Posts tagged health care providers.
Blogs
Clock 6 minute read

On December 6, 2023, Senate Budget Committee Ranking Member Chuck Grassley (R-Iowa) and Chair Sheldon Whitehouse (D.-R.I.) announced a new bipartisan investigation into private equity ownership in hospitals—just ahead of a new plan by the Biden-Harris Administration to crack down on anticompetitive practices in health care.

Under the Biden plan, announced December 7, the Department of Justice (DOJ), the Federal Trade Commission (FTC), and Department of Health and Human Services (HHS) will seek input on how private equity is affecting the health care of Americans and the ...

Blogs
Clock 13 minute read

In October 2023, the FDA released draft guidance entitled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers Guidance for Industry” (“2023 Draft Guidance”).[1] The 2023 Draft Guidance supersedes previous draft guidance from 2014 entitled “Distributing Scientific and Medical Publications on Unapproved New Uses–Recommended Practices” (“2014 Draft Guidance”), which was a revision of a 2009 final guidance entitled “Good Reprint ...

Blogs
Clock 22 minute read

Introduction

Hardly a day goes by when we don’t see some media report of health care providers experimenting with machine learning, and more recently with generative AI, in the context of patient care. The allure is obvious. But the question is, to what extent do health care providers need to worry about FDA requirements as they use AI?

Blogs
Clock 2 minute read

In this episode of the Diagnosing Health Care Podcast:  The Federal Reserve’s steady increase of interest rates and the slowed economic growth have increased fiscal pressure on health care providers, leaving many to look for ways to bridge budget shortfalls through injections of capital, asset sales, or other strategic transactions. 

What options are there for providers moving forward?

Blogs
Clock 2 minute read

Throughout 2021, we closely monitored the latest privacy laws and a surge of privacy, cybersecurity, and data asset management risks that affect organizations, small and large. As these laws continue to evolve, it is important for companies to be aware and compliant. We will continue to monitor these trends for 2022.

The attorneys of the Privacy, Cybersecurity & Data Asset Management group have written on a wide range of notable developments and trends that affect employers and health care providers. In case you missed any, we have assembled a recap of our top 10 blog posts of 2021, with links to each, below:

Blogs
Clock 3 minute read

On Tuesday, August 24, 2021, California Attorney General Rob Bonta issued a guidance bulletin (the “Guidance”) to health care providers reminding them of their compliance obligations under California’s health data privacy laws, and urging providers to take proactive steps to protect against cybersecurity threats. This Guidance comes, in part, as a response to federal regulators sounding the alarm over an uptick in cybercrime against hospitals and other health providers. The Guidance follows an October 2020 Joint Cybersecurity Advisory issued by the Cybersecurity and ...

Blogs
Clock 4 minute read

The roll out of the Office of the National Coordinator’s (ONC) 21st Century Cures Act Interoperability and Information Blocking Rules is reminiscent of the way HIPAA has rolled out over the course of the past 25 years. As of May 1, 2021, Actors have been required to comply with the Information Blocking rules. However, it will take some time before all Actors know who they are and for complaints of Information Blocking to be determined to be actual instances of Information Blocking, by which time the penalties that have not yet been finalized may also need to be adjusted.

While ONC defined ...

Blogs
Clock 3 minute read

At the end of March, Florida joined the roster of states that have erected legal shields for health care providers against COVID-19-oriented liability claims. Concerned about uncertainty surrounding the emergency measures taken in response to COVID-19 and the effects that lawsuits could have on the economic recovery and the ability of health care providers to remain focused on serving the needs of their communities, the Florida Legislature passed CS/SB 72 on March 29, 2021.  Governor Ron DeSantis signed CS/SB 72 into law as Laws of Florida 2021-1.  This law creates two new statutory provisions - section 768.38 and section 768.381, Florida Statutes – effective on passage.

What Are the Liability Protections?

Section 768.381, Florida Statutes provides protection for health care providers regarding COVID-19-related claims, as follows:

  • Complaints alleging claims subject to the law must be pled with particularity, or will be dismissed. This is a higher pleading standard than typically required for a civil complaint, and requires a greater degree of specificity.
  • Plaintiffs must prove gross negligence or intentional misconduct. This is a higher standard than ordinary negligence or professional malpractice.
  • Health care providers are provided with several affirmative defenses which, if proven, preclude liability. These defenses primarily relate to a provider’s substantial compliance with government-issued standards regarding COVID-19, infectious disease generally in the absence of standards specifically applicable to COVID-19 or the inability to comply with applicable standards in light of medical supply shortages.
  • There is a one-year statute of limitations on COVID-19-related claims against health care providers, which is substantially shorter than that for simple and medical negligence claims. When this statute starts to run depends on whether the claim arises out of the transmission, diagnosis, or treatment of COVID-19, or from other circumstances such as a delayed or canceled procedure. Actions for COVID-19 related claims that accrued before the law’s effective date must commence within one year of the effective date.
Blogs
Clock 4 minute read

Among the many concerns arising from rampant spread of COVID-19, are provider concerns regarding potential liability for care provided during the pandemic due to limited medical resources. Providers and policy makers have discussed such concerns particularly given the currently limited number of available ventilators and qualified technicians as compared to the numbers of patients who may need access to such equipment.[1] Congress and states have provided varying levels of liability protection, though such protections are themselves limited.

Under the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”), Congress provided liability protection to volunteer health care professionals providing health care services during the current public health emergency. [2] Specifically, the CARES Act exempts volunteer health care professionals from liability under federal or state law for any harm caused by an act or omission, unless the harm was caused by willful or criminal misconduct, gross negligence, reckless misconduct, conscious flagrant indifference, or under the influence of alcohol or intoxicating drugs, in providing health care services during the public health emergency with respect to the coronavirus. This provision preempts state or local laws that provide such volunteers with lesser protection from liability.

Notably, Congress chose not to extend liability protection to non-volunteer health care professionals, affording no wide-spread federal protection to those employed or contracted professionals treating patients during the emergency. Certain states, however, have extended liability protection to employed or contracted health care professionals through state orders. For example, Governor Cuomo of New York, through executive order, waived certain state laws to provide immunity from civil liability to certain health care professionals for any injury or death alleged to have been sustained directly as a result of an act or omission by such professional in providing medical services during the pandemic, unless such injury or death was caused by the professional’s gross negligence.[3]

Blogs
Clock 6 minute read

On March 11, 2020, the World Health Organization declared that COVID-19 is now a pandemic.  The effects continue to be felt in the United States, which now has well over 1,000 confirmed novel Coronavirus disease (COVID-19) cases.  As of March 12, 2020, nineteen states have declared a state of emergency to ensure there are resources to address the Coronavirus, and President Trump has announced a ban on travel to and from Europe for 30 days starting on Friday, March 13, 2020.  Given the prevalence of the Coronavirus in the U.S. and the growing numbers of cases globally, health care providers should take extra precaution with their patients, employees, and visitors.  As all public health communications are making clear, efforts to limit the spread of COVID-19 will not only prevent illness, but they will also reduce the pandemic’s potential to overwhelm critical health care resources.

This advisory provides guidance for health care providers in responding to the COVID-19 pandemic.  Our best practices for all employers can be found here and here, and all businesses should visit our Coronavirus Resource Center.

Blogs
Clock 3 minute read

Many physicians rely on publicly available reports to assess the safety of the devices they use on patients, but in some cases, these reports aren’t painting the full picture.  A recent Kaiser Health News (“KHN”) article raises serious questions about FDA’s practice of allowing a significant number of medical device injury and malfunction reports to stay out of the public eye.

Under FDA’s Medical Device Reporting (“MDR”) regulation (21 CFR part 803), device manufacturers, importers, and device user facilities (which include hospitals, ambulatory surgery ...

Blogs
Clock 4 minute read

On August 31, 2016, FDA issued a notification of public hearing and request for comments on manufacturer communications regarding unapproved uses of approved or cleared medical products. The hearing will be held on November 9-10, 2016, and individuals wishing to present information at the hearing must register by October 19, 2016. The deadline for written comments is January 9, 2017.

In the notice, FDA posed a series of questions on which it is seeking input from a broad group of stakeholders, including manufacturers, health care providers, patient advocates, payors, academics ...

Blogs
Clock less than a minute

Epstein Becker Green's slides from the "Eye on Ebola: A Discussion About the Health Regulatory, Risk Management, and Labor and Employment Issues Impacting Health Care Providers" webinar is featured on the American Hospital Association's Ebola Preparedness Resources - click here.

The November 17 webinar addressed the professional and business challenges encountered by health care providers dealing with Ebola and other infectious diseases, and featured 4 fantastic speakers.

  • Bruno Petinaux, M.D., Associate Professor, Co-Chief of the Emergency Management Section ...
Blogs
Clock less than a minute

Epstein Becker Green’s slides from the “Eye on Ebola: A Discussion About the Health Regulatory, Risk Management, and Labor and Employment Issues Impacting Health Care Providers” webinar is featured on the American Hospital Association’s Ebola Preparedness Resources - click here.

The November 17 webinar addressed the professional and business challenges encountered by health care providers dealing with Ebola and other infectious diseases, and featured 4 fantastic speakers.

  • Bruno Petinaux, M.D., Associate Professor, Co-Chief of the Emergency Management Section ...
Blogs
Clock less than a minute

In response to the ongoing threat of the Ebola Virus Disease ("EVD" or "Ebola") and the increased risk of individuals traveling from the affected countries to the United States, The Joint Commission recently launched an Ebola Preparedness Resources portal on its website.  The portal contains information addressing various safety actions for health care providers to consider, such as ensuring that all staff and clinicians who may come in contact with Ebola patients are educated and trained on Ebola guidance, re-evaluating infection control plans to ensure proper guidelines ...

Blogs
Clock 3 minute read

Under Title III of the Americans with Disabilities Act (“ADA”), private health care providers, including clinics, hospitals and doctor’s offices, as places of public accommodation, are required to provide their services to individuals with disabilities in an accessible manner.  Specifically, the ADA requires that providers provide individuals with disabilities full and equal access to their health care services and facilities and provide reasonable modifications to policies, practices and procedures when necessary to make health care services fully available to ...

Search This Blog

Blog Editors

Recent Updates

Related Services

Topics

Archives

Jump to Page

Subscribe

Sign up to receive an email notification when new Health Law Advisor posts are published:

Privacy Preference Center

When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. This information might be about you, your preferences or your device and is mostly used to make the site work as you expect it to. The information does not usually directly identify you, but it can give you a more personalized web experience. Because we respect your right to privacy, you can choose not to allow some types of cookies. Click on the different category headings to find out more and change our default settings. However, blocking some types of cookies may impact your experience of the site and the services we are able to offer.

Strictly Necessary Cookies

These cookies are necessary for the website to function and cannot be switched off in our systems. They are usually only set in response to actions made by you which amount to a request for services, such as setting your privacy preferences, logging in or filling in forms. You can set your browser to block or alert you about these cookies, but some parts of the site will not then work. These cookies do not store any personally identifiable information.

Performance Cookies

These cookies allow us to count visits and traffic sources so we can measure and improve the performance of our site. They help us to know which pages are the most and least popular and see how visitors move around the site. All information these cookies collect is aggregated and therefore anonymous. If you do not allow these cookies we will not know when you have visited our site, and will not be able to monitor its performance.