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.

Continue Reading <em>Podcast:</em> Owner’s Outlook: Renovating and Expanding Critical Access Hospitals in a Volatile Market – <em>Diagnosing Health Care</em>

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.]

Continue Reading Unpacking Averages: Assessing Whether FDA’s Breakthrough Device Designation Is Helpful

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.

Continue Reading <em>Podcast:</em> Interoperability: Health Care’s Next Disruptor Is openEHR – <em>Diagnosing Health Care</em>

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.

Continue Reading <em>Podcast:</em> Interoperability: A New Vision Through openEHR – <em>Diagnosing Health Care</em>

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.

Continue Reading <em>Podcast:</em> Owner’s Outlook: Health Care Construction in a Period of Labor Shortages / Cost Inflation – <em>Diagnosing Health Care</em>

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.

Continue Reading The Pendulum Swings Both Ways: State Responses to Protect Reproductive Health Data, Post-<em>Roe</em>

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 FDA issues.

Background

As you probably know, FDA has a formal process for evaluating inspection records and other materials to determine whether issuing a warning letter is appropriate.  Those procedures can be found in chapter 4 of FDA’s Regulatory Procedures Manual.  Section 4-1-10 of that chapter requires that warning letters include specific legal citations, in addition to plain English explanations of violations.  The citations are supposed to make reference to both the statute and any applicable regulations.

As a consequence, to understand the content of the warning letters, we need to search for both statutory references as well as references to regulations.  Because statutes are deliberately drafted to be broader in their language, references to the regulations tend to be more meaningful. Continue Reading Unpacking Averages: Violations Found in Medical Device Warning Letters

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 DadikaBob O’Hara, and Tim Murphy review the provisions of OSHA’s temporary COVID-19 standard for health care workers and what’s expected to change under the permanent rules. They also discuss how the agency’s current enforcement push is impacting health care providers.

Continue Reading <em>Podcast:</em> OSHA’s Permanent COVID-19 Standard and Enforcement Blitz – <em>Diagnosing Health Care</em>