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Regulatory law

Court Rules Federal Law Bars State Ban on Pain Drug

A federal judge ruled that a Massachusetts state ban on the sale of prescription painkiller Zohydro violates federal law, Reuters reports. Governor Deval Patrick had banned the drug when declaring a public health emergency about the abuse of opoids in his state. But Judge Rya Zobel ruled that the ban interferes with the Food and Drug Administration's "constitutionally mandated" regulatory authority, Reuters also reports.

FDA Hints At Space for Innovation in Regulating Health IT

Information technology is changing health care. Federal regulators are looking to draft rules to protect patient safety in this new landscape.

The Food and Drug Administration is trying to draw up a framework for the FDA, the Federal Communications Commission and the Office of the National Coordinator for Health Information Technology to regulate information technology related to medical devices, electronic health records, and other health IT, the Washington Post reports.

The recent report on the plan is out for public comment and "signals that the FDA might pursue a loose regulatory framework for some elements of health-care IT, allowing technologists to innovate without being burdened by federal oversight, said Gartner analyst Wes Rishel," the Post further reports.

Feds Seek to Hold Business Owner Personally Liable For Consumer Recall

Craig Zucker founded Buckyballs, a desk toy of small magnets that can be stacked into infinite shapes. But "perhaps more than 1,000" kids have swallowed the magnets and needed to undergo surgery, The Washington Post reports. Now the Consumer Product Safety Commission is seeking to hold Zucker personally liable for the $57 million recall because he dissolved his business, The Post further reports: "The commission supported that move with a legal precedent known as the Park doctrine, which allows the government to criminally prosecute corporate officers for failing to prevent violations of the Food, Drug and Cosmetic Act."

Final Regulatory Rule Issued For Electronic Health Records

The Inspector General of the U.S. Department of Health & Human Services has issued final safe-harbor regulations for payments and business practices related to electronic health records. Some of these payments and practices would otherwise implicate the federal anti-kickback statute. EHR Intelligence reports that federal regulators have extended the safe harbor until Dec. 31, 2021, with three goals: to incentivize the adoption of EHRs, align the date on which the safe harbor will sunset along with the ending of incentives for the meaningful use of such EHRs, and to provide protection against “'foreseeable future fraud risks.'”

China Tightens Consumer Safety Rules

Even as China's economy continues to thrive, issues with consumer safety have arisen not only with products sold abroad in the United States but domestically. In a promising sign that the rule of law is catching up to China's economic growth, Chinese consumer safety rules have been tightened. The changes, Reuters reported, "increase consumer powers, add rules for the booming Internet shopping sector and stiffen punishments for businesses that mislead shoppers."

Case Sets Up Conflict Between American Indian Sovereignty and Fair Lending

A federal judge in New York has ruled the state's banking regulator can control the lending done to New York consumers by online lenders associated with sovereign American Indian tribes, the Washington Post reports. Loans are made by the lenders that violate state law, including on maximum interest rates. "Once states began introducing interest rate caps, some ... lenders began forging relationships with Native American groups to take advantage of their sovereign-nation status," the Post reports. The tribal plaintiffs argued the ruling undermines their sovereignty and their ability to be economically self-sufficient, the Post also reports.

Despite Mental Health Parity, Insurers Still Deny Coverage

The Mental Health Parity and Addiction Equity Act of 2008 was supposed to ensure mental-health treatment and addiction-treatment services get the same coverage from insurers as physical ailments. "But five years after President George W. Bush signed the law, there is widespread agreement that it has fallen short of its goal of creating parity for mental health coverage," the New York Times reports. One of the issues is regulations to put meat on the bones of the statute have never been written by federal regulators. 


First South-Asian American Becomes Federal Appellate Judge

When Sri Srinivasan was sworn in as a judge on the U.S. Court of Appeals for the District of Columbia Circuit Thursday, he became the first South-Asian American to sit as a federal appellate judge, the Washington Post reports. He may even become a future U.S. Supreme Court nominee: he "joins a court that is often referred to as the nation’s second-highest court because of its rulings on regulatory and separation-of-powers issues. In addition, four of the Supreme Court’s nine justices served on the D.C. Circuit," the Washington Post also reported.

FAA To Relax Rules On Use of Electronics On Airplanes?

Remember that scene in West Wing in which Toby Ziegler wanted to use his cell phone while in the air on a commercial passenger jet? Well, he still wouldn't be able to make a cell phone call, but he could read his e-book, listen to a podcast or watch a video. The New York Times reports an advisory panel to the Federal Aviation Authority is expected to make such a proposal soon. "The guidelines are expected to allow reading e-books or other publications, listening to podcasts, and watching videos, according to several of the panel’s members who requested anonymity because they could not comment on the recommendations," according to the report. "The ban on making phone calls, as well as sending and receiving e-mails and text messages or using Wi-Fi, is expected to remain in place, the panel members said."

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