Administrative Agency Science, Computers & Technology

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Annual Compensations Must Be Posted by Local Government Agencies in California

Law That Takes Effect Jan. 1 Requires Sharing Public Employee Pay Information Online - Starting Jan. 1, local public agencies will be required to post information on the annual compensation of their elected officials,...more

Counties Seek To Implement Drug Disposal Ordinances

The Northern California County of Alameda has apparently begun to seek payment from select pharmaceutical manufacturers pursuant to the Alameda County Safe Drug Disposal Ordinance (Alameda County Code Chapter 6.53, §§...more

President Obama Signs Several Bills Aimed at Cybersecurity

On December 18, 2014, President Barack Obama signed several significant cybersecurity bills into law. These bills include the Federal Information Security Modernization Act, the Border Patrol Agent Pay Reform Act, the...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

Congress Confirms NIST’s Role in Cybersecurity – and the Continuation of the Cybersecurity Framework

The Cybersecurity Enhancement Act of 2014 (CEA) was passed by the House and the Senate on December 11th, and signed by the President on the 18th. The bill formalizes the role of the National Institute for Standards and...more

Congress Passes the National Cybersecurity Protection Act: Codifies National Cybersecurity Center & Creates Federal Agency Data...

The National Cybersecurity Protection Act of 2014 (NCPA) was passed by the House on December 8th, by the Senate on December 10th, and signed by the President on December 18th. Senate Committee on Homeland Security and...more

Before Driverless Cars, Questions

Although it is unclear when autonomous vehicles will be hitting the roads, what is clear is that this technology is coming. Automakers to suppliers to lawmakers to insurers will want to carefully consider the following issues...more

Cybersecurity Legislation Focuses on Federal Government Initiatives – Leaves Private Sector Reforms for 2015

One of the few things the parties in Congress can agree upon these days is cybersecurity – at least when it comes to directing the federal government’s cyber activities. In its final days, the 113th Congress reached agreement...more

Congress Passes The Federal Information Security Modernization Act of 2014: Bringing Federal Agency Information Security into the...

The Federal Information Security Modernization Act of 2014 (FISMA) was passed by the Senate on December 8th, by the House on December 10th, and by the President on December 18th. It is a comprehensive bill intended to bring...more

Blog: No More Paper PIs? FDA Issues Proposed Rule on Electronic Distribution of Prescribing Information

Yesterday, the U.S. Food and Drug Administration (FDA) announced a proposed rule to require electronic distribution of the prescribing information intended for health care professionals (often called the “PI”) for human...more

FDA Science Chief Reports Quicker Medical Device Clinical Trial Approvals

In a speech in Cambridge on December 11, 2014 (which was reported on in an article in the Boston Business Journal), Dr. Bill Maisel- the science chief of the U.S. Food and Drug Administration’s center to oversee approval of...more

FDA Issues Guidance on “Patient Counseling Information”

The Food and Drug Administration (FDA) has released new Guidance to assist in developing the “Patient Counseling Information” section of labeling required under § 201.57(c)(18) of the “Physician Labeling Rule.” See 21 C.F.R....more

Advertising Law - December 2014 #2

Uber’s Privacy Mess Results in Legislative Inquiry - Providing a lesson in how not to handle a privacy policy, car service app Uber is now facing questions from the Senate Subcommittee on Privacy, Technology and the...more

DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished Prescription Drugs: How to...

On December 8, 2014, FDA issued new guidance, “DSCSA Implementation: Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers”. As the title suggests, the Guidance is part of FDA’s...more

FDA Issues Guidance on Registration, Fees and Reporting Requirements for Drug Compounding Outsourcing Facilities

On November 21, 2014, the U.S. Food and Drug Administration (FDA) announced the release of three new guidance documents related to drug compounding outsourcing facilities. These documents include...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

NIH Issues Proposed Rule Expanding Clinical Trial Registration and Reporting Obligations

On November 21, 2014, the National Institutes of Health (“NIH”) published a notice of proposed rulemaking regarding requirements for clinical trial registration and the reporting of results (“Notice” or “Proposed Rule”)....more

What’s Next for the FDA’s Draft Social Media Guidances?

As many of our life sciences clients know, 2014 brought long-awaited draft guidance documents from the FDA regarding three social media-related topics of interest. The FDA provided its much-anticipated views on...more

Technology may reduce fraud but doesn’t fix regulatory confusion

President Barack Obama recently announced the administrtion’s BuySecure initiative. At a meeting at the Consumer Financial Protection Bureau Oct. 17, the president outlined the program, aimed at increasing the security of...more

Inspector General’s Report Criticizes the Department of Homeland Security for Inadequate Privacy Policies and Controls

On November 14, 2014, the Office of Inspector General (OIG) for the Department of Homeland Security (DHS) issued a report critical of the agency’s performance in protecting personally identifiable information (PII) and...more

TSCA Reform a Viable Contender For Serious Legislative Attention Next Year

I have been asked to say a few words about 2015 legislative expectations regarding environmental laws, particularly and most likely with respect to reform of the Toxic Substances Control Act (TSCA). In my view, TSCA reform is...more

Do-Gooders Won’t Take “No” For An Answer

About a month ago we posted an article on the dismissal of Consumer Watchdog’s appeal at the Court of Appeals for the Federal Circuit following a loss at the USPTO in an inter partes reexamination. Consumer Watchdog, Inc. had...more

FDA Updates Manual on Review of INDs Seeking Exception from Informed Consent for Emergency Research under 21 C.F.R. § 50.24

On November 17, 2014, the U.S. Food and Drug Administration (FDA) published a revised version of its internal review procedures and policies for Investigational New Drug applications (INDs) that implicate the exception to the...more

FDA Report on Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS)

The U.S. Food and Drug Administration (FDA) recently published a report titled "Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (REMS)," which summarizes stakeholder engagements completed in fiscal year...more

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