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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

Fourth Circuit Upholds Coverage Under CGL Policy for Data Breach Claims

The United States Court of Appeals for the Fourth Circuit (“Fourth Circuit”) recently concluded that an insurer had a duty to defend a health care company that was sued by individuals whose personal health information was...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

Insurer Must Defend Data Breach Claim Under Traditional Commercial General Liability Policies

On April 11, 2016, the U.S. Court of Appeals for the Fourth Circuit affirmed a ruling by Judge Gerald Bruce Lee of the U.S. District Court for the Eastern District of Virginia that Travelers Indemnity Company of America...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

Good News for Corporate Policy Holders: Court Finds Cyber Coverage Under Standard Liability Policy

Corporate policy holders received good news on April 11 when the U.S. Court of Appeals for the Fourth Circuit issued its opinion in the case captioned: The Travelers Indemnity Company of America v. Portal Healthcare...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

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

Fiduciary Regulation and How Recent Cybersecurity Government Publications Impact HIPAA Security Compliance and the New Audit...

Fiduciary Regulation - The Office of Management and Budget released the final Fiduciary or Conflict of Interest regulation and related prohibited transaction exemption modifications from its review today. The next...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

Seven-Figure Settlement Reinforces Necessity of Business Associate Agreements

On March 16, 2016, the U.S. Department of Health and Human Services, Office for Civil Rights (“OCR”) announced that North Memorial Health Care of Minnesota (“Memorial”) agreed to pay $1.55 million to resolve allegations that...more

AGG Food and Drug Newsletter - March 2016

Arnall Golden Gregory LLP's 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 Washington, DC...more

Don’t Neglect Your Business Associate Agreements!

As we have repeatedly emphasized on this blog, HIPAA Covered Entities must ensure that they have compliant business associate agreements (“BAAs”) in place with all of their business associates and must ensure that they have...more

New EU/US Privacy Shield Details Announced Program Includes Provisions for Pharmaceutical and Medical Products

On February 29th, the European Commission (the “Commission”) published the details of the new EU/US Privacy Shield program (“Privacy Shield”) which is intended to replace the EU/US Safe Harbor (“Safe Harbor”) program that was...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

Four Questions to Ask before Disclosing (or Withholding) PHI in Transaction Due Diligence

HIPAA’s restrictions on the use or disclosure of protected health information (“PHI”) by a covered entity or business associate may be familiar to many in healthcare. Also familiar may be the exception that allows covered...more

2015 – The Health Law Year in Review

With 2015 in the books, we are pleased to reflect on some of the major developments over the past year in the field of health law. The year was marked by changes in Medicare payment models—from government pronouncements...more

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