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Harmonizing the Common Rule and U.S. Food and Drug …

WebOn September 28, 2022, the U.S. Food and Drug Administration (“FDA”) issued two Notices of Proposed Rule Making to harmonize FDA’s regulations pertaining to human subjects …

Actived: 2 days ago

URL: https://www.ropesgray.com/en/insights/alerts/2022/09/harmonizing-the-common-rule-and-us-food-and-drug-administration-human-subjects-research-regulations

ONC Proposes Significant Changes to Health IT

WebOn April 18, 2023, the Office of the National Coordinator for Health Information Technology (“ONC”) within the U.S. Department of Health and Human Services published a …

Category: Health Go Health

2024 U.S. Health Care Fraud, Waste & Abuse Trends (Part …

WebIn this first podcast episode of a 3-part series, Ropes & Gray's health care partners Devin Cohen and Michael Lampert discuss key considerations for …

Category: Health Go Health

Brett R. Friedman People Ropes & Gray LLP

WebBrett Friedman is a health care partner who advises clients at the forefront of the health care industry in areas such as government insurance programs, digital health, …

Category: Health Go Health

CMS’s AHEAD Model: The Next Step in Multi-Payor Value …

WebThe voluntary model is CMS’s most significant effort to date to engage States in multi-payor payment reform aimed at curbing health care cost growth, improving …

Category: Health Go Health

Recent Trends & Developments in Health Care Joint …

WebOn this fourth episode of Ropes & Gray’s Recent Trends & Developments in Health Care Joint Ventures podcast series, health care partners Devin Cohen and Brett …

Category: Health Go Health

CMS Releases Rules on 2024 Payment under Hospital …

WebOn November 2, 2023, the Centers for Medicare & Medicaid Services (“CMS”) released the final rules for the calendar year (“CY”) 2024 outpatient prospective payment system …

Category: Health Go Health

HHS and FTC Warning Letters Highlight Continued …

WebOn July 20, 2023, the U.S. Department of Health and Human Services’ Office for Civil Rights (“OCR”) and the Federal Trade Commission (“FTC”) sent warning letters …

Category: Health Go Health

Implications of the Corporate Transparency Act for Health …

WebAs part of Ropes & Gray’s ongoing efforts (see here) to advise on the impact of the Corporate Transparency Act (“CTA”), this Alert focuses on considerations for …

Category: Health Go Health

DOL, HHS, and Treasury Propose Rules to Amend …

WebOn July 25, 2023, the Departments of the Treasury (Treasury), Labor (DOL), and Health and Human Services (HHS) (collectively, the Departments) proposed rules …

Category: Health Go Health

HHS Proposes Changes to the HIPAA Privacy Rule to Strengthen …

WebHHS Proposes Changes to the HIPAA Privacy Rule to Strengthen Privacy Protections for Reproductive Health Care Information

Category: Health Go Health

CMS Releases 2024 Final Rule for Inpatient and Long-Term Care …

WebOn August 1, 2023, the Centers for Medicare & Medicaid Services (CMS) released the final rule for the federal fiscal year (FFY) 2024 inpatient prospective payment system (IPPS) …

Category: Health Go Health

OHCA Publishes Final Regulations for California’s New Health Care

WebOn December 18, 2023, the Office of Administrative Law (“OAL”) approved the California Office of Healthcare Affordability’s (“OHCA’s”) Cost and Market Impact Review …

Category: Health Go Health

Insights from OIG’s Strategic Plan for Oversight of Managed Care …

WebFollowing their first discussion surrounding the Strategic Plan for Oversight of Managed Care for Medicare and Medicaid and its impact on the first two phases of the …

Category: Health Go Health

California Authorities Issue a Wide Range of Rules and Guidance …

WebOn March 4, 2020, California governor Gavin Newsom declared a statewide State of Emergency in response to the rapidly growing number of COVID-19 cases within the …

Category: Health Go Health

Christine Moundas and Gideon Palte Analyze Consequences of …

WebIn a New York State Bar Association Health Law Journal article, health care partner Christine Moundas and health care associate Gideon Palte examined the …

Category: Health Go Health

Minal Caron to Present at Three I’s Biosecurity and Research …

WebHealth care counsel Minal Caron will present at the Three I’s: Biosecurity and Research Integrity Conference, taking place in Portsmouth, New Hampshire on May 1 to …

Category: Health Go Health

Recent Cigna Settlements Demonstrate Government’s Continued …

WebOn September 29, 2023, Cigna agreed to pay $172 million—through two settlements 1 —and to enter a corporate integrity agreement 2 with the Department of …

Category: Health Go Health

Massachusetts’ Section 1115 Waiver Approval: Full

WebI. Background and Overview. On September 28, 2022, Center for Medicare & Medicaid Services (“CMS”) and the Massachusetts Executive Office of Health and …

Category: Health Go Health

FY 2023 Hospital IPPS/LTCH PPS Final Rule

WebOn August 1, 2022, CMS released the final rule for the federal fiscal year (“FY”) 2023 inpatient prospective payment system (“IPPS”) and long-term care hospital (“LTCH”) …

Category: Health Go Health

CMS Finalizes HCBS Payment Adequacy Requirements, But Critical

WebOn May 10, 2024, the Centers for Medicare & Medicaid Services (“CMS”) will publish the “Ensuring Access to Medicaid Services Rule” (the “Access Rule”), which …

Category: Health Go Health

June 24, 2019 New York’s Highest Court Holds that Medical …

Webropesgray.com ATTORNEY ADVERTISING June 24, 2019 . New York’s Highest Court Holds that Medical Practices that Cede Too Much Control to MSOs Are …

Category: Medical Go Health

Greg Levine and Lincoln Tsang to Present HLTH Webinar on …

WebArtificial intelligence and Machine Learning (AI/ML) functionality in medical devices and software has been a focus area for regulators, as these tools represent a …

Category: Medical Go Health

Effects Of Biosimilars Legislation On Patent Litigation

WebAll Content Copyright 2003-2009, Portfolio Media, Inc. If a lawsuit is commenced, the first step in any civil case is, of course, the filing of a

Category: Course Go Health

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