From the Diagnosing Health Care Podcast: Over the last 12–24 months, Critical Access Hospitals (CAHs) have seen steep cost escalation in their expansion and renovation plans, with expense increases exceeding 10 percent. Combined with nationwide staffing shortages, CAHs are
You might be thinking, that’s an odd title: obviously FDA’s breakthrough device designation is helpful. However, after looking at the data, my conclusion is that I would avoid the breakthrough device designation for any product that qualifies for the 510(k)
Featured on the Diagnosing Health Care Podcast: How is openEHR transforming the way health data is managed and stored across Europe? Will it soon disrupt the U.S. marketplace?
In this episode of our special series on interoperability, hear from Alastair Allen,
In this episode of the Diagnosing Health Care Podcast: In the past decade, certified electronic health records (EHRs) have been instrumental in transforming medical records from paper to digital formats.
What obstacles are currently preventing providers from sharing patient data
Recalls have always been a bit of a double-edged sword. Obviously, companies hate recalls because a recall means their products are defective in some manner, potentially putting users at risk and damaging the brand. They are also expensive to execute.
In this episode of the Diagnosing Health Care Podcast: Staffing challenges and cost inflation are seriously impacting health care construction as well as other sectors of the U.S. construction economy.
In two recent memoranda, the Centers for Medicare and Medicaid Services (CMS) made changes to previously issued survey guidance related to COVID-19 vaccination issues.
The U.S. Supreme Court is expected to imminently issue its opinion in the case Dobbs v. Jackson Women’s Health Organization (“Dobbs”). If the Court rules in a manner to overturn Roe v. Wade, states will have discretion in determining how
Most companies want to avoid FDA warning letters. To help medical device companies identify violations that might lead to a warning letter, this post will dive deeply into which specific types of violations are often found in warning letters that
In this episode of the Diagnosing Health Care Podcast: What challenges are providers likely to face as the Occupational Safety and Health Administration (OSHA) prepares its permanent COVID-19 standard for health care workers?
Attorneys Denise Dadika, Bob O’Hara,