The DEA Is Knocking at Your Door . . . Are You Prepared? – Diagnosing Health Care
The Latest on Healthcare Enforcement
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 178: Life Sciences Industry Impact with Bob Coughlin, JLL Director and Former MassBio CEO
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 175: Healthcare Inequity with Kim Smith, Healthcare Advocate and Founder of Health Evolve Technologies
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 174: Artificial Intelligence in Healthcare with Jonathan Samples, Partner at 121G
Podcast: Telehealth Post-Public Health Emergency – What to Expect in 2024 – Diagnosing Health Care
Health + Tech - Future of Precision Medicine With Dr. Amrie Grammer
Podcast: Direct Access Laboratory Testing - Physician Orders and Specimen Collection - Diagnosing Health Care
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 127: Kelli Ferry, Deputy Chief Legal Officer, and Angela Yochem, Chief Transformation and Digital Officer, Novant Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 118: Matthew Roberts and Darra Coleman, Health Care Attorneys, Nexsen Pruet
Malpractice Insurance: What Physicians And Dentists Should Know About Their Coverage
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
regulators. The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) regulates medical devices, including software-as-a-medical-device (SaMD). Several years ago, the FDA upgraded its...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
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
In the digital health market, new trends reveal future opportunities for innovators and shape healthcare investors’ strategies. Trends for 2022 include regulatory developments regarding digital health, telehealth expansion,...more
Telemedicine and telehealth have significantly reshaped how consumers access health care services. Even before the COVID-19 pandemic, online portals were jockeying to replace visits to primary care providers and urgent care...more
How should booming medical spa businesses proceed with little to no guidance from state medical boards? The American medspa industry, dominated by small, single-location, single-owned businesses, is booming in the wake of...more
The pace of impact through digital health in 2021 is off to a rapid start—be it the number of transactions, the numerous legislative proposals and actions, or the focused attention of enforcement bodies. Given the accelerated...more
The use of digital technologies has accelerated almost overnight due to the COVID-19 pandemic, with healthcare providers and patients finding new and innovative, socially-distanced ways to deliver and receive services. This...more
On August 3, 2020, the Centers for Medicare and Medicaid Services (CMS) issued a number of clarifications and proposals on remote patient monitoring (RPM) services reimbursed under the Medicare program. The changes, part of...more
Note From the Editors - With this Summer 2020 issue of Vital Signs, we take a moment to again applaud the remarkable actions of all the health care and life science organizations around the globe working tirelessly on our...more
In response to the COVID-19 pandemic, the Food and Drug Administration issued a guidance document on non-invasive remote monitoring devices to assist in facilitating patient monitoring during the COVID-19 public health...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 August 8, 2019, FDA issued a notice on its medical device recall database stating that a company called Opternative, Inc. had initiated a recall for the Visibly Online Refractive Vision Test, a software application offered...more
Navigating the U.S. Healthcare Regulatory Landscape for Wearable Devices - Complex Environment Includes Key Federal Agencies FDA, FTC, OCR, CPSC, CMS, and OIG - The wearable device market is emerging as a key player...more
Federal authorities have busted up what they say is a $1.2 billion Medicare fraud that should give taxpayers and patients pause about long-distance medical consultations and the huge sums of cash washing around the medical...more
On January 7, 2019 the U.S. Food and Drug Administration (“FDA”) issued three new documents related to the Agency’s Software Precertification (“Pre-Cert”) Pilot Program. These documents include (1) the Developing a Software...more
Regulation - OIG Issues Advisory Opinion Addressing Eligible Managed Care Organizations' Safe Harbor - On Oct. 11, 2018, the Office of Inspector General (OIG) for the U.S. Department of Health and Human Services (HHS)...more
Digital health—the convergence of healthcare, devices, genomics (in some instances), and digital technology—is a fast-growing sector teeming with the promise to improve the health of millions of people. A key feature of...more
Cadillac Tax Repeal Garners Bipartisan Support; Prospects for Implementation Delay Increase - Last week, the Senate passed its reconciliation package by a vote of 52-47, sending it back to the House for approval and...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
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
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