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Washington Amends its State Data Breach Notification Law

On April 13, the Washington State Senate unanimously passed an amendment to the state’s data breach notification law. The amendment, which was requested by Washington Attorney General Bob Ferguson, and which we discussed in...more

SEC Secures Victory on Fraud Allegations Against Technology Executive

The US District Court for the District of Columbia took the unusual step of granting summary judgment against a technology company executive who the Securities and Exchange Commission accused of various violations of the...more

Assuring Regulatory Compliance Doesn’t Get Lost in Translation

With the expansion of large multinational corporations into developing countries such as Russia, Brazil, India, Mexico and China, a proliferation of global regulatory enforcement actions, including anti-bribery and...more

Prosecutors Strike Gold in Retailers’ Dumpsters with Hazardous Waste Enforcement Action

Retailers should implement hazardous waste management plans, even for simple consumer goods, as California, New York and other states launch aggressive enforcement campaigns. In recent years, California prosecutors...more

Orthofix secures option to acquire eNeura for $65 million

On March 31, 2015, Orthofix International N.V. announced it entered into an 18-month option agreement to acquire eNeura, Inc. Orthofix’s website states that the focus of the company is on “improving patients’ lives by...more

Denied Again: FDA Denies Amgen’s Citizen Petition Requesting Certification of Compliance with BPCIA Patent Dance

As discussed previously in Next Steps in the Dance: Amgen Files Citizen Petition at FDA Requesting Mandatory Compliance with BPCIA Patent Procedures, Amgen Inc. (“Amgen”) filed a Citizen Petition with the FDA requesting that...more

The SEC and the Pharmaceutical Industry - Recent Commentary by the SEC's Enforcement Director Identifies Areas of SEC Focus...

Recently, the United States Securities and Exchange Commission’s (“SEC”) Enforcement Director, Andrew Ceresney (“Ceresney”), spoke to pharmaceutical compliance personnel at the CBI’s Annual Pharmaceutical Compliance Congress...more

NAIC Amps Up Cybersecurity Oversight

The NAIC has begun its efforts to amp up state insurance department oversight of cybersecurity practices with the release of two documents for public comment. The first, entitled Principles for Effective Cybersecurity...more

New FDA Guidance Opens the Door for Electronic Consent Forms That Come with Significant Advantages and Raise Privacy and Secure...

On March 9, 2015, the U.S. Food and Drug Administration (FDA) published a draft guidance that allows for the use of electronic informed consent (eIC) in human clinical trials. eICs have the potential to...more

Going Paperless: FDA Releases Draft Guidelines to Digitize Clinical Trials

The FDA released draft guidelines (“Guidelines”) on Monday, March 9, 2015 establishing recommendations on the use of e-media and processes to obtain informed consent for clinical investigations (trials) of medical products...more

Another Good Reason to Pay Heed to Cyber Security

For many companies, the prospect of a dreadful, costly and reputation-damaging cyber-attack and data breach is all the motivation they need to assess and improve their cyber security and data protection posture RIGHT NOW. ...more

Privacy commissioner to audit 21 privacy policies for compliance: it may be you!

The Australian Privacy Commissioner (Commissioner) is preparing to conduct an assessment of 21 online privacy policies at random. The Commissioner also noted: "[we've] been talking for a long time about the need to build...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

How Does Your Firm Compare? Results from the SEC’s Cybersecurity Examinations

On Feb. 3, 2015, the Securities and Exchange Commission (SEC) published a Risk Alert summarizing observations gleaned from a cybersecurity examination sweep of 57 registered broker-dealers (BDs) and 49 registered investment...more

In Case You Missed It - Interesting Items for Corporate Counsel - February 2015

It’s still the case that commentators have said nothing revelationary about “proxy access ,” the recent private-ordering push, and the SEC’s flip-floppery on its Whole Foods no-action letter. “Proxy access” is short hand for...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

UK's Information Commissioner's Office Enters Corrective Action Agreement With Shoe Retailer For Data Breach

On January 19, 2015, the United Kingdom’s Information Commissioner’s Office (“ICO”) — an independent UK body created to uphold information rights — published a corrective action agreement with shoe retailer Office Holdings...more

SEC Charges Chilean Citizens With Insider Trading Concerning Tender Offer for Chilean

The Securities and Exchange Commission recently filed suit in the US District Court for the Southern District of New York, alleging that defendants, Juan Cruz Bilbao Hormaeche and Thomas Andres Hurtado Rourke, both Chilean...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

Marriott Fined $600,000 For Wi-Fi Jamming

On October 3, 2014, Marriott International entered into a consent decree with the Federal Communications Commission (FCC) where Marriott agreed to pay a $600,000 fine for jamming conference guests' Wi-Fi hotspots at the...more

SEC Fines Virtual Currency Operator For Alleged Registration Violations

On December 8, the SEC fined a computer programmer $68,387.07 for operating two separate online exchanges that traded securities using virtual currency without registering the businesses as broker dealers. Further, the SEC...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

Nevada Secretary Of State Denies Hacking Claim

Recently, Cytta Corp., a small Nevada corporation, filed this Form 8-K reporting that it had “discovered that it was the victim of an online hacking incident on October 30th, 2014 in that, unauthorized person or persons...more

The SEC and the DMV

“The SEC Should Copy the DMV” is the title of an article published in the New York Times by Joseph S. Fichera recently. The article focuses on the use of corporate fines, questioning whether they are effective: “The SEC and...more

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