The FDA recently published two draft guidance documents to clarify which types of medical software, based on their functionality, are no longer considered medical devices as a result of the changes imposed under section 3060...more
Overview and General Principles -
On October 2, 2014, the Food and Drug Administration (“FDA”) finalized guidance describing the FDA’s position on cybersecurity standards for medical devices. The guidance discusses...more
Beginning Monday, July 14, 2014, the review, dispute and correction process outlined the National Physician Payment Transparency Program (also known as the "Sunshine Act") opens on CMS's Open Payments website. Physicians and...more
7/16/2014
/ Affordable Care Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Health Insurance ,
Hospitals ,
Manufacturers ,
Medical Devices ,
Pharmaceutical Industry ,
Physicians ,
Prescription Drugs ,
Provider Payments ,
Reporting Requirements ,
Sunshine Act