Posts tagged Bradley S. Davidsen.
Blogs
Clock 5 minute read

At first blush, the passage of House Bill 5483, entitled the “Special Registration for Telemedicine Clarification Act of 2018” (the “Bill”), appears to address the issue concerning the lack of regulatory guidance regarding the “Special Registration” exception to the Ryan Haight Act of 2008; however, a deeper and more careful analysis reveals that the Bill may not be as effective as most health care practitioners may hope. The Bill, sponsored by Rep. Carter (R-Georgia), a pharmacist, Rep. Bustos (D-Illinois), and nine others, cleared the House on June 12, 2018 without ...

Blogs
Clock 4 minute read

The calls for utilizing telemedicine in battling the opioid crises in the U.S. are growing louder. On January 30, 2018, Senators Claire McCaskill (D-Mo.), Lisa Murkowski (R-Alaska), and Dan Sullivan (R-Alaska), sent a letter to Robert W. Patterson, the Acting Administrator of the U.S. Drug Enforcement Administration (DEA), urging the agency to promulgate regulations that would allow healthcare providers to prescribe medication-assisted treatments via telemedicine for persons with opioid dependence disorder.

The letter specifically addresses the Ryan Haight Online ...

Blogs
Clock 5 minute read

On October 26, 2017, President Trump directed the Secretary of the Department of Health and Human Services (“Secretary”) to declare a National Public Health Emergency on the opioid epidemic. While the President offered few details regarding how his administration will address the challenge of treating patients struggling with opioid addiction, a previous statement from the White House indicated that the Administration plans to expand access to treatment via telemedicine and more specifically, remote prescribing of the necessary controlled substances used to treat ...

Blogs
Clock 6 minute read

You need not spend much time reading the news to know that recent Hurricanes Harvey and Irma have disrupted the lives of tens of thousands of individuals, many of whom may already have behavioral health needs; however, the trauma caused by these recent natural disasters, and others, has created an immense need for additional behavioral and mental health services. For example, a 2012 study entitled “The Impact of Hurricane Katrina on the Mental and Physical Health of Low-Income Parents in New Orleans” reported elevated rates of incidence of Post-Traumatic Stress Disorder ...

Blogs
Clock 5 minute read

The passage of the 21st Century Cures Act ("Cures Act") and revisions to the Common Rule (45 CFR Part 46) ("Common Rule") in the last year mandated significant changes to informed consent laws.  As a result of these changes, sponsors of research ("Sponsors"), institutions conducting research ("Institutions"), and the institutional review boards ("IRBs") approving research will need to review policies and practices involving informed consent.  As explained below, a recently published FDA guidance document makes a first step toward implementing some of these changes by ...

Blogs
Clock less than a minute

After July 1, 2017, optometrists and ophthalmologists ("Ophthalmic Providers") in Virginia will be able to practice through telehealth. Va. Code § 54.1-2400.01:2 permits Ophthalmic Providers to establish a bona fide provider-patient relationship "by an examination through face-to-face interactive, two-way, real-time communication" or through "store-and-forward technologies." Licensed Ophthalmic Providers may establish a provider-patient relationship so long as the provider conforms to the in-person standard of care.  To the extent that an Ophthalmic Provider ...

Blogs
Clock 2 minute read

On May 9, 2017, Scott Gottlieb, M.D. was confirmed by the Senate as the new Commissioner of the Food and Drug Administration ("FDA").  As Commissioner, he will be immediately responsible for shaping FDA policy on a number of current issues, including addressing and implementing several mandates stemming from the 21st Century Cures Act, ("Cures Act"), which was signed into law on December 13, 2016 with tremendous bipartisan support. The Cures Act contains over 200 sections that create new obligations for FDA; however, most pressing for Commissioner Gottlieb are three requirements ...

Blogs
Clock 5 minute read

Recent federal and state legislative efforts signal an increased focus on a significant and largely underappreciated public health threat – antimicrobial resistance (i.e., when a microorganism (such as a bacteria or virus) is able to resist the effects of medications such as antibiotics and antivirals, causing such medications to be ineffective). The results of a 2014 study underscore the magnitude of the threat of so-called "superbugs," estimating that the number of deaths worldwide attributable to antimicrobial resistance will reach 10 million by 2050.  By comparison, the ...

Blogs
Clock 3 minute read

Health care providers, life sciences companies and other entities subject to regulation by the Food and Drug Administration ("FDA") or the Centers for Medicare & Medicaid Services ("CMS") should be aware that the U.S. Department of Health and Human Services ("HHS") is increasing the maximum civil monetary penalty amounts that may be assessed by the agency.

The new maximum adjusted penalty amounts may have a significant impact on entities that violate or fail to meet mandatory reporting requirements set by FDA or CMS. Of the 299 enumerated increased fines, 137 fines (45.8%) have ...

Blogs
Clock 5 minute read

The Food and Drug Administration (FDA) issued a draft guidance (Draft Guidance) on July 11, 2016 that allows some generic drug manufacturers holding an Abbreviated New Drug Application (ANDA) to update the label of the drug they manufacture with new safety information.  The Draft Guidance provides new clarifications and recommendations to generic drug manufacturers seeking to update a generic label after withdrawal by the name brand manufacturer of the reference listed drug (RLD) (a "Withdrawn RLD").  The Draft Guidance explains how a generic manufacturer may submit an updated ...

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.