In this episode of the Diagnosing Health Care Podcast:   The Dobbs v. Jackson Women’s Health Organization decision, which effectively removed the federal constitutional protections for abortion, triggered a series of changes for health care providers and patients alike across the nation with respect to abortion services.

What additional implications are there for certain aspects of clinical trials and research?

On this episode, Epstein Becker Green attorneys Kate Heffernan, Marylana Helou, and Megan Robertson discuss how the changing state laws and regulations post-Dobbs may impact clinical research in different ways for different stakeholders.

Continue Reading Podcast: Post-Dobbs: Considerations for Clinical Trials and Research – Diagnosing Health Care

The Joint Commission, one of the leading accrediting organizations of health care entities, recently announced significant updates to require that health care organizations invest in their health equity promotion infrastructure and The Joint Commission’s intention to acknowledge those organizations with more robust health equity initiatives and programs.

Effective January 1, 2023, The Joint Commission implemented new and revised standards for hospitals, ambulatory health care organizations, and behavioral health care organizations aimed at reducing health care disparities.

Most significantly, The Joint Commission added a new standard, LD.04.03.08, to the Leadership (LD) chapter. This standard provides: “Reducing health care disparities for the [organization’s] [patients] is a quality and safety priority.”[1] The new standard, which applies to all hospitals and certain ambulatory health care organizations and behavioral health care organizations, has the following six elements of performance: Continue Reading The Joint Commission’s 2023 Focus on Health Equity

In this episode of the Diagnosing Health Care Podcast:   With the recent midterm elections changing the composition of Congress, and the Biden administration’s first opportunities to advance its policy priorities from the very beginning of the rulemaking process, what are the key health care developments to watch out for in 2023?

Epstein Becker Green attorneys Ted Kennedy, Jr.; Alexis Boaz; and Philo Hall discuss the current landscape of health care policy from both the legislative and regulatory perspectives and analyze which key health care issues may arise.

Continue Reading Podcast: 2023 Health Policy Outlook – Diagnosing Health Care

More than just New Year’s resolutions went into effect when the clock struck midnight on January 1, 2023. The California Privacy Rights Act (“CPRA”) and the Virginia Consumer Data Protection Act (“VCPDA”) are now effective in California and Virginia, respectively. These comprehensive data privacy laws, along with three other state laws going into effect this year, establish new and complex obligations for businesses. If your business has not taken steps to prepare for these privacy laws, it is high time to start that process to avoid violations and enforcement likely to follow later in the year. See below for a timeline of key dates.

Continue Reading 2023 New Year’s Resolution: Effectively Comply with New Comprehensive State Privacy Laws

The regulatory environment at the US Food and Drug Administration (“FDA”) has a tremendous impact on how companies operate, and consequently data on that environment can be quite useful in business planning.  In keeping with the theme of these posts of unpacking averages, it’s important to drill down sufficiently to get a sense of the regulatory environment in which a particular company operates rather than rely on more global averages for the entire medical device industry.  On the other hand, getting too specific in the data and focusing on one particular product category can prevent a company from seeing the forest for the trees.

Recently, I was asked by companies interested in the field of digital medical devices used in the care of people with diabetes to help them assess trends in the regulatory environment.  To do that, I decided to create an index that would capture the regulatory environment for medium risk digital diabetes devices, trying to avoid getting too specific but also avoiding global data on all medical devices.  In this sense, the index is like any other index, such as the Standard & Poor 500, which is used to assess the economic performance of the largest companies in terms of capitalization.  My plan was to first define an index of product codes for these medium risk digital diabetes products, then use that index to assess the regulatory environment in both premarket and postmarket regulatory requirements. Continue Reading Unpacking Averages: Creating an Industry-Specific Index to Track the FDA Regulatory Environment

It is certainly easy, when writing code to accomplish some data science task, to start taking the data on face value.  In my mind, the data can simply become what they claim to be.  But it’s good to step back and remember the real world in which these data are collected, and how skeptical we need to be regarding their meaning.  I thought this month might be an opportunity to show how two different FDA databases produce quite different results when they should be the same. Continue Reading Unpacking Averages: The Difference Between Data and the Truth: Comparing FDA’s UDI Database with FDA’s 510(k) Database

On December 1, 2022, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) published a bulletin warning that commonly used website technologies, including cookies, pixels, and session replay, may result in the impermissible disclosure of Protected Health Information (“PHI”) to third parties in violation of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”). The bulletin advises that “[r]egulated entities are not permitted to use tracking technologies in a manner that would result in impermissible disclosures of Protected Health Information (“PHI”) to tracking technology vendors or any other violations of the HIPAA Rules.” The bulletin is issued amidst a wider national and international privacy landscape that is increasingly focused on regulating the collection and use of personal information through web-based technologies and software that may not be readily apparent to the user.

Continue Reading HHS Warns HIPAA Covered Entities and Business Associates That Use of Website Cookies, Pixels, and Other Tracking Technology May Violate HIPAA Rules

In this episode of the Diagnosing Health Care Podcast:  In the aftermath of the Dobbs v. Jackson Women’s Health Organization decision, important questions have emerged about the current legal and regulatory landscape surrounding patient access to drugs that have historically been used to induce abortions.

How can health care providers and pharmacies navigate these new restrictions?

Continue Reading <em>Podcast:</em> Post-<em>Dobbs:</em> Access to Reproductive Health Care and Abortion-Inducing Drugs – <em>Diagnosing Health Care</em>

Effective November 16, 2022,  non-governmental health care entities must offer eligible employees continued employment for at least four months following a change in control without any reduction in their wages and benefits – including paid time off, health care, retirement, and education benefits in accordance with Senate Bill No. 315 (the Law). Change in control includes sales, transfers, assignments, mergers, and reorganizations and is deemed to “occur on the date of execution of the document effectuating the change.”

Continue Reading New Job Protections for New Jersey Health Care Workers Following Changes in Control of Their Health Care Entity Employer

In this episode of the Diagnosing Health Care Podcast:  The past three years have been tumultuous in the health care construction economy, and the patterns in recent construction claims might surprise some. Which types of claims are popping up, in what regions are they appearing, and what types of facilities are involved?

On this episode of our Owner’s Outlook series, hear from special guest Brett Lamb, co-founder and CEO of Construction Discovery Experts.

Continue Reading <em>Podcast:</em> Owner’s Outlook: National Trends in Construction Claims – <em>Diagnosing Health Care</em>