Enforcement of FDA’s Unique Device Identification Law Begins as Hospitals, ASCs, and Nursing Homes Must Now Report Adverse Patient Events from High-Risk Medical Devices

Some clinical laboratory and pathology equipment are Class III (high-risk) medical devices and may be eventually subject to FDA adverse patient event reporting rules Effective on September 1, 2014, providers using Class III (high-risk) medical devices are required to report adverse patient events involving such devices. That reporting is to include the unique device identification (UDIs) labels of the Class III device. The primary goal of the new regulation is to have specified providers...

Attention Pathologists and Clinical Laboratory Professionals: New ‘Sunshine Act’ Requirements Will Track and Publish Financial Relationships Providers Have with Healthcare Vendors

Some physicians fear disclosure of payments by drug and medical device companies could damage patient confidence and physician-patient relationships Over the course of 2014, pathologists and medical laboratory managers will experience a different relationship with in vitro diagnostic (IVD) manufacturers and other lab industry vendors. That’s because a new federal law requires vendors to publicly disclose financial and other arrangements they have with providers. That law is the Physician...

Health Kiosk Offers Consumers Self-Serve Health Screenings, Preventative Health Help, and Information on Health Plans and Obamacare

SoloHealth Stations are in 3,200 retail stores nationwide and growing  There’s a hot new consumer health product working its way into pharmacies across the nation. Say goodbye to the ubiquitous self-serve blood pressure stations found next to the pharmacy counter. Say hello to the next generation of consumer self-serve health kiosks. This trend may open a door for innovative clinical laboratories to add their service offerings to the kiosks in their communities. One example of the fast...