Many physicians rely on publicly available reports to assess the safety of the devices they use on patients, but in some cases, these reports aren’t painting the full picture. A recent Kaiser Health News (“KHN”) article raises serious questions about FDA’s practice of allowing a significant number of medical device injury and malfunction reports to stay out of the public eye.
Under FDA’s Medical Device Reporting (“MDR”) regulation (21 CFR part 803), device manufacturers, importers, and device user facilities (which include hospitals, ambulatory surgery ...
2016 is poised to be a major year in network adequacy developments across public and private insurance markets. Changes are ahead in the Medicare and Medicaid managed care programs, the Exchange markets and the state-regulated group and individual markets, including state-run Exchanges. The developing standards and enforcement will vary significantly across these markets.
Through 2014 and 2015, major news stories discussed concerns over the growing use of narrow provider networks by issuers on the Affordable Care Act's insurance exchanges ("Exchanges"). Others reported on ...
A Nelson Hardiman and Epstein Becker Green Webinar Series
The post-acute spectrum of care is going through a period of profound legal changes, from newly emerging risks to integration with acute care and the transition to managed care. This series features leading attorneys sharing insights into compliance challenges and strategies. Join us for this series and stay ahead of the latest regulatory updates in long-term care.
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A Complimentary Two-Part Webinar on the Americans with Disabilities Act (ADA)
Health Care Entities and the ADA: Part I - Complex Issues in the Reasonable ...
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Recent Updates
- Supreme Court of Ohio Decides on a Peer-Review Privilege Issue in Stull v. Summa
- Unpacking Averages: Exploring Data on FDA’s Breakthrough Device Program Obtained Through FOIA
- Importance of Negotiating the Letter of Intent for Health Care Leases
- Importance of Negotiating Default Provisions in Health Care Leases
- Podcast: Health Policy Update: Impact of the 2024 U.S. Elections – Diagnosing Health Care