals, & Medical Practices Millions to Settle Allegations of Anti-Kickback Statute Violations
The DOJ reported several new cases in which health care companies and doctors agreed to pay millions to settle claims of healthcare fraud due to AKS and Stark violations.
Compliance Issues For Medical Specialties
Regulatory compliance review and business review for dentists, veterinarians, therapists, and chiropractors
Physician Run and Physician Driven Practices – Part 2
Experienced healthcare lawyers advise doctors, physicians, and medical practices or a full range of regulatory and compliance issues including HIPAA, Stark Law, and the AKS.
Compliance Concerns for Artificial Intelligence and Telemedicine
Developers are working on new AI programs that enhance, support, or enable telemedicine. New uses include diagnostic tools and online tools that have legal compliance pitfalls
Compliance with the California Consumer Privacy Act
The California Consumer Privacy Act affect hospitals, medical practices, and medical companies who buy or receive large blocks of data. California compliance lawyers help businesses comply.
Centers-Academic, ASC, Home, Hospice, Urgent Care, & MedSpa
Experienced healthcare lawyers providing proactive advice for Academic Medical Centers, ASCs, Home Health Care, Hospices, Urgent Care Centers, and Medical Spas.
