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Do You Really Know Your China Telemedicine Partners? China Anti-Corruption Effort Focuses on Major Medical Institutions

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

HIPAA and “Meaningful Use” Audits: Issues to Consider and How to Prepare

As more and more providers adopt electronic health records (“EHRs”) systems (and with new regulations concerning their required use for purposes of Medicare billing for chronic care management, their popularity can only...more

The U.S. Complaint Against the Government of China in the WTO, Including the Targeting of Chinese Medical Device Manufacturers

On February 11, 2015, the United States filed a complaint before the World Trade Organization (WTO), alleging that certain actions by the national, regional and local governments of the People’s Republic of China are in...more

Blog: Vermont AG Announces Another Disclosure Law Enforcement Action

the Vermont Office of the Attorney General (“VT AG”) previously published several enforcement actions taken against manufacturers of pharmaceutical, biological and medical devices for failing to comply with the state’s...more

Blog: Congress Eyes Pharmaceutical Company Settlement Agreements as Source for Additional FDA & NIH Funding

Senator Elizabeth Warren (D-MA) recently introduced legislation that, if passed, would require certain pharmaceutical companies that enter into settlement agreements with the Department of Justice or other governmental...more

FDA Issues Draft Guidance on Medical Device Accessories

On January 20, 2015, the U.S. Food and Drug Administration (FDA) issued a draft guidance document titled Medical Device Accessories: Defining Accessories and Classification Pathway for New Accessory Types (January 20, 2015)...more

8 Things Healthcare Providers Should Know About E-Signatures

Electronic signatures can be legally valid to execute documents that require written signatures, and electronic documents can be legally valid when applicable laws require documents to be in writing....more

Anti-Kickback and Stark Law: Pitfalls and Problems

When you think your life is tough in the FCPA compliance arena, just remember you could be head of compliance for a pharmaceutical company or hospital responsible for domestic anti-kickback and Stark law compliance....more

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

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