K&L Gates Healthcare Triage

K&L Gates LLP 192 - What the FDA's Botox Warning Letter Means for DSCSA Compliance

Triage: Rapid Legal Lessons for Busy Health Care Professionals has been created by K&L Gates to convey information about developments in health law through short podcasts. If you work in the health care industry, you have grown accustomed to frequent changes in laws and regulations. On some days, it may seem like an insurmountable task to keep up with every change, especially as a new presidential administration and new policies take shape. The K&L Gates Health Care practice will regularly create Triage podcasts to help you learn about the latest developments in health law. Our lawyers will identify the most important changes and analyze the impact of these changes on our clients.

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K&L Gates Healthcare Triage

Episodes

What the FDA's Botox Warning Letter Means for DSCSA Compliance

No Surprises Act Check-In: The Latest Changes to the IDR Process

HIPAA Modernization: HHS's Proposed Privacy and Security Rule Updates

Privileged Matters: A Closer Look at Attorney-Client Privilege

Next Steps for Provider-Based Departments After the Consolidated Appropriations Act of 2026

LEAD the Way: An 8-Minute Primer on Accountable Care's Next Chapter

340B Drug Pricing Program: Rebate Model Considerations

A Closer Look at HHS's RFI on Accelerating the Adoption of AI in Clinical Care

RWI in Healthcare M&A: Part 2

RWI in Healthcare M&A: Part 1

Veterans Day Special Episode: Combating Traumatic Brain Injury

Corporate Practice of Medicine: New Relevance in a Changing World

Health System Cybersecurity Risks: Part Two

Health System Cybersecurity Risks: Part One

Highlights from FDA Regulatory Developments in Clinical Trials: 2023 Recap and 2024 Forecast

FDA Issues Guidance on Informed Consent for IRBs, Clinical Investigators, and Sponsors

Ensuring Continuity of Care Following a Cyberattack: ARPA-H Launches Project to Enhance Cybersecurity Tools for Health Care Organizations

Unpacking CMS's Proposed Rule for Correcting Underpayments for 340B Drug Reimbursement

The End of Continuous Medicaid Enrollment—What Health Systems Should Know

Value-Based Lessons Learned: Two Years Later, How Have Providers Utilized New AKS and Stark Flexibilities?

Highlights for Research Institutions and Sponsors in FDA's Recent Draft Guidance on Decentralized Clinical Trials

2022 Health Care Employment Law Year in Review

Rural Emergency Hospitals — Transformative Change or Limited Impact?

Stark Law and the Anti-Kickback Statute Under the False Claims Act

Recent Developments to the 340B Drug Pricing Program

The Information Blocking Rule's "Glide Path" - Compliance with the Information Blocking Rule After the Limitation on the Scope of EHI is Lifted

New Data Available Under the Hospital Price Transparency Rule

Issue-Spotting Hospital Activities that May Trigger FDA Regulatory Oversight

Cybersecurity & HIPAA: NIST's Practical Guidance Updates for Covered Entities and Business Associates

Genesis Healthcare and the 340B Program Patient Definition

Medicare Advantage False Claims Act Developments

Hospitals, Physician Practices, and Labs – Are You Ready to Report Private Payor Rates for Laboratory Tests?

The Drive to Align ESG and Health Equity Priorities With Medicare Reimbursement Models

Regulatory, Contractual, and Governance Considerations for Data Transactions

Medical Laboratories Under the Microscope

Navigating the Independent Dispute Resolution Process Under the No Surprises Act

2021 Health Care Employment Law Year in Review and a Look Forward

Medicare Reimbursement for Community Hospital Residency Programs

Data Security Breaches in the Health Care Sector

What Health Care Providers Should Expect in an FDA Inspection

An Update on the CMS Hospital Price Transparency Rule

FTC Reminds Vendors of Personal Health Records of Breach Rule Obligations

No Surprises: New Balance Billing Regulations for Health Care Providers

CMS's Proposal for New Remote Therapeutic Monitoring Codes under the 2022 Medicare Physician Fee Schedule

Key Considerations for Officers and Directors of Distressed Companies

Cybersecurity Risk in the Health Care Industry

When Regulatory Review is Necessary: Clinical Research vs. Quality Initiatives

OFCCP Enforcement in the Health Care Space

Understanding OIG and CMS Audits

The Power of Health Care: Renewable Energy Transactions from the Health Care Perspective