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Healthcare › Regulatory Reform › Comment Period

BakerHostetler

HHS Issues a Request for Information on Deregulation and Innovation: Considerations for Legal and Compliance Teams

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On May 14, 2025, the U.S. Department of Health and Human Services (HHS) issued its Request for Information (RFI) “Ensuring Lawful Regulation and Unleashing Innovation To Make American Healthy Again,” which HHS describes as...more

Jones Day

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

Jones Day on

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

Sheppard Mullin Richter & Hampton LLP

CMS Proposes Medicare Payment Policies for Hospital Inpatient Services for Federal Fiscal Year 2026

Sheppard Mullin Richter & Hampton LLP on

The Centers for Medicare & Medicaid Services (CMS) recently published the fiscal year (“FY”) 2026 proposed rule for Hospital Inpatient Prospective Payment Systems (IPPS) (the “Proposed Rule”). Comments to the Proposed Rule...more

Ballard Spahr LLP

HHS Proposes Significant Updates to HIPAA Security Rule

Ballard Spahr LLP on

On January 6, 2025, the U.S. Department of Health and Human Services (“HHS”) Office for Civil Rights (“OCR”) published a Notice of Proposed Rulemaking (“NPRM”) to amend the Health Insurance Portability and Accountability Act...more

Jones Day

FDA Announces Proposed Rule Regarding Laboratory Developed Tests

Jones Day on

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

Nelson Mullins Riley & Scarborough LLP

FDA Revises Guidance Concerning Scientific Communications to HCPs about Unapproved Uses of Approved/Cleared Medical Products

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The U.S. Food and Drug Administration (FDA) issued a long-awaited revised draft guidance on October 23, 2023, which focuses on communications to healthcare providers (HCPs) regarding scientific information on unapproved uses...more

Polsinelli

CMS Proposes Changes to Medicare Provider Enrollment Rules

Polsinelli on

The Centers for Medicare & Medicaid Services (“CMS”) published proposed changes to the Medicare Provider Enrollment requirements in the 2024 Medicare Physician Fee Schedule Proposed Rule (the “Proposed Rule”). If finalized,...more

Nelson Mullins Riley & Scarborough LLP

FDA Publishes Groundbreaking AI/ML Medical Device Draft Guidance

Nelson Mullins Riley & Scarborough LLP on

The U.S. Food and Drug Administration (“FDA”) has announced its first-ever draft guidance specifically addressing the use of artificial intelligence/machine learning (“AI/ML”) in medical devices (“Draft Guidance”).This...more

Nelson Mullins Riley & Scarborough LLP

Proposed Changes to Confidentiality of Substance Use Disorder Patient Records Rules Would Support Better Care, Decrease Stigma,...

Nelson Mullins Riley & Scarborough LLP on

Amid the ongoing proliferation of headlines about the mental health crisis in the United States, of which substance use disorder is a large part, the recent issuance by the U.S. Department of Health and Human Services (HHS)...more

Knobbe Martens

FDA Draft Guidance for Fostering Medical Device Improvement Using the Voluntary Improvement Program

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On May 5, 2022, the FDA’s Center for Devices and Radiological Health (CDRH) issued draft guidance regarding the FDA’s Voluntary Improvement Program (“VIP”). The draft guidance, Fostering Medical Device Improvement: FDA...more

Proskauer on Privacy

Department of Health and Human Services Issues Request for Information on Cybersecurity Standards

Proskauer on Privacy on

The Department of Health and Human Services (“HHS”) has issued a formal request for information from the public about how regulated entities are implementing industry recognized security practices. The request for information...more

Robinson+Cole Health Law Diagnosis

OSHA Taking Comments on Proposed Permanent Healthcare COVID-19 Standard

Robinson+Cole Health Law Diagnosis on

OSHA has partially reopened the rulemaking record and scheduled an informal public hearing to seek comments on several topics relating to the development of a final standard to protect healthcare and healthcare support...more

Arnall Golden Gregory LLP

Roll With the Changes: FDA’s Proposed Amendments to Converge its Quality Management System Requirements With ISO Requirements

Arnall Golden Gregory LLP on

In the words of the rock band REO Speedwagon, from the 1978 song “Roll with the Changes,” “It had to happen, felt the tables turnin’.” Earlier this month, the Food and Drug Administration’s Device Good Manufacturing Practice...more

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