Can Food Really Be Medicine? Transforming Health Care One Bite at a Time – Diagnosing Health Care Video Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 243: HIPAA Compliance and Potential Changes with Shannon Lipham of Maynard Nexsen
HHS OIG’s Nursing Facility: Industry Segment-Specific Compliance Program Guidance
False Claims Act Insights - Will Recent Leadership Changes Lead to FCA Enforcement Policy Changes?
Breaking Down the Shifting Vaccine Policy Landscape – Diagnosing Health Care Video Podcast
Healthcare Industry Segment-Specific Compliance Program Guidances (ICPGs)
2025 Outlook: The Department of Health and Human Services Under the Second Trump Administration – Diagnosing Health Care
New HIPAA Final Rule: Key Changes to Reproductive Health Care Privacy - Thought Leaders in Health Law®
Navigating the Labyrinth of Private Equity Investments in Health Care – Diagnosing Health Care
HHS Office for Civil Rights Director Melanie Fontes Rainer on Progress and News at OCR
ERISA Blog | Changes to the HIPAA Privacy Rules A Primer for Self-Insured Group Health Plans
Hospice Insights Podcast - A Refresh: What’s New in the New OIG General Compliance Program Guidance
The Presumption of Innocence Podcast: Special Edition | Episode 36 - Rolling Change: The DEA Turns Over a New Leaf on Marijuana Scheduling
Understanding the HHS OIG’s General Compliance Program Guidance
OMG. . .The OIG is at it Again
The FTC's Health Privacy Enforcement Actions
Medical Device Legal News with Sam Bernstein: Episode 19
Episode 303 --- Deep Dive into the HHS-OIG Compliance Program Guidance
Counsel That Cares - The Private Payer's Perspective on Value-Based Care
Medical Device Legal News with Sam Bernstein: Episode 17
The Department of Health and Human Services (“HHS”) recently proposed a policy that would require all new vaccines to undergo placebo-controlled clinical trials prior to FDA approval. The proposal, while controversial, is...more
On January 6, 2025, the US Food and Drug Administration (FDA) and the US Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) released a joint draft guidance document: Considerations for...more
For more than a decade, the Food and Drug Administration (FDA) has made diversity in clinical trials a focus, including by issuing guidance, convening public-private workshops, and completing data analyses in an effort to...more
The U.S. Food and Drug Administration (FDA), and the Office of Human Research protections (OHRP) released draft guidance titled, “Considerations for Including Tissue Biopsies in Clinical Trials.” Although non-binding, the...more
DTC Telehealth Platforms - Arrangements involving telemedicine and direct-to-consumer (“DTC”) business services are expected to be a source of major regulatory scrutiny. In 2024, such arrangements were the focus of proposed...more
On January 6, 2025, the U.S. Food and Drug Administration (“FDA”) and the Office for Human Research Protections (“OHRP”) issued a joint draft guidance on including tissue biopsies in clinical trials that evaluate...more
The Office for Human Research Protections (OHRP) of the U.S. Department of Health and Human Services on Oct. 25, 2024, issued nonsubstantive amendments to subparts B, C and D of 45 CFR Part 46, which provide additional...more
The HIPAA Privacy Rule sets forth provisions related to the waiver or alteration of authorization in relation to clinical research studies for circumstances in which it would be impractical or impossible to obtain...more
This issue of McDermott’s Healthcare Regulatory Check-Up highlights significant regulatory activity for December 2023. We discuss several civil and criminal enforcement actions that involve alleged violations of the False...more
Hear directly from the enforcement community - Want to gain insight into properly monitoring, detecting, investigating, and managing violations? Join us at HCCA’s Annual Healthcare Enforcement Compliance Conference to...more
The US District Court for the Southern District of New York issued a potentially significant opinion with respect to ClinicalTrials.gov results posting on February 24. If upheld, clinical study sponsors and investigators may...more
This two-day Regional Compliance and Ethics Conferences provide attendees with a forum to interact with local compliance professionals, share information about your compliance successes and challenges, and create educational...more