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Finance Committee Report Places Medical Device Arrangements under Increasing Scrutiny

Hospitals and providers participating in physician-owned distributorships, or “PODs” may be at increased risk for government investigation or enforcement. A Senate Finance Committee (SFC) Report issued this month highlights...more

What's New with HIPAA?

A number of new developments have taken place related to Health Insurance Portability and Accountability Act (HIPAA) privacy and security compliance, and enforcement is increasing. Healthcare providers, health plans and other...more

FTC Enters into Consent Agreement Regarding Company's Use of Exclusive Contracts

The Federal Trade Commission (FTC) recently announced that Invibio, which sells high-performance polymer for medical implants, has settled charges that the company monopolized sales to medical device makers through unlawful...more

Negotiating Software Agreements – Key Terms For Electronic Health Records

Healthcare providers (Providers) rely on third party vendors for providing Electronic Health Record (EHR) software services. Due to the amount of protected health information Providers store in these software services, and...more

Breaking: Third Circuit Dismisses Antitrust Suit Concerning Marketing of Lovenox

Earlier today, the Third Circuit Court of Appeals upheld the decision of the District of New Jersey trial court dismissing the antitrust claims lobbed against Sanofi-Aventis by its rival pharmaceutical company Eisai. The...more

Phase 2 of the OCR HIPAA Audit Program Already Underway

On March 21, 2016, the Department of Health and Human Services, Office for Civil Rights (OCR) announced the launch of the long-awaited Phase 2 HIPAA Audit Program (Phase 2), and OCR activities related to Phase 2 are already...more

Hello Insurers – Court says CGL may Cover Privacy Breaches Occurring Prior to 2014

In April 2013, Glens Falls Hospital admitted that the medical records for more than 2,300 of its patients were stored for several months on an unprotected computer server. The hospital’s outside records contractor, Portal...more

FTC Settles Monopolization Charges Stemming from Contract Exclusivity Terms Used by First-to-Market Medical Polymer Maker

The mere possession of monopoly power does not violate federal antitrust laws. The laws only address the anticompetitive acquisition, maintenance, or abuse of that power. The Federal Trade Commission (“FTC”) entered into a...more

New HIPAA Phase 2 Audits: Targets Notified by Email Only

The U.S. Department of Health and Human Services Office for Civil Rights (OCR) recently announced the long-awaited launch of Phase 2 of its HIPAA Audit Program (Phase 2 Audits). The Phase 2 Audits will review the policies...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

Keeping Coverage Online: Fourth Circuit Confirms Internet Data Breach Claim Triggers Commercial General Liability Policies

In a clear rejection of insurers’ attempts to artificially narrow the broad coverage provided by commercial general liability (“CGL”) policies, the United States Court of Appeals for the Fourth Circuit recently held that an...more

AGG Food and Drug Newsletter - April 2016

Arnall Golden Gregory LLP's (AGG) Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s...more

OCR issues audit protocol and targets over 800 entities—business associates too

The Office for Civil Rights (OCR) has issued its revamped audit protocol for its second phase of auditing covered entities and business associates’ compliance with the HIPAA Privacy, Security and Breach Notification Rules....more

Alert on Ransomware Attacks and Prevention

Imagine entering your office, sitting down with a cup of coffee, and going through the routine task of logging on to your computer to review your emails and schedule for the day. Except this time, there is a problem. A...more

When a Published Data Breach is a Covered Data Breach

Can an inadvertent Internet posting of a patient’s medical information trigger insurance coverage for liability stemming from a data-breach class action? The Fourth Circuit held last week that it can, and it added to the...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

FCC Proposed Rule Will Change Business Data Services (Also Known as Special Access) Marketplace

Public and Private Agencies' Rates Could Be Impacted - The FCC is expected to issue a Further Notice of Proposed Rulemaking on April 28 that will rewrite the rules that protect local governments, public agencies and...more

Fourth Circuit Finds Potential Coverage For Data Leak As Publication Under CGL Policy

This week, a Fourth Circuit panel in an unpublished decision validated arguments long made by policyholders: that commercial general liability policies may provide coverage for certain data breach liabilities. In this case,...more

HIPAA Audits Coming Your Way – Are You Ready?

The Office of Civil Rights (OCR) of the Department of Health and Human Services has begun Phase 2 of its audit program under the Health Insurance Portability and Accountability Act (HIPAA). In this phase, OCR will: -...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

Indiana Medical Device Manufacturer’s Deferred Prosecution Agreement with DOJ Extended for a Second Time

On March 25, an Indiana-based medical device manufacturer announced that the deferred prosecution agreement it entered into with the DOJ to settle FCPA charges in 2012 would be extended a second time. The company reported...more

Pharmaceutical Company Settles with SEC Regarding FCPA Offenses in China

On March 23, the SEC announced that it settled FCPA allegations with a Switzerland-based pharmaceutical company, via a cease and desist order finding that the company violated the FCPA’s book and records and internal controls...more

HIPAA Phase 2 Audits Begin: What Are The Risks?

On March 21st, OCR1 commenced Phase 2 of its HIPAA2 Audit Program. OCR will audit health plans, hospitals, physician groups and other healthcare entities for compliance with HIPAA’s Privacy, Security and Breach Notification...more

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