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NIST Issues Draft Report Enumerating Risks and Protections to Consider When Evaluating Mobile Apps for Your Enterprise

As the world recovers from the excitement leading up to Tuesday’s Apple Live Event announcement of the new iPhone 6 and Apple Watch, mobile app developers are chomping at the bit to create software that leverages the new...more

MoFo New York Tax Insights - Volume 5, Issue 9 - September 2014

In This Issue: - ALJ Upholds Denial of Sales Tax Refund Because Vendor Failed to First Make Refunds to Customers - HMO Held Exempt from New York City General Corporation Tax - State Tax Department Issues...more

Business Associate Agreements May Require Amendment

The Omnibus Final Rule (the "Omnibus Rule") under the Health Insurance Portability and Accountability Act of 1996 ("HIPAA"), was issued in January, 2013 effective March 26, 2013, but with a general compliance deadline of...more

New Data Disposal Law in Delaware Requires Action by Impacted Businesses

While the federal government continues its inaction on data security bills pending in Congress, some U.S. states have been busy at work on this issue over the summer. A new Delaware law H.B. 295, signed into law on July 1,...more

Deadline For Business Associate Agreement And Data Use Agreement Compliance Is September 22, 2014

September 22, 2014 is the deadline to have all business associate and data use agreements updated to conform to the new requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Final Omnibus...more

Community Health Systems' HIPAA Breach: Significant Lessons for Health Care and Non-Health Care Companies

On August 18, 2014, Community Health Systems, Inc. (CHS) publicly confirmed, in a filing with the Securities and Exchange Commission (CHS filing), that its computer network was attacked between April and June 2014 by hackers...more

Dark Clouds Over Sunshine Act

Once again the Obama administration has been tripped up in launching a healthcare-related online system. This time the problem concerns the Physician Payments Sunshine Act—the act that is supposed to enable the public to see...more

ANDA Preparation (with an Eye toward Approval and Litigation) and the FDA Review

As a manufacturer of generic drug products, undoubtedly one of your goals is to prepare an Abbreviated New Drug Application (ANDA) that will pass regulatory scrutiny efficiently. Your ANDA submission is a culmination of time,...more

Privacy Tuesday – August 2014

We are just two Mondays away from Labor Day, the traditional end of summer in the United States. Here are some privacy tidbits to get your week started. See especially Jake Romero’s piece on the new Delaware data...more

Levick Monthly - July 2014: DAVIS: Jeb Bush a formidable candidate

In This Issue: - COVER STORY: Davis: Jeb Bush a Formidable Candidate - CRISIS: The Real Cancer that Caused the VA Scandal - DIGITAL ENGAGEMENT: Aereo and Meltwater: The Ghost of Napsters Past - FINANCIAL: Dov...more

WEBINAR: Preparing for the HITECH September Deadline - Tips for Negotiating Effective Business Associate Agreements under HIPAA

Business Associate Agreements (BAAs), in the current regulatory and technological environment, require careful review and negotiation of the implementation of the regulatory requirements. In meeting the September 23, 2014...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

The FDA’s Informed Consent Draft Guidance: Insights and Challenges for IRBs, Clinical Investigators and Sponsors

On July 15, 2014, the FDA released a draft guidance document (“Guidance”), proposing recommendations to Institutional Review Boards (IRBs), clinical investigators and research sponsors relating to the informed consent process...more

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

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