Science, Computers & Technology General Business Health

Read Science, Computers & Technology updates, news, alerts, and legal analysis from leading lawyers and law firms:
News & Analysis as of

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China Issues Draft Guidance on Multi-Regional Clinical Trials

On November 21, 2014, China Food and Drug Administration (“CFDA”) released a Draft Guidance on Multi-Regional Clinical Trials (Provisional) (“Guidance”) for public comments through December 21.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

FDA Publishes Second Draft Guidance for Further Clarification of Drug Supply Chain Security Act

Earlier this year, the U.S. Food and Drug Administration (FDA) requested information and commentary for the implementation of the Drug Supply Chain Security Act (DSCSA) that in part "establishes a Federal system for tracing...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

FDA's Final Guidance on Determination of Five-Year NCE Exclusivity for Certain Fixed-Combination Drug Products Under Federal FDCA

The U.S. Food and Drug Administration (FDA) recently published its final Guidance for Industry detailing circumstances under which a fixed-combination drug product (FCD) may be entitled to five-year new chemical entity (NCE)...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

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

436 Results
|
View per page
Page: of 18

Follow Science, Computers & Technology Updates on: