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 [...]
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 [...]
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
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.
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 of cosmetics, diet, and CBD products including FDA misbranding and adulteration, FTC compliance, labeling requirements, and other legal issues.
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.
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.