Mobile health application developers, manufacturers, investors, healthcare providers and others received welcome news late last month when the U.S. Food and Drug Administration published its long-awaited final guidance on mobile medical applications under the Federal Food, Drug, and Cosmetic Act. It is vital for any app developer to understand whether the guidance applies to their product from the initial design stage. Those who are already marketing software and apps that involve healthcare should also review the guidance with care to try to determine how FDA’s new regime impacts both business plans and continuing operations.
The Centers for Medicare & Medicaid Services on February 1, 2013, published long-awaited rules (the “Rules”) detailing manufacturers’ and group purchasing organizations’ reporting requirements under Section 6002 of the Patient Protection and Affordable Care Act, otherwise known as the Physician Payment Sunshine Act. This Alert is the second in Duane Morris’ series of Alerts on the new Sunshine Act reporting requirements, and addresses the unique reporting requirements for applicable manufacturers’ making payments or transfers of value related to clinical research and pre-clinical research. The Rules contain different reporting requirements for these research-related payments, so applicable manufacturers may want to analyze their relationships now in preparation for the August 1, 2013, data collection start date.
Click here to read more about the Rules and what every applicable manufacturer should know about reporting research-related payments.