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Medical Device Updates: U.S. Food and Drug Administration (FDA) Releases Numerous and Important Draft Guidance Documents

The summer of 2016 saw a flood of new medical device-related guidance documents coming out of FDA’s Center for Devices and Radiological Health (CDRH). Some of these draft guidance documents, such as those addressing device...more

Third Circuit Delivers Resounding Victory for FTC in Pennsylvania Hospital Merger Case

On September 27, 2016, the U.S. Court of Appeals for the Third Circuit handed the Federal Trade Commission (FTC) a significant antitrust victory by granting its request for a preliminary injunction to stay the pending merger...more

DOJ-AmEx Case Could Have Ramifications for Health Care Providers

The U.S. Department of Justice's loss to American Express sends a message to health care providers: Steering, tiering, exclusive dealing and other contractual arrangements that appear to suppress competition in one part of...more

The Dennis Decision: A Shot Across the Bow for Hospitals

A recent Virginia court decision questions the reasonable value of health care services and creates a challenge to debt collection efforts by hospitals. In March, the Circuit Court for Henry County, Patrick County, and the...more

HHS OCR Guidance on Ransomware Attacks: They Constitute a “Security Incident” and Are Likely a Data Breach

On July 11, 2016, the HHS Office of Civil Rights (OCR) released guidance on HIPAA covered entities’ responsibilities in a ransomware attack, a type of cyber-attack that has targeted the health care sector extensively in...more

Breach of ePHI Results in $2.7 Million Fine

Oregon Health & Science University (“OHSU”) has paid $2.7 million to the U.S. Department of Health and Human Services, Office for Civil Rights (“OCR”) to settle allegations that it violated the Health Insurance Portability...more

Entity Fined $650,000 in First HIPAA Settlement with a Business Associate

The possibility of business associates potentially being audited, investigated, and ultimately fined is now a reality. On June 24, 2016, the United States Department of Health and Human Services’ Office of Civil Rights...more

Business Associate Settles HIPAA Investigation for $650,000

The U.S. Office for Civil Rights (OCR), the agency responsible for enforcing the HIPAA Privacy and Security rules, has just sent a strong message that business associates are not immune from scrutiny. On June 24, 2016, in a...more

HIPAA Compliance: Navigating a Health Care Minefield

In the two decades since its original passage, complying with the federal Health Insurance Portability and Accountability Act (HIPAA) hasn’t gotten any easier. Enacted with the primary goal of protecting the confidentiality,...more

One-Two Punch on Hospital Challenges: Is the FTC Down for the Count?

There was a time not long ago when the odds of beating the Federal Trade Commission on a hospital merger antitrust challenge were slim. Two recent defeats, however, may change that some. Late last year, the FTC, in quick...more

DOJ and North Carolina Challenge Anti-Steering and Tiering Provisions in Managed Care Contracts

The Department of Justice’s antitrust division (the “DOJ”)and the State of North Carolina (“NC”) jointly sued, on June 9, 2016, Carolinas HealthCare System (“CHS”), the largest healthcare system in North Carolina, over...more

Cybersecurity News & Notes – June 2016 #3

In Case You Missed It: Illinois strengthened its data privacy and security law, with the amendments going into effect in January 2017. The amendments include expanding the definition of “personal information” to include a...more

FTC Suffers Setback in Campaign to Slow the Rising Tide of Healthcare Consolidations

The FTC just suffered a major setback in its concerted efforts to challenge the ever growing number of consolidations in the healthcare industry, failing to secure a preliminary injunction to block a hospital merger in...more

A Sweet Win for Hershey Medical Center's Proposed Merger: District Court Denies FTC's Attempt to Block Pennsylvania Hospital...

The district court’s decision may mark a turning point away from purely formulaic reliance on the FTC’s preferred approach and the testimony of self-interested payers....more

FTC Finally Loses a Hospital Merger Challenge … Now What?

Handing the Federal Trade Commission (FTC) its first defeat in a federal court hospital merger challenge in more than a decade, a federal district court judge yesterday denied the joint request of the FTC and the Attorney...more

Spring Showers Bring HIPAA Breaches

OCR has announced several recent settlement agreements to resolve violations of the Health Insurance Portability and Accountability Act (“HIPAA”). These settlement amounts range from $25,000 to $3.9 million dollars and...more

OCR Releases Updated HIPAA Audit Protocol and Business Associate Listing Template

The Office of Civil Rights (OCR) recently updated the audit protocol that it will be using to assess Covered Entities’ and Business Associate’s compliance with the Health Insurance Portability and Accountability Act (HIPAA)...more

Department of Health and Human Services Cracks Down on Vendor Oversight in Recent Hospital Settlements

From the rise in ransomware attacks to inadvertent disclosure of information by subcontractors, the health services industry is reminded that a potential consequence of a data breach is the threat of a regulatory enforcement...more

How to Prepare for the Next Round of HIPAA Audits

Nearly two years after the Office of Civil Rights (“OCR”) first announced its preparation for another round of HIPAA audits, Phase II of OCR’s HIPAA audit program is finally underway. On March 21, OCR began emailing...more

SOS Answered: New Guidance on HIPAA for App Developers

Amidst criticism that the Health Insurance Portability and Accountability Act (“HIPAA”) lags behind technological innovation, the Office for Civil Rights (“OCR”) released new guidance to aid app developers in determining how...more

OCR Kicks Off HIPAA Audits After Issuing Two Major Settlements

On March 21, 2016, the HHS Office for Civil Rights (OCR) launched phase two of its much-anticipated audit program for covered entities and business associates. The announcement comes in the wake of OCR's issuance of two major...more

Does Arbitration Belong in the Nursing Home World?

As part of admission into a nursing home, a facility typically requires prospective residents to agree to binding arbitration. Arbitrating disputes generally allows nursing facilities to handle disputes without incurring the...more

UnitedHealth Settles NY Attorney General Antitrust Probe

In early January, the New York Attorney General's Office announced that it had reached an agreement with UnitedHealth that would conclude the AG Office's investigation into UnitedHealth's marketing of elder care and nursing...more

Court Temporarily Tables Controversial NYC Salt Warning Rule

In September 2015, the New York City Board of Health unanimously passed a unique measure that would require chain restaurants to warn consumers about the sodium content of certain menu items. In particular, restaurants with...more

Developments in Cybersecurity: Privacy Laws, Hacking Beyond Customer Data, and Communicating with Corporate Boards

I. Legal Exposure to Federal and State Privacy Laws - A. Federal Statutes and Enforcement - 1. Federal Trade Commission Act, 15 U.S.C. §§ 41-58 - The Federal Trade Commission (FTC) has emerged as the leading...more

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