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|FDA Issues Draft Guidance Aimed at Reducing Oversight of Low Risk General Wellness Products and Medical Device Accessories|
Evan C. Holden, Victoria Davis Lockard; Greenberg Traurig, LLP;
February 27, 2015, previously published on February 6, 2015On Jan. 20, 2015, the U.S. Food & Drug Administration (FDA) issued two anticipated draft guidance documents proposing reduced FDA oversight of two types of products: low risk general wellness products and medical device accessories. The guidances are intended to provide clarity to industry and...
|Low Testosterone Medication May Raise Chance of Serious Health Problems|
Brayton Purcell LLP;
February 27, 2015Men who take prescription medication to raise their testosterone levels also may be raising their risk of other serious health problems. Research studies and professional opinions are amassing that support the conclusion that low testosterone medicines are dangerous, and hundreds of lawsuits have...
|Flus, Pandemics, Paranoia and Common Sense|
Howard A. Mavity; Fisher & Phillips LLP;
February 27, 2015, previously published on January 5, 2015I recently read a fictional account of a 1918 flu-like pandemic which shut down basic services for an extended period. I come from a less conspiratorial perspective, but the Annapolis grad author raised some valid points and painted an all too vivid picture of how badly people might behave.
|Getting the Deal Through: Life Sciences 2015|
Rose Marie M. King-Dominguez, Carlos Roberto Z. Lopez; SyCip Salazar Hernandez & Gatmaitan;
February 27, 2015Download a free copy of the Philippine section of Getting the Deal Through: Life Sciences 2015, which was contributed by SyCipLaw partners Rose Marie M. King-Dominguez and Carlos Roberto Z. Lopez with senior associate John Paul V. de Leon and associate Mark Xavier D. Oyales.
|Preparing for a Data Breach - What to Know about Breach Notification|
Kelsey S. Farbotko; Williams Mullen;
February 27, 2015, previously published on February 13, 2015Data breaches are at the forefront of the news, and many companies, including those dominant in the health care industry, have found themselves front and center in the headlines. Although recent news stories have focused their attention on attacks on major, nationwide companies resulting in massive...
|FTC v. St. Luke's Health System, Ltd.: Ninth Circuit Holds that Acquisition of Physician Group Practice Violates Antitrust Laws, Requires Divestiture|
Peter M. Boyle, Christina E. Fahmy, Cybil Roehrenbeck Gregory; Kilpatrick Townsend Stockton LLP;
February 26, 2015, previously published on February 11, 2015 On February 10, 2015, the Ninth Circuit affirmed a district court ruling in favor of the Federal Trade Commission that the acquisition of an Idaho physician group practice by St. Luke’s Health System violated the antitrust laws, specifically Section 7 of the Clayton Act. Closely watched by...
|Hospital Liability for Employee HIPAA Breaches|
Breazeale Sachse Wilson L.L.P.;
February 26, 2015, previously published on February 13, 2015A hospital employee, who has been “HIPAA-trained” and admits to knowing better, accesses his ex-wife’s new boyfriend’s medical records and posts sensitive information on social media. Is the hospital liable for the employee’s actions?
|Healthcare Employer Lands in Patient-Privacy Predicament|
Sally F. Barron; Fisher & Phillips LLP;
February 26, 2015, previously published on February 2, 2015Healthcare providers are required by law to maintain the privacy of most patient information, and there are good business reasons for medical practices to protect patients’ personal information. In a recent case, a medical practice group found itself unwittingly having to disclose what it...
|Data Breaches Come in Many Forms|
Dennis P. Kennedy; Dressman Benzinger LaVelle psc;
February 26, 2015Reports of data breaches are appearing in the media at an alarming rate. No one industry is safe from cyber attacks. In fact, recent attacks have been made against financial institutions, retail outlets, and health insurance companies. Most recently, Anthem announced a data breach affecting more...
|Clean-Uniform Policy May Lead to Additional Pay|
Fisher Phillips LLP;
February 26, 2015, previously published on February 2, 2015Most healthcare employers require employees to wear some sort of uniform. Of course, the most familiar uniforms in this setting are “scrubs,” but some employers require lab coats or other garments.