Legal and practical healthcare information.
Originally published in Healthcare Michigan, Volume 40, No. 3 As the year 2020 began, it would have been difficult for most Americans to imagine how life, as we knew it at that time, would change in the coming months and years. You likely recall generally, if not specifically, that on January 31, 2020, the Secretary of …
Continue reading “Keep the End in Sight: Expiration of the COVID-19 Declared Emergencies”
ONC Final Rule Information blocking On May 1, 2020, the Federal Department of Health and Human Services (“HHS”), Office of the National Coordinator for Health Information Technology (“ONC”) released a Final Rule (the “ONC Final Rule”), which implements the information blocking provision of the 21st Century Cures Act, enacted in 2016. The information blocking provision …
Continue reading “HOW APPLICATION PROGRAMMING INTERFACES APPLY TO HEALTHCARE ENTITIES”
One year ago, in March of 2020, the Secretary of the U.S. Department of Health and Human Services (Secretary) declared that, because of the public health emergency resulting from the number of confirmed cases of 2019 Novel Coronavirus (COVID), circumstances exist to justify the authorization by the Food and Drug Administration (FDA) of emergency use …
Continue reading “FDA Authorization of COVID Vaccines – What Does it Mean?”
On June 19, 2020, the Department of Health and Human Services (“HHS”) released its final rule[i] (the “Final Rule”) revising its enforcement of Section 1557 of the Patient Protection and Affordable Care Act (“ACA”).[ii] In this rule, HHS reversed many of the requirements of the prior rule issued in 2016 (the “2016 Rule”).[iii] For example, the Final Rule …
Continue reading “Summary of Key Changes to Rules Implementing ACA Nondiscrimination Provisions”
In light of the COVID-19 pandemic, on March 30, 2020, the Secretary of the U.S. Department of Health and Human Services (the “Secretary”) released blanket waivers (the “Waivers”) under Section 1135 of the Social Security Act (the “Act”) as to certain referral-related activities that would normally result in sanctions under the Federal Physician Self-Referral Law, …
Continue reading “Stark Law and Anti-Kickback Statute Waivers for COVID-19”
You’ve probably heard that every provider’s favorite laws, the Anti-Kickback Statute and its related, strict liability counterpart, the Stark Law (formally known as the Physician Self-Referral Law), are getting a makeover from the Department of Health and Human Services (HHS). Here’s what you need to know. Quick Legal Refresher: (A) What is the Anti-Kickback Statute? …
On October 9, 2019, the U.S. Department of Health and Human Services (“HHS”) released newly proposed modifications to the safe harbor provisions for the Federal Anti-Kickback Statute. Among other proposals, HHS is proposing three substantive changes to the personal services safe harbor. Section 1128B(b) of the Social Security Act (commonly referred to as the “Anti-Kickback …
When healthcare providers are subject to a bad review on Yelp! or similar customer-review websites and apps, it can be difficult to hold back and not provide a response or at least attempt to clarify the situation. However, healthcare providers, including dental providers, must ensure that employees who handle their social media, including customer-review websites …
Continue reading “Healthcare Provider Fined for Disclosing PHI in Response to a Yelp! Review”
Individuals who use healthcare apps such as fitness trackers, weight loss, wellness, exercise, etc., BEWARE! A couple of recent developments have highlighted the fact that most apps are not subject to HIPAA, which means that with broadly-worded privacy policy these healthcare apps can and do readily share healthcare and other data collected by the apps …
By Rose Willis A U.S. government interagency report indicates that there has been a 300 percent increase in the daily ransomware attacks in 2016 as compared to 2015. Ransomware is malicious software that, when introduced into a system, gives a hacker access to the user’s system, and the ability to encrypt data and hold it …
Continue reading “New HIPAA Guidance on Ransomware Prevention and Recovery”