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CMS Updates Kidney Care Choices Model

The Center for Medicare and Medicaid Innovation ("CMMI") announced sweeping changes to the Kidney Care Choices Model ("KCC Model"), a key set of value-based programs....more

Medicare's Innovation Center Charts New Direction: Part 3 – Drugs, Devices, and Data

The Center for Medicare and Medicaid Innovation ("CMMI") is set to reshape value-based care. In the third of a three-part series highlighting this new direction, this summary is focused on CMMI's efforts regarding drugs,...more

Medicare's Innovation Center Charts New Direction: Part 2 – Digital Health and AI

The Center for Medicare and Medicaid Innovation ("CMMI") is set to reshape value-based care. In the second of a three-part series highlighting this new direction, this summary is focused on CMMI's efforts regarding digital...more

California Prosecutors Aggressively Pursue Compliance With Medical and Hazardous Waste Disposal Requirements

Health care facilities' compliance with medical and hazardous waste disposal laws comes under scrutiny in recent—and costly—investigations in California. ...more

Judge Blocks FDA Regulation of Laboratory-Developed Tests

On March 31, 2025, a judge in the Eastern District of Texas struck down a 2024 Final Rule (the "Final Rule") by the Food and Drug Administration ("FDA") that exerted jurisdiction over the regulation of laboratory-developed...more

DEA Releases Rules on Telemedicine Prescribing of Controlled Substances, Proposes Special Registrations

The Drug Enforcement Administration ("DEA") announced three new regulations related to the prescription of controlled substances resulting from a telemedicine encounter, including the long-anticipated Proposed Rule on Special...more

CMS's New TCET Pathway Expedites Medicare Coverage for FDA Breakthrough Devices

The Centers for Medicare and Medicaid Services ("CMS") published a final notice outlining the processes and procedures for the Transitional Coverage for Emerging Technologies ("TCET") pathway, a Medicare coverage pathway...more

CMS Finalizes The Increasing Organ Transplant Access Model

The Increasing Organ Transplant Access Model ("IOTA Model") introduces mandatory financial incentives and penalties for selected kidney transplant hospitals....more

Immigration Enforcement Directives Create New Hurdles for Hospitals Advancing Standard Patient Care

While hospitals will no longer be formally considered sensitive locations under new immigration directives, health care facilities and providers maintain responsibility to protect access to patient care and confidentiality....more

FTC's Final Health Breach Notification Rule: Expanded Scope, New Obligations, and Modified Reporting Requirements

The Federal Trade Commission ("FTC") intends to "strengthen and modernize" the Health Breach Notification Rule with revamped and increased scrutiny on entities holding health information, including health apps, websites, and...more

California Health Care Providers to Face Greater Headwinds as State Implements Health Care Cost Targets

Pursuant to California's Health Care Quality and Affordability Act (the "HCQA"), the newly created Office of Health Care Affordability ("OHCA") recently proposed statewide health care cost targets and standards and goals for...more

New State Health Privacy Laws—Moving Beyond HIPAA and Recasting Consumer Health Data Rights?

New, first-of-their-kind consumer health data privacy laws in Washington and Nevada are designed to provide state-level protections for personal health data not covered by the Health Insurance Portability and Accountability...more

HHS Releases Cybersecurity Performance Goals to Enhance Cybersecurity for Health Care and Public Health Sectors

The Department of Health and Human Services ("HHS") has released voluntary cybersecurity performance goals for the health care and public health sectors, which outline an increasingly standardized regulatory approach and...more

HHS Announces Upcoming Federal Strategies to Enhance Cybersecurity for Health Care and Public Health Sectors

The Department of Health and Human Services ("HHS") has released a concept paper outlining its new cybersecurity strategies for the health care sector, identifying cybersecurity priorities, potential future regulations and...more

Federal Agencies Seeking Patent Seizure Authority Through Draft NIST Guidance

The Situation: On December 8, 2023, the National Institute of Standards and Technology ("NIST") released a proposed framework for federal agencies regarding the exercise of the government's march-in rights for federally...more

HHS Enters Into First-Ever Ransomware Resolution Agreement and Corrective Action Plan

The U.S. Department of Health and Human Services ("HHS") Office of Civil Rights ("OCR") has entered into its first settlement of potential Health Insurance Portability and Accountability Act ("HIPAA") violations arising out...more

HHS-OIG Issues Long-Anticipated General Compliance Program Guidance for All Health Care Stakeholders

In Short - The Situation: On November 6, 2023, the Office of Inspector General ("OIG") of the U.S. Department of Health and Human Services ("HHS") released its "General Compliance Program Guidance" ("GCPG"). The GCPG...more

FDA Announces Proposed Rule Regarding Laboratory Developed Tests

The highly anticipated rule, which would make explicit that LDTs are medical devices subject to FDA oversight, proposes to end the agency's general enforcement discretion approach to such devices....more

California Becomes the First State to Ban Four Common Food Additives

With the swipe of a pen, California Governor Gavin Newsom starts the California Food Safety Act countdown to a 2027 statewide ban on four popular food additives. Starting January 1, 2027, companies manufacturing, selling,...more

Industry Anticipates Impending FDA Proposed Regulation Addressing Laboratory Developed Tests

Stakeholders prepare for the U.S. Food and Drug Administration's ("FDA") rulemaking effort to "make explicit" that laboratory developed tests ("LDTs") are devices subject to the agency's oversight, reigniting outstanding...more

Clarifying Cosmetics Reform: FDA Issues Draft Guidance on Registration and Product Listings

Heralding the significant changes coming to the U.S. cosmetics industry starting in 2023, the U.S. Food and Drug Administration ("FDA") has issued draft guidance to companies regarding cosmetic facility registrations and...more

HHS-OIG Issues FAQ Guidance Related to Pharmacy Benefit Manager Arrangements

The U.S. Department of Health and Human Services, Office of Inspector General ("OIG") has provided insight into the applicability of the discount and group purchasing organization safe harbors to payments retained by pharmacy...more

FTC Proposes Updates to the Health Breach Notification Rule for Health Apps and Consumer Health Technologies

The Federal Trade Commission seeks to clarify how the Health Breach Notification Rule applies to health records collected by health apps and similar consumer health technologies. ...more

Vital Signs Digital Health Law Update | Spring 2023

Note From the Editors - This edition of Vital Signs is filled with digital health developments from around the world. In Industry Insights, you'll see and hear from Alexis Gilroy and Claire Castles, each in a short video...more

My Health, My Data: Washington Enacts First State Comprehensive Health Privacy Law

The sweeping law imposes new requirements on the processing and sale of consumer health data in the state. On April 27, 2023, Washington State Governor Inslee signed the "My Health My Data Act" ("Act"). This Act marks the...more

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