PUBLIC JUSTICE - The U.S. Chamber of Commerce, one of the country’s largest corporate lobbying organizations, wants American consumers to believe that it has their best interests at heart. This is a myth.
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Law Firms Behind the Curve on Data Security($)
In 2009, the Federal Bureau of Investigation (FBI) first warned that law firms were the targets of hackers. The agency repeated the warning in 2013 with the special agent in charge of cyber and special operations for the FBI’s New York Office saying, “We have hundreds of law firms that we see increasingly being targeted by hackers.”
This should not come as a surprise. Law firms have a wide range of types of valuable information from the identities of targets of takeovers to corporate financial information to trade secrets to embarrassing details of the lives of client. There is a ready and eager market for this information, and it easily can end up in the hands of unscrupulous opposing counsel, business competitors or a foreign competitor.
Further, there are now a number of ABA Model Rules of Professional Conduct that speak to a lawyer’s ethical cybersecurity duty. Under the Model Rules lawyer are required “to make reasonable efforts to prevent the inadvertent or unauthorized disclosure of, or unauthorized access to, information relating to the representation of a client.” Model Rule 1.6(c).
In turn, “reasonable efforts” may include taking steps to prevent someone from hacking into a law firm’s computer network or a staff posting client information on the Internet. Comment [16] to Model Rule 1.6(c). Further, Comment [17] now states: “Whether a lawyer may be required to take additional steps in order to comply with other law, such as state and federal laws that govern data privacy, is beyond the scope of these rules.” Thus, a lawyer must also consider duties arising under HIPAA, for example, and other laws intended to protect data privacy. Finally, ignorance of technology is not a defense to an ethical violation: Comment [6] to Rule 1.1 (Competence) provides lawyers must “stay abreast of changes in the law and its practice, [and] need to have a basic understanding of the benefits and risks of relevant technology.”
Yet, despite all this, many law firms and lawyers still are not doing enough.
Forbes: ‘What Ted Cruz Gets Wrong About The FDA: Tough Regulation Can Spark Innovation’
Republican presidential hopeful Senator Ted Cruz laid out a plan to fix the Food and Drug Administration in The National Review, a conservative weekly. “We need to tear down the barriers blocking a new era of medical innovation, and the primary inhibitor is the government itself.”
Cruz’s main example that the FDA is being too tough? A multiple sclerosis drug called Lemtrada, developed by Sanofi . Cruz claimed the FDA was refusing to approve the drug because studies of the drug did not fit the agency’s “placebo testing requirements.” One problem there. When Cruz wrote his piece, Lemtrada had been approved for an entire year. That error didn’t keep Cruz from introducing a bill that would force the FDA to honor approvals made by regulators in Europe or Japan.
In reality, the FDA is approving 9 of 10 new drug applications that are filed. Drugs for serious diseases are making it from test tubes to the market faster than ever before. What Cruz, and most FDA critics, miss is that there is a delicate balance to what the FDA does. True, tough regulations stifle innovation, keeping innovators from even trying. But they also can spark it, setting the bar high enough that patients get the effective drugs they want and need–the ones that will save their lives.
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Does Off-Label Promotion Settlement Signal Change in FDA Policy?
FIERCE PHARMA - Amarin has won the FDA's blessing to push their products for unapproved uses if it will drop its free speech lawsuit against the agency, providing the opening U.S. pharma has been looking for to market drugs for uses other than those for which they are approved.
Troubling Statistics For Large Company Data Security
While cyberattacks across industries continue to increase, many tasked with oversight of the business may be unequipped to handle breaches, one survey suggests.
Titled “C-Suite/Board Member Attitudes On Cybersecurity Culture in the Workplace,” the joint survey from cybersecurity training company CyberVista and Zogby Analytics polled board members and C-suite executives from various industries about how they prioritize cybersecurity. According to a statement by CyberVista, the survey’s findings suggested when it comes to the individuals “responsible for safeguarding companies” from cyberattacks, there appears to be “continued gaps” in their “cybersecurity education.”
“We don’t have enough people with the right technical skills,” Ron Hale, chief knowledge officer at ISACA, told Legaltech News in a recent conversation. “[Similarly], we don’t have the right people to translate technology into the business. … These are big issues. These are business issues.” s
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Petition Asks DOT to Abandon Cost-Benefit Policy for Safety In Favor of ‘Vision Zero’ Strategy
The Karth family – a Rocky Mount, North Carolina family who lost their two teenage daughters in a 2013 truck crash – will travel to Washington, D.C. Friday March 4 to deliver a Vision Zero petition with over 20,000 signatures to the Department of Transportation.
The Department of Transportation currently makes highway safety rules based on a cost benefit analysis resulting in many highway safety measures being blocked.
The petition, launched in 2015, urges Department of Transportation and the Office of Management and Budget to change that practice, and move toward a Vision Zero safety strategy model with goals of: Zero Deaths, Zero Serious Injuries, Zero Fear of Traffic.
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Will the New FDA Chief be an Industry Stooge or an Approval Process Reformer?
Everyone wants to know what Rob Califf is going to do at the FDA. His critics say he’s going to hand the car keys over to industry and allow them to drive the agenda.
On the other hand, his supporters think he’ll improve the approval process, perhaps removing some unnecessary hoops through which industry is forced to jump but also adding rigor where necessary.
The big hope is that Califf, with his extensive insider knowledge, won’t be easily surprised or fooled by industry tricks.
Senate Confirms New FDA Chief Over Objections of Ties to Pharma
The U.S. Senate voted overwhelmingly on Wednesday to confirm Dr. Robert Califf as head of the Food and Drug Administration, an agency that regulates everything from food and drugs to tobacco, cosmetics and dietary supplements.
Califf, 64, a well-regarded cardiologist and researcher, takes the helm at the FDA when lawmakers are pressuring it to speed the approval process for drugs and medical devices and to finalize a proposed rule giving it authority to regulate e-cigarettes.
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