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A Legal Guide to Privacy and Data Security

A Legal Guide to Privacy and Data Security, a new book offering guidance on a wide variety of privacy and data security laws and how those laws may impact your business, is now available from the Minnesota Department of...more

Florida Information Protection Act of 2014 Goes Into Effect; Regulator Notification Required

Effective July 1, 2014, Florida has repealed its existing data breach law in favor of a new, more stringent, law. Florida has joined the list of states requiring notice to regulators: specifically, an entity must notify the...more

Florida Information Protection Act of 2014 - Florida Means Business When It Comes to Protecting Customers' Personal Information

On June 20, 2014, Governor Rick Scott signed into law the Florida Information Protection Act of 2014 ("FIPA"), which became effective July 1, 2014. FIPA expands the obligations of businesses and government entities that...more

HIPAA Data Breaches

HIPAA has been on the books since 1996. With the advent of electronic health records, HHS adopted security regulations to require covered entities to protect the integrity, confidentiality, and availability of electronic...more

CMS Proposes Changes to Sunshine Act Reporting

Drug and device manufacturers breathing a sigh of relief after completing their 2013 data submissions under the Physician Payment Sunshine Act (the “Sunshine Act’) must now contend with four proposed changes to the Sunshine...more

New HIPAA Reports to Congress Shed Light on OCR Enforcement

The Department of Health and Human Services’ Office for Civil Rights (OCR) has issued two reports to Congress, as required by the HITECH Act. The compliance report details OCR’s enforcement activities for 2011 and 2012 and...more

New Connecticut Pharmacy Rewards Disclosure Bill Took Effect July 1

On June 12th, Connecticut governor Dannel P. Malloy signed into law ”An Act Concerning Pharmacy Rewards Programs And Protected Health Information“. The law went into effect July 1st, and applies to pharmacy retailers in the...more

OCR Annual Report Highlights Breaches Of Unsecured Protected Health Information

The Health Information Technology for Economic and Clinical Health Act ("HITECH") requires Covered Entities and Business Associates to provide notification of breaches of unsecured Protected Health Information. The Department...more

HIPAA/HITECH Business Associate Agreements: The Home Stretch

The one-year transition rule expires on September 22, 2014. The final regulations under the HIPAA Privacy, Security, and Enforcement Rules as amended by HITECH, make several changes, including modifying the...more

Anti-Kickback and Stark Law Violations Form Basis for Unfair Competition Claims

On June 16, 2014, a federal district court jury in Florida awarded $14.755 million to plaintiff Ameritox, Ltd., a Maryland-based clinical lab, for state law claims alleging tortious interference with business relationships...more

Five Lessons from OCR’s Report to Congress on Breaches and HIPAA Rules Compliance

Last week, the HHS Office of Civil Rights (OCR) released two reports required by the Health Information Technology for Economic and Clinical Health (HITECH) Act: (i) the Annual Report to Congress on Breaches of Unsecured...more

Florida Overhauls Its Data Security Breach Notification Law Effective July 1, 2014

On June 20, 2014 Governor Rick Scott approved the Florida Information Protection Act of 2014, overhauling the requirements and steps companies must follow when faced with a potential or actual security breach resulting in the...more

The Success Checklist: What mHealth Investors and Entrepreneurs Should Know

A healthcare start-up developer has an intriguing concept for an app or a software solution. It may be an app tied to a sensor that is designed to transmit a diabetic's blood glucose levels to her physician, or an app that...more

China Amends Key Medical Device Regulations

The State Council of China passed amendments to the Regulations on Supervision and Administration of Medical Devices which came into effect on June 1, 2014. The amendments present significant regulatory changes that will...more

Minnesota Federal District Court Explores Application of Corporate Practice of Medicine Doctrine to MRI Scans

On March 25, 2014, in State Farm Mutual Automobile Insurance Company v. Mobile Diagnostic Imaging, Inc., the U.S. District Court for the District of Minnesota held that a corporation not owned or controlled by physicians does...more

As Sunshine Act Reporting Deadline Looms, CMS Issues Additional Guidance

With the June 30 deadline for Phase 2 Sunshine Act reports by pharmaceutical and medical device manufacturers (“Applicable Manufacturers”) and group purchasing organizations (“GPOs’) quickly approaching, the Centers for...more

Applicable Manufacturers Face June 30th Deadline for Sunshine Act Reporting

CMS will begin to enforce what could be significant penalties on manufacturers who fail to report required data. The Centers for Medicare & Medicaid Services (CMS) has announced a short timeframe before detailed...more

IRS Ruling Addresses Application of Medical Device Excise Tax in Contract Manufacturing Arrangement

In Private Letter Ruling 201420004 (released May 16, 2014), the Internal Revenue Service (IRS) has ruled on the question of which party in a contract manufacturing arrangement is the "manufacturer" for purposes of the medical...more

Nanotech Drug Formulations Drive Dealmaking

Some of the most commercially successful products to arise out of nanotechnology in terms of sheer size of revenues generated are nanotech drug formulations. This area continues to be hot in the wake of two recent deals, both...more

Connecticut Pharmacy Rewards Program Disclosure Bill Could Cause Headaches

The Connecticut State Senate recently passed a bill that would impose additional disclosure and consent requirements on retailers offering pharmacy rewards programs to consumers. If the bill passes the Connecticut House and...more

New York AG Action Targets Out-Of-State Retail Installment Obligation Finance Companies

On April 30, New York Attorney General (AG) Eric Schneiderman announced that four out-of-state companies alleged to have financed retail installment obligations (RIOs) at rates in excess of the state’s usury cap agreed to...more

Florida Legislature Passes Stringent New Data Breach Law

On April 30, the Florida Legislature passed Senate Bill 1524, otherwise known as the Florida Information Protection Act of 2014. If signed by the governor, starting July 1, this bill will impose stringent new requirements on...more

Why Do I Need a Business Associate Agreement? Ensuring Your Business is HIPAA and HITECH Compliant

Many companies have recently begun receiving Business Associate Agreements from healthcare entities, including hospitals, clinics, physician offices, public health facilities and similar types of organizations. Business...more

The Heartbleed Bug's Impact on EHR Systems

As reported in the media, a serious vulnerability in the popular OpenSSL cryptographic software library, called the Heartbleed bug, was recently discovered. This vulnerability permits the theft of information, including...more

Health Law Insights Newsletter - April 2014

In This Issue: - Federal Updates - State Updates - HIPAA Updates - Excerpt from Centers for Medicare & Medicaid Services Issues Guidance for Meaningful Use Hardship Exception: The Centers...more

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