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Key Issues Facing Places of Public Accommodation at the 25th Anniversary of the ADA

With all of the presents, decorations, and champagne now firmly in the rearview mirror, January is a time customarily spent reflecting on the year that was and planning for the year ahead. For places of public accommodation,...more

Nothin’ from Nothin’ Leaves Nothin’

Axiom Worldwide Inc. v. Excite Medical Corp. et al. - The U.S. Court of Appeals for the Eleventh Circuit affirmed a district court’s $1.32 million judgment in favor of a medical device maker, ruling that it never owned...more

Cybersecurity Resolutions for the New Year

In this presentation: - Why cybersecurity matters - Recently-implemented cybersecurity rules and laws - Rapid reporting of cyber incidents and additional cybersecurity measures coming soon -...more

Healthcare & Life Sciences Private Equity Deal Tracker: Vascular Dynamics Secures $17 Million in Financing

Vascular Dynamics, headquartered in Mountain View, Calif., provides minimally invasive solutions for the treatment of refractive or resistant hypertension....more

IT Maintenance Crucial for HIPAA Compliance

The Department of Health and Human Services' (HHS) Office for Civil Rights (OCR) recently announced an agreement with a medical center to settle charges stemming from the center’s failure to prevent malware from infecting its...more

Blog: FDA Releases List of FY 2015 of Guidance Priorities

On January 9th, the Food and Drug Administration (FDA) released lists of final and draft guidance documents they intend to publish in Fiscal Year 2015. This guidance is a first for the FDA and comes as a product of...more

Digital Health Investors Catch Their Breath in November

Digital health investors seem to have taken a step back to catch their breath in November after 10 months of record-breaking activity. There were only 6 investments in November of $10 million or more and only one for more...more

New Colorado Durable Medical Equipment Supplier License Requirements Become Effective 12-31-14

Effective December 31, 2014, durable medical equipment (DME) suppliers that do business in the State of Colorado will be required to have a license from the Colorado Secretary of State. In addition, as part of the license...more

Failure to take basic security measures may result in HIPAA penalties – 6 tips to keep up with updates and patches

Covered Entities and their Business Associates must comply with HIPAA’s Security Rule, or they may face substantial penalties. The Office of Civil Rights (OCR) recently shared a resolution agreement that emphasizes the...more

Medical Billing Provider and its Former CEO Settle FTC Charges That They Misled Consumers About Collection of Personal Health Data

In an age when many of us briskly scroll through website terms and conditions and check, “I agree” without thinking, how should businesses design their websites to obtain proper authorization to access users’ sensitive...more

Survey Says Sharing Information is Crucial in a Volatile Data Security Environment

Information sharing allows for better insight into existing threats and vulnerabilities and alerts organizations to the existence of important data that can help prevent cyberattacks and mitigate the effects of ongoing...more

Blog: Cyberthieves Collect Confidential Information, Apparently To Conduct Insider Trading

Here is an unnerving warning from FireEye, a cybersecurity firm, discussed in this article from MarketWatch, regarding a sophisticated, native-English-speaking group, designated FIN4, that has targeted almost 100 public...more

China Issues Draft Guidance on Multi-Regional Clinical Trials

On November 21, 2014, China Food and Drug Administration (“CFDA”) released a Draft Guidance on Multi-Regional Clinical Trials (Provisional) (“Guidance”) for public comments through December 21. The Guidance aims to set forth...more

Proposed Mega Rule Abandoned Under the 340B program

In very broad terms, the 340B program allows some safety-net health care providers to provide qualifying patients with affordable prescription drugs. In January, the Office of Pharmacy Affairs (OPA) of the Health Resources...more

Health Insurer Antitrust Claim Against Drug Company Remanded to State Court

Over the last several years, several health insurers have brought antitrust claims against drug companies, contending that they were overcharged for drugs as a result of agreements reached by the drug companies in the...more

The Medical Device Tax in the Wake of 2014 Midterm Elections

Repeal of the medical device tax has seen frequent news coverage since the tax’s enactment in 2010 as part of the Affordable Care Act. The tax, which went into effect in January, 2013, imposes a 2.3% sales tax on a range of...more

Africa Update - October 2014 #5

In This Issue: - Leading the News - United States – Africa Relations - North Africa - East Africa - West Africa - Sub-Saharan Africa - General Africa News - Excerpt from...more

California Attorney General Releases Breach Report with Key Findings and Recommendations for Retailers, Financial Institutions and...

California Attorney General Kamala D. Harris has released a “California Data Breach Report,” which presents a series of findings and recommendations based on a review of breaches reported to the Attorney General’s office in...more

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

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