Physician Burnout: The Next Pandemic?
Second-Wave Contingency Planning and Risk Mitigation Strategies - Diagnosing Health Care Podcast
Long-Term Care Investigations: Critical Steps To Mitigate Risk and Protect Your Residents, Staff and Reputation
Compliance Perspectives: Health Care Compliance and the COVID-19 Virus
Podcast - Developments in FDA & DOJ Regulation and Enforcement of Manufacturer Communications
The FDA has been continuing to work on protecting medical devices from the threats of cybersecurity. In April of this year, the Agency released the latest draft guidance addressing cybersecurity in the medical device...more
The Centers for Medicare & Medicaid Services (“CMS”) recently released draft guidance for state survey agencies regarding shared space and co-location arrangements between hospitals and other hospitals or health care...more
On May 3, 2019, the Centers for Medicare and Medicaid Services (“CMS”) released long-awaited draft guidance (the “Guidance”), proposing to allow hospitals to co-locate with other hospitals or healthcare facilities in certain...more
On May 3, 2019, the Centers for Medicare and Medicaid Services (CMS) issued a draft of long-awaited guidance for hospitals on how they can share space, services and staff with other co-located hospitals and health care...more
The Centers for Medicare and Medicaid Services has issued long-awaited draft guidance addressing the use of shared space and contracted services. Though aiming to increase transparency into the scope and interpretation of its...more
As new healthcare delivery models evolve, we may see an increase in hospitals that share space with other hospitals or healthcare entities. On May 3, 2019, Centers for Medicare and Medicaid Services (CMS) issued draft...more
The Food & Drug Administration has recently released for comment a draft expansion of guidance regarding Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. Although the FDA issued existing...more
The U.S. Food and Drug Administration (FDA) is moving aggressively in the month of October to continue to raise concerns about cybersecurity risks to medical devices, with three recent updates. The FDA just released new draft...more
On January 15, 2016, the U.S. Food and Drug Administration (FDA) published a draft guidance entitled Postmarket Management of Cybersecurity in Medical Devices (Draft Guidance), which outlines FDA’s recommendations for...more
Health care practitioners are more frequently using laboratory developed tests (LDTs) to diagnose and predict the risk of developing a disease, as well as to inform decisions on disease state management such as for cancer,...more