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California Attorney General Releases 2014 Data Breach Report and Recommendations, Finding More of the Same.

On October 28, 2014, Attorney General Kamala Harris released the second annual California Data Breach Report. The report detailed the nature and scope of data breach notifications that her office received in 2013. Her office...more

Health Alert (Australia) - October 27, 2014

In This Issue: Judgments; Legislation; and Reports. Excerpt from Judgments: Queensland - 23 October 2014 - Vision Eye Institute Ltd v Kitchen & Anor [2014] QSC 260 In 2006, Kitchen sold...more

mHealth Technology – Development in an Uncertain Regulatory Climate

The development and use of mobile technologies and devices is expanding at an incredibly fast pace and is changing, and in fact revolutionizing, the way patients and healthcare providers interact. Mobile medical technologies...more

Will your errors and omissions policy pay your defense costs?

The hypothetical - HealthPayPlus (HPP) designs custom record management systems for large hospital systems. HPP developed a system for Research Hospitals of America (RHA) that HPP promised would revolutionize RHA’s...more

Introducing a New Drug Into the Marketplace in the Lifecycle of a Pre-Sales Revenue Biotechnology Venture Destined for IPO Success

Mindful that this series of articles describes biotech ventures that are ripe for initial public offerings even before launching an income-producing drug product into the commercial market, the paramount objective for all...more

Amgen Poised to Enter Biosimilars Market

As reported in Fierce Biotech earlier today, Amgen announced the results of a Phase III clinical trial of its biosimilar drug (designated ABP 501) for moderate-to-sever plaque psoriasis conducted in comparison with adalimumab...more

NIST RFI to Solicit Feedback on Cybersecurity Framework Closing: Good Opportunity to Assess Suggestions and Concerns

On Friday, October 10th, an opportunity to submit comments on a Request for Information concerning awareness and implementation of the “Framework for Improving Critical Infrastructure Cybersecurity” closes. Companies of all...more

Cliff Notes from the Joint OCR/NIST HIPAA Security Conference

As a service to our readers, we have distilled last week’s joint HHS Office of Civil Rights (OCR) and National Institute of Standards in Technology (NIST) conference, “Safeguarding Health Information: Building Assurance...more

Realizing the Potential of Telemedicine in China, Part 1: Protecting Your IP

This post is the second in Foley’s blogs on China telemedicine and the first in the blog series, “Realizing the Potential of Telemedicine in China,” meant to address top issues facing U.S. companies looking to enter the...more

Three Things Tech Titans Have That eHealth Needs

Large tech companies have been virtually lining up to announce their foray into the digital health space recently. Industry analysts have long suspected that an incumbent industry with a strong customer base could come in and...more

Medical Software Licensing - Tips from the Trenches

Medical offices are adopting complex software products such as electronic health record (EHR) systems and practice management systems in increasing numbers. While the ultimate hope is to improve patient care and practice...more

FDA Regulation of Laboratory Developed Tests on the Horizon

At a contentious hearing of the House Energy and Commerce Health Subcommittee on September 9, 2014, lawmakers and the Food and Drug Administration (FDA) clashed over proposed guidance from the FDA regarding the regulation of...more

HIPAA Omnibus Rule: Deadline Approaching to Update Grandfathered Business Associate Agreements

Although the HIPAA Omnibus Rule (the “Rule”) went into effect nearly 18 months ago, the transition period for bringing business associate agreements into compliance with the Rule’s new requirements will end on September 23,...more

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

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