In this episode of the Diagnosing Health Care Podcast: For years, pharmacy advocates have urged policymakers to make changes to state scope of practice laws that would permit pharmacists to prescribe and administer certain tests and vaccines at the pharmacy. How has COVID-19 impacted these efforts?
Hear from special guest Will Chang, Chief Legal Officer of UpStream.
On July 8, two weeks following the Supreme Court’s ruling in Dobbs v. Jackson that invalidated the constitutional right to abortion, President Biden signed Executive Order 14076 (E.O.). The E.O. directed federal agencies to take various actions to protect access to reproductive health care services,[1] including directing the Secretary of the U.S. Department of Health and Human Services (HHS) to “consider actions” to strengthen the protection of sensitive healthcare information, including data on reproductive healthcare services like abortion, by issuing new guidance under the Health Insurance and Accountability Act of 1996 (HIPAA).[2]
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 at a crossroads as to how to proceed.
On this episode of our Owner’s Outlook series, hear from special guest Eric Shell, Chairman of Stroudwater Associates, a national advisory firm that designs solutions for rural and community hospitals.
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) process. The process is likely not helpful for such devices.
[Update – August 3, 2022: See the bottom of this post.]
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, CTO of Better.
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 with each other or patients from sharing health information from their personal devices with their providers? In this episode of our special series on interoperability, hear from Tomaž Gornik, founder and CEO of Better.
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. But a lack of recalls can also be a problem, if the underlying quality issues still exist but the companies are simply not conducting recalls. Recalls are necessary and appropriate in the face of quality problems.
Thus, in terms of metrics, medical device companies should not adopt as a goal reducing recalls, as that will lead to behavior that could put users at risk by leaving bad products on the market. Instead, the goal should be to reduce the underlying quality problems that might trigger the need for recall.
What are those underlying quality problems? To help medical device manufacturers focus on the types of quality problems that might force them to conduct a recall, we have used the FDA recall database to identify the most common root causes sorted by the clinical area for the medical device. Continue Reading Unpacking Averages: Common Root Causes Driving Medical Device Recalls
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. Continue Reading CMS Reduces COVID-19 Vaccine Mandate Surveys and Rescinds Surveyor Vaccination Requirements
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 to regulate abortion services.[1] Such a ruling would overturn nearly 50 years of precedent, leaving patients, reproductive health providers, health plans, pharmacies, and may other stakeholders to navigate a host of uncharted legal issues. Specifically, stakeholders will likely need to untangle the web of cross-state legal issues that may emerge.