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Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 118: Matthew Roberts and Darra Coleman, Health Care Attorneys, Nexsen Pruet
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Digital Health Trends Shaping 2021: Traditional Retail, Tech & Telecom Giants Making Big Moves
Digital Health Trends Shaping 2021: Virtual Care 2.0: The Future of Digital Health
Healthcare Tech: What Legal Pitfalls Should Tech Companies Avoid As They Jump Into Healthcare?
JONES DAY TALKS®: Helping Health Care Providers Fight Human Trafficking
Darren Black on The Future of Health Care: Health Care Delivery and Consolidation Trends in 2020 and Beyond - Diagnosing Health Care Podcast
Carsten Beith on The Future of Health Care: Health Care Delivery and Consolidation Trends in 2020 and Beyond - Diagnosing Health Care Podcast
Preparing Employers and Employees for 2021 Benefit Plans Decisions
Barry Ostrowsky on The Future of Health Care: Health Care Delivery and Consolidation Trends in 2020 and Beyond - Diagnosing Health Care Podcast
Telehealth Flexibility: Key Regulatory Changes Impacting Providers During and Beyond the Coronavirus Pandemic - Diagnosing Health Care Podcast
Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on recent developments in the U.S. Food and Drug Administration's ("FDA") regulatory...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights regulatory activity for April 2024. We discuss several US Department of Health and Human Services (HHS) agency actions, including the Calendar Year (CY) 2025...more
Both chambers of Congress are out of session today and return for the rest of the week. Most healthcare priorities remain out of the congressional spotlight this week, but telehealth is still top of mind. As we...more
Ketamine clinics have been on the rise in the U.S. in recent years. As a byproduct of the common practice of prescribing drugs “off-label,” these clinics are not necessarily new in their operating model. Off-label use is the...more
For the first time in almost 10 years, the U.S. Food and Drug Administration (FDA) released a draft guidance related to certain communications by firms to healthcare providers (HCPs) of scientific information on unapproved...more
THIS WEEK’S DOSE - Uncharted Territory in the House: The House voted to remove Rep. McCarthy (R-CA) as Speaker of the House, then recessed until at least October 11, when the House is slated to reconvene to elect a new...more
We are pleased to bring you our 11th annual Healthcare Fraud & Abuse Review. Our Review provides comprehensive coverage of the most significant civil and criminal enforcement issues facing healthcare providers. Each year, we...more
The medical product and healthcare service industry is one of the most closely regulated sectors in the U.S. Several agencies actively exercise authority with constantly changing legislation and policies to keep pace with...more
For the last few years, we have been closely monitoring and reporting on COVID-19 related fraud enforcement efforts by federal agencies. We detailed those findings in our Health Care Enforcement 2020 Year in Review & 2021...more
The incoming Biden Administration promises a more nationalized approach to combatting the COVID-19 public health crisis, plus a large economic stimulus response focused on unemployment, paid leave, state and local government...more
During this unprecedented time, digital health is disrupting our healthcare delivery system for the better. Digital health companies are working hard to provide innovative telehealth, digital screening, and testing services....more
As the telemedicine regulatory and reimbursement environment becomes more cohesive and providers and patients alike embrace technology, opportunities for telemedicine collaborations are likely to grow. Like any collaboration,...more
On November 30, 2016, the House of Representatives passed the 21st Century Cures Act, a bill intended to modernize health care delivery and speed up and improve medical research and innovations by removing bureaucratic...more
Ways & Means Leadership Changes – Health Policy Implications Looming: As Congress pushes forward with a two-year budget deal, and new Speaker Paul Ryan begins his tenure as the top Republican in the House of...more
Senate Working Group Pressing Forward on Telehealth - As Congress focuses on bigger picture policy decisions, including broad budget negotiations and raising the debt ceiling, there are some exciting developments on the...more
Lions and Tigers and Bears, Oh My! The Unexpected Laws that May Affect Your Telehealth Business - An increasing number of health care providers are exploring telemedicine, either as an adjunct to their primary physical...more
On August 28, 2015, the Health Resources and Services Administration (“HRSA”) published proposed Omnibus Guidance (the “Proposed Guidance”) governing policies related to section 340B of the Public Health Service Act (“PHSA”),...more
As hospitals become increasingly technologically savvy, they are looking to do more and more with their electronic health record systems. What many hospitals do not realize is that some of the functionality they are seeking...more
According to a recent study by Accenture, by 2017 approximately 18 percent of the American public will purchase insurance through exchanges versus relying on traditional employer healthcare coverage or foregoing insurance...more
In recent months, as the conversation about reforming the health care system has shifted to achieving greater delivery system efficiencies, cost containment, and patient satisfaction, the role of health care...more
On August 1, 2014, the Food and Drug Administration (FDA) released draft guidance that would exempt from premarket 510(k) review many low-risk medical devices--including certain mobile applications that can convert a cell...more
On September 23, 2013, the U.S. Food and Drug Administration (the “FDA” or the “Agency”) issued long-awaited final guidance for developers of mobile medical or health applications (or “mobile medical apps”) used on...more
The FDA was granted authority to regulate mobile health care applications (apps) as part of the Food and Drug Administration and Innovation Act. (For a detailed discussion of the FDA’s authority, see “FDA Safety and...more
Last week, the U.S. Food and Drug Administration (FDA) sent an enforcement letter to a mobile medical app developer for failing to obtain a 510(k) clearance before marketing the app, which the FDA said appears to be a...more